Periprocedural Stroke and Bleeding Complications in Patients undergoing Catheter Ablation of Atrial Fibrillation with Different Anticoagulation Management: Results from the "COMPARE" Randomized Trial
Background—Periprocedural thromboembolic (TE) and hemorrhagic events are worrisome complications of catheter ablation for atrial fibrillation (AF). The periprocedural anticoagulation management could play a role in the incidence of these complications. Although, ablation procedures performed without warfarin discontinuation seem to be associated with lower TE risk, no randomized study exists.
Methods and Results—This was a prospective open-label, randomized, parallel-group, multicenter study assessing the role of continuous warfarin therapy in preventing periprocedural TE and hemorrhagic events after radiofrequency catheter ablation. Patients with CHADS2 score ≥ 1 were included. Patients were randomly assigned in a 1:1 ratio to the off-warfarin or on-warfarin arm. Incidence of TE events in the 48 hours post-ablation was the primary end point of the study. The study enrolled 1584 patients; 790 assigned to discontinue warfarin (group I) and 794 to continuous warfarin (group II). No statistical difference in the baseline characteristics was observed. There were 39 TE [3.7% (29) strokes and 1.3% (10) TIA] events in group I; 2 (0.87%) in PAF (paroxysmal), 4 (2.3%) in persistent AF, and 33 (8.5%) in long standing persistent (LSP) AF. Only 2 (0.25%) strokes in LSP patients were observed in group II (p <0.001). Warfarin discontinuation emerged as a strong predictor of periprocedural TE (odds ratio (OR) 13, 95% CI 3.1 to 55.6 p<0.001).
Conclusions—This is the first randomized study showing that performing catheter ablation of AF without warfarin discontinuation reduces the occurrence of peri-procedural stroke and minor bleeding complications when compared to bridging with low molecular weight heparin.
Clinical Trial Registration Information—www.clinicaltrials.gov/. Identifier: NCT01006876.
- Received September 23, 2013.
- Revision received March 6, 2014.
- Accepted April 11, 2014.