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Impact of treatment crossovers on clinical outcomes in the rate and rhythm control strategies for atrial fibrillation: Insights from the AFFIRM (Atrial Fibrillation Follow‐up Investigation of Rhythm Management) trial
Author(s) -
Maan Abhishek,
Zhang Zheng,
Qin Ziling,
Wang Yanbing,
Dudley Samuel,
Dabhadakar Kaustubh,
Refaat Marwan,
Mansour Moussa,
Ruskin Jeremy N.,
Heist E. Kevin
Publication year - 2017
Publication title -
pacing and clinical electrophysiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.686
H-Index - 101
eISSN - 1540-8159
pISSN - 0147-8389
DOI - 10.1111/pace.13112
Subject(s) - medicine , atrial fibrillation , hazard ratio , sinus rhythm , crossover study , rhythm , cardiology , confidence interval , randomized controlled trial , adverse effect , heart rate , blood pressure , alternative medicine , pathology , placebo
We investigated the rates and reasons for crossover to alternative treatment strategies and its impact on mortality in patients who were enrolled in the Atrial Fibrillation Follow‐up Investigation of Rhythm Management (AFFIRM) trial. Over a mean follow‐up period of 3.5 years, 842 patients underwent crossover to the alternative treatment arms in AFFIRM. The rate of crossover from rhythm to rate control (594/2,033, 29.2%) was more frequent than the rate of crossover from rate to rhythm control (248/2,027, 12.2%, P < 0.0001). The leading reasons for crossover from rhythm to rate control were failure to achieve or maintain sinus rhythm (272/594, 45.8%) and intolerable adverse effects (122/594, 20.5%). In comparison, the major reasons for crossover from rate to rhythm control were failure to control atrial fibrillation symptoms (159/248, 64.1%) and intolerable adverse effects (9/248, 3.6%). This difference in crossover pattern was statistically significant (P < 0.0001). There was a significantly decreased risk of all‐cause mortality (adjusted HR: 0.61, 95% CI: 0.48–0.78, P < 0.0001) and cardiac mortality (adjusted hazard ratio [HR]: 0.61, 95% confidence interval [CI]: 0.43–0.88, P = 0.008) in the subgroup of patients who crossed over from rhythm to rate control as compared to those who continued in rhythm control. There was a nonsignificant trend toward decreased all‐cause (adjusted HR: 0.76, 95% CI: 0.53–1.10, P = 0.14) and cardiac mortality (adjusted HR: 0.70, 95% CI: 0.42–1.18, P = 0.18) in patients who crossed over from rate to rhythm control as compared to those who continued rate control.