LAA closure noninferior to direct oral anticoagulants in high-risk AF
Among patients with atrial fibrillation at high risk for stroke, left atrial appendage closure was noninferior compared with direct oral anticoagulants, researchers reported in the randomized PRAGUE-17 trial.
“To our knowledge, among patients with nonvalvular AF at high risk for stroke, PRAGUE-17 is the first randomized trial comparing percutaneous left atrial appendage closure with direct oral anticoagulants, primarily apixaban, for the prevention of all-cause stroke, systemic embolism, cardiovascular death, clinically significant bleeding, or procedure-/device-related complications,” Pavel Osmancik, MD, PHD, of the Cardiocenter at Charles University Prague and University Hospital Kralovske Vinohrady, Prague, and colleagues wrote. “Left atrial appendage closure was noninferior to direct oral anticoagulants for this composite endpoint, in both the prespecified modified intention-to-treat primary analysis and the post hoc on-treatment and per protocol analyses.”
According to research published in the Journal of the American College of Cardiology, patients with AF who were indicated for oral anticoagulation; had a history of bleeding requiring intervention or hospitalization; had a prior cardioembolic event while on oral anticoagulation; and/or had a CHA2DS2-VASc score of at least 3 and a HAS-BLED score greater than 2 were enrolled. The composite outcome included stroke, transient ischemic attack, clinically significant bleeding and CV death.
Overall noninferiority between groups
Researchers observed that at a median of 19.9 months follow-up, incidence of the primary composite outcome was 10.99% among patients who underwent left atrial appendage (LAA) closure and 13.42% among those who received direct oral anticoagulation (subdistribution HR [sHR] = 0.84; 95% CI, 0.53-1.31; P for noninferiority = .004).
Investigators found no between groups difference for the individual components of the composite outcome:
- all-stroke or TIA (sHR = 1; 95% CI, 0.4-2.51);
- clinically significant bleeding (sHR = 0.81; 95% CI, 0.44-1.52); and
- CV death (sHR = 0.75; 95% CI, 0.34-1.62).
Moreover, major procedure- and/or device-related complications occurred in 4.5% of those assigned LAA closure.
“Although enhancements in LAA closure technology improve the safety of the device-based strategy, longer-term follow-up of larger numbers of patients will be needed to establish relative risks and benefits and inform selection of these alternative treatments,” the researchers wrote.
‘Important step forward’
“Although this trial begins to move the needle toward supporting transcatheter LAA occlusion as an alternative in patients who are direct oral anticoagulant candidates, enthusiasm to expand the target population for LAA occlusion should be tempered by several caveats,” Matthew J. Price, MD, interventional cardiologist in the division of cardiovascular diseases at Scripps Clinic, La Jolla, California, and Jacqueline Saw, MD, interventional cardiologist in the division of cardiology at Vancouver General Hospital, British Columbia, Canada, wrote in a related editorial. “The patients evaluated in PRAGUE-17 were not optimal candidates for long-term oral anticoagulant but were selected because they were at high risk for bleeding or because oral anticoagulant treatment had already failed. Notably, the pivotal trials leading to direct oral anticoagulant approval excluded patients who were deemed to have high bleeding risk, so PRAGUE-17 does not address the relative safety and efficacy of transcatheter LAA occlusion for the populations in which the current direct oral anticoagulant indications are derived.
“Despite its imperfections, PRAGUE-17 is an important step forward and reinforces the role of transcatheter LAA occlusion as a stroke-prevention strategy for patients with AF at high risk of bleeding or medical treatment failure, even in the modern era of the direct oral anticoagulants,” Price and Saw wrote.
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