Doctors & patients are saying about 'A-Fib.com'...


"A-Fib.com is a great web site for patients, that is unequaled by anything else out there."

Dr. Douglas L. Packer, MD, FHRS, Mayo Clinic, Rochester, MN

"Jill and I put you and your work in our prayers every night. What you do to help people through this [A-Fib] process is really incredible."

Jill and Steve Douglas, East Troy, WI 

“I really appreciate all the information on your website as it allows me to be a better informed patient and to know what questions to ask my EP. 

Faye Spencer, Boise, ID, April 2017

“I think your site has helped a lot of patients.”

Dr. Hugh G. Calkins, MD  Johns Hopkins,
Baltimore, MD


Doctors & patients are saying about 'Beat Your A-Fib'...


"If I had [your book] 10 years ago, it would have saved me 8 years of hell.”

Roy Salmon, Patient, A-Fib Free,
Adelaide, Australia

"This book is incredibly complete and easy-to-understand for anybody. I certainly recommend it for patients who want to know more about atrial fibrillation than what they will learn from doctors...."

Pierre Jaïs, M.D. Professor of Cardiology, Haut-Lévêque Hospital, Bordeaux, France

"Dear Steve, I saw a patient this morning with your book [in hand] and highlights throughout. She loves it and finds it very useful to help her in dealing with atrial fibrillation."

Dr. Wilber Su,
Cavanaugh Heart Center, 
Phoenix, AZ

"...masterful. You managed to combine an encyclopedic compilation of information with the simplicity of presentation that enhances the delivery of the information to the reader. This is not an easy thing to do, but you have been very, very successful at it."

Ira David Levin, heart patient, 
Rome, Italy

"Within the pages of Beat Your A-Fib, Dr. Steve Ryan, PhD, provides a comprehensive guide for persons seeking to find a cure for their Atrial Fibrillation."

Walter Kerwin, MD, Cedars-Sinai Medical Center, Los Angeles, CA


Understanding A-Fib

New Video: EKG of Actual Heart in Atrial Fibrillation

We’ve added a new video to our Library of Videos & Animations. A graphic display of actual heart in Atrial Fibrillation. How it could look to your doctor on an EKG/ECG monitor; (Your EKG may look different, but will be fast and erratic). Includes display of the changing heartbeat rate in the lower left.

For comparison, we’ve included a graphic comparing the tracing of a heart in normal sinus rhythm vs. a heart in A-Fib.

Share with you family and friends when you talk about your A-Fib. (:59 sec)  Go to video->

EKG tracing

How to Interpret an ECG Signal

A-Fib is fairly easy to diagnose using EKG. The ECG signal strip is a graphic tracing of the electrical activity of the heart.

An electrocardiogram, ECG (EKG), is a test used to measure the rate and regularity of heartbeats. To learn more, see our article, Understanding the EKG Signal.

Video: EKG of Heart in Atrial Fibrillation on Monitor

Graphic display of actual heart in Atrial Fibrillation. How it could look to your doctor on an EKG/ECG monitor; (Your EKG may look different, but will be fast and erratic). Notice the changing heartbeat rate in the lower left. Compare to normal ECG below.

Share with you family and friends when you talk about your A-Fib. (:59 sec) Posted by jason king, Published on Aug 24, 2017.

Graphic: ECG of Heart in Normal Heart Rhythm and in Atrial Fibrillation

In the case of Atrial Fibrillation, the consistent P waves are replaced by fibrillatory waves, which vary in amplitude, shape, and timing (compare the two illustrations below).

How to Interpret an ECG Signal

EKG signal components at A-Fib.com

EKG signal components

An electrocardiogram, ECG (EKG), is a test used to measure the rate and regularity of heartbeats, as well as the size and position of the chambers, the presence of any damage to the heart, and the effects of drugs or devices used to regulate the heart.

The ECG signal strip is a graphic tracing of the electrical activity of the heart. To learn more, see our article, Understanding the EKG Signal.

If you find any errors on this page, email us. Y Last updated: Friday, September 8, 2017

Return to Instructional A-Fib Videos and Animations

VIDEOS: Endoscopic Views of a Beating Heart in Atrial Fibrillation

The Left Atrium in Atrial Fibrillation

Endoscopic video of a beating heart; shows the Left Atrium during Atrial Fibrillation. Looped footage with voice-over narration. (:32 sec.) Posted by BillSchnee

YouTube video playback controls: When watching this video, you have several playback options. The following controls are located in the lower right portion of the frame: Turn on closed captions, Settings (speed/quality), Watch on YouTube website, and Enlarge video to full frame. Click an icon to select.

Amputation of the Left Atrial Appendage

Endoscopic video of a beating heart; shows placement of the Left Atrial Appendage into the jaws of the stapling device before amputation and removal (using a EZ45 linear stapler). With voice-over narration, (1:34 min.) Posted by BillSchnee.

YouTube video playback controls: When watching this video, you have several playback options. The following controls are located in the lower right portion of the frame: Turn on closed captions, Settings (speed/quality), Watch on YouTube website, and Enlarge video to full frame. Click an icon to select.


If you find any errors on this page, email us. Y Last updated: Thursday, August 31, 2017

Return to Instructional A-Fib Videos and Animations

Your Heart’s Electrical System & How Clots Form: An Introduction 

Basic introduction to how the heart works. Identifies the parts of the heart and illustrates the role of each, and shows how clots form; Detail animation of the heart processes accompanied by narration. Transcript below. (3:50 min.)

Animation from the National Heart Lung and Blood Institute.

TO PLAY VIDEO: Click the PLAY  button to start video
(The controls inside the video frame don’t work.)

Transcript of this Article

If you find any errors on this page, email us. Y Last updated: Monday, September 11, 2017

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New FAQ about Asymptomatic Long-Standing Persistent A-Fib

We’ve posted a new FAQ and answer based on an email I received from a fellow with a very challenging case of Long-standing Persistent Atrial Fibrillation:

“I am 69 years old, in permanent A-Fib for 15 years, but non-symptomatic. My left atrium is over 55mm and several cardioversions have failed. My EP won’t even try a catheter ablation. I exercise regularly and have met some self-imposed extreme goals. What more can I do?

My answer: As you may know, being in permanent (long-standing persistent) Atrial Fibrillation can cause other long term problems like fibrosis, increased risks of heart failure and dementia. So you are wise to be concerned.

I’m not surprised your electrophysiologist (EP) is reluctant about performing a catheter ablation. Being asymptomatic with 15 years of long-standing persistent A-Fib and a Left Atrium diameter of 55mm, most EPs wouldn’t recommend or perform a catheter ablation on you.

Tikosyn: generic name dofetilide at A-Fib.com

Tikosyn: (dofetilide)

Drug Therapy Option: Tikosyn

Have you tried the newer antiarrhythmic drug Tikosyn (generic name dofetilide)?

Tikosyn was designed for cases like yours. It’s a Class 1A drug that works by blocking the activity of certain electrical signals in the heart that can cause an irregular heartbeat. Read more of my answer…

Infographic: My Best A-Fib Reference Books for Patients and Their Families

On a regular basis, we search the web for the best informational reading for Atrial Fibrillation patients and their families. We recommend only up-to-date, unbiased resources. To read my description of each book, see my ‘Wish List’ on Amazon.com. (Note: Use our Amazon portal link to order your books and your purchases help support A-Fib.com.)

 

Infographic: September is Atrial Fibrillation Awareness Month

During September each year, we focus our efforts on reaching those who may have Atrial Fibrillation and don’t know it. We offer a our infographic to educate the public about this healthcare issue, along with a free promotional banner and poster.

Share it! Pin it or Download (click on link to view full size, then ‘Save As’ )

Download (600 x 1875-pix): PNG format or JPEG format. Also available: Promo banner and promo poster.

A-Fib.com A-FibFacts.info

About Atrial Fibrillation: An estimated 30%−50% of those affected with Atrial Fibrillation are unaware they have it—often only learning about their A-Fib during a routine medical exam. Of untreated patients, 35% will suffer a stroke. Half of all A-Fib-related strokes are major and disabling.

For more facts about Atrial Fibrillation, go to A-FibFacts.info or download the A-Fib Facts 5-page report.

Also available (click to enlarge, then Save As):

Promotional bannersept-is-a-fib-awareness-month-bannerPromotional poster:

sept-is-a-fib-month-orange-head-poster

 

 

 

InfoGFX: How Atrial Fibrillation Damages Your Heart, Brain and Other Organs

by Steve S. Ryan, PhD

It’s a bad idea to just live with your Atrial Fibrillation. A-Fib is a progressive disease. It reduces the amount of blood flowing to the rest of your body by about 15%–30% with damaging effects. At the same time, your heart is working progressively harder and harder.
A-Fib is progressive disease - Infographic Aug 2016

A-Fib is definitely curable. (I was cured of my A-Fib in 1998). If you have A-Fib, no matter how long you’ve had it, you should aim for a complete and permanent cure.

If your doctor is satisfied with just keeping your A-Fib “under control,” I recommend you get a second opinion.

Refer to our Finding the Right Doctor page and related readings. We step you through all you need to know to find the right doctor for you and your treatment goals.

#AtrialFibrillation #afib #Arrhythmia #AtrialTachycardia #Tachycardia

New FAQ Answered: Which Procedure Has the Best Success Rate?

