Cardiovascular Outcomes in the AFFIRM Trial (Atrial Fibrillation Follow-Up Investigation of Rhythm Management)

• Published in: Journal of the American College of Cardiology Vol. 58; no. 19; pp. 1975 - 1985
• Main Authors: Saksena, Sanjeev, MD, Slee, April, MS, Waldo, Albert L., MD, Freemantle, Nick, PhD, Reynolds, Mathew, MD, MS, Rosenberg, Yves, MD, Rathod, Snehal, MS, Grant, Shannon, MS, Thomas, Elizabeth, MS, Wyse, D. George, MD, PhD
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 01.11.2011
• Subjects: antiarrhythmic drugs; atrial fibrillation; Cardiovascular; cardiovascular hospitalizations; cardiovascular outcomes; clinical trials; Internal Medicine; outcomes research; cardiovascular outcomes; AAD; AF; CI; Rate; cardiovascular hospital stay(s); HR; outcomes research; cardiovascular; antiarrhythmic drug; atrial fibrillation; CV; CVH; rate control strategy arm; hazard ratio; antiarrhythmic drugs; cardiovascular hospitalizations; clinical trials; confidence interval; ICU; intensive care unit
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2011.07.036

Objectives The impact of individual antiarrhythmic drugs (AADs) on mortality and hospital stay in atrial fibrillation (AF) was evaluated. Background Cardiovascular (CV) outcomes in AF patients receiving pharmacologic rhythm control therapy have not been compared with rate control therapy on the basis of AAD selection. Methods We compared CV outcomes in the AFFIRM (Atrial Fibrillation Follow-Up Investigation of Rhythm Management) trial in subgroups defined by the initial AAD selected with propensity score matched subgroups from the rate arm (Rate). Results Seven hundred twenty-nine amiodarone patients, 606 sotalol patients, and 268 Class 1C patients were matched. The composite outcome of mortality or cardiovascular hospital stays (CVH) showed better outcomes with Rate compared with amiodarone (hazard ratio [HR]: 1.18, 95% confidence interval [CI]: 1.03 to 1.36, p = 0.02), sotalol (HR: 1.32, 95% CI: 1.13 to 1.54, p < 0.001), and Class 1C (HR: 1.22, 95% CI: 0.97 to 1.56, p = 0.10). There was a nonsignificant increase in mortality with amiodarone (HR: 1.20, 95% CI: 0.94 to 1.53, p = 0.15) with the risk of non-CV death being significantly higher with amiodarone versus Rate (HR: 1.11, 95% CI: 1.01 to 1.24, p = 0.04). First CVH event rates at 3 years were 47% for amiodarone, 50% for sotalol, and 44% for Class 1C versus 40%, 40%, and 36%, respectively, for Rate (amiodarone HR: 1.20, 95% CI: 1.03 to 1.40, p = 0.02, sotalol HR: 1.364, 95% CI: 1.16 to 1.611, p < 0.001, Class 1C HR: 1.24, 95% CI: 0.96 to 1.60, p = 0.09). Time to CVH with intensive care unit stay or death was shorter with amiodarone (HR: 1.22, 95% CI: 1.02 to 1.46, p = 0.03). Conclusions In AFFIRM, composite mortality and CVH outcomes differed for Rate and AADs due to differences in CVH; CVH event rates during follow-up were high for all cohorts, but they were higher for all groups on AADs. Death, intensive care unit hospital stay, and non-CV death were more frequent with amiodarone. (Atrial Fibrillation Follow-Up Investigation of Rhythm Management; NCT00000556 )