SynthesisCatheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions2025
30-Day DAPT in Patients at High Bleeding Risk Undergoing PCI With Biodegradable-Polymer Sirolimus-Eluting Ultra-Thin Stent.
Synthesis in Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
10 authors.
Funding
Abstract
backgroundThere is limited evidence on the safety and efficacy of biodegradable-polymer sirolimus-eluting ultra-thin stent (BP-SES) in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI).
aimsThis study aims to evaluate the clinical outcomes of HBR patients treated with BP-SES and ≤ 30-day dual antiplatelet therapy (DAPT) regimen.
methodsA systematic review was conducted to identify relevant studies involving HBR patients who underwent PCI with BP-SES (Supraflex Cruz). Individual patient-level data were extracted from the included studies. The primary endpoint was the composite of cardiovascular death, myocardial infarction, or clinically driven target lesion revascularization at 1-year. The safety endpoint was the 1-year occurrence of Bleeding Academic Research Consortium (BARC) type 3-5.
resultsThe study population included 1691 patients. Of these, 928 patients (55%) received a ≤ 30-day DAPT, while 763 patients (45%) received a longer DAPT regimen. In the ≤ 30-day DAPT group, primary outcome events occurred in 89 patients (9.5%, 95% CI: 7.7%-11.6%). The upper limit of the one-sided 95% CI of 11.6% was below the pre-specified non-inferiority margin of 14%. There was no significant difference in the primary endpoint between the ≤ 30-day DAPT group and the >30-day DAPT group (propensity score adjusted HR: 0.95, 95% CI: 0.67-3). Notably, the incidence of BARC 3-5 bleeding events was significantly lower in the ≤ 30-day DAPT group.
conclusionsIn HBR patients treated with BP-SES, a ≤ 30-day DAPT regimen is associated with a low rate of ischemic events and a significant reduction in major bleeding events.
trial registrationPROSPERO CRD42024524208.
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