Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
Department of Cardiology, Ludwig-Maximilians-Universität, Munich, Germany; DZHK (German Centre for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany.
JACC Cardiovasc Interv. 2016 Apr 25;9(8):784-792. doi: 10.1016/j.jcin.2016.01.009. Epub 2016 Mar 23.
The aim of this study was to evaluate the late clinical performance of a polymer-free sirolimus- and probucol-eluting stent compared with a new-generation durable polymer-based zotarolimus-eluting stent.
It was previously shown that polymer-free sirolimus- and probucol-eluting stents were noninferior to zotarolimus-eluting stents at 12 months. However, long-term follow-up of these devices is critical to evaluate late comparative efficacy.
In a clinical trial with minimal exclusion criteria, 3,002 patients were randomly assigned to treatment with polymer-free sirolimus- and probucol-eluting stents versus zotarolimus-eluting stents. The primary endpoint was the combined incidence of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization.
At 5 years, there was no difference in the incidence of the primary endpoint between sirolimus- and probucol-eluting stents and zotarolimus-eluting stents (23.8% vs. 24.2%, respectively; hazard ratio: 0.98; 95% confidence interval: 0.84 to 1.15; p = 0.80). The rates of the individual components of the primary endpoint were also comparable in both groups. The incidence of definite or probable stent thrombosis was low in both groups (1.3% vs. 1.6%, respectively; hazard ratio: 0.86; 95% confidence interval: 0.46 to 1.62; p = 0.64). The rates of any death, myocardial infarction, and revascularization were similar in both groups. Results were consistent across pre-specified subgroups of age, sex, diabetes, and vessel size.
Long-term outcomes of patients treated with polymer-free sirolimus- and probucol-eluting stents compared with a new-generation durable polymer-based zotarolimus-eluting stent were similar. Rates of stent thrombosis were low and comparable in both treatment groups, with few events beyond 12 months. (Efficacy Study of Rapamycin- vs. Zotarolimus-Eluting Stents to Reduce Coronary Restenosis [ISAR-TEST-5]; NCT00598533).
本研究旨在评估无聚合物西罗莫司和普罗布考洗脱支架与新一代耐用聚合物佐他莫司洗脱支架的晚期临床性能。
先前的研究表明，无聚合物西罗莫司和普罗布考洗脱支架在 12 个月时与佐他莫司洗脱支架相比非劣效。然而，这些设备的长期随访对于评估晚期比较疗效至关重要。
在一项排除标准最小的临床试验中，3002 例患者被随机分配接受无聚合物西罗莫司和普罗布考洗脱支架与佐他莫司洗脱支架治疗。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综合发生率。
5 年时，无聚合物西罗莫司和普罗布考洗脱支架与佐他莫司洗脱支架组之间主要终点的发生率无差异（分别为 23.8%和 24.2%；风险比：0.98；95%置信区间：0.84 至 1.15；p=0.80）。两组的主要终点各组成部分的发生率也相似。两组的确定或可能的支架血栓形成发生率均较低（分别为 1.3%和 1.6%；风险比：0.86；95%置信区间：0.46 至 1.62；p=0.64）。两组的任何死亡、心肌梗死和血运重建发生率相似。结果在预先指定的年龄、性别、糖尿病和血管大小亚组中一致。
与新一代耐用聚合物佐他莫司洗脱支架相比，接受无聚合物西罗莫司和普罗布考洗脱支架治疗的患者的长期结果相似。两组的支架血栓形成发生率均较低且相似，12 个月后事件较少。（雷帕霉素与佐他莫司洗脱支架减少冠状动脉再狭窄的疗效研究[ISAR-TEST-5]；NCT00598533）。
