Author + information
- Received November 12, 1991
- Revision received February 25, 1992
- Accepted March 30, 1992
- Published online September 1, 1992.
- Greg C. Flaker, MD, FACCa,
- Joseph L. Blackshear, MD, FACC∗,
- Ruth McBride∗,†,
- Richard A. Kronmal, PhD†,
- Jonathan L. Halperin, MD, FACC‡ and
- Robert G. Hart, MD§
- ↵∗Address for correspondence: Ruth McBride, Statistics and Epidemiology Research Corporation, 1107 NE 45th, Suite 520, Seattle, Washington 98105.
Background and Objectives.The relation between cardiac mortality and antiarrhythmic drug administration has not been fully determined. This relation was analyzed in 1,330 patients enrolled in the Stroke Prevention in Atrial Fibrillation Study, a randomized clinical trial comparing warfarin, aspirin and placebo for the prevention of ischemic stroke or systemic embolism in patients with nonvalvular atrial fibrillation.
Methods.Patients who received antiarrhythmic drug therapy for atrial fibrillation in this study were compared with patients not receiving antiarrhythmic agents. The relative risk of cardiac mortality, including arrhythmic death, in patients receiving antiarrhythmic drug therapy was determined and adjusted for other cardiac risk factors.
Results.In patients receiving antiarrhythmic drug therapy, cardiac mortality was increased 2.5-fold (p = 0.006, 95% confidence interval [CI] 1.3 to 4.9) and arrhythmic death was increased 2.6-fold (p = 0.02, 95% CI 1.2 to 5.6). Among patients with a history of congestive heart failure, Shose given antiarrhythmic medications had a relative risk of cardiac death of 4.7 (p < 9.001, 95% CI 1.9 to 11.6) compared with that of patients not so treated; the relative risk of arrhythmic death in the treated group was 3.7 (p = 0.01, 95% CI 1.3 to 10.4). Patients without a history of congestive heart failure had no increased risk of cardiac mortality (relative risk 0.70, 95% CI 0.2 to 3.1) during antiarrhythmic drug therapy.
After exclusion of 23 patients with documented ventricular arrhythmias and adjustment for other variables predictive of cardiac death, patients receiving antiarrhythmic drugs were not at increased risk of cardiac death or arrhythmic death. However, in patients with a history of heart failure who received antiarrhythmic drug therapy, the relative risk of cardiac death was 3.3 (p = 0.05, 95% CI 0.99 to 11.1) and that of arrhythmic death was 5.8 (p = 0.009, 95% CI 1.5 to 21.7) compared with the risk in patients not taking antiarrhythmic medications.
Conclusions.Although antiarrhythmic drug therapy was not randomly determined in this trial, the data suggest that in patients with artrial fibrillation and a history of congestive heart failure, the risk of such therapy may outweigh the potential benefit of maintaining sinus rhythm.
On behalf of the Stroke Prevention in Atrial Fibrillation Investigators
☆ This study was supported by Grant R01-NS-24424 from the Division of Stroke and Trauma, National Institute of Neurological Disorders and Stroke, Bethesda, Maryland.
- Received November 12, 1991.
- Revision received February 25, 1992.
- Accepted March 30, 1992.