We’ve answered a new FAQ under the category: Understanding Atrial Fibrillation. Thanks to Thomas Scheben for this question:

I have paroxysmal A-Fib and would like to know your opinion on which procedure has the best cure rate.

The best cure rate isn’t the only criteria you should consider when seeking your Atrial Fibrillation cure. Let me first review your top three procedure options: cardioversion, catheter ablation, and surgical Maze/Mini-Maze. 

Atrial Fibrillation is not a one-size fits all type of disease.

Electrocardioversion: When first diagnosed with Atrial Fibrillation, doctors often recommend an Electrocardioversion to get you back into normal sinus rhythm. But for most patients, their A-Fib returns within a week to a month. (However, you might be lucky like the A-Fib patient who wrote us that he was A-Fib free for 7 years after a successful cardioversion.)

Catheter Ablations: Radio-frequency and CryoBalloon catheter ablations have similar success rates 70%-85% for the first ablation, around 90% is you need a second ablation.

How to achieve these high success rates? It’s crucial you choose the right electrophysiologist (EP)…Continue to read my full answer.

FAQs Understanding A-Fib: Which Procedure Has the Best Cure Rates

 FAQs Understanding A-Fib: Best Cure Rate

FAQs Understanding Your A-Fib A-Fib.com15. “I have paroxysmal A-Fib and would like to know your opinion on which procedure has the best cure rate.”

The best cure rate isn’t the only criteria you should consider when seeking your Atrial Fibrillation cure.

Let me first review your top three procedure options: cardioversion, catheter ablation, and surgical Maze/Mini-Maze.

Electrocardioversion: When first diagnosed with Atrial Fibrillation, doctors often recommend an Electrocardioversion to get you back into normal sinus rhythm. But for most patients, their A-Fib returns within a week to a month. (However, you might be lucky like the A-Fib patient who wrote us that he was A-Fib free for 7 years after a successful cardioversion.)

Catheter Ablations: Radio-frequency and CryoBalloon catheter ablations have similar success rates 70%-85% for the first ablation, around 90% is you need a second ablation. Currently, CryoBalloon ablation has a slightly better cure rate with the least recurrence.

It’s crucial you choose the right electrophysiologist (EP), one with a high success rate and the best you can afford.

How to achieve these high success rates? It’s crucial you choose the right electrophysiologist (EP), one with a high success rate and the best you can afford (considering cost and travel expense). What counts is the EP’s skill and experience.

You want an EP who not only ablates your pulmonary veins, but will also look for, map and ablate non-pulmonary vein (PV) triggers. That may require advanced techniques like withdrawing the CryoBalloon catheter and replacing it with an RF catheter to ablate the non-PV triggers. (See our Choosing the Right Doctor: 7 Questions You’ve Got to Ask [And What the Answers Mean].) 

Cox Maze and Mini-Maze surgeries: Success rates are similar to catheter ablation, 75%–90%. But surgery isn’t recommended as a first choice or option by current A-Fib treatment guidelines. Compared to catheter ablations, the maze surgeries are more invasive, traumatic, risky and with longer (in hospital) recovery times

When should you consider the Maze/Mini-Maze? The primary reasons to consider a Maze surgery is because you can’t have a catheter ablation (ex: can’t take blood thinners), you’ve had several failed ablations, or if you are morbidly obese.

Atrial Fibrillation is not a one-size fits all type of disease.

You should also consider that Mini-Maze surgeries have built in limitations. For example, unlike catheter ablations, mini-maze surgery currently can’t reach the right atrium, or other areas of the heart where A-Fib signals may originate (non-PV locations). The more extensive surgeries create a great deal of lesions burns on the heart which may impact heart function.

So How Do You Choose the Best Treatment For You?

Atrial Fibrillation is not a one-size fits all type of disease.

Your first step is to see a heart rhythm specialist, a cardiac electrophysiologist (EP), who specializes in the electrical function of the heart.

An EP will work with you to consider the best treatment options for you. If your best treatment option is surgical, your EP will refer you to a surgeon and continue to manage your care after your surgery.

To help you find the right EP for you, see Finding the Right Doctor for You and Your A-Fib.

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If you find any errors on this page, email us. Last updated: Monday, February 13, 2017

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Blizzard of 2016 Increases Risk of A-Fib Stroke

We’ve all heard of someone dropping dead from a heart attack while shoveling snow. But along with record snowfall and subfreezing temperatures comes a warning for those with Atrial Fibrillation. Winter increases stroke risk in people with A-Fib.

Winter and increased risk of stoke at A-Fib.com

Winter: increased stroke risk

Do You Live in a Cold Climate?

In a study from Taiwan, nearly 300,000 people with new-onset A-Fib were followed for eleven years. Almost 35,000 suffered an ischemic (A-Fib) stroke.

The risk for an ischemic stroke was nearly 20% higher in winter than in summer.

“When the average temperature was below 68⁰ F (20⁰C), the risk of ischemic stroke significantly increased compared to days with an average temperature of 86⁰F (30⁰C).”

Why More Ischemic Strokes During Winter?

Cold weather may make blood more prone to coagulate.

Cooler temperatures may produce greater plasm fibrinogen levels and factor VII clotting activity and may lead to “increased coagulability and plasma viscosity,” according to the author of this study, Dr. Tze-Fan Chao. 

Ischemic stroke was nearly 20% higher in winter than in summer.

What Patients Need To Know

The cold temperatures can put you more at risk for an A-Fib (Ischemic) stroke. So act accordingly. Bundle up during winter. Keep the thermostat set to keep you warm enough.
If you’re on a blood thinner, discuss this research with your doctor. You need to keep your anticoagulant levels up during winter.
References for this article

My 2015 Top Five List: Advancements in the Treatment of A-Fib

Looking back over 2015, I found five significant developments for those ‘living’ with A-Fib and those seeking their ‘cure’. My ‘Top Five List’ focuses on the Watchman device, a Pradaxa antidote and research findings about lifestyle choices, and reducing fibrosis.

1. FDA Approves the Watchman Device

The Watchman occlusion device

The Watchman is positioned via catheter

Anticoagulant Alternative: Because A-Fib patients are at high risk of stroke and clots, a blood thinner (anticoagulant) like warfarin is often prescribed. If you can’t or don’t want to be on blood thinners, you had few options.

That was until March 2015 when the US Food and Drug Administration (FDA) approved the Watchman device. There’s now an option to blood thinners! The Watchman device (Boston Scientific) is inserted to close off the Left Atrial Appendage (LAA), the origin of 90%-95% of A-Fib clots.

To read my complete Top Five List…go to My 2015 Top Five List: A Review of Advancements in the Treatment of A-Fib->.

Pinterest: Profiles of Over 40 Celebs with A-Fib

Ellen Degeners, TV host and comedian

Ellen Degeneres, TV host and comedian

Atrial Fibrillation doesn’t discriminate. Our Pinterest board has over 40 celebs who have dealt with A-Fib. You might be surprised to learn of the many celebrities with A-Fib. From the NBA, NFL, MLB, NHL to track & field athletes and Olympic champions. Political leaders and public servants to musicians, actors and performers.

For example, ELLEN DEGENERES, Talk show host, comedian, KEVIN NEALON, comedian-actor-writer and Saturday Night Live alumni and HERB ALBERT (and the Tijuana Brass), the king of easy listening in the 1960s; Co-founder of A&M Records.

Billie Jean King

Billie Jean King, Tennis legend

BILLIE JEAN KING, Tennis legend (Wimbledon champ 20 times) and advocate for gender equality, MARIO LEMIEUX, Canadian American NHL/AHL Hockey Hall of Fame and LARRY BIRD, NBA star and coach.

See many, many more Celebs with A-Fib on our Pinterest page: “Celebs With A-Fib“. #afib. Visit all our A-Fib-related Pinterest boards at https://www.pinterest.com/stevesryan/

Free Report: How & Why to Read An Operating Room Report

Special 12-page report by Steve S. Ryan, PhD

FREE 12-page Report by Steve S. Ryan, PhD

In our free Special Report, How and Why to Read Your OR Report – Special Report by Steve S. Ryan PhD – A-Fib.com, we examine the actual O.R. report of the catheter ablation of Travis Van Slooten, publisher of Living With Atrial Fibrillation performed by Dr. Andrea Natale, Austin, TX.

What is an O.R. Report?

An O.R. report is a document written by the electrophysiologist who performed the catheter ablation. It contains a detailed account of the findings, the procedure used, the preoperative and postoperative diagnoses, etc.

It’s a very technical document. Because of this, it’s usually given to a patient only when they ask for it. You need to call your doctor or his office to obtain it.

Why to Request and Read Your O.R. Report

The O.R. report is a historical record of how you became A-Fib free.
The O.R. report is a blow-by-blow account of your EP’s actions. It’s as close as you’ll get to understanding your own ablation without actually looking over the EP’s shoulder during the ablation. The O.R. report is a historical record of how you became A-Fib free. (File with your A-Fib medical records for future reference.)

If you’ve had an ablation that was less than successful, you want to know why! Your O.R. report would show what they found in your heart, what was done, and possibly why the ablation didn’t fulfill expectations.

Studying an O.R. report can be very revealing…you may decide to change EPs going forward!

