BACKGROUND 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. OBJECTIVES 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. METHODS 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. RESULTS 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). CONCLUSIONS 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).

中文翻译：

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无聚合物与耐用聚合物药物洗脱冠状动脉支架的随机试验的 10 年结果

背景 在随机临床试验中，对接受药物洗脱支架 (DES) 治疗的冠状动脉疾病患者进行长期随访后的结果数据很少。目标 设备之间的性能差异可能会随着时间的推移而出现，这取决于支架植入是使用无聚合物还是耐用的聚合物 DES。本研究评估了参加 ISAR-TEST-5（西罗莫司和普罗布考洗脱与佐他莫司洗脱支架的测试功效）试验的患者的 10 年结果。方法 共有 3,002 名患者随机接受无聚合物西罗莫司和普罗布考洗脱支架（n = 2,002）或耐用聚合物佐他莫司洗脱支架（n = 1,000）治疗。主要终点是心源性死亡、靶血管相关心肌梗死、或目标病变血运重建（面向设备的复合终点 [DOCE]）。其他感兴趣的终点是面向患者的复合终点 (POCE)，包括全因死亡、任何心肌梗塞或任何血运重建；复合终点的各个组成部分；明确或可能的支架内血栓形成。结果随机分组时患者的中位年龄为 67.8 岁。10 年时，63.9% 的患者存活。两组的 DOCE 和 POCE 发生率都很高，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没有差异（DOCE：分别为 43.8% 和 43.0%；风险比： 1.01；95% 置信区间 [CI]：0.89 至 1.14；p = 0.90；POCE：分别为 66.2% 与 67.7%；风险比：0.94；95% CI：0.86 至 1.04；p = 0.22）。两组复合终点的各个组成部分的比率具有可比性。10 年内明确/可能支架内血栓形成的发生率在两组中均较低且具有可比性（1.6% 与 1.9%；风险比：0.85；95% CI：0.46 至 1.54；p = 0.58）。结论 在 10 年时，无聚合物 DES 与持久聚合物 DES 治疗的患者之间的结果没有可测量的差异。两组支架内血栓的发生率均较低且具有可比性。在长期随访期间观察到较高的总体不良临床事件发生率。（西罗莫司和普罗布考洗脱支架与佐他莫司洗脱支架的测试功效 [ISAR-TEST-5]；NCT00598533）。10 年内明确/可能支架内血栓形成的发生率在两组中均较低且具有可比性（1.6% 与 1.9%；风险比：0.85；95% CI：0.46 至 1.54；p = 0.58）。结论 在 10 年时，无聚合物 DES 与持久聚合物 DES 治疗的患者之间的结果没有可测量的差异。两组支架内血栓的发生率均较低且具有可比性。在长期随访期间观察到较高的总体不良临床事件发生率。（西罗莫司和普罗布考洗脱支架与佐他莫司洗脱支架的测试功效 [ISAR-TEST-5]；NCT00598533）。10 年内明确/可能支架内血栓形成的发生率在两组中均较低且具有可比性（1.6% 与 1.9%；风险比：0.85；95% CI：0.46 至 1.54；p = 0.58）。结论 在 10 年时，无聚合物 DES 与持久聚合物 DES 治疗的患者之间的结果没有可测量的差异。两组支架内血栓的发生率均较低且具有可比性。在长期随访期间观察到较高的总体不良临床事件发生率。（西罗莫司和普罗布考洗脱支架与佐他莫司洗脱支架的测试功效 [ISAR-TEST-5]；NCT00598533）。两组支架内血栓的发生率均较低且具有可比性。在长期随访期间观察到较高的总体不良临床事件发生率。（西罗莫司和普罗布考洗脱支架与佐他莫司洗脱支架的测试功效 [ISAR-TEST-5]；NCT00598533）。两组支架内血栓的发生率均较低且具有可比性。在长期随访期间观察到较高的总体不良临床事件发生率。（西罗莫司和普罗布考洗脱支架与佐他莫司洗脱支架的测试功效 [ISAR-TEST-5]；NCT00598533）。