Safety and Performance of the Orsiro Sirolimus-Eluting Stent in the Treatment of All-Comers Patient Population in Daily Clinical Practice
In: Cardiovascular revascularization medicine : including molecular interventions, Jg. 21 (2020-03-12), Heft 11
Online
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Zugriff:
Background The BIOFLOW-III Canada registry aimed to evaluate the safety and efficacy of Orsiro sirolimus-eluting stents (SES) with biodegradable polymer, in an all-comers patient population. Methods We conducted a prospective, non-randomized, multi-center, observational all-comers registry of patients undergoing percutaneous coronary intervention (PCI) with Orsiro SES at two high-volume Canadian centers. The primary endpoint was one-year target lesion failure (TLF) defined as a composite of cardiac death, target-vessel myocardial infarction (MI), coronary artery bypass grafting and clinically driven target lesion revascularization. Four subgroups were pre-defined: i) diabetic patients; ii) small vessels (≤2.75 mm); iii) chronic total occlusions (CTO) and iv) acute MI. Results From May 2014 to July 2016, 250 patients (mean age 66.2 ± 10.8 years, 75.6% males, 30% diabetes) underwent PCI with Orsiro SES for 385 coronary lesions. The mean stent diameter was 2.98 ± 0.50 mm and the mean stent length was 22 ± 8 mm. Clinical device and procedural success rates were with 99.5% and 97.6%, respectively. The overall one-year TLF rate was 2.8% [95% confidence interval (CI) 1.4–5.8%], whereas TLF rates were 4.1% [95%CI 1.3–12.2%], 3.2% [95%CI 1.2–8.4%], 8.3% [95%CI 2.2–29.4%], and 2.6% [95%CI 0.7–9.9%] in patients with diabetes, small vessels, CTO, and acute MI, respectively. One case of possible stent thrombosis (ST) was reported (0.4% [95%CI 0.1–2.8%]), while no cases of definite/probable ST was observed at one year. Conclusion Our data provide further evidence of the safety and clinical performance of Orsiro SES in an unselected, real-world, complex patient population. Condensed abstract The BIOFLOW-III Canada registry is a prospective, non-randomized, multi-center, observational all-comers registry designed to evaluate the safety and performance of the Orsiro SES in non-selected, real-world patients. A total of 250 patients (mean age 66.2 ± 10.8 years, 75.6% males, 30% diabetes) who underwent PCI with Orsiro SES, were enrolled at two high-volume Canadian centers. The overall rate of TLF at one year was 2.8% [95%CI 1.4–5.8%], whereas TLF rates were 4.1%, 3.2%, 8.3%, and 2.6% in patients with diabetes, small vessels ≤2.75 mm, CTO, and acute MI, respectively. No case of definite/probable ST was observed.
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Safety and Performance of the Orsiro Sirolimus-Eluting Stent in the Treatment of All-Comers Patient Population in Daily Clinical Practice
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Autor/in / Beteiligte Person: | Graham, John J. ; Boukhris, Marouane ; Potter, Brian J. ; Gobeil, François ; Matteau, Alexis ; Hillani, Ali ; Mansour, Samer ; Fam, Neil ; Michael J.B. Kutryk |
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Zeitschrift: | Cardiovascular revascularization medicine : including molecular interventions, Jg. 21 (2020-03-12), Heft 11 |
Veröffentlichung: | 2020 |
Medientyp: | unknown |
ISSN: | 1878-0938 (print) |
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