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Effect of Catheter Ablation vs Antiarrhythmic Drug Therapy on Mortality, Stroke, Bleeding, and Cardiac Arrest Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial.


ABSTRACT: Importance:Catheter ablation is effective in restoring sinus rhythm in atrial fibrillation (AF), but its effects on long-term mortality and stroke risk are uncertain. Objective:To determine whether catheter ablation is more effective than conventional medical therapy for improving outcomes in AF. Design, Setting, and Participants:The Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation trial is an investigator-initiated, open-label, multicenter, randomized trial involving 126 centers in 10 countries. A total of 2204 symptomatic patients with AF aged 65 years and older or younger than 65 years with 1 or more risk factors for stroke were enrolled from November 2009 to April 2016, with follow-up through December 31, 2017. Interventions:The catheter ablation group (n?=?1108) underwent pulmonary vein isolation, with additional ablative procedures at the discretion of site investigators. The drug therapy group (n?=?1096) received standard rhythm and/or rate control drugs guided by contemporaneous guidelines. Main Outcomes and Measures:The primary end point was a composite of death, disabling stroke, serious bleeding, or cardiac arrest. Among 13 prespecified secondary end points, 3 are included in this report: all-cause mortality; total mortality or cardiovascular hospitalization; and AF recurrence. Results:Of the 2204 patients randomized (median age, 68 years; 37.2% female; 42.9% had paroxysmal AF and 57.1% had persistent AF), 89.3% completed the trial. Of the patients assigned to catheter ablation, 1006 (90.8%) underwent the procedure. Of the patients assigned to drug therapy, 301 (27.5%) ultimately received catheter ablation. In the intention-to-treat analysis, over a median follow-up of 48.5 months, the primary end point occurred in 8.0% (n?=?89) of patients in the ablation group vs 9.2% (n?=?101) of patients in the drug therapy group (hazard ratio [HR], 0.86 [95% CI, 0.65-1.15]; P?=?.30). Among the secondary end points, outcomes in the ablation group vs the drug therapy group, respectively, were 5.2% vs 6.1% for all-cause mortality (HR, 0.85 [95% CI, 0.60-1.21]; P?=?.38), 51.7% vs 58.1% for death or cardiovascular hospitalization (HR, 0.83 [95% CI, 0.74-0.93]; P?=?.001), and 49.9% vs 69.5% for AF recurrence (HR, 0.52 [95% CI, 0.45-0.60]; P?

SUBMITTER: Packer DL 

PROVIDER: S-EPMC6450284 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Effect of Catheter Ablation vs Antiarrhythmic Drug Therapy on Mortality, Stroke, Bleeding, and Cardiac Arrest Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial.

Packer Douglas L DL   Mark Daniel B DB   Robb Richard A RA   Monahan Kristi H KH   Bahnson Tristram D TD   Poole Jeanne E JE   Noseworthy Peter A PA   Rosenberg Yves D YD   Jeffries Neal N   Mitchell L Brent LB   Flaker Greg C GC   Pokushalov Evgeny E   Romanov Alexander A   Bunch T Jared TJ   Noelker Georg G   Ardashev Andrey A   Revishvili Amiran A   Wilber David J DJ   Cappato Riccardo R   Kuck Karl-Heinz KH   Hindricks Gerhard G   Davies D Wyn DW   Kowey Peter R PR   Naccarelli Gerald V GV   Reiffel James A JA   Piccini Jonathan P JP   Silverstein Adam P AP   Al-Khalidi Hussein R HR   Lee Kerry L KL  

JAMA 20190401 13


<h4>Importance</h4>Catheter ablation is effective in restoring sinus rhythm in atrial fibrillation (AF), but its effects on long-term mortality and stroke risk are uncertain.<h4>Objective</h4>To determine whether catheter ablation is more effective than conventional medical therapy for improving outcomes in AF.<h4>Design, setting, and participants</h4>The Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation trial is an investigator-initiated, open-label, multicenter, randomiz  ...[more]

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