PROTECT-AF trial of Watchman LAAC (Boston Scientific) successful for Stroke Prevention

Four-year follow-up data from the PROTECT AF clinical trial demonstrated the Watchman Left Atrial Appendage (LAA) Closure device, from Boston Scientific, was statistically superior to warfarin for preventing cardiovascular death, all-cause Stroke and systemic embolization. The data demonstrated significant reductions in both cardiovascular and all death compared to warfarin.

The observed primary efficacy event rate was 2.3 percent and 3.8 percent in the Watchman and control groups, respectively, demonstrating a 40 percent relative risk reduction in primary efficacy in the Watchman group. Secondary analysis also showed a relative risk reduction and superiority to control for all-cause mortality and cardiovascular mortality. The data were presented at Heart Rhythm 2013. The device is approved in the EU but still in trials in the US.