Reading an O.R. report can be very revealing. Were there complications? Was your fibrosis more extensive than expected? Was there a problem with the EP’s ablation techniques? Or with the EP lab equipment? This information will help you and your healthcare team decide how next to proceed.

Also, depending on what you read in your O.R. report, you may decide to change EPs going forward!

O.R. Report with closeup

Close-up of O.R. Report with markups

FREE Report: How & Why to Read Your Operating Room Report

In our FREE Special Report: How and Why to Read Your OR Report – Special Report by Steve S. Ryan PhD – A-Fib.com, I make it easy (well, let’s say ‘easier’) to learn how to read an O.R. report.

Along with an introduction, I’ve annotated every technical phrase or concept (in purple text) so you will understand each entry. I then translate what each comment means and summarize Travis’ report.

Get your PDF copy TODAY. Download How and Why to Read Your OR Report – Special Report by Steve S. Ryan PhD – A-Fib.com our FREE 12-page Special Report (Remember: Save to PDF  to your hard drive.)

Tip: If you’ve had an ablation, ask for your O.R. Report. If you or a loved one is planning a catheter ablation, make a note to yourself to ask for the O.R. report.

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If you find any errors on this page, email us. Y Last updated: Monday, July 18, 2016

FAQs Understanding A-Fib: Stiff Heart & Diastolic Dysfunction

 FAQs Understanding A-Fib: Stiff Heart

FAQs Understanding Your A-Fib A-Fib.com7. I’ve heard about ‘stiff heart’ or diastolic dysfunction. When you have A-Fib, do you automatically have diastolic heart failure? What exactly is diastolic dysfunction?

Someone with A-Fib can have much the same symptoms as someone with a ‘stiff heart’ or diastolic dysfunction. But A-Fib is an electrical problem that is often fixable, whereas diastolic dysfunction is a structural (or plumbing) problem usually not easily fixed.

Here are some statements from doctors I asked about this question:

• “Diastolic dysfunction (stiff heart) can lead to congestive heart failure. A-Fib is electrical. But some patients with A-Fib also have diastolic dysfunction.”

• “While many people with A-Fib do indeed have diastolic dysfunction (usually as a result of hypertension), this is not always the case.  On the other hand, there is no doubt that hypertension and the consequent effect on atrial stretch exacerbates the situation.  Perhaps the best way to think about it is that based on one’s genetic predisposition, one has a certain propensity to develop A-Fib. This can be modulated (i.e., exacerbated) by conditions that increase atrial pressure—such as hypertension, valve disease, heart failure, etc.”

Diastolic dysfunction refers to a decline in performance of one or both ventricles. ‘Diastole’ refers to the time when the ventricles are relaxing and filling with incoming blood as compared to when the ventricles are propelling blood out to the rest of the body. Diastolic Dysfunction may refer to both the left atrium and left ventricle being stiff and not functioning properly. (Whereas in A-Fib the focus is on the left atrium.)

When someone in A-Fib is restored to normal sinus rhythm, usually both the left atrium and left ventricle begin to function normally again. But someone with long term A-Fib may also develop an anatomical or mechanical pumping problem—diastolic dysfunction (stiff heart), fibrosis, scarring, cardiomyopathy, etc. which are more permanent and harder to improve. (Another reason to treat your A-Fib as soon as possible.)

Last updated: Monday, February 13, 2017

Go back to FAQ Understanding A-Fib

VIDEO: Atrial Fibrillation—A Conversation with Dr. Steve S. Ryan

Resources & Links

Video Interview: Steve S. Ryan, PhD, Author of Beat Your A-Fib

Host Skip E. Lowe interviews Steve S Ryan, PhD, about Atrial Fibrillation. Topics include A-Fib symptoms, causes, cures and Dr. Ryan’s book, Beat Your A-Fib – The Essential Guide to Finding Your Cure. Skip E. relays his own experiences with A-Fib. Dr. Ryan warns about incorrect A-Fib information found on the internet and in print media.  Recorded in W. Hollywood, CA. 14:53 min.

About Steve S. Ryan, PhD: An advocate for patients with Atrial Fibrillation, Dr. Ryan is publisher of the patient education website ‘Atrial Fibrillation: Resources for Patients’  (A-Fib.com), author of the award-winning book, ‘Beat Your A-Fib: The Essential Guide to Finding Your Cure’ (BeatYourA-Fib.com) and known as The A-Fib Coach for his one-to-one mentoring of A-Fib patients.

Return to Videos Featuring Steve S. Ryan, PhD

Last updated: Tuesday, April 21, 2015

 

VIDEO: Steve Ryan With Dr David Snow on A-Fib and Mineral Deficiencies

Resources & Links

Doctor Health Radio Interview: Common Mineral Deficiencies in A-Fib Patients

Dr David Snow, host of Doctor Health Radio, talks with Steve S. Ryan, PhD, about magnesium and potassium deficiencies, both common among A-Fib patients; how ‘calcium overload’ can actually bring on Atrial Fibrillation; and other supplements to promote a healthy heart. (Format: radio interview with graphic slides.) 5:27 min.

About Steve S. Ryan, PhD: An advocate for patients with Atrial Fibrillation, Dr. Ryan is publisher of the patient education website ‘Atrial Fibrillation: Resources for Patients’  (A-Fib.com), author of the award-winning book, ‘Beat Your A-Fib: The Essential Guide to Finding Your Cure’ (BeatYourA-Fib.com) and known as The A-Fib Coach for his one-to-one mentoring of A-Fib patients.

Return to Videos Featuring Steve S. Ryan, PhD

Last updated: Tuesday, April 21, 2015

 

VIDEO: Steve Ryan Warns A-Fib Patients Beware

Resources & Links

Video: Buyer Beware of Misleading A-Fib Information on the Web and in the Media

Beware of misleading and incorrect A-Fib information published by reputable sources on the internet and in print media. Steve S. Ryan, PhD, gives three specific examples of why you need to be on the lookout for inaccurate statements about Atrial Fibrillation. 3:59 min.

About Steve S. Ryan, PhD: An advocate for patients with Atrial Fibrillation, Dr. Ryan is publisher of the patient education website ‘Atrial Fibrillation: Resources for Patients’  (A-Fib.com), author of the award-winning book, ‘Beat Your A-Fib: The Essential Guide to Finding Your Cure’ (BeatYourA-Fib.com) and known as The A-Fib Coach for his one-to-one mentoring of A-Fib patients.

Return to Videos Featuring Steve S. Ryan, PhD

Last updated: Tuesday, April 21, 2015

 

Videos Featuring Steve S. Ryan, PhD, Publisher of A-Fib.com

Video Interviews Featuring Steve S. Ryan, PhD

Steve’s been on many radio and TV shows talking about Atrial Fibrillation. We’ve edited the best and most interesting segments to create several short (3-5 min.) videos. (We encourage you to SHARE Steve’s videos with others and to post links to your online accounts.)

Video: Buyer Beware of Misleading or Inaccurate A-Fib Information

Video with Steve S. Ryan, PhD

Click image to go to video

Beware of misleading and incorrect A-Fib information published by reputable sources on the internet and in print media. Steve S. Ryan, PhD, gives three specific examples of why you need to be on the lookout for inaccurate statements about Atrial Fibrillation. 3:59 min. Click to Watch video.

 

Video: Steve S. Ryan on Atrial Fibrillation: A-Fib Can be Cured!

Click image to go to video

Steve Ryan and host Skip E. Lowe talk about the heart in Atrial Fibrillation: how the quivering heart muscle leads to reduced blood flow to the brain and other organs, to re-shaping (remodeling) over time, and the importance of seeking treatment. Dr. Ryan describes how his A-Fib was cured by catheter ablation in 1998. 3:31 min. Click to Watch video.



Doctor Health Radio Interview:
Common Mineral Deficiencies in A-Fib Patients

Click image to go to video

Dr David Snow, host of Doctor Health Radio, talks with Steve S. Ryan, PhD, about magnesium and potassium deficiencies, both common among A-Fib patients; how ‘calcium overload’ can actually bring on Atrial Fibrillation; and other supplements to promote a healthy heart. (Format: radio interview with graphic slides.) 5:27 min. Click to watch video.

 
Video Interview: Steve S. Ryan, PhD, Author of
Beat Your A-Fib

Click image to go to video

Host Skip E. Lowe interviews Steve S Ryan, PhD, about Atrial Fibrillation. Topics include A-Fib symptoms, causes, cures and Dr. Ryan’s book, Beat Your A-Fib – The Essential Guide to Finding Your Cure. Skip E. relays his own experiences with A-Fib. Dr. Ryan warns about incorrect A-Fib information found on the internet and in print media. 14:53 min. Click to Watch video.

 

Highlights Video: The A-Fib Digital Influencer Summit

Summit video frame of SSR 400 pix wide at 300 res

Click image to go to video

Steve Ryan was one of eight A-Fib bloggers and social media authors invited to attend a first-of-its-kind “AFib Digital Influencer Summit” to discuss Atrial Fibrillation from a patient’s perspective. Highlights of participants who reflect on the needs of A-Fib patients. Hosted by Janssen Pharmaceuticals, Chicago, IL, November 2014. 4:13 min.
Click to Watch video.

