Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
EuroIntervention. 2017 Dec 20;13(11):1336-1344. doi: 10.4244/EIJ-D-17-00434.
Our aim was to report the long-term safety and efficacy of the biodegradable polymer-coated biolimus- eluting Nobori stent compared to the durable polymer-coated sirolimus-eluting CYPHER stent.
SORT OUT V randomised 2,468 patients 1:1 to the Nobori (n=1,229) versus the CYPHER stent (n=1,239). Clinically driven event detection based on Danish registries was used. The primary endpoint was a composite of safety (cardiac death, myocardial infarction, definite stent thrombosis) and efficacy (target vessel revascularisation). Individual components of the primary endpoint comprise the secondary endpoints. At five-year follow-up, the composite endpoint rate was found to be similar in patients treated with the two study stents (Nobori 182/1,229 [14.8%] vs. CYPHER 197/1,239 [15.8%]; odds ratio [OR] 0.93, 95% CI: 0.75-1.16; p=0.53). The rates of definite stent thrombosis were also found to be similar in patients treated with the two study stents (Nobori 23/1,229 [1.9%] vs. CYPHER 18/1,239 [1.5%]; OR 1.31, 95% CI: 0.70-2.47; p=0.40), as were the other secondary endpoints.
At five-year follow-up, the Nobori stent with a biodegradable polymer coating provided a similar safety and efficacy profile when compared to the durable polymer first-generation CYPHER stent.
本研究旨在报告可生物降解聚合物涂层的比马前列素洗脱 Nobori 支架与持久性聚合物涂层的西罗莫司洗脱 Cypher 支架相比的长期安全性和疗效。
SORT OUT V 研究将 2468 例患者按 1:1 随机分为 Nobori 组（n=1229）和 Cypher 组（n=1239）。采用基于丹麦注册中心的临床驱动事件检测。主要终点是安全性（心源性死亡、心肌梗死、明确支架血栓形成）和疗效（靶血管血运重建）的复合终点。主要终点的各个组成部分构成次要终点。在 5 年随访时，两种研究支架治疗的患者复合终点发生率相似（Nobori 组 1229 例中有 182 例[14.8%]，Cypher 组 1239 例中有 197 例[15.8%]；比值比[OR]0.93，95%CI：0.75-1.16；p=0.53）。两种研究支架治疗的患者明确支架血栓形成发生率也相似（Nobori 组 1229 例中有 23 例[1.9%]，Cypher 组 1239 例中有 18 例[1.5%]；OR 1.31，95%CI：0.70-2.47；p=0.40），其他次要终点也是如此。
在 5 年随访时，与持久性聚合物第一代 Cypher 支架相比，具有可生物降解聚合物涂层的 Nobori 支架具有相似的安全性和疗效。
