Department of Internal Medicine, Division of Cardiology, Washington Hospital Center, Washington, District of Columbia, USA.
Am J Cardiol. 