One‐month dual antiplatelet therapy after bioresorbable polymer everolimus‐eluting stents in high bleeding risk patients
Journal of the American Heart Association Feb 08, 2022
Findings demonstrate the safety of a 1‐month dual antiplatelet therapy (DAPT) regimen in high bleeding risk patients receiving percutaneous coronary interventions with the Synergy bioresorbable‐polymer everolimus‐eluting stent. DAPT regimen was associated with low rates of ischemic and bleeding events.
This prospective, multicenter trial was conducted to assess the safety of percutaneous coronary interventions with Synergy bioresorbable‐polymer everolimus‐eluting stent followed by 1‐month dual antiplatelet therapy in patients (n=443; age, 74.8±9.2 years; women, 29.1%) with high bleeding risk.
If an oral anticoagulant was required, patients were administered an oral anticoagulant in addition to a P2Y <sub>12</sub> inhibitor for 1 month, followed by an oral anticoagulant only.
The composite of cardiac death, myocardial infarction, or definite or probable stent thrombosis at 1‐year follow‐up was the primary endpoint.
In 4.82% of patients, the 1‐year primary outcome occurred, meeting the noninferiority relative to the predefined objective performance criterion of 9.4% and the noninferiority margin of 3.85% notwithstanding the lower‐than‐expected sample size.
Cardiac death, myocardial infarction, and definite or probable stent thrombosis rates were reported to be 1.88%, 3.42%, and 0.94%, respectively.
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