Cardiology Division, Centre Hospitalier de l'Université de Montréal (CHUM), Quebec, Canada.
Cardiology Division, St. Michael's Hospital, Toronto, Ontario, Canada.
Cardiovasc Revasc Med. 2020 Nov;21(11):1348-1354. doi: 10.1016/j.carrev.2020.04.021. Epub 2020 Apr 23.
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.
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.
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.
Our data provide further evidence of the safety and clinical performance of Orsiro SES in an unselected, real-world, complex patient population.
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.
BIOFLOW-III 加拿大注册研究旨在评估在所有患者人群中使用具有生物可降解聚合物的 Orsiro 西罗莫司洗脱支架（SES）的安全性和疗效。
我们进行了一项前瞻性、非随机、多中心、观察性的所有患者注册研究，在加拿大的两个高容量中心，对接受 Orsiro SES 经皮冠状动脉介入治疗（PCI）的患者进行了研究。主要终点是一年靶病变失败（TLF），定义为心脏死亡、靶血管心肌梗死（MI）、冠状动脉旁路移植术和临床驱动的靶病变血运重建的复合终点。预先定义了四个亚组：i）糖尿病患者；ii）小血管（≤2.75mm）；iii）慢性完全闭塞（CTO）和 iv）急性 MI。
2014 年 5 月至 2016 年 7 月，250 例患者（平均年龄 66.2±10.8 岁，75.6%为男性，30%患有糖尿病）接受了 385 个冠状动脉病变的 Orsiro SES PCI。支架平均直径为 2.98±0.50mm，平均支架长度为 22±8mm。临床器械和手术成功率分别为 99.5%和 97.6%。总的一年 TLF 率为 2.8%[95%置信区间（CI）1.4-5.8%]，而糖尿病、小血管、CTO 和急性 MI 患者的 TLF 率分别为 4.1%[95%CI 1.3-12.2%]、3.2%[95%CI 1.2-8.4%]、8.3%[95%CI 2.2-29.4%]和 2.6%[95%CI 0.7-9.9%]。报告了一例可能的支架血栓形成（ST）（0.4%[95%CI 0.1-2.8%]），但在一年时未观察到任何确定/可能的 ST 病例。
我们的数据为在未选择的真实世界复杂患者人群中，Orsiro SES 的安全性和临床性能提供了进一步的证据。
