Effect of Catheter Ablation vs Antiarrhythmic Drug Therapy on Mortality, Stroke, Bleeding, and Cardiac Arrest Among Patients With Atrial Fibrillation

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 < .001). CONCLUSIONS AND RELEVANCE Among patients with AF, the strategy of catheter ablation, compared with medical therapy, did not significantly reduce the primary composite end point of death, disabling stroke, serious bleeding, or cardiac arrest. However, the estimated treatment effect of catheter ablation was affected by lower-than-expected event rates and treatment crossovers, which should be considered in interpreting the results of the trial.

One‐year clinical outcomes of anticoagulation therapy among Japanese patients with atrial fibrillation: The Hyogo AF Network (HAF‐NET) Registry

“…Recently, Packer et al reported that the composite endpoints of mortality and cardiovascular hospitalization exhibited a significant 17% relative lower event rate for the CA group than medical therapy group. To improve the mortality as well as quality of life, CA might be aggressively considered especially in patients with heart failure or a stroke history …”

“…Furthermore, the impact of CA has been greater in patients with an age of <65 years old, heart failure of <NYHA functional class II, and EF of ≧ 25%. The CABANA study also reported that the impact of CA was greater in patients with an age of <65 years old . Those two RCTs indicated the importance of early intervention to maintain sinus rhythm by CA in patients with AF.…”

“…AF catheter ablation (AFCA) is widely performed, and some investigations have reported that it is more effective for preventing AF recurrences than medical therapy . CA in patients with heart failure has been reported to be associated with a significantly lower rate of a composite end point of death from any cause or hospitalization for worsening heart failure than medical therapy, while the impact is less in patients without heart failure . Evidence that the mortality improves in patients who undergo CA is still limited.…”

The new era of atrial fibrillation treated by direct oral anticoagulants and catheter ablation—Comment on the “HAF‐NET Registry”

“…The CABANA study had a lower rate of disabling strokes in the catheter ablation group compared to the drug therapy group, but there was no significant difference (0.3% vs 0.6%, P = .1). The rate of major bleeding was almost the same between the two groups (3.2% vs 3.3%, P = .7) . The high‐performing rate of catheter ablation and discontinuation of anticoagulation therapy after catheter ablation might lead to a lower stroke/systemic embolism and major bleeding rate in the HAF‐NET Registry.…”

“…The HAF‐NET Registry showed that catheter ablation reduced the cardiac events requiring hospitalization. In a randomized trial, the CABANA study presented a reduction in the mortality or cardiovascular hospitalizations in the catheter ablation group . The CATLE‐AF study also showed that catheter ablation reduced hospitalizations for worsening heart failure .…”