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

In this large RCT involving patients with symptomatic atrial fib, catheter ablation, compared with medical therapy, did not significantly reduce the primary composite end point of death, disabling stroke, serious bleeding, or cardiac arrest. James Mold, MD, MPH

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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.

Author/s:

Packer, Douglas L., Mark, Daniel B., Robb, RIchard A., Monahan, Kristi H., Bahnson, Tristram D., Poole, Jessica E., Noseworthy, Peter A., Rosenberg, Yves D., Jeffries, Neal, Mitchell, L. Brent, Flaker, Greg C., Pokushalov, Evgeny, Romanov, ALexander, Bunch, T. Jared, Noelker, Georg, Ardashev, Andrey, Revishvili, Amiran, Wilber, David J., Cappato, Riccardo, Kuck, Karl-Heinz, Hindricks, Gerhard, Davies, D. Wyn, Kowey, Peter R., Naccarelli, Gerald V., Reiffel, James A., Piccini, Jonathan P., Silverstein, Adam P., Al-Khalidi, Hussein R., Lee, Kerry L.

Effect of Catheter Ablation vs Medical Therapy on Quality of Life Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial

Jeffrey Wilson — Mon, 18 Mar 2019 14:11:48 +0000

Date Added:

March 18, 2019

Journal/Publication:

JAMA

Publisher:

American Medical Association

Publication Date:

March 15, 2019

URL:

Effect of Catheter Ablation vs Medical Therapy on Quality of Life Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1001/jama.2019.0692

Keywords

PMID (1):

30874716

MeSH

In this large RCT, treatment of patients with symptomatic atrial fibrillation with catheter ablation improved quality of life significantly more than medical therapy. James Mold, MD, MPH

Free full text

IMPORTANCE:

Catheter ablation is more effective than drug therapy in restoring sinus rhythm in patients with atrial fibrillation (AF), but its incremental effect on long-term quality of life (QOL) is uncertain.

OBJECTIVE:

To determine whether catheter ablation is more beneficial than conventional drug therapy for improving QOL in patients with AF.

DESIGN, SETTING, AND PARTICIPANTS:

An open-label randomized clinical trial of catheter ablation vs drug therapy in 2204 symptomatic patients with AF older than 65 years or 65 years or younger with at least 1 risk factor for stroke. Patients were enrolled from November 2009 to April 2016 from 126 centers in 10 countries. Follow-up ended in December 2017.

INTERVENTIONS:

Pulmonary vein isolation, with additional ablation procedures at the discretion of the investigators, for the catheter ablation group (n = 1108) and standard rhythm and/or rate-control drugs selected and managed by investigators for the drug therapy group (n = 1096).

MAIN OUTCOMES AND MEASURES:

Prespecified co-primary QOL end points at 12 months, including the Atrial Fibrillation Effect on Quality of Life (AFEQT) summary score (range, 0-100; 0 indicates complete disability and 100 indicates no disability; patient-level clinically important difference, ≥5 points) and the Mayo AF-Specific Symptom Inventory (MAFSI) frequency score (range, 0-40; 0 indicates no symptoms and 40 indicates the most severe symptoms; patient-level clinically important difference, ≤-1.6 points) and severity score (range, 0-30; 0 indicates no symptoms and 30 indicates the most severe symptoms; patient-level clinically important difference, ≤-1.3 points).

RESULTS:

Among 2204 randomized patients (median age, 68 years; 1385 patients [63%] were men, 946 [43%] had paroxysmal AF, and 1256 [57%] had persistent AF), the median follow-up was 48.5 months, and 1968 (89%) completed the trial. The mean AFEQT summary score was more favorable in the catheter ablation group than the drug therapy group at 12 months (86.4 points vs 80.9 points) (adjusted difference, 5.3 points [95% CI, 3.7-6.9]; P < .001). The mean MAFSI frequency score was more favorable for the catheter ablation group than the drug therapy group at 12 months (6.4 points vs 8.1 points) (adjusted difference, -1.7 points [95% CI, -2.3 to -1.2]; P < .001) and the mean MAFSI severity score was more favorable for the catheter ablation group than the drug therapy group at 12 months (5.0 points vs 6.5 points) (adjusted difference, -1.5 points [95% CI, -2.0 to -1.1]; P < .001).

CONCLUSIONS AND RELEVANCE:

Among patients with symptomatic atrial fibrillation, catheter ablation, compared with medical therapy, led to clinically important and significant improvements in quality of life at 12 months. These findings can help guide decisions regarding management of atrial fibrillation.

Author/s:

Mark, Daniel B., Anstrom, Kevin J., Sheng, Shubin, Piccini, Jonathan P., Baloch, Khaula N., Monahan, Kristi H., Daniels, Melanie R., Bahnson, Tristram D., Poole, Jeanne E., Rosenberg, Yves, Lee, Kerry L., Packer, Douglas L.