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Women in A-Fib Not at Greater Risk of Stroke!
by Steve S. Ryan, PhD, Last updated: March 24, 2018
April 2016 related article: The Controversy Continues: Women, Anticoagulants, CHA2DS2-VASc and Risk of Bleeding
Denmark Study—Being a woman not a risk factor for stroke
The new guidelines for stroke prevention in A-Fib (CHA2DS2-VASc) state that simply being a woman is a risk factor for stroke. But a recent comprehensive study from Denmark indicates this may not be true. (The guidelines were first adopted in Europe in 2012 and in the US in May 2014).
The Danes seem to have an effective health care system for everyone which includes, among other benefits, data on anyone with A-Fib. They looked at 44,744 women with A-Fib. Female gender did not increase the risk of stroke in patients aged less than 75 years. (According to most guidelines, being over 75 years old is a risk factor for stroke irrespective of whether one is female or male.)
According to the study’s Dr. Anders Mikkelsen, “This suggests that female sex should not be included as an independent stroke/TE risk factor in guidelines or in risk stratification schemes used in treatment of patients with atrial fibrillation.”
Dr. Peter Nielsen added, that women with no additional risk factors had a 1-year stroke risk below 0.5%, “which is likely too low to warrant lifelong antithrombotic treatment.”
Israeli Study 2015
An Israeli observational study of 100,000 people came to the same conclusions as the above Denmark study. See Israeli Study—Being Female Not a Risk Factor for Stroke.
Dr. Day—Risks of Life-Long Anticoagulant Therapy
Dr. John Day, in a May 2014 editorial in The Journal of Innovations in Cardiac Rhythm Management, discusses the new CHA2DS2-VASc guidelines for anticoagulation therapy that call for many more people to be on anticoagulant therapy, particularly women. Dr. Day does not go so far as to say the new guidelines are in error (as I do), but he does ask,” What about the 35 year old woman with borderline hypertension and only one A-Fib recurrence each year? Should she now take anticoagulants for the rest of her life even if she has had a successful ablation?”
This editorial was very personal for Dr. Day. One of his patients, after a successful catheter ablation, was on anticoagulant therapy for 10 years and developed early onset dementia. A cranial MRI revealed many cerebral microbleeds. Both antiplatelet and anticoagulant therapy significantly increase the risk of cerebral microbleeds which are associated with dementia. Microbleeds are considered permanent and irreversible.
Dr. Day concludes, “Somehow I think we have lost sight of the total picture with the new A-Fib management guidelines. In my mind, I am not convinced that the long-term stroke risk of a CHA2DS2-VASc score of 1 or 2 (depending on which risk factors are present) justifies all of the risks of life-long anticoagulation therapy, particularly if the patient has had a successful ablation procedure.” For more of Dr. Day’s comments, see The New CHA2DS2-VASc Guidelines and the Risks of Life-Long Anticoagulation Therapy.
Dr. John Mandrola echoes Dr. Day, “And if there is no A-Fib, there is no benefit from anticoagulation.”
Editor’s Comments:
For additional insights, also see: Women with A-Fib: Mother Nature and Gender Bias—Or—Get Thee to an EP ASAP
Intuitively it doesn’t make sense that simply being a woman makes you more at risk of having an A-Fib stroke. This study seems to confirm what common sense would indicate and is most welcome news for women.
Anticoagulants Not Like Taking Vitamins
Women (and men) should be aware that anticoagulants increase the risk of bleeding disorders and should be given only to patients at a real risk of stroke. “In addition to bleeding, Pradaxa can cause stomach upset or burning, and stomach pain.” (Pradaxa Fact Sheet PX81802) (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.) According to Dr. David Graham of the FDA, the anticoagulant “Coumadin provides a benefit, but it is also responsible for probably more deaths than any single drug currently marketed.”
Many people have problems when taking anticoagulants and would prefer not to have to take them. One bruises easily, cuts take a long time to stop bleeding, one can’t participate in any contact sports or any activities like mountain climbing, bike riding, etc. If in an accident, one risks bleeding to death, because there is currently no practical way to reverse the anticlotting effect of the newer anticoagulants. When taking anticoagulants, there is an increased risk of developing an hemorrhagic stroke and gastrointestinal bleeding. And anticoagulants often have other bad side effects, make one feel sick, and diminish one’s quality of life.
Update October 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.
TV Ads for Anticoagulants
Recent advertising campaigns give the impression that you must take anticoagulants if you have A-Fib, that anticoagulants are the be-all and end-all for treating A-Fib, that if you take anticoagulants, then you will live happily ever after. (Actually anticoagulants are not a treatment for A-Fib, but for the risk of an A-Fib stroke). However, no matter how altruistic these national campaigns sound in trying to increase people’s awareness and knowledge of A-Fib, be advised that their primary purpose is to sell pharmaceuticals.
Gender Bias to Sell More Anticoagulants
If someone tells you that you must take anticoagulants because you are a woman, it may be time to get a second opinion. Don’t let a form of gender bias intimidate you into taking anticoagulants.
Realize also that adding a point to a person’s risk score translates into a huge increase in sales for pharmaceutical companies. The guidelines were written by doctors with major conflicts of interest.
However, if you know the risks and bad side effects of taking anticoagulants but still want to take them, that is certainly an option to discuss with your doctor.
(Thanks to David C. Holzman for calling our attention to this important study for women.)
Return to Treatments for A-Fib
Last updated: Saturday, March 24, 2018
