Department of Cardiology, Odense University Hospital, Odense, Denmark.
Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus, Denmark.
EuroIntervention. 2022 Jun 3;18(2):e124-e131. doi: 10.4244/EIJ-D-21-00874.
For patients with high bleeding risk, the BioFreedom stent is safer and more effective than a bare metal stent. However, at the one-year follow-up of the SORT OUT IX trial, the BioFreedom stent did not meet the criteria for non-inferiority for target lesion failure (TLF) when compared with the Orsiro stent and had a higher incidence of target lesion revascularisation (TLR).
The aim of the study was to compare the two-year outcomes following coronary implantation of the BioFreedom or the Orsiro stents in all-comer patients.
The Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) IX trial is a prospective, multicentre, randomised clinical trial comparing the BioFreedom and the Orsiro stents. The primary endpoint, TLF, was a composite of cardiac death, myocardial infarction (MI; not related to other lesions) and TLR.
A total of 1,572 patients were randomised to treatment with the BioFreedom stent and 1,579 patients with the Orsiro stent. At two-year follow-up, TLF was 7.8% in the BioFreedom and 6.3% in the Orsiro stent groups (rate ratio [RR] 1.23, 95% confidence interval [CI]: 0.94-1.61). Risks of cardiac death, MI and definite stent thrombosis did not differ significantly between the groups, whereas more patients in the BioFreedom group had TLR (5.1% vs 2.6%; RR 1.98, 95% CI: 1.26-2.89) attributable to a higher risk of TLR within the first year (3.5% vs 1.3%; RR 2.77, 95% CI: 1.66-4.62).
At two years, there were no significant differences between the BioFreedom and Orsiro stents for TLF. TLR was significantly higher with the BioFreedom stent due to higher risk of TLR within the first year.
对于高出血风险的患者，BioFreedom 支架在安全性和疗效方面优于裸金属支架。然而，在 SORT OUT IX 试验的一年随访中，与 Orsiro 支架相比，BioFreedom 支架在靶病变失败（TLF）方面未达到非劣效性标准，并且靶病变血运重建（TLR）的发生率更高。
本研究旨在比较所有患者接受 BioFreedom 或 Orsiro 支架冠状动脉植入后的两年结果。
斯堪的纳维亚组织随机临床试验与临床结局（SORT OUT）IX 试验是一项前瞻性、多中心、随机临床试验，比较了 BioFreedom 和 Orsiro 支架。主要终点 TLF 是心脏死亡、心肌梗死（MI；与其他病变无关）和 TLR 的复合终点。
共有 1572 例患者被随机分配至接受 BioFreedom 支架治疗，1579 例患者接受 Orsiro 支架治疗。在两年随访中，BioFreedom 组 TLF 为 7.8%，Orsiro 组为 6.3%（率比 [RR] 1.23，95%置信区间 [CI]：0.94-1.61）。两组间心脏死亡、MI 和明确支架血栓形成的风险无显著差异，而 BioFreedom 组发生 TLR 的患者更多（5.1% vs 2.6%；RR 1.98，95%CI：1.26-2.89），这归因于第一年 TLR 风险较高（3.5% vs 1.3%；RR 2.77，95%CI：1.66-4.62）。
在两年时，BioFreedom 支架与 Orsiro 支架在 TLF 方面无显著差异。由于第一年 TLR 风险较高，BioFreedom 支架 TLR 发生率显著更高。