 

For a list of TV and Radio Shows and Interviews with Steve S. Ryan, PhD, go to the Press Room for Dr. Ryan’s book, Beat Your A-Fib: The Essential Guide to Finding Your Cure.

Warfarin vs. Pradaxa and the Other New Anticoagulants

Ryan, PhD, Update July 2014, June 2015, October 2015
red-heart-negative 150 pix by 96 res

“I’ve read about people bleeding to death in the ER because they are on the new anticoagulant Pradaxa. Doctors can’t stop the bleeding, even from minor cuts. Is that true? Doesn’t Coumadin carry the same risk? What about the other new anticoagulants Xarelto and Eliquis?”

You’re correct about Pradaxa and the reported bleeding deaths (See “Stop Prescribing or Taking Pradaxa: Suspect in 542 deaths.”) None of the new anticoagulants (including Xarelto and Eliquis) has a proven, reliable antidote or reversal mechanism. But, Pradaxa, in particular, has been associated with tragic deaths in the ER where doctors are helpless and can only watch as someone bleeds to death.

(Update October 26, 2015: FDA Approves Reversal Agent for Pradaxa (dabigatran) 
In a new study of 90 patients who had uncontrolled bleeding with Pradaxa, Praxbind (idarucizumad) stopped this bleeding within minutes. No serious side effects were reported.
We have previously reported on the reversal agent Andexanet Alfa which is on FDA fast track approval as an antidote to the Factor Xa inhibitors Xarelto and Eliquis. FDA approval is pending.15,16)

 Stroke Prevention

Most would agree that the worst thing that can happen to a patient with A-Fib is a life-altering stroke. A stroke often causes death or permanent disability. Thus the importance of anticoagulation therapy for A-Fib patients.

For many years, there was only one proven therapy for stroke prevention in A-Fib patients at high or intermediate risk for stroke: the anticoagulant Coumadin (warfarin). It’s readily available and inexpensive.

But maintaining correct Coumadin levels is difficult especially over the long haul (studies indicate around 30% of people will stop taking Coumadin).

But maintaining correct Coumadin levels is difficult especially over the long haul (studies indicate around 30% of people will stop taking it).

Frequent blood tests are required to regulate the dose. Coumadin also has many interactions with other drugs, herbs, and food sources. If taken incorrectly, Coumadin can increase your risk of dangerous bleeding (yes, just like with Pradaxa).

In addition, Coumadin taken over several years may lead in microbleeds in the brain and dementia. (Read about the post-ablation patient on anticoagulation therapy for 10 years who develops cerebral microbleeds and early dementia: The New CHA2DS2-VASc Guidelines and the Risks of Life-Long Anticoagulation Therapy )

For patients at low or intermediate risk of stroke (including younger patients without any additional stroke risk factors), aspirin may be prescribed, or no anticoagulation therapy at all.

Read about the post-ablation patient on anticoagulation therapy for 10 years who develops cerebral microbleeds and early dementia: The New CHA2DS2-VASc Guidelines and the Risks of Life-Long Anticoagulation Therapy

 The NOACs Trials

For over 20 years there have been extensive efforts to replace warfarin with other drugs. In the US, we have four new anticoagulants to consider: Pradaxa (dabigatran), Xarelto (rivaroxaban), Eliquis (apixaban), (added January, 2015) and the recently approved (January, 2015) Savaysa (edoxaban)).

The data on the new anticoagulant come from three randomized controlled trials involving more than 50,000 A-Fib patients:

RE-LY (dabigatran)1
• ROCKET-AF (rivaroxaban)2
• ARISTOTLE (apixaban)3

Each study compared one drug against warfarin (not against each other). Taken together, these studies consistently revealed that A-Fib patients who took the non-warfarin blood thinners suffered fewer strokes, intracranial bleeds, and serious bleeds than those who took warfarin.

All of these drugs are at least as good as warfarin for preventing stroke and all are better than warfarin in reducing your risk of serious bleeding in the brain. But only Pradaxa has an antidote or reversal agent (at this time).

Note: Each of these NOAC trials had a questionable bias toward the new drug when compared against warfarin. Warfarin users are notoriously non-compliant, up to 50% are inconsistent in managing their diet, monitoring their INR levels and taking the correct dosage.4 Each of the three trials compared a group of compliant patients against a group of inconsistent warfarin patients. So results should be viewed with a critical eye.

For a more in-depth look at the clinical trials of the new NOACs, see 2013 BAFS: The New Anticoagulants (NOACs).

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 Three Notable Concerns

The new anticoagulants offer several advantages over warfarin. They are fast acting. And when stopped (i.e., for surgery), they just as quickly clear your body (a short “half-life). There’s a broad therapeutic window (wide range of safe use), and they have minimal drug or dietary interactions. They can be administered in fixed doses without monitoring, making them potentially more convenient to use than warfarin.

Remember: The goal of anticoagulation therapy is to reduce your risk of life-altering stroke.

Enthusiasm for the new anticoagulants, (NOACs), however, must be tempered by three notable concerns in patients taking these drugs:

1. No readily available means for assessing the degree of anticoagulation
2. No readily available reversal strategy
3. Life-threatening bleeding complications can occur after an injury
(Added May, 2015) Dr. Stephen Kimmel of the Un. of Pennsylvania discusses a fourth concern—stomach problems and gastrointestinal bleeding. “If you have a history of stomach problems or gastrointestinal bleeding, you may want to avoid Pradaxa and Xarelto—both medications have the highest risk for those complications.”5

 No Way to Measure Effectiveness

One of the problems with the newer anticoagulants (NOACs) is we don’t have a good way to measure how effective they are or how much of an anti-clotting effect there is at a given point in time. (For example, in treating trauma patients, ER doctors can only use the elapsed time from the last dose to estimate the clotting effect.)

With Coumadin (warfarin), on the other hand, we can measure how effective it is by its level in the blood stream measured in INR (International Normalized Ratio). A person not on anticoagulants will have an INR slightly above 1 (the author’s INR is 1.1). Someone with A-Fib on Coumadin should have an INR between 2.0 and 3.0. At this INR level a person will bleed more than someone with an INR of 1.0, but the blood will still clot.

With an INR below 2.0 you are more in danger of having an ischemic (clotting) stroke, the kind that most often occurs in A-Fib. With an INR of 4.0 and above, there is much more risk of blood not clotting and of developing a hemorrhagic stroke.

But the INR blood test doesn’t work with the new anticoagulants which affects only one particular stage in the anticoagulation process. Pradaxa, for example, is a direct thrombin inhibitor, whereas Coumadin affects nearly every stage in the anticoagulation process. (Thrombin is an enzyme that converts soluble fibrinogen into insoluble fibrin. Fibrin is a fibrous protein involved in the clotting of blood. It forms a mesh or clot over a wound.)

The lack of a readily available method to determine the degree or current level of anticoagulation is a major challenge for ER physicians and staff treating trauma patients.

Medical ID: If you’re on any blood thinner, it’s a good idea to carry some kind of medical ID. (See our Resources and Links for MedIDs free medical ID wallet card generator.) If you have an accident involving bleeding, EMTs don’t normally carry anticlotting meds. But they can call ahead to the ER and get the staff ready to help you.

 Are the NOACs Too Effective?

Pradaxa, in particular seems to work almost too well.

Pradaxa, in particular seems to work almost too well.

In some patients there is excessive bleeding that is catastrophic (usually in older or weaker patients). Pradaxa has been associated with some deaths in the ER where doctors currently have no antidote to stop people from bleeding to death.

Coumadin on the other hand has several proven, time-tested reversal or antidote strategies.6

Pradaxa (dabigatran) won the FDA sweepstakes by being the first new anticoagulant to get FDA approval and consequently captured a significant share of the anticoagulant market. Pradaxa comes in two doses in the United States, 150 mg twice daily or 75 mg twice daily. It’s large and harder to swallow, comes in a bottle with a 30-day shelf life once opened (or in blister packs which eliminates the shelf-life problem.) And it’s expensive.7 In the RELY trial, Pradaxa was not only equal to warfarin, but it proved to be superior to it in preventing stroke. Bleeding rates in the head were lower than with Coumadin. However, bleeding from the stomach or bowels was higher. The most common side effect was stomach pain.

In addition to the bleeding deaths in the ER mentioned above, Pradaxa’s own fact sheet states common side effects of Pradaxa include:8

• Indigestion, Upset Stomach, or Burning
• Stomach Pain

[These statements don’t capture the actual human toll—burning throat, roiling intestines, diarrhea, burning anus, lasting intestinal damage, etc. that Pradaxa can produce in some people.]

 Xarelto and Eliquis Test Better

Xarelto (rivaroxaban) was the second drug available in the United States. Xarelto comes in two doses, 20 mg daily or 15 mg daily. In contrast to Pradaxa, it is a small pill taken once-a-day that doesn’t seem to cause a lot of intestinal problems. In the Rocket AF trial, Xarelto also significantly lowered the risk of bleeding in the brain and head compared to Coumadin. Like the other new anticoagulants, Xarelto also doesn’t have a reversal agent; but anecdotally we don’t seem to see a lot of deaths in the ER from Xarelto.

