One-year clinical outcome of biodegradable polymer sirolimus-eluting stent in patients needing short dual antiplatelet therapy. Insight from the ULISSE registry (ULtimaster Italian multicenter all comerS Stent rEgistry)

Cosmo Godino, Alessandro Beneduce, Giuseppe Ferrante, Alfonso Ielasi, Carlo Andrea Pivato, Mauro Chiarito, Alberto Cappelletti, Giulia Perfetti, Valeria Magni, Eugenio Prati, Stefania Falcone, Adele Pierri, Stefano De Martini, Matteo Montorfano, Rosario Parisi, David Rutigliano, Nicola Locuratolo, Angelo Anzuini, Maurizio Tespili, Alberto MargonatoAlberto Benassi, Carlo Briguori, Franco Fabbiocchi, Bernhard Reimers, Antonio Bartorelli, Antonio Colombo

Research output: Contribution to journalArticlepeer-review

Abstract

Background: This study aimed to evaluate real-world clinical outcome of patients needing short dual antiplatelet therapy (S-DAPT) following PCI with Ultimaster® thin-strut, biodegradable polymer sirolimus-eluting stent (BP-SES), which was supposed to induce faster stent endothelialization and reduce device thrombogenicity. Methods: In this sub-group analysis of patients enrolled in the ULISSE registry, two groups were identified: 1) patients discharged with S-DAPT (≤3-month) due to high bleeding risk or need for urgent major non-cardiac surgery and 2) patients discharged with recommended DAPT (R-DAPT) duration (≥6-month). The primary ischemic-safety and bleeding-safety endpoints were TLF (composite of cardiac-death, target vessel MI, and clinically driven target lesion revascularization), and BARC major bleedings (≥type-3a) at 1-year follow-up. To account for events occurring before DAPT discontinuation we performed 3-month landmark analysis. Results: 82 patients (5%) were discharged with ≤3-month DAPT (57 ± 27 days), and 1558 patients (94%) were discharged with ≥6-month DAPT (318 ± 75 days). No significant differences between S-DAPT and R-DAPT group were observed in TLF at 1-year (7.9% vs. 4.6%). The rate of BARC major bleeding resulted significantly higher in S-DAPT group (3.9% vs. 0.3%; p = 0.001), with the majority of bleeding events occurring within 3 months. The landmark analysis showed no significant differences in BARC major bleedings between groups (1.4% vs. 0.3%; p = 0.142). Conclusions: As compared to those treated with R-DAPT (≥6-month), patients needing -S-DAPT (≤3-month) after PCI with Ultimaster® BP-SES had similar rates of 1-year TLF and BARC major bleedings following early DAPT discontinuation.

Original languageEnglish
Pages (from-to)52-58
Number of pages7
JournalInternational Journal of Cardiology
Volume290
DOIs
Publication statusPublished - Sep 1 2019

Keywords

  • Biodegradable polymer sirolimus-eluting stent
  • Dual antiplatelet therapy
  • High bleeding risk
  • Percutaneous coronary intervention
  • Stent thrombosis

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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