PRAGUE-17: LAAC Noninferior to DOAC in Preventing CV Death, Complications in High-Risk AFib Patients
Mechanical left atrial appendage closure (LAAC) was no better than direct oral anticoagulation (DOAC) in preventing cardioembolic events, cardiovascular death, bleeding or complications in patients with nonvalvular atrial fibrillation (AFib) at high risk for stroke, according to a results of the PRAGUE-17 trial published June 22 in the Journal of the American College of Cardiology.
Pavel Osmancik, MD, PhD, et al., compared LAAC and DOAC in high-risk patients with nonvalvular AFib. A total of 402 patients were randomly assigned to receive DOACs (n = 201) or undergo LAAC (n = 201). All patients had nonvalvular AFib; were indicated for oral anticoagulation; and had a history of bleeding requiring intervention or hospitalization; history of cardioembolic event while taking an OAC; and/or a CHA2DS2-VASc score ≥3 and HAS-BLED score >2.
The study's primary outcome was a composite of stroke, transient ischemic attack, systemic embolism, cardiovascular-related death, bleeding, or procedure- or device-related complications. The primary analysis was by modified intention to treat.
The two groups were well-balanced for clinical characteristics. The mean age was 73.3 years, and 34.4% of participants were women. Most patients had previously received anticoagulants. Of the 187 patients who ultimately underwent LAAC, the device was successfully implanted in 181 patients (96.8%). In the LAAC group, six patients (3.4%) experienced device-related thrombus. In addition, four patients (2.2%) experienced a >5-mm leak, 20 patients (11.2%) experienced a 1- to 5-mm leak, and 154 patients (86.5%) did not experience a leak. In the DOAC group, 192 patients (95.5%) received apixaban, eight patients (4%) received dabigatran, and one patient (0.5%) received rivaroxaban.
At a median 19.9 months of follow up, the annual rates of the primary outcome were 10.99% in the LAAC group vs. 13.42% in the DOAC group. There were no differences in stroke/transient ischemic attacks, clinically significant bleeding or cardiovascular death between the two groups. In the LAAC group, major LAAC-related complications occurred in nine patients and there were two procedure- or device-related deaths.
According to the researchers, mechanical LAAC was "noninferior" to DOACs for the primary composite endpoint in patients with nonvalvular AFib at high risk for stroke and increased risk for bleeding. "However, safety issues remain with LAAC, warranting further refinements in both operator technique and device technology," they conclude.
The study is an "important step forward and reinforces the role of transcatheter LAAO as a stroke-prevention strategy for patients with AFib at high risk of bleeding or medical treatment failure, even in the modern era of the DOACs," Matthew J. Price, MD, FACC, and Jacqueline Saw, MD, FACC, write in an accompanying editorial comment.
Keywords: Ischemic Attack, Transient, Atrial Fibrillation, Anticoagulants, Atrial Appendage, Intention to Treat Analysis, Stroke, Pyridones, Pyrazoles, Embolism, Thrombosis, Treatment Failure
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