Eliquis (apixaban) was third to be approved, comes in two doses, 5 mg twice daily or 2.5 mg twice daily (the lower for A-Fib patients with kidney dysfunction). Similar to Xarelto, the risk of bleeding in the brain and head was lower versus Coumadin. However, this drug was unique in that bleeding from other sites including the stomach, bowels, and bladder was less. In the Aristotle trial, Eliquis was at least as good and tended to be better than warfarin at preventing stroke.  Eliquis is the only drug that can claim that survival improved with its use compared to warfarin.

Xarelto and Eliquis, just like Pradaxa, are also very expensive.

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 Bleeding Complications

The reported bleeding events tend to occur mainly in elderly patients (median age of 80) which raises a question regarding safe dosing and monitoring in older patients. Elderly patients often have mild to moderate renal impairment, which can cause plasma levels of the NOAC to increase to up to three times those in normal renal function.

“One-size-fits-all” dosage of these new anticoagulants may need to be re-examined for elderly patients. (The FDA rejected the lower 110-mg twice-daily dose of Pradaxa (dabigatran) tested in the RE-LY trial, instead approving a 75-mg twice-daily dose just for patients with severe renal impairment.)

Lack of a proven, reliable antidote or reversal mechanism creates a major challenge for trauma staff.

 Lack of a proven, reliable antidote or reversal mechanism creates a major challenge for trauma staff and emergency physicians treating injured and often unstable patients (as does the lack of a readily available method to determine the degree or current level of anticoagulation). Currently, the only reversal option is emergency dialysis. The ability to perform rapid dialysis in patients with bleeding whose condition is unstable or in those with large intracranial hemorrhages is an incredible challenge, even at the best trauma centers.

With a relatively short elimination half-life, for now, time may be the most important antidote for NOACs.

 Adverse-Events Analysis

Eliquis Earns Best Safety Score

Through an analysis of data from the FDA Adverse Event Reporting System by AdverseEvents, Inc., Eliquis has received an “RxScore” safety score of 39.45 on a 100 point scale, with 100 representing the highest risk. In comparison, warfarin had a score of 67.57. Pradaxa (dabigatran) had a score of 67.15, Xarelto (rivaroxaban) 67.08.9,10

The FDA’s database comprises all the reports made by doctors, patients and other healthcare providers, which means it’s not a “scientific” finding with the authority of a clinical trial. AdverseEvents applies logic, math and software to the database to sift out the important data.

For Eliquis, “the rate of suspect cases was lower in every type of adverse-event report, from hospitalization to death.” For example, among Eliquis patients reporting side effects, only 21% cited hospitalization, while Pradaxa had 39%, Xarelto 43% and warfarin 50%.

The results all point to the same general conclusion: Eliquis may be a safer choice among the new NOACs.

 Update May 2014: Pradaxa

Since it was approved for use in 2010, Pradaxa has been linked to more than 500 patient deaths. More than 1,600 individuals have filed lawsuits in state and federal courts in the United States alleging they suffered bleeding events caused by the drug.

In May 2014, Boehringer-Ingelheim, the privately held German company that makes Pradaxa, settled 4,000 Pradaxa lawsuits and will pay $650 million. The lawsuit states that Pradaxa can cause bleeding events that cannot be controlled and are sometimes fatal.11

Pradaxa has generated $1 Billion in revenue for Boehringer-Ingelheim. So, will this $650 million settlement hurt BI’s bottom line and affect its marketing of Pradaxa? (BI’s revenues in 2012 were $1.5 billion). Probably not.

 Author’s Recommendations

If you’re conscientious and are pretty good at staying in the proper INR range, stick with Coumadin if you can. It may not be as convenient and easy to use as the newer anticoagulants, but we know Coumadin works if you stay within the proper INR range. And there are proven reversal agents for Coumadin, unlike for the newer anticoagulants. The cost of Coumadin is significantly lower when compared to the new anticoagulants.12

Update June 2015: Instead of the above statement, I suggest you talk with your doctor about switching from warfarin (Coumadin) to the NOAC Eliquis (apixaban). Studies show that warfarin produces arterial calcification and plaque which damage your heart over time. (See Stop Taking Warfarin! Switch to Eliquis.) Eliquis doesn’t block Vitamin K like warfarin, it tested better than the other NOACs and is safer.

If you struggle with staying in the proper INR range13, can’t juggle the diet restrictions or monthly monitoring, you should talk with your doctor about switching to Eliquis. It has no interactions with food (not even spinach) and requires NO monitoring (no more finger stick checks). Though be aware of Eliquis’  much higher monthly price.14 You will need to judge if the benefits outweigh the costs.

When choosing an anticoagulant, you need to consider which is worse: the risk of uncontrolled bleeding or the risk of a debilitating stroke.

Update October 26, 2015: FDA Approves Reversal Agent for Pradaxa (dabigatran) 
In a new study of 90 patients who had uncontrolled bleeding with Pradaxa, Praxbind (idarucizumad) stopped this bleeding within minutes. No serious side effects were reported.
We have previously reported on the reversal agent Andexanet Alfa which is on FDA fast track approval as an antidote to the Factor Xa inhibitors Xarelto and Eliquis. FDA approval is pending.15,16

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Return to Index of Articles: Drug Therapies (Medicines)

Last updated: Wednesday, May 17, 2017

 

Footnote Citations    (↵ returns to text)

  1. Marzo, Kevin. Blood thinner Antidote. Bottom Line Health, Volume 29, Number 9, September 2015, p. 1.
  2. Mundell, E.J.. Drug May Be Antidote to Bleeding Tied to Blood Thinner Pradaxa. Medline Plus. Monday, June 22, 2015. http://www.nlm.nih.gov/medlineplus/news/fullstory_153206.html
  3. Connolly SJ, et al. RE-LY Steering Committee and Investigators.  Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361(12):1139-51. Last accessed July 10, 2014 URL: http://www.ncbi.nlm.nih.gov/pubmed/19717844
  4. Patel MR, et al. ROCKET AF Investigators.  Rivaroxaban versus warfarin in nonvalvular atrial fibrillation.  N Engl J Med. 2011;365(10):883-91. Last accessed July 10, 2014, http://www.ncbi.nlm.nih.gov/pubmed/2183095
  5. Granger CB, et al. ARISTOTLE Committees and Investigators.  Apixaban versus warfarin in patients with atrial fibrillation.  N Engl J Med. 2011; 365(11):981-92 Last accessed July 10, 2014
  6. Ansell J, et al. Descriptive analysis of the process and quality of oral anticoagulation management in real-life practice in patients with chronic non-valvular atrial fibrillation: the interactional study of anticoagulation management (ISAM) J Thromb Thrombolysis 2007; 23: 83—91. Last accessed July 10, 2014
  7. Kimmel, Stephen. The Truth About Blood Thinners, Bottom Line/Health, May 2015, p. 11
  8. Coumadin reversal or antidote strategies: Vitamin K antagonist, Fresh Frozen Plasma, Prothrombin Complex Concentrate (PCC), and the newly FDA-approved Kcentra.
  9. Pradaxa costs about $250 a month; By comparison, warfarin (Coumadin) costs about $60-$80/month when you add in INR monitoring once a month. Last accessed July 10, 2014
  10. Pradaxa: Highlights of Prescribing Information. Boehringer-Ingelheim website. Last accessed March 13, 2014 URL: http://tinyurl.com/PraxadaInfo
  11. Examining the Comparative Safety of Blood Thinners: An Analysis Utilizing AdverseEvents Explorer, February 2014, Special Report Download. http://info.adverseevents.com/special-report-blood-thinner Last accessed July 10, 2014
  12. Staton, Tracy. Eliquis earns best safety score in its class in analysis of FDA adverse event reports. FiercePharma, February 26, 2014. Last accessed July 10, 2014, http://www.fiercepharma.com/story/eliquis-earns-best-safety-score-its-class-analysis-fda-adverse-event-report/2014-02-26
  13. Feeley, Jef. Boehringer Pays $650 Million to End Blood-Thinner Cases. May 28, 2014. Bloomberg.com. Last accessed July 10, 2014, URL: http://www.bloomberg.com/news/2014-05-28/boehringer-pays-650-million-to-end-blood-thinner-cases.html
  14. Your insurance provider will have a direct say into which drug you take.
  15. Consider a warfarin sensitivity test. About a third of the people who take warfarin are at a higher risk of bleeding because their genes make them more sensitive to warfarin. If a family member experienced side effects, talk to your doctor about taking a genetic warfarin sensitivity test.
  16. For those in the US and on Medicare with Part D coverage, the monthly cost may range from $30 to $50.
  17. ve S. Ryan, PhD, Update July 2014, June 2015, October 2015
    red-heart-negative 150 pix by 96 res

    “I’ve read about people bleeding to death in the ER because they are on the new anticoagulant Pradaxa. Doctors can’t stop the bleeding, even from minor cuts. Is that true? Doesn’t Coumadin carry the same risk? What about the other new anticoagulants Xarelto and Eliquis?”

    You’re correct about Pradaxa and the reported bleeding deaths (See “Stop Prescribing or Taking Pradaxa: Suspect in 542 deaths.”) None of the new anticoagulants (including Xarelto and Eliquis) has a proven, reliable antidote or reversal mechanism. But, Pradaxa, in particular, has been associated with tragic deaths in the ER where doctors are helpless and can only watch as someone bleeds to death.

