30-Day DAPT in Patients at High Bleeding Risk Undergoing PCI With Biodegradable-Polymer Sirolimus-Eluting Ultra-Thin Stent.

Background: There 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).

Aims: This study aims to evaluate the clinical outcomes of HBR patients treated with BP-SES and ≤ 30-day dual antiplatelet therapy (DAPT) regimen.

Methods: A 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.

Results: The 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.

Conclusions: In 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 Registration: PROSPERO CRD42024524208.