The BIOFLOW-III Italian Satellite Registry: 18-month results of the Orsiro stent in an all-comer high-risk population. Issue 7 (July 2019)

• Record Type: Journal Article
• Authors: Bartorelli, Antonio Luca; Versaci, Francesco; Briguori, Carlo; Tomai, Fabrizio; Aprigliano, Gianfranco; Poli, Arnaldo; Vigna, Carlo; Marinucci, Lucia; My, Luigi; Masi, Filippo; Turturo, Maurizio
• Is Part Of: Journal of cardiovascular medicine. Volume 20:Issue 7(2019:Jul.)
• Publication Date: 2019-07
• Subjects: ACS/NSTEMI -- acute myocardial infarction/STEMI -- DES -- diabetes mellitus -- percutaneous coronary intervention; Cardiology -- Periodicals; Cardiovascular system -- Diseases -- Periodicals; Cardiology -- Periodicals; Cardiovascular Diseases -- Periodicals; 616.1005
• DOI: 10.2459/JCM.0000000000000795
• Languages: English
• ISSNs: 1558-2027

Abstract

Abstract : 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. Abstract : Supplemental Digital Content is available in the text