    (Update October 26, 2015: FDA Approves Reversal Agent for Pradaxa (dabigatran) 
    In a new study of 90 patients who had uncontrolled bleeding with Pradaxa, Praxbind (idarucizumad) stopped this bleeding within minutes. No serious side effects were reported.
    We have previously reported on the reversal agent Andexanet Alfa which is on FDA fast track approval as an antidote to the Factor Xa inhibitors Xarelto and Eliquis. FDA approval is pending.15,16)

     Stroke Prevention

    Most would agree that the worst thing that can happen to a patient with A-Fib is a life-altering stroke. A stroke often causes death or permanent disability. Thus the importance of anticoagulation therapy for A-Fib patients.

    For many years, there was only one proven therapy for stroke prevention in A-Fib patients at high or intermediate risk for stroke: the anticoagulant Coumadin (warfarin). It’s readily available and inexpensive.

    But maintaining correct Coumadin levels is difficult especially over the long haul (studies indicate around 30% of people will stop taking Coumadin).

    But maintaining correct Coumadin levels is difficult especially over the long haul (studies indicate around 30% of people will stop taking it).

    Frequent blood tests are required to regulate the dose. Coumadin also has many interactions with other drugs, herbs, and food sources. If taken incorrectly, Coumadin can increase your risk of dangerous bleeding (yes, just like with Pradaxa).

    In addition, Coumadin taken over several years may lead in microbleeds in the brain and dementia. (Read about the post-ablation patient on anticoagulation therapy for 10 years who develops cerebral microbleeds and early dementia: The New CHA2DS2-VASc Guidelines and the Risks of Life-Long Anticoagulation Therapy )

    For patients at low or intermediate risk of stroke (including younger patients without any additional stroke risk factors), aspirin may be prescribed, or no anticoagulation therapy at all.

    Read about the post-ablation patient on anticoagulation therapy for 10 years who develops cerebral microbleeds and early dementia: The New CHA2DS2-VASc Guidelines and the Risks of Life-Long Anticoagulation Therapy

     The NOACs Trials

    For over 20 years there have been extensive efforts to replace warfarin with other drugs. In the US, we have four new anticoagulants to consider: Pradaxa (dabigatran), Xarelto (rivaroxaban), Eliquis (apixaban), (added January, 2015) and the recently approved (January, 2015) Savaysa (edoxaban)).

    The data on the new anticoagulant come from three randomized controlled trials involving more than 50,000 A-Fib patients:

    RE-LY (dabigatran)1
    • ROCKET-AF (rivaroxaban)2
    • ARISTOTLE (apixaban)3

    Each study compared one drug against warfarin (not against each other). Taken together, these studies consistently revealed that A-Fib patients who took the non-warfarin blood thinners suffered fewer strokes, intracranial bleeds, and serious bleeds than those who took warfarin.

    All of these drugs are at least as good as warfarin for preventing stroke and all are better than warfarin in reducing your risk of serious bleeding in the brain. But only Pradaxa has an antidote or reversal agent (at this time).

    Note: Each of these NOAC trials had a questionable bias toward the new drug when compared against warfarin. Warfarin users are notoriously non-compliant, up to 50% are inconsistent in managing their diet, monitoring their INR levels and taking the correct dosage.4 Each of the three trials compared a group of compliant patients against a group of inconsistent warfarin patients. So results should be viewed with a critical eye.

    For a more in-depth look at the clinical trials of the new NOACs, see 2013 BAFS: The New Anticoagulants (NOACs).

    Back to top

     Three Notable Concerns

    The new anticoagulants offer several advantages over warfarin. They are fast acting. And when stopped (i.e., for surgery), they just as quickly clear your body (a short “half-life). There’s a broad therapeutic window (wide range of safe use), and they have minimal drug or dietary interactions. They can be administered in fixed doses without monitoring, making them potentially more convenient to use than warfarin.

    Remember: The goal of anticoagulation therapy is to reduce your risk of life-altering stroke.

    Enthusiasm for the new anticoagulants, (NOACs), however, must be tempered by three notable concerns in patients taking these drugs:

    1. No readily available means for assessing the degree of anticoagulation
    2. No readily available reversal strategy
    3. Life-threatening bleeding complications can occur after an injury
    (Added May, 2015) Dr. Stephen Kimmel of the Un. of Pennsylvania discusses a fourth concern—stomach problems and gastrointestinal bleeding. “If you have a history of stomach problems or gastrointestinal bleeding, you may want to avoid Pradaxa and Xarelto—both medications have the highest risk for those complications.”5

     No Way to Measure Effectiveness

    One of the problems with the newer anticoagulants (NOACs) is we don’t have a good way to measure how effective they are or how much of an anti-clotting effect there is at a given point in time. (For example, in treating trauma patients, ER doctors can only use the elapsed time from the last dose to estimate the clotting effect.)

    With Coumadin (warfarin), on the other hand, we can measure how effective it is by its level in the blood stream measured in INR (International Normalized Ratio). A person not on anticoagulants will have an INR slightly above 1 (the author’s INR is 1.1). Someone with A-Fib on Coumadin should have an INR between 2.0 and 3.0. At this INR level a person will bleed more than someone with an INR of 1.0, but the blood will still clot.

    With an INR below 2.0 you are more in danger of having an ischemic (clotting) stroke, the kind that most often occurs in A-Fib. With an INR of 4.0 and above, there is much more risk of blood not clotting and of developing a hemorrhagic stroke.

    But the INR blood test doesn’t work with the new anticoagulants which affects only one particular stage in the anticoagulation process. Pradaxa, for example, is a direct thrombin inhibitor, whereas Coumadin affects nearly every stage in the anticoagulation process. (Thrombin is an enzyme that converts soluble fibrinogen into insoluble fibrin. Fibrin is a fibrous protein involved in the clotting of blood. It forms a mesh or clot over a wound.)

    The lack of a readily available method to determine the degree or current level of anticoagulation is a major challenge for ER physicians and staff treating trauma patients.

    Medical ID: If you’re on any blood thinner, it’s a good idea to carry some kind of medical ID. (See our Resources and Links for MedIDs free medical ID wallet card generator.) If you have an accident involving bleeding, EMTs don’t normally carry anticlotting meds. But they can call ahead to the ER and get the staff ready to help you.

     Are the NOACs Too Effective?

    Pradaxa, in particular seems to work almost too well.

    Pradaxa, in particular seems to work almost too well.

    In some patients there is excessive bleeding that is catastrophic (usually in older or weaker patients). Pradaxa has been associated with some deaths in the ER where doctors currently have no antidote to stop people from bleeding to death.

    Coumadin on the other hand has several proven, time-tested reversal or antidote strategies.6

    Pradaxa (dabigatran) won the FDA sweepstakes by being the first new anticoagulant to get FDA approval and consequently captured a significant share of the anticoagulant market. Pradaxa comes in two doses in the United States, 150 mg twice daily or 75 mg twice daily. It’s large and harder to swallow, comes in a bottle with a 30-day shelf life once opened (or in blister packs which eliminates the shelf-life problem.) And it’s expensive.7 In the RELY trial, Pradaxa was not only equal to warfarin, but it proved to be superior to it in preventing stroke. Bleeding rates in the head were lower than with Coumadin. However, bleeding from the stomach or bowels was higher. The most common side effect was stomach pain.

    In addition to the bleeding deaths in the ER mentioned above, Pradaxa’s own fact sheet states common side effects of Pradaxa include:8

    • Indigestion, Upset Stomach, or Burning
    • Stomach Pain

    [These statements don’t capture the actual human toll—burning throat, roiling intestines, diarrhea, burning anus, lasting intestinal damage, etc. that Pradaxa can produce in some people.]

     Xarelto and Eliquis Test Better

    Xarelto (rivaroxaban) was the second drug available in the United States. Xarelto comes in two doses, 20 mg daily or 15 mg daily. In contrast to Pradaxa, it is a small pill taken once-a-day that doesn’t seem to cause a lot of intestinal problems. In the Rocket AF trial, Xarelto also significantly lowered the risk of bleeding in the brain and head compared to Coumadin. Like the other new anticoagulants, Xarelto also doesn’t have a reversal agent; but anecdotally we don’t seem to see a lot of deaths in the ER from Xarelto.

    Eliquis (apixaban) was third to be approved, comes in two doses, 5 mg twice daily or 2.5 mg twice daily (the lower for A-Fib patients with kidney dysfunction). Similar to Xarelto, the risk of bleeding in the brain and head was lower versus Coumadin. However, this drug was unique in that bleeding from other sites including the stomach, bowels, and bladder was less. In the Aristotle trial, Eliquis was at least as good and tended to be better than warfarin at preventing stroke.  Eliquis is the only drug that can claim that survival improved with its use compared to warfarin.

    Xarelto and Eliquis, just like Pradaxa, are also very expensive.

    Back to top

     Bleeding Complications

    The reported bleeding events tend to occur mainly in elderly patients (median age of 80) which raises a question regarding safe dosing and monitoring in older patients. Elderly patients often have mild to moderate renal impairment, which can cause plasma levels of the NOAC to increase to up to three times those in normal renal function.

    “One-size-fits-all” dosage of these new anticoagulants may need to be re-examined for elderly patients. (The FDA rejected the lower 110-mg twice-daily dose of Pradaxa (dabigatran) tested in the RE-LY trial, instead approving a 75-mg twice-daily dose just for patients with severe renal impairment.)

