University Hospital Clinic, IDIBAPS, Cardiology Department, Barcelona, Spain.
University Hospital Clinic, IDIBAPS, Cardiology Department, Barcelona, Spain.
JACC Cardiovasc Interv. 2014 Jan;7(1):64-71. doi: 10.1016/j.jcin.2013.09.006. Epub 2013 Dec 11.
This study sought to assess the 2-year outcomes of the population included in the EXAMINATION (Everolimus-Eluting Stents Versus Bare-Metal Stents in ST-Segment Elevation Myocardial Infarction) trial beyond the 1-year prescription period of dual antiplatelet therapy.
The EXAMINATION trial compared the performance of everolimus-eluting stents (EES) versus bare-metal stents (BMS) in an all-comer ST-segment elevation myocardial infarction (STEMI) population.
This was a multicenter, multinational, prospective, randomized, single-blind, controlled trial in patients with STEMI. The primary endpoint, which was the combined endpoint of all-cause death, any recurrent myocardial infarction, and any revascularization, and the endpoints target lesion revascularization and stent thrombosis were assessed at 2 years.
Between December 31, 2008, and May 15, 2010, 1,498 patients were randomized to receive EES (n = 751) or BMS (n = 747). Compliance with dual antiplatelet regimen was reduced at 2 years to a similar degree (17.3% vs. 17.2%, p = 0.91). At 2 years, the primary endpoint occurred in 108 (14.4%) patients of the EES group and in 129 (17.3%) patients of the BMS group (p = 0.11). Rate of target lesion revascularization was significantly lower in the EES group than in the BMS group (2.9% vs. 5.6%; p = 0.009). Rates of definite and definite or probable stent thrombosis were also significantly reduced in the EES group (0.8% vs. 2.1%; p = 0.03, and 1.3% vs. 2.8%; p = 0.04, respectively).
The 2-year follow-up of the EXAMINATION trial confirms the safety and efficacy of the EES compared with BMS in the setting of STEMI. Specifically, both rates of target lesion revascularization and stent thrombosis were reduced in recipients of EES without any signs of late attrition for either of these endpoints. (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction: EXAMINATION Study; NCT00828087).
本研究旨在评估 EXAMINATION 试验中纳入的人群在双重抗血小板治疗 1 年处方期结束后 2 年的结果。
EXAMINATION 试验比较了依维莫司洗脱支架（EES）与裸金属支架（BMS）在所有符合条件的 ST 段抬高型心肌梗死（STEMI）患者中的表现。
这是一项多中心、多国、前瞻性、随机、单盲、对照试验，纳入了 STEMI 患者。主要终点为全因死亡、任何复发性心肌梗死和任何血运重建的联合终点，以及靶病变血运重建和支架血栓形成的终点，在 2 年时进行评估。
2008 年 12 月 31 日至 2010 年 5 月 15 日，共有 1498 例患者随机分为 EES 组（n=751）或 BMS 组（n=747）。2 年后，双重抗血小板治疗方案的依从性也相似地降低（17.3% vs. 17.2%，p=0.91）。在 2 年时，EES 组有 108 例（14.4%）患者和 BMS 组有 129 例（17.3%）患者发生主要终点事件（p=0.11）。EES 组的靶病变血运重建率明显低于 BMS 组（2.9% vs. 5.6%；p=0.009）。EES 组的明确或明确或可能的支架血栓形成率也明显降低（0.8% vs. 2.1%；p=0.03，1.3% vs. 2.8%；p=0.04）。
EXAMINATION 试验的 2 年随访结果证实，在 STEMI 患者中，EES 与 BMS 相比具有安全性和疗效。具体而言，EES 组的靶病变血运重建率和支架血栓形成率均降低，且这两个终点均无晚期失访的迹象。（依维莫司洗脱冠状动脉支架治疗 ST 段抬高型心肌梗死患者的临床评价：EXAMINATION 研究；NCT00828087）。
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