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Rome, Italy

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

5-Year CABANA Trial: Compares Catheter Ablation with Antiarrhythmic Drug Therapy

Published January 10, 2019

The catheter ablation procedure for Atrial Fibrillation has been around for 20+ years.

In a randomized controlled trial, the 5-year CABANA study is the largest to compare the A-Fib treatments of catheter ablation (PVI) and antiarrhythmic drug therapy (AAD).

CABANA stands for Catheter Ablation versus Antiarrhythmic Drug Therapy.

CABANA Trial Design

Worldwide, 2,204 patients with new onset or undertreated Atrial Fibrillation were randomized between two treatments: catheter ablation (PVI) or antiarrhythmic drug (AAD) therapy. Patient participants were followed for nearly 5 years.

Patients details: Many patients had concurrent illnesses with Atrial Fibrillation: cardiomyopathy (9%), chronic heart failure (15%), prior cerebrovascular accidents or TIAs (mini-strokes) (10%).

Over half of participants (57%) had persistent or long-standing persistent A-Fib [i.e. harder types of A-Fib to cure].

Drug details: Antiarrhythmic drug (AAD) therapy was mostly rhythm control (87.2%), some received rate control drug therapy.

Anticoagulation drug therapy was used in both groups.

CABANA Trial Results

There was no significant difference between the two arms in the primary endpoint of the trial (the composite of all-cause mortality, disabling stroke, serious bleeding, or cardiac arrest), which occurred in 9.2% of patients in the drug group and 8% of patients in the ablation group (hazard ratio 0.86, CI 0.65-1.15, p =0.303).

Crossover a Major Problem: Many in the AAD therapy arm decided to have a catheter ablation instead (27.5%). And some in the ablation arm decided not to have an ablation (9.2%). [One can not blame patients or their doctors for making these life-impacting choices.]

The problem arises when so many of the AAD therapy arm cross over. In the primary endpoint “intent to treat” group, those who wound up having an ablation were still included in the ADD arm. Whereas when researchers looked at actual “treatment received”, the CABANA results showed catheter ablation was significantly better than drug therapy for the primary endpoint (a composite of all-cause mortality, disabling stroke, serious bleeding or cardiac arrest). [See Additional Research Findings below.] Mortality and death rate were also significantly better for catheter ablation.

Additional CABANA Findings: Ablation vs AAD Therapy

▪ Catheter Ablation significantly reduced the recurrence of A-Fib versus AAD therapy.

▪ Catheter Ablation improved ‘quality of life’ (QofL) more than AAD therapy, though both groups showed substantial improvement.

▪ Catheter Ablation patients had incremental, clinically meaningful and significant improvements in A-Fib-related symptoms. This benefit was sustained over 5 years of follow-up.

▪ Catheter Ablation was found to be a safe and effective therapy for A-Fib and had low adverse event rates.

Take-Aways for A-Fib Patients

Ablation Works Better than Antiarrhythmic Drugs: Rather than a life on antiarrhythmic drug therapy, the CABANA trial and other studies show that a catheter ablation is the better choice over antiarrhythmic drug therapy.

For related studies, see CASTLE AF: Live Longer-Have a Catheter Ablation and AATAC AF: Catheter Ablation Compared to Amiodarone Drug Therapy.

In an editorial in the Journal of Innovations in Cardiac Rhythm Management, Dr. Moussa Mansour, Massachusetts General Hospital, wrote about the CABANA trial:

“It confirmed our belief that catheter ablation is a superior treatment to the use of pharmacological agents, and corroborates the findings of many other radomized clinical trials.”

Lower Recurrence: What’s also important for patients is the lower risk of recurrence of A-Fib versus AAD therapy.

Reduced Ablation Safety Concerns: Ablation significantly improved overall mortality and major heart problems.

Immeasurable Improvement in Quality of Life! Perhaps even more important for patients on a daily basis, catheter ablation significantly improved quality of life.

Don’t Settle for a Lifetime on Drugs

Over the years, catheter ablation for A-Fib has become an increasingly low risk procedure with reduced safety concerns. (Ablation isn’t surgery. There’s no cutting involved. Complication risk is similar to tubal ligation or vasectomy.)

An ablation can reduce or entirely rid you of your A-Fib symptoms, make you feel better, and let you live a healthier and longer life (for people who are older, too). A catheter ablation significantly improves your quality of life (even if you need a second “re-do ablation” down the road).

For many, many patients, A-Fib is definitely curable. Getting back into normal sinus rhythm and staying in sinus rhythm is a life-changing experience, as anyone who’s free from the burden of A-Fib can tell you.

Additional Study Findings

• Primary endpoints: Results of the primary endpoints were not significant. This is probably due to the crossovers and the lower than expected adverse event rates (5.2% for ablation versus 6.1% for AAD therapy).

• Deeper Analysis of Data: The researchers performed sensitivity analyses on the primary results using “treatment received” and “per protocol” rather than “intent to treat”.

Research Terms: Primary endpoint—specific event the study is designed to assess. Intent to treat—all assigned to the AAD group compared to the assigned ablation group (even though 1/4 crossed over to the ablation group). Treatment received—compared all who received an ablation to all who received AAD therapy.

References for this article

• Packer, Douglas. CABANA trial provides important new data on clinical and quality of life effects of ablation for atrial fibrillation. Cardiac Rhythm News: October 18, 2018, Issue 42. P. 1.

• Mansour, Moussa. Letter from the Editor in Chief. The Journal of Innovations in Cardiac Rhythm Management, June 2018. DOI: 10.19102/icrm.2018.090609.