    Lack of a proven, reliable antidote or reversal mechanism creates a major challenge for trauma staff.

     Lack of a proven, reliable antidote or reversal mechanism creates a major challenge for trauma staff and emergency physicians treating injured and often unstable patients (as does the lack of a readily available method to determine the degree or current level of anticoagulation). Currently, the only reversal option is emergency dialysis. The ability to perform rapid dialysis in patients with bleeding whose condition is unstable or in those with large intracranial hemorrhages is an incredible challenge, even at the best trauma centers.

    With a relatively short elimination half-life, for now, time may be the most important antidote for NOACs.

     Adverse-Events Analysis

    Eliquis Earns Best Safety Score

    Through an analysis of data from the FDA Adverse Event Reporting System by AdverseEvents, Inc., Eliquis has received an “RxScore” safety score of 39.45 on a 100 point scale, with 100 representing the highest risk. In comparison, warfarin had a score of 67.57. Pradaxa (dabigatran) had a score of 67.15, Xarelto (rivaroxaban) 67.08.9,10

    The FDA’s database comprises all the reports made by doctors, patients and other healthcare providers, which means it’s not a “scientific” finding with the authority of a clinical trial. AdverseEvents applies logic, math and software to the database to sift out the important data.

    For Eliquis, “the rate of suspect cases was lower in every type of adverse-event report, from hospitalization to death.” For example, among Eliquis patients reporting side effects, only 21% cited hospitalization, while Pradaxa had 39%, Xarelto 43% and warfarin 50%.

    The results all point to the same general conclusion: Eliquis may be a safer choice among the new NOACs.

     Update May 2014: Pradaxa

    Since it was approved for use in 2010, Pradaxa has been linked to more than 500 patient deaths. More than 1,600 individuals have filed lawsuits in state and federal courts in the United States alleging they suffered bleeding events caused by the drug.

    In May 2014, Boehringer-Ingelheim, the privately held German company that makes Pradaxa, settled 4,000 Pradaxa lawsuits and will pay $650 million. The lawsuit states that Pradaxa can cause bleeding events that cannot be controlled and are sometimes fatal.11

    Pradaxa has generated $1 Billion in revenue for Boehringer-Ingelheim. So, will this $650 million settlement hurt BI’s bottom line and affect its marketing of Pradaxa? (BI’s revenues in 2012 were $1.5 billion). Probably not.

     Author’s Recommendations

    If you’re conscientious and are pretty good at staying in the proper INR range, stick with Coumadin if you can. It may not be as convenient and easy to use as the newer anticoagulants, but we know Coumadin works if you stay within the proper INR range. And there are proven reversal agents for Coumadin, unlike for the newer anticoagulants. The cost of Coumadin is significantly lower when compared to the new anticoagulants.12

    Update June 2015: Instead of the above statement, I suggest you talk with your doctor about switching from warfarin (Coumadin) to the NOAC Eliquis (apixaban). Studies show that warfarin produces arterial calcification and plaque which damage your heart over time. (See Stop Taking Warfarin! Switch to Eliquis.) Eliquis doesn’t block Vitamin K like warfarin, it tested better than the other NOACs and is safer.

    If you struggle with staying in the proper INR range13, can’t juggle the diet restrictions or monthly monitoring, you should talk with your doctor about switching to Eliquis. It has no interactions with food (not even spinach) and requires NO monitoring (no more finger stick checks). Though be aware of Eliquis’  much higher monthly price.14 You will need to judge if the benefits outweigh the costs.

    When choosing an anticoagulant, you need to consider which is worse: the risk of uncontrolled bleeding or the risk of a debilitating stroke.

    Update October 26, 2015: FDA Approves Reversal Agent for Pradaxa (dabigatran) 
    In a new study of 90 patients who had uncontrolled bleeding with Pradaxa, Praxbind (idarucizumad) stopped this bleeding within minutes. No serious side effects were reported.
    We have previously reported on the reversal agent Andexanet Alfa which is on FDA fast track approval as an antidote to the Factor Xa inhibitors Xarelto and Eliquis. FDA approval is pending.15,16

    Back to top

    Return to Index of Articles: Drug Therapies (Medicines)

    Last updated: Wednesday, May 17, 2017

  18. Ryan, PhD, Update July 2014, June 2015, October 2015
    red-heart-negative 150 pix by 96 res

    “I’ve read about people bleeding to death in the ER because they are on the new anticoagulant Pradaxa. Doctors can’t stop the bleeding, even from minor cuts. Is that true? Doesn’t Coumadin carry the same risk? What about the other new anticoagulants Xarelto and Eliquis?”

    You’re correct about Pradaxa and the reported bleeding deaths (See “Stop Prescribing or Taking Pradaxa: Suspect in 542 deaths.”) None of the new anticoagulants (including Xarelto and Eliquis) has a proven, reliable antidote or reversal mechanism. But, Pradaxa, in particular, has been associated with tragic deaths in the ER where doctors are helpless and can only watch as someone bleeds to death.

    (Update October 26, 2015: FDA Approves Reversal Agent for Pradaxa (dabigatran) 
    In a new study of 90 patients who had uncontrolled bleeding with Pradaxa, Praxbind (idarucizumad) stopped this bleeding within minutes. No serious side effects were reported.
    We have previously reported on the reversal agent Andexanet Alfa which is on FDA fast track approval as an antidote to the Factor Xa inhibitors Xarelto and Eliquis. FDA approval is pending.15,16)

     Stroke Prevention

    Most would agree that the worst thing that can happen to a patient with A-Fib is a life-altering stroke. A stroke often causes death or permanent disability. Thus the importance of anticoagulation therapy for A-Fib patients.

    For many years, there was only one proven therapy for stroke prevention in A-Fib patients at high or intermediate risk for stroke: the anticoagulant Coumadin (warfarin). It’s readily available and inexpensive.

    But maintaining correct Coumadin levels is difficult especially over the long haul (studies indicate around 30% of people will stop taking Coumadin).

    But maintaining correct Coumadin levels is difficult especially over the long haul (studies indicate around 30% of people will stop taking it).

    Frequent blood tests are required to regulate the dose. Coumadin also has many interactions with other drugs, herbs, and food sources. If taken incorrectly, Coumadin can increase your risk of dangerous bleeding (yes, just like with Pradaxa).

    In addition, Coumadin taken over several years may lead in microbleeds in the brain and dementia. (Read about the post-ablation patient on anticoagulation therapy for 10 years who develops cerebral microbleeds and early dementia: The New CHA2DS2-VASc Guidelines and the Risks of Life-Long Anticoagulation Therapy )

    For patients at low or intermediate risk of stroke (including younger patients without any additional stroke risk factors), aspirin may be prescribed, or no anticoagulation therapy at all.

    Read about the post-ablation patient on anticoagulation therapy for 10 years who develops cerebral microbleeds and early dementia: The New CHA2DS2-VASc Guidelines and the Risks of Life-Long Anticoagulation Therapy

     The NOACs Trials

    For over 20 years there have been extensive efforts to replace warfarin with other drugs. In the US, we have four new anticoagulants to consider: Pradaxa (dabigatran), Xarelto (rivaroxaban), Eliquis (apixaban), (added January, 2015) and the recently approved (January, 2015) Savaysa (edoxaban)).

    The data on the new anticoagulant come from three randomized controlled trials involving more than 50,000 A-Fib patients:

    RE-LY (dabigatran)1
    • ROCKET-AF (rivaroxaban)2
    • ARISTOTLE (apixaban)3

    Each study compared one drug against warfarin (not against each other). Taken together, these studies consistently revealed that A-Fib patients who took the non-warfarin blood thinners suffered fewer strokes, intracranial bleeds, and serious bleeds than those who took warfarin.

    All of these drugs are at least as good as warfarin for preventing stroke and all are better than warfarin in reducing your risk of serious bleeding in the brain. But only Pradaxa has an antidote or reversal agent (at this time).

    Note: Each of these NOAC trials had a questionable bias toward the new drug when compared against warfarin. Warfarin users are notoriously non-compliant, up to 50% are inconsistent in managing their diet, monitoring their INR levels and taking the correct dosage.4 Each of the three trials compared a group of compliant patients against a group of inconsistent warfarin patients. So results should be viewed with a critical eye.

    For a more in-depth look at the clinical trials of the new NOACs, see 2013 BAFS: The New Anticoagulants (NOACs).

    Back to top

     Three Notable Concerns

    The new anticoagulants offer several advantages over warfarin. They are fast acting. And when stopped (i.e., for surgery), they just as quickly clear your body (a short “half-life). There’s a broad therapeutic window (wide range of safe use), and they have minimal drug or dietary interactions. They can be administered in fixed doses without monitoring, making them potentially more convenient to use than warfarin.

    Remember: The goal of anticoagulation therapy is to reduce your risk of life-altering stroke.

