Department of Interventional Cardiology, Cardiovascular Institute, Hospital Clinic IDIBAPS, Barcelona, Spain.
EuroIntervention. 2021 Jun 25;17(3):233-239. doi: 10.4244/EIJ-D-20-01162.
The BioFreedom drug-coated stent with a stainless steel platform (BF-SS) has been demonstrated to be efficacious in patients at high bleeding risk and receiv-ing only one-month dual antiplatelet therapy.
The aim of this study was to evaluate the efficacy of the new BioFreedom Ultra drug-coated stent with a thin-strut cobalt-chromium platform (BF-CoCr) compared to the BF-SS in an all-comers population undergoing percutaneous coronary intervention (PCI).
This was a prospective, multicentre, non-inferiority trial. The primary endpoint was in-stent late lumen loss (LLL) as determined by quantitative coronary angiography at nine-month follow-up. Clinical evaluation was performed at one year.
A total of 200 patients were randomised (1:1) to either the BF-CoCr or the BF-SS stent at eight centres in Spain and Denmark. Baseline clinical and lesion characteristics were similar between the groups. Mean age was 66 years and 23% were female. The mean number of stents implanted per patient was 1.5. At nine-month follow-up, mean in-stent LLL was 0.34±0.49 mm in the BF-CoCr group versus 0.29±0.37 mm in the BF-SS group, p=0.005 for non-inferiority. At one year, target lesion failure was similar between the groups (7.3% in BF-CoCr vs 9.3% in the BF-SS group; p=0.60).
The BF-CoCr was non-inferior to the BF-SS in terms of in-stent LLL at nine months. Larger studies powered for clinical endpoints are warranted to compare the efficacy of this new platform with currently available DES.
载药不锈钢平台 BioFreedom 药物洗脱支架（BF-SS）在高出血风险患者中接受单月双联抗血小板治疗时已被证明有效。
本研究旨在评估新型薄壁钴铬平台 BioFreedom Ultra 药物洗脱支架（BF-CoCr）与 BF-SS 在接受经皮冠状动脉介入治疗（PCI）的所有患者中的疗效。
这是一项前瞻性、多中心、非劣效性试验。主要终点是 9 个月随访时定量冠状动脉造影测定的支架内晚期管腔丢失（LLL）。临床评估在一年时进行。
在西班牙和丹麦的 8 个中心，共有 200 名患者（1:1）随机分配至 BF-CoCr 或 BF-SS 支架组。两组患者的基线临床和病变特征相似。平均年龄为 66 岁，23%为女性。平均每位患者植入的支架数为 1.5 个。9 个月随访时，BF-CoCr 组支架内平均 LLL 为 0.34±0.49mm，BF-SS 组为 0.29±0.37mm，BF-CoCr 组非劣效性优于 BF-SS 组（p=0.005）。一年时，两组间靶病变失败率相似（BF-CoCr 组为 7.3%，BF-SS 组为 9.3%；p=0.60）。
BF-CoCr 在 9 个月时的支架内 LLL 方面非劣效于 BF-SS。需要更大的研究来比较该新型平台与目前可用的 DES 的疗效。
