Columbia University, Medical Center and Cardiovascular Research Foundation, New York, New York 10022, USA.
JACC Cardiovasc Interv. 2011 Oct;4(10):1104-15. doi: 10.1016/j.jcin.2011.06.018.
This study sought to compare the clinical outcomes of everolimus-eluting stents (EES) versus paclitaxel-eluting stents (PES) in patients with acute coronary syndromes (ACS) and stable coronary artery disease (CAD).
Although randomized trials have shown superiority of EES to PES, the safety and efficacy of EES in ACS is unknown.
We performed a patient-level pooled analysis from the prospective, randomized SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) II, III, IV, and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) trials in which 2,381 patients with ACS and 4,404 patients with stable CAD were randomized to EES or to PES. Kaplan-Meier estimates of death, myocardial infarction (MI), ischemia-driven target lesion revascularization, and stent thrombosis were assessed at 2 years and stratified by clinical presentation (ACS vs. stable CAD).
At 2 years, patients with ACS compared with stable CAD had higher rates of death (3.2% vs. 2.4%, hazard ratio [HR]: 1.37 [95% confidence interval (CI): 1.02 to 1.85], p = 0.04) and MI (4.9% vs. 3.4%, HR: 1.45 [95% CI: 1.14 to 1.85], p = 0.02). In patients with ACS, EES versus PES reduced the rate of death or MI (6.6% vs. 9.3%, HR: 0.70 [95% CI: 0.52 to 0.94], p = 0.02), stent thrombosis (0.7% vs. 2.9%, HR: 0.25 [95% CI: 0.12 to 0.52], p = 0.0002), and ischemia-driven target lesion revascularization (4.7% vs. 6.2%, HR: 0.69 [95% CI: 0.48 to 0.99], p = 0.04). In patients with stable CAD, EES reduced the rate of death or MI (4.5% vs. 7.1%, HR: 0.62 [95% CI: 0.48 to 0.80], p = 0.0002), stent thrombosis (0.7% vs. 1.8%, HR: 0.34 [95% CI: 0.19 to 0.62], p = 0.0002), and ischemia-driven target lesion revascularization (3.9% vs. 6.9%, HR: 0.55 [95% CI: 0.42 to 0.73], p < 0.0001).
Treatment with EES versus PES provides enhanced safety and efficacy regardless of the acuity of the clinical syndrome being treated and appears to mitigate the increased risk of stent thrombosis associated with ACS. (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions [SPIRIT II]; NCT00180310; SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With de Novo Native Coronary Artery Lesions [SPIRIT III]; NCT00180479; SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions [SPIRIT IV]; NCT00307047; A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice: the COMPARE Trial [COMPARE]; NCT01016041).
本研究旨在比较急性冠状动脉综合征（ACS）和稳定型冠状动脉疾病（CAD）患者中使用依维莫司洗脱支架（EES）与紫杉醇洗脱支架（PES）的临床结果。
虽然随机试验已经显示 EES 优于 PES，但 EES 在 ACS 中的安全性和疗效尚不清楚。
我们对前瞻性、随机的 SPIRIT（依维莫司洗脱冠状动脉支架系统的临床评价）II、III、IV 和 COMPARE（依维莫司洗脱支架与紫杉醇洗脱支架在日常实践中的冠状动脉血运重建试验）试验中的患者进行了汇总分析，共有 2381 例 ACS 患者和 4404 例稳定型 CAD 患者被随机分配至 EES 或 PES。使用 Kaplan-Meier 估计 2 年时的死亡率、心肌梗死（MI）、缺血驱动的靶病变血运重建和支架血栓形成，并按临床表现（ACS 与稳定型 CAD）进行分层。
在 2 年时，与稳定型 CAD 相比，ACS 患者的死亡率（3.2% vs. 2.4%，HR：1.37 [95% CI：1.02 至 1.85]，p = 0.04）和 MI（4.9% vs. 3.4%，HR：1.45 [95% CI：1.14 至 1.85]，p = 0.02）更高。在 ACS 患者中，与 PES 相比，EES 降低了死亡率或 MI 发生率（6.6% vs. 9.3%，HR：0.70 [95% CI：0.52 至 0.94]，p = 0.02）、支架血栓形成（0.7% vs. 2.9%，HR：0.25 [95% CI：0.12 至 0.52]，p = 0.0002）和缺血驱动的靶病变血运重建（4.7% vs. 6.2%，HR：0.69 [95% CI：0.48 至 0.99]，p = 0.04）发生率。在稳定型 CAD 患者中，EES 降低了死亡率或 MI 发生率（4.5% vs. 7.1%，HR：0.62 [95% CI：0.48 至 0.80]，p = 0.0002）、支架血栓形成（0.7% vs. 1.8%，HR：0.34 [95% CI：0.19 至 0.62]，p = 0.0002）和缺血驱动的靶病变血运重建（3.9% vs. 6.9%，HR：0.55 [95% CI：0.42 至 0.73]，p < 0.0001）发生率。
与 PES 相比，使用 EES 治疗可提供更好的安全性和疗效，无论治疗的临床综合征的严重程度如何，并且似乎可以减轻与 ACS 相关的支架血栓形成风险增加。（依维莫司洗脱冠状动脉支架系统在治疗新发病变的冠状动脉病变患者中的临床评价 [SPIRIT II]；NCT00180310；依维莫司洗脱冠状动脉支架系统在治疗新发病变的冠状动脉病变患者中的临床评价 [SPIRIT III]；NCT00180479；依维莫司洗脱冠状动脉支架系统在治疗新发病变的冠状动脉病变患者中的临床评价 [SPIRIT IV]；NCT00307047；依维莫司洗脱支架与紫杉醇洗脱支架在日常实践中的冠状动脉血运重建试验：COMPARE 试验 [COMPARE]；NCT01016041）。
