Low stroke risk after elective cardioversion of atrial fibrillation: an analysis of the Flec-SL trial

Int J Cardiol. 2013 Oct 9;168(4):3977-81. doi: 10.1016/j.ijcard.2013.06.090. Epub 2013 Jul 18.

Abstract

Background: Current recommendations for anticoagulation management during cardioversion are largely based on historical data and expert consensus.

Methods and results: To characterize current practice of anticoagulation during and after elective cardioversion for AF and the risk of stroke and bleeding events, all patients enrolled into the Flec-SL trial were analyzed for stroke/transient ischemic attack and major bleeds after cardioversion. Flec-SL (ISRCTN62728743, NCT00215774) enrolled 635 patients (mean age 63.7 ± 10.9, 66% male). 629 (99.1%) patients received periprocedural anticoagulation, 556 (87.6%) were adequately anticoagulated following current recommendations. 202 (31.8%) patients underwent transesophageal echocardiography-guided cardioversion. Electrical cardioversion was used in 508 patients (80.0%), pharmacological cardioversion in 127 (20%). Six patients suffered from stroke (n = 5) or transient ischemic attack (3 TIAs in 1 patient, event rate 0.9%, 95% CI 0.4-2.1), five others from major bleeds (event rate 0.8%, 95% CI 0.3-1.9), consistent with the low reported event rates in prior studies. Three strokes occurred in the first 5 days after cardioversion. Events were independent of type of cardioversion or the use of TEE to exclude thrombi.

Conclusion: Strokes are rare in this large, prospectively followed cohort of patients undergoing cardioversion for AF and receiving antithrombotic therapy following local routine. These results support adherence to current recommendations for anticoagulation during cardioversion of AF.

Keywords: Anticoagulation; Atrial fibrillation; Cardioversion; Major bleeding; Stroke.

Publication types

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

MeSH terms

  • Aged
  • Aged, 80 and over
  • Anti-Arrhythmia Agents / therapeutic use
  • Atrial Fibrillation / diagnosis
  • Atrial Fibrillation / epidemiology*
  • Atrial Fibrillation / therapy*
  • Cohort Studies
  • Electric Countershock / methods*
  • Electric Countershock / trends
  • Female
  • Flecainide / therapeutic use*
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Risk Factors
  • Single-Blind Method
  • Stroke / diagnosis
  • Stroke / epidemiology*
  • Stroke / prevention & control*
  • Treatment Outcome

Substances

  • Anti-Arrhythmia Agents
  • Flecainide

Associated data

  • ClinicalTrials.gov/NCT00215774
  • ISRCTN/ISRCTN62728743