Columbia University Medical Center, New York, New York 10032, USA.
JACC Cardiovasc Interv. 2010 Oct;3(10):1043-50. doi: 10.1016/j.jcin.2010.07.008.
The increased frequency of very late (>1 year) stent thrombosis (VLST) has raised concerns with regard to the safety of sirolimus-eluting stents and paclitaxel-eluting stents (PES).
Experimental and preliminary clinical findings with the zotarolimus-eluting stent (ZES) have suggested a favorable safety profile.
The ENDEAVOR IV (Randomized Comparison of Zotarolimus- and Paclitaxel-Eluting Stents in Patients With Coronary Artery Disease) trial is a single-blind randomized ZES versus PES clinical trial in 1,548 patients with de novo native coronary lesions; the primary end point-9-month target vessel failure-was previously reported, annual clinical follow-up is planned for 5 years, and this report describes the 3-year outcomes.
The ZES compared with PES reduced target vessel failure (12.3% vs. 15.9%, hazard ratio [HR]: 0.76, 95% confidence interval [CI]: 0.58 to 1.00, p = 0.049), myocardial infarctions (MI) (2.1% vs. 4.9%, HR: 0.44, 95% CI: 0.25 to 0.80, p = 0.005), and cardiac death plus MI (3.6% vs. 7.1%, HR: 0.52, 95% CI 0.32 to 0.82, p = 0.004). Although the overall 3-year rate of Academic Research Consortium definite/probable stent thrombosis did not differ significantly (1.1% vs. 1.7%, HR: 0.67, 95% CI 0.28 to 1.64, p = 0.380), VLST (between 1 and 3 years) was significantly reduced in ZES patients (1 event vs. 11 events; 0.1% vs. 1.6%, HR: 0.09, 95% CI: 0.01 to 0.71, p = 0.004). Ischemia-driven target lesion revascularization at 3 years was similar with ZES versus PES (6.5% vs. 6.1%, HR: 1.10, 95% CI: 0.73 to 1.65, p = 0.662).
Three-year follow-up results from the ENDEAVOR IV trial indicate similar antirestenosis efficacy but improved clinical safety associated with ZES compared with PES, due to significantly fewer peri-procedural and remote MIs associated with fewer VLST events. (A Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions; NCT00217269).
极晚期（＞1 年）支架血栓形成（VLST）的频率增加引起了人们对西罗莫司洗脱支架和紫杉醇洗脱支架（PES）安全性的关注。
西罗莫司洗脱支架（ZES）的实验和初步临床研究结果表明其安全性良好。
ENDEAVOR IV（随机比较冠状动脉疾病患者中使用佐他莫司和紫杉醇洗脱支架）试验是一项单盲随机 ZES 与 PES 在 1548 例初发的原发性冠状动脉病变患者中的临床试验；主要终点-9 个月的靶血管失败-之前已经报道过，计划进行 5 年的年度临床随访，本报告描述了 3 年的结果。
与 PES 相比，ZES 降低了靶血管失败（12.3%比 15.9%，风险比[HR]：0.76，95%置信区间[CI]：0.58 至 1.00，p=0.049）、心肌梗死（MI）（2.1%比 4.9%，HR：0.44，95%CI：0.25 至 0.80，p=0.005）和心脏死亡加 MI（3.6%比 7.1%，HR：0.52，95%CI 0.32 至 0.82，p=0.004）。虽然总体 3 年学术研究联合会明确/可能的支架血栓形成率没有显著差异（1.1%比 1.7%，HR：0.67，95%CI：0.28 至 1.64，p=0.380），但 ZES 患者的极晚期（1 至 3 年）支架血栓形成明显减少（1 例与 11 例；0.1%比 1.6%，HR：0.09，95%CI：0.01 至 0.71，p=0.004）。3 年时 ZES 与 PES 的缺血驱动的靶病变血运重建相似（6.5%比 6.1%，HR：1.10，95%CI：0.73 至 1.65，p=0.662）。
ENDEAVOR IV 试验的 3 年随访结果表明，与 PES 相比，ZES 的抗再狭窄疗效相似，但临床安全性得到改善，这归因于与极晚期支架血栓形成事件减少相关的围手术期和远处 MI 减少。（一项比较美敦力 Endeavor 药物[ABT-578]洗脱冠状动脉支架系统与紫杉醇洗脱 Taxus 冠状动脉支架系统在初发原发性冠状动脉病变中的随机对照试验；NCT00217269）。
