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

Andrea Enriquez¹ | David M. Leistner² | Valeria Paradies³ | Rita Pavasini¹ | Matteo Serenelli¹ | Gianni Casella⁴ |
Simone Biscaglia¹ | Christoph Naber⁵ | Gianluca Campo¹  | Pieter C. Smits³

¹Cardiology Unit, Azienda Ospedaliero Universitaria di Ferrara, Cona, Ferrara, Italy | ²Department of Cardiology, Angiology and Intensive Care Medicine, Goethe University Hospital, Frankfurt, Germany | ³Department of Cardiology, Maasstad Hospital, Rotterdam, the Netherlands | ⁴Cardiology Unit, Ospedale Maggiore, Bologna, Italy | ⁵Facharztpraxis Baldeney, Essen, Germany

Correspondence: Gianluca Campo (cmpgluc@unife.it)
Received: 28 December 2024 | Revised: 15 February 2025 | Accepted: 27 February 2025

Funding: The present analysis did not receive any economic support. However, Sahajanand Medical Technologies Ltd. (SMT) provided unrestricted funding for the conduction of the trials included in the present meta-analysis. SMT was not involved in the design, data collection, analysis, interpretation, or writing of the present manuscript.

Keywords: dual antiplatelet therapy | high bleeding risk | meta-analysis | percutaneous coronary intervention | sirolimus-eluting biodegradable polymer stent

ABSTRACT
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: 0.67–1.33). 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.