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The BIOFLOW-III Italian Satellite Registry

18-month results of the Orsiro stent in an all-comer high-risk population

Bartorelli, Antonio Lucaa; Versaci, Francescob; Briguori, Carloc; Tomai, Fabriziod; Aprigliano, Gianfrancoe; Poli, Arnaldof; Vigna, Carlog; Marinucci, Luciah; My, Luigii; Masi, Filippoj; Turturo, Mauriziok

Journal of Cardiovascular Medicine: July 2019 - Volume 20 - Issue 7 - p 464–470
doi: 10.2459/JCM.0000000000000795
Research articles: Interventional cardiology. Coronary artery disease
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Aims 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.

Methods 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).

Results 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.

Conclusions 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: antonio.bartorelli@ccfm.it

Received 26 November, 2018

Revised 18 February, 2019

Accepted 17 March, 2019

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© 2019 Italian Federation of Cardiology. All rights reserved.