Department of Cardiology, Odense University Hospital, Denmark (L.O.J., J.E., K.T.V., O.A., K.N.H., A.A., A.J., J.F.L., H.S.H.).
Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Denmark (M.M., L.J., S.D.K., S.C., C.J.T., H.E.B., T.T., A.E., E.H.C.).
Circulation. 2020 Jun 23;141(25):2052-2063. doi: 10.1161/CIRCULATIONAHA.119.040241. Epub 2020 May 21.
In patients with increased bleeding risk, the biolimus A9-coated BioFreedom stent, a stainless steel drug-coated stent free from polymer, has shown superiority compared with a bare-metal stent. The aim of this study was to investigate whether the BioFreedom stent is noninferior to a modern ultrathin strut biodegradable polymer cobalt-chromium sirolimus-eluting Orsiro stent in an all-comers patient population treated with percutaneous coronary intervention.
The SORT OUT IX trial (Scandinavian Organization for Randomized Trials With Clinical Outcome IX), was a large-scale, registry-based, randomized, multicenter, single-blind, 2-arm, noninferiority trial. The primary end point, major adverse cardiovascular events, was defined as the composite of cardiac death, myocardial infarction not related to any segment other than the target lesion, or target lesion revascularization within 1 year, analyzed by intention-to-treat. The trial was powered to assess noninferiority for major adverse cardiovascular events of the BioFreedom stent compared with the Orsiro stent with a predetermined noninferiority margin of 0.021.
Between December 14, 2015 and April 21, 2017, 3151 patients were assigned to treatment with the BioFreedom stent (1572 patients, 1966 lesions) or to the Orsiro stent (1579 patients, 1985 lesions). Five patients were lost to follow-up because of emigration (99.9% follow-up rate). Mean age was 66.3±10.9, diabetes mellitus was seen in 19.3% of patients, and 53% of the patients had acute coronary syndromes. At 1 year, intention-to-treat analysis showed that 79 (5.0%) patients, who were assigned the BioFreedom stent, and 59 (3.7%), who were assigned the Orsiro stent, met the primary end point (absolute risk difference 1.29% [upper limit of one-sided 95% CI 2.50%]; =0.14). Significantly more patients in the BioFreedom stent group had target lesion revascularization than those in the Orsiro stent group (55 [3.5%] vs 20 [1.3%], rate ratio 2.77 [95% CI, 1.66-4.62]; <0.0001).
The biolimus A9-coated BioFreedom polymer-free stent did not meet criteria for noninferiority for major adverse cardiovascular events at 12 months when compared with the ultrathin strut biodegradable polymer sirolimus-eluting Orsiro stent in an all-comers population Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02623140.
在出血风险增加的患者中，不含聚合物的不锈钢药物洗脱 BioFreedom 支架比裸金属支架具有优势。本研究旨在探讨在所有接受经皮冠状动脉介入治疗的患者中，BioFreedom 支架是否不劣于现代超薄支架生物可降解聚合物依维莫司洗脱 Orsiro 支架。
SORT OUT IX 试验（斯堪的纳维亚随机临床试验组织 9 期）是一项大规模、基于注册、随机、多中心、单盲、2 臂、非劣效性试验。主要心血管不良事件是心脏死亡、与靶病变以外的任何节段无关的心肌梗死或 1 年内靶病变血运重建的复合终点，通过意向治疗进行分析。该试验的目的是评估 BioFreedom 支架与 Orsiro 支架相比，在主要心血管不良事件方面的非劣效性，预定的非劣效性边界为 0.021。
2015 年 12 月 14 日至 2017 年 4 月 21 日，3151 例患者被分配接受 BioFreedom 支架治疗（1572 例患者，1966 处病变）或 Orsiro 支架治疗（1579 例患者，1985 处病变）。由于移民，5 例患者失访（99.9%的随访率）。平均年龄为 66.3±10.9 岁，19.3%的患者患有糖尿病，53%的患者患有急性冠脉综合征。1 年时，意向治疗分析显示，79 例（5.0%）接受 BioFreedom 支架治疗的患者和 59 例（3.7%）接受 Orsiro 支架治疗的患者达到了主要终点（绝对风险差异 1.29%[单侧 95%CI 的上限 2.50%]；=0.14）。生物可吸收聚合物洗脱支架组的靶病变血运重建发生率明显高于 Orsiro 支架组（55[3.5%]vs 20[1.3%]，率比 2.77[95%CI，1.66-4.62]；<0.0001）。
在所有接受经皮冠状动脉介入治疗的患者中，与超薄支架生物可降解聚合物依维莫司洗脱 Orsiro 支架相比，不含聚合物的雷帕霉素洗脱 BioFreedom 支架在 12 个月时未达到主要心血管不良事件非劣效性标准。
