The BIOFLOW-III Italian Satellite Registry: 18-month results of the Orsiro stent in an all-comer high-risk population

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.

Evaluation of Ultrathin Strut Biodegradable Polymer-Coated Sirolimus-Eluting Stents in an All-Comers Patient Population: 1-Year Results of the S-FLEX Slovakia Registry

“…This rate is on par with the 0.5% definite/probable stent thrombosis documented in the BIOFLOW-III Italian Satellite registry. 23 Additionally, this is comparable to the T-FLEX registry, 24 Thailand Orsiro registry, 25 and BIONYX trial, 26 which reported rates of definite/probable stent thrombosis as 0.6%, 0.7%, and 0.7%, respectively. The SORT OUT IX trial 27 reported 1.1% definite/probable stent thrombosis, which is numerically more than double that observed in the present registry at the 1-year follow-up.…”

Clinical outcomes of ultrathin biodegradable polymer-coated sirolimus-eluting stents in an all-comer population: One-year results from the T-FLEX registry including high-risk subgroups

“…During the study period, the SES was made available in lengths of 8,12,16,20,24,28,32,36,40,44, and 48 mm and diameters of 2.00, 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, and 4.50 mm.…”

Treatment Pattern of Antithrombotic Therapy over Time after Percutaneous Coronary Intervention in Patients with Atrial Fibrillation in Real-World Practice in Korea

“…It is reported that the incidence of stent thrombosis has been decreasing, owing to the improvement of stent design and procedures [17,18]. Although the reported incidence of stent thrombosis varies depending on clinical settings and definitions, the reported incidences have been decreasing to <1% [19,20]. In addition, there are several procedurerelated factors that affect the incidence of stent thrombosis, not just post-PCI antithrombotic treatment.…”