OBJECTIVE: The objective of this study was to assess the safety and efficacy of a polymer-free sirolimus coated, ultrathin strut drug-eluting stent (PF-SES) in an unselected patient population with a focus on acute coronary syndrome (ACS). Furthermore, stable coronary artery disease (CAD) with short (≤6 months) versus long (>6 months) dual antiplatelet therapy (DAPT) were also studied. METHODS: Patients who received PF-SES were investigated in an unselected large-scale international, single-armed, multicenter, 'all comers' observational study. The primary endpoint was the 9-month target lesion revascularisation (TLR) rate, whereas secondary endpoints included the 9-month major adverse cardiac events (MACE) and procedural success rates. A priori defined subgroups such as patients with ACS, diabetes, lesion subsets and procedural characteristics relative to DAPT were investigated. RESULTS: A total of 2877 patients of whom 1084 had ACS were treated with PF-SES (1.31±0.75 stents per patient). At 9 months, the accumulated overall TLR rate was 2.3% (58/2513). There was no significant difference between ACS and stable CAD (2.6% vs 2.1%, p=0.389). However, the overall MACE rate was 4.3% (108/2513) with a higher rate in patients with ACS when compared with the stable CAD subgroup (6.1%, 58/947 vs 3.2%, 50/1566, p<0.001). CONCLUSIONS: PF-SES angioplasty is safe and effective in the daily clinical routine with low rates of TLR and MACE in an unselected patient population. Our data are in agreement with prior clinical findings that extended DAPT duration beyond 6 months do not improve clinical outcomes in patients with stable CAD (ClinicalTrials.gov Identifier NCT02629575). TRIAL REGISTRATION NUMBER: NCT02629575.

Ambulantes Herzzentrum Kassel Kassel Germany

Cardiocentre of Teaching Hospital of J A Reiman Prešov Slovakia

Department of Cardiology Gil Hospital Gachon University Incheon Republic of Korea

Department of Cardiology SUSCCH a s Banská Bystrica Slovakia

Department of Cardiology University Hospital Královské Vinohrady Prague Czech Republic

Department of Kardiologie Elblandklinikum Riesa Riesa Germany

Department of Kardiologie Helmut G Walther Klinikum Lichtenfels Lichtenfels Germany

Department of Kardiologie Sudharz Klinikum Nordhausen gGmbH Nordhausen Thüringen Germany

Department of Medical Scientific Affairs B Braun Melsungen AG Berlin Germany

Division Cardiology Department of Medicine University Malaya Medical Centre Kuala Lumpur Malaysia

Division of Cardiology Chonnam National University Hospital Gwangju Republic of Korea

Kardiologie Campus Virchow Klinikum Charité Berlin Germany

Klinik für Kardiologie Angiologie Pneumologie Klinikum Esslingen Esslingen Baden Württemberg Germany

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ClinicalTrials.gov
NCT02629575