DENVER – Using dabigatran rather than warfarin for periprocedural anticoagulation in patients undergoing radiofrequency ablation for atrial fibrillation may entail a small but statistically increased risk of stroke or transient ischemic attack, according to a meta-analysis of 10 observational cohort studies.
Guidelines recommend periprocedural anticoagulation for at least 2 months post ablation. Warfarin continues to be the most widely used agent for this purpose, but new oral alternatives are attracting a great deal of interest from physicians and patients.
Dr. Benjamin Steinberg
The meta-analysis, which included 1,501 patients on periprocedural dabigatran (Pradaxa) and 2,356 on warfarin, had dual primary end points. One was stroke or TIA, which occurred in 0.7% of the dabigatran group, compared with 0.2% of those on warfarin – a statistically significant difference (P = .0007), Dr. Benjamin A. Steinberg reported at the annual meeting of the Heart Rhythm Society.
The co-primary end point, major bleeding, was recorded in 1.6% of the dabigatran group, with a closely similar 1.7% incidence in the warfarin group, added Dr. Steinberg of Duke University in Durham, N.C.
Rates of cardiac tamponade, a secondary end point, were also similar: 1.1% with dabigatran and 0.9% with warfarin.
Although dabigatran is approved for the prevention of stroke or systemic embolism in patients with AF, a definitive determination of its safety and effectiveness in the setting of AF ablation therapy will require randomized trials, Dr. Steinberg observed.
Such trials would, of necessity, have to be quite large. The data from this meta-analysis suggest that, for every 200 patients undergoing AF ablation under the protection of dabigatran rather than warfarin, one additional case of stroke or TIA would occur.
The meta-analysis was supported in part by the Agency for Healthcare Research and Quality. Dr. Steinberg reported having no conflicts of interest.