Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
J Am Coll Cardiol. 2020 Jul 14;76(2):146-158. doi: 10.1016/j.jacc.2020.05.026.
Outcome data after extended long-term follow-up of patients with coronary artery disease treated with drug-eluting stents (DES) in randomized clinical trials are scant.
Performance differences among devices may be expected to emerge over time depending on whether stenting is done with polymer-free or durable polymer DES. This study assessed the 10-year outcomes of patients enrolled in the ISAR-TEST-5 (Test Efficacy of Sirolimus- and Probucol-Eluting Versus Zotarolimus-Eluting Stents) trial.
A total of 3,002 patients were randomized to treatment with either polymer-free sirolimus- and probucol-eluting stents (n = 2,002) or durable polymer zotarolimus-eluting stents (n = 1,000). The primary endpoint was the composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization (a device-oriented composite endpoint [DOCE]). Additional endpoints of interest were the patient-oriented composite endpoint (POCE), including all-cause death, any myocardial infarction, or any revascularization; individual components of the composite endpoints; and definite or probable stent thrombosis.
The median age of the patients at randomization was 67.8 years. At 10 years, 63.9% of patients were alive. The rates of DOCE and POCE were high in both groups with no difference in the incidence between polymer-free sirolimus- and probucol-eluting stents and durable polymer zotarolimus-eluting stents (DOCE: 43.8% vs. 43.0%, respectively; hazard ratio: 1.01; 95% confidence interval [CI]: 0.89 to 1.14; p = 0.90; POCE: 66.2% vs. 67.7%, respectively; hazard ratio: 0.94; 95% CI: 0.86 to 1.04; p = 0.22). The rates of the individual components of the composite endpoints were comparable in both groups. The incidence of definite/probable stent thrombosis over 10 years was low and comparable in both groups (1.6% vs. 1.9%; hazard ratio: 0.85; 95% CI: 0.46 to 1.54; p = 0.58).
At 10 years, there were no measurable differences in outcomes between patients treated with polymer-free versus durable polymer DES. The incidence of stent thrombosis was low and comparable in both groups. High overall adverse clinical event rates were observed during extended follow-up. (Test Efficacy of Sirolimus- and Probucol-Eluting Versus Zotarolimus-Eluting Stents [ISAR-TEST-5]; NCT00598533).
经药物洗脱支架（DES）治疗的冠状动脉疾病患者的长期随访结果数据稀少。
根据支架是否采用无聚合物或耐用聚合物 DES 进行，设备之间的性能差异可能会随时间显现。本研究评估了 ISAR-TEST-5（西罗莫司和普罗布考洗脱与佐他莫司洗脱支架的疗效测试）试验中入组患者的 10 年结局。
共 3002 例患者随机分为无聚合物西罗莫司和普罗布考洗脱支架（n=2002）或耐用聚合物佐他莫司洗脱支架（n=1000）治疗。主要终点是心脏死亡、靶血管相关心肌梗死或靶病变血运重建的复合终点（以器械为导向的复合终点[DOCE]）。其他感兴趣的终点包括患者为导向的复合终点（POCE），包括全因死亡、任何心肌梗死或任何血运重建；复合终点的各个组成部分；以及明确或可能的支架血栓形成。
随机分组时患者的中位年龄为 67.8 岁。10 年后，63.9%的患者存活。两组的 DOCE 和 POCE 发生率均较高，无聚合物西罗莫司和普罗布考洗脱支架与耐用聚合物佐他莫司洗脱支架之间的发生率无差异（DOCE：43.8%比 43.0%，风险比：1.01；95%置信区间[CI]：0.89 至 1.14；p=0.90；POCE：66.2%比 67.7%，风险比：0.94；95%CI：0.86 至 1.04；p=0.22）。两组复合终点各个组成部分的发生率相当。10 年内明确/可能的支架血栓形成发生率较低，两组间相当（1.6%比 1.9%，风险比：0.85；95%CI：0.46 至 1.54；p=0.58）。
10 年后，无聚合物与耐用聚合物 DES 治疗患者的结局无明显差异。两组支架血栓形成的发生率较低且相当。在延长随访期间，观察到总体不良临床事件发生率较高。（西罗莫司和普罗布考洗脱与佐他莫司洗脱支架的疗效测试[ISAR-TEST-5]；NCT00598533）。
