Outcomes after cardioversion and atrial fibrillation ablation in patients treated with rivaroxaban and warfarin in the ROCKET AF trial

J Am Coll Cardiol. 2013 May 14;61(19):1998-2006. doi: 10.1016/j.jacc.2013.02.025. Epub 2013 Mar 14.

Abstract

Objectives: This study sought to investigate the outcomes following cardioversion or catheter ablation in patients with atrial fibrillation (AF) treated with warfarin or rivaroxaban.

Background: There are limited data on outcomes following cardioversion or catheter ablation in AF patients treated with factor Xa inhibitors.

Methods: We compared the incidence of electrical cardioversion (ECV), pharmacologic cardioversion (PCV), or AF ablation and subsequent outcomes in patients in a post hoc analysis of the ROCKET AF (Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation) trial.

Results: Over a median follow-up of 2.1 years, 143 patients underwent ECV, 142 underwent PCV, and 79 underwent catheter ablation. The overall incidence of ECV, PCV, or AF ablation was 1.45 per 100 patient-years (n = 321; 1.44 [n = 161] in the warfarin arm, 1.46 [n = 160] in the rivaroxaban arm). The crude rates of stroke and death increased in the first 30 days after cardioversion or ablation. After adjustment for baseline differences, the long-term incidence of stroke or systemic embolism (hazard ratio [HR]: 1.38; 95% confidence interval [CI]: 0.61 to 3.11), cardiovascular death (HR: 1.57; 95% CI: 0.69 to 3.55), and death from all causes (HR: 1.75; 95% CI: 0.90 to 3.42) were not different before and after cardioversion or AF ablation. Hospitalization increased after cardioversion or AF ablation (HR: 2.01; 95% CI: 1.51 to 2.68), but there was no evidence of a differential effect by randomized treatment (p value for interaction = 0.58). The incidence of stroke or systemic embolism (1.88% vs. 1.86%) and death (1.88% vs. 3.73%) were similar in the rivaroxaban-treated and warfarin-treated groups.

Conclusions: Despite an increase in hospitalization, there were no differences in long-term stroke rates or survival following cardioversion or AF ablation. Outcomes were similar in patients treated with rivaroxaban or warfarin. (An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation [ROCKET AF]; NCT00403767).

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Anticoagulants / therapeutic use
  • Atrial Fibrillation / therapy*
  • Catheter Ablation / statistics & numerical data*
  • Electric Countershock / statistics & numerical data*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Morpholines / therapeutic use
  • Multicenter Studies as Topic
  • Multivariate Analysis
  • Rivaroxaban
  • Stroke / epidemiology*
  • Stroke / prevention & control*
  • Thiophenes / therapeutic use
  • Treatment Outcome
  • Warfarin / therapeutic use

Substances

  • Anticoagulants
  • Morpholines
  • Thiophenes
  • Warfarin
  • Rivaroxaban

Associated data

  • ClinicalTrials.gov/NCT00403767