We aimed to corroborate clinical evidence on the safety and efficacy of the ultrathin-strut biodegradable-polymer sirolimus-eluting Orsiro stent in an all-comer population including high-risk subgroups.
The nationwide, prospective, all-comer BIOFLOW-III Satellite Registry was conducted at 18 Italian sites. High-risk subgroups [diabetes, small vessels (≤2.75 mm), acute myocardial infarction (AMI), and chronic total occlusions (CTOs)] were prespecified. The primary endpoint was target lesion failure (TLF) at 12 months, a composite of cardiac death, target vessel myocardial infarction (MI), emergent coronary artery bypass graft, and clinically driven target lesion revascularization (TLR).
In all, 601 patients were enrolled (31.9% diabetes, 34.6% AMIs) with 736 lesions (37.2% small vessels, 5.7% CTOs, and 15.5% bifurcation lesions). Cumulative TLF rate at 12 months was 4.6% [95% confidence interval (CI) 3.2–6.6]: 6.9% (95% CI 4.1–11.6) in the diabetic patients, 5.0% (95% CI 2.7–9.1) in acute MI subgroup, 4.2% (95% CI 2.3–7.7) in small vessels, and 5.3% (95% CI 1.4–19.7) in CTOs. At 18-month follow-up, TLF, target vessel revascularization, and clinically driven TLR rates in the overall population were 5.2% (95% CI 3.7–7.4), 1.8% (95% CI 1.0–3.3), and 1.6% (95% CI 0.8–3.1), respectively. Probable stent thrombosis rate was 0.5% (95% CI 0.1–1.4), whereas no definite stent thrombosis was observed.
The study results confirmed the excellent clinical performance of the Orsiro drug-eluting stents at 18 months in the whole all-comer population and in the prespecified high-risk subgroups.
aCentro Cardiologico Monzino, IRCCS, Department of Biomedical and Clinical Sciences ‘Luigi Sacco’, University of Milan, Milan
bDivision of Cardiology, S. Maria Goretti Hospital, Latina
cLaboratory of Interventional Cardiology and Department of Cardiology, Clinica Mediterranea, Naples
dDepartment of Cardiovascular Sciences, European Hospital, Rome
eIstituto Clinico Città Studi, Milan
fDepartment of Cardiology, ASST Ovest Milanese, Legnano
gDepartment of Cardiology, Casa Sollievo della Sofferenza Hospital IRCCS, San Giovanni Rotondo (FG)
hPresidio Ospedaliero San Salvatore, Pesaro
iCardiology Unit, Casa di Cura Villa Verde, Taranto
jPoliclinico di Bari, Bari
kDivision of Cardiology, Presidio Ospedaliero Di Venere, Bari Carbonara, Italy
Correspondence to Professor Antonio Luca Bartorelli, MD, Centro Cardiologico Monzino, IRCCS, Department of Biomedical and Clinical Sciences ‘Luigi Sacco’, University of Milan, Via Carlo Parea, 4, 20138 Milan, Italy Tel: +39 0258002331; e-mail: email@example.com
Received 26 November, 2018
Revised 18 February, 2019
Accepted 17 March, 2019
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