    Enthusiasm for the new anticoagulants, (NOACs), however, must be tempered by three notable concerns in patients taking these drugs:

    1. No readily available means for assessing the degree of anticoagulation
    2. No readily available reversal strategy
    3. Life-threatening bleeding complications can occur after an injury
    (Added May, 2015) Dr. Stephen Kimmel of the Un. of Pennsylvania discusses a fourth concern—stomach problems and gastrointestinal bleeding. “If you have a history of stomach problems or gastrointestinal bleeding, you may want to avoid Pradaxa and Xarelto—both medications have the highest risk for those complications.”5

     No Way to Measure Effectiveness

    One of the problems with the newer anticoagulants (NOACs) is we don’t have a good way to measure how effective they are or how much of an anti-clotting effect there is at a given point in time. (For example, in treating trauma patients, ER doctors can only use the elapsed time from the last dose to estimate the clotting effect.)

    With Coumadin (warfarin), on the other hand, we can measure how effective it is by its level in the blood stream measured in INR (International Normalized Ratio). A person not on anticoagulants will have an INR slightly above 1 (the author’s INR is 1.1). Someone with A-Fib on Coumadin should have an INR between 2.0 and 3.0. At this INR level a person will bleed more than someone with an INR of 1.0, but the blood will still clot.

    With an INR below 2.0 you are more in danger of having an ischemic (clotting) stroke, the kind that most often occurs in A-Fib. With an INR of 4.0 and above, there is much more risk of blood not clotting and of developing a hemorrhagic stroke.

    But the INR blood test doesn’t work with the new anticoagulants which affects only one particular stage in the anticoagulation process. Pradaxa, for example, is a direct thrombin inhibitor, whereas Coumadin affects nearly every stage in the anticoagulation process. (Thrombin is an enzyme that converts soluble fibrinogen into insoluble fibrin. Fibrin is a fibrous protein involved in the clotting of blood. It forms a mesh or clot over a wound.)

    The lack of a readily available method to determine the degree or current level of anticoagulation is a major challenge for ER physicians and staff treating trauma patients.

    Medical ID: If you’re on any blood thinner, it’s a good idea to carry some kind of medical ID. (See our Resources and Links for MedIDs free medical ID wallet card generator.) If you have an accident involving bleeding, EMTs don’t normally carry anticlotting meds. But they can call ahead to the ER and get the staff ready to help you.

     Are the NOACs Too Effective?

    Pradaxa, in particular seems to work almost too well.

    Pradaxa, in particular seems to work almost too well.

    In some patients there is excessive bleeding that is catastrophic (usually in older or weaker patients). Pradaxa has been associated with some deaths in the ER where doctors currently have no antidote to stop people from bleeding to death.

    Coumadin on the other hand has several proven, time-tested reversal or antidote strategies.6

    Pradaxa (dabigatran) won the FDA sweepstakes by being the first new anticoagulant to get FDA approval and consequently captured a significant share of the anticoagulant market. Pradaxa comes in two doses in the United States, 150 mg twice daily or 75 mg twice daily. It’s large and harder to swallow, comes in a bottle with a 30-day shelf life once opened (or in blister packs which eliminates the shelf-life problem.) And it’s expensive.7 In the RELY trial, Pradaxa was not only equal to warfarin, but it proved to be superior to it in preventing stroke. Bleeding rates in the head were lower than with Coumadin. However, bleeding from the stomach or bowels was higher. The most common side effect was stomach pain.

    In addition to the bleeding deaths in the ER mentioned above, Pradaxa’s own fact sheet states common side effects of Pradaxa include:8

    • Indigestion, Upset Stomach, or Burning
    • Stomach Pain

    [These statements don’t capture the actual human toll—burning throat, roiling intestines, diarrhea, burning anus, lasting intestinal damage, etc. that Pradaxa can produce in some people.]

     Xarelto and Eliquis Test Better

    Xarelto (rivaroxaban) was the second drug available in the United States. Xarelto comes in two doses, 20 mg daily or 15 mg daily. In contrast to Pradaxa, it is a small pill taken once-a-day that doesn’t seem to cause a lot of intestinal problems. In the Rocket AF trial, Xarelto also significantly lowered the risk of bleeding in the brain and head compared to Coumadin. Like the other new anticoagulants, Xarelto also doesn’t have a reversal agent; but anecdotally we don’t seem to see a lot of deaths in the ER from Xarelto.

    Eliquis (apixaban) was third to be approved, comes in two doses, 5 mg twice daily or 2.5 mg twice daily (the lower for A-Fib patients with kidney dysfunction). Similar to Xarelto, the risk of bleeding in the brain and head was lower versus Coumadin. However, this drug was unique in that bleeding from other sites including the stomach, bowels, and bladder was less. In the Aristotle trial, Eliquis was at least as good and tended to be better than warfarin at preventing stroke.  Eliquis is the only drug that can claim that survival improved with its use compared to warfarin.

    Xarelto and Eliquis, just like Pradaxa, are also very expensive.

    Back to top

     Bleeding Complications

    The reported bleeding events tend to occur mainly in elderly patients (median age of 80) which raises a question regarding safe dosing and monitoring in older patients. Elderly patients often have mild to moderate renal impairment, which can cause plasma levels of the NOAC to increase to up to three times those in normal renal function.

    “One-size-fits-all” dosage of these new anticoagulants may need to be re-examined for elderly patients. (The FDA rejected the lower 110-mg twice-daily dose of Pradaxa (dabigatran) tested in the RE-LY trial, instead approving a 75-mg twice-daily dose just for patients with severe renal impairment.)

    Lack of a proven, reliable antidote or reversal mechanism creates a major challenge for trauma staff.

     Lack of a proven, reliable antidote or reversal mechanism creates a major challenge for trauma staff and emergency physicians treating injured and often unstable patients (as does the lack of a readily available method to determine the degree or current level of anticoagulation). Currently, the only reversal option is emergency dialysis. The ability to perform rapid dialysis in patients with bleeding whose condition is unstable or in those with large intracranial hemorrhages is an incredible challenge, even at the best trauma centers.

    With a relatively short elimination half-life, for now, time may be the most important antidote for NOACs.

     Adverse-Events Analysis

    Eliquis Earns Best Safety Score

    Through an analysis of data from the FDA Adverse Event Reporting System by AdverseEvents, Inc., Eliquis has received an “RxScore” safety score of 39.45 on a 100 point scale, with 100 representing the highest risk. In comparison, warfarin had a score of 67.57. Pradaxa (dabigatran) had a score of 67.15, Xarelto (rivaroxaban) 67.08.9,10

    The FDA’s database comprises all the reports made by doctors, patients and other healthcare providers, which means it’s not a “scientific” finding with the authority of a clinical trial. AdverseEvents applies logic, math and software to the database to sift out the important data.

    For Eliquis, “the rate of suspect cases was lower in every type of adverse-event report, from hospitalization to death.” For example, among Eliquis patients reporting side effects, only 21% cited hospitalization, while Pradaxa had 39%, Xarelto 43% and warfarin 50%.

    The results all point to the same general conclusion: Eliquis may be a safer choice among the new NOACs.

     Update May 2014: Pradaxa

    Since it was approved for use in 2010, Pradaxa has been linked to more than 500 patient deaths. More than 1,600 individuals have filed lawsuits in state and federal courts in the United States alleging they suffered bleeding events caused by the drug.

    In May 2014, Boehringer-Ingelheim, the privately held German company that makes Pradaxa, settled 4,000 Pradaxa lawsuits and will pay $650 million. The lawsuit states that Pradaxa can cause bleeding events that cannot be controlled and are sometimes fatal.11

    Pradaxa has generated $1 Billion in revenue for Boehringer-Ingelheim. So, will this $650 million settlement hurt BI’s bottom line and affect its marketing of Pradaxa? (BI’s revenues in 2012 were $1.5 billion). Probably not.

     Author’s Recommendations

    If you’re conscientious and are pretty good at staying in the proper INR range, stick with Coumadin if you can. It may not be as convenient and easy to use as the newer anticoagulants, but we know Coumadin works if you stay within the proper INR range. And there are proven reversal agents for Coumadin, unlike for the newer anticoagulants. The cost of Coumadin is significantly lower when compared to the new anticoagulants.12

    Update June 2015: Instead of the above statement, I suggest you talk with your doctor about switching from warfarin (Coumadin) to the NOAC Eliquis (apixaban). Studies show that warfarin produces arterial calcification and plaque which damage your heart over time. (See Stop Taking Warfarin! Switch to Eliquis.) Eliquis doesn’t block Vitamin K like warfarin, it tested better than the other NOACs and is safer.

    If you struggle with staying in the proper INR range13, can’t juggle the diet restrictions or monthly monitoring, you should talk with your doctor about switching to Eliquis. It has no interactions with food (not even spinach) and requires NO monitoring (no more finger stick checks). Though be aware of Eliquis’  much higher monthly price.14 You will need to judge if the benefits outweigh the costs.

    When choosing an anticoagulant, you need to consider which is worse: the risk of uncontrolled bleeding or the risk of a debilitating stroke.

    Update October 26, 2015: FDA Approves Reversal Agent for Pradaxa (dabigatran) 
    In a new study of 90 patients who had uncontrolled bleeding with Pradaxa, Praxbind (idarucizumad) stopped this bleeding within minutes. No serious side effects were reported.
    We have previously reported on the reversal agent Andexanet Alfa which is on FDA fast track approval as an antidote to the Factor Xa inhibitors Xarelto and Eliquis. FDA approval is pending.15,16

    Back to top

    Return to Index of Articles: Drug Therapies (Medicines)

    Last updated: Wednesday, May 17, 2017

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