Device an alternative to long-term warfarin?

In patients with non-valvular atrial fibrillation percutaneous closure of the left atrial appendage (LAA) instead of long-term warfarin therapy is feasible but is associated with increased short-term complications, researchers report. The PROTECT AF study randomised over 700 high-risk patients with non-valvular AF in a 2:1 ratio to percutaneous closure of the LAA with a WATCHMAN device and subsequent discontinuation of warfarin or to long term warfarin therapy. The authors found that after 1065 patient years of follow up, there were 3 efficacy events per 100 patient-years in the device group, compared with 4.9 in the warfarin group—a relative reduction of 38%. However, serious safety events were more common in the device group (7.4 events per 100 patient-years) compared with the warfarin group (4.4) but most of these events tended to occur early and declined over the course of the trial. According to the authors, this high initial risk is offset by the progressive cumulative risk of chronic warfarin therapy. However, an accompanying comment said that because of some limitations of the study there is not enough evidence to recommend routine LAA in a diverse population of patients with non-valvular AF. “Despite its limitations, warfarin is still the treatment of choice for patients with non-valvular atrial fibrillation who have clear indications for, and who are suitable for long-term oral anticoagulation” it said. Nevertheless, further research is warranted into the use of left atrial appendage occlusion devices, particularly for patients unsuitable for long term warfarin therapy, the authors concluded. Lancet 2009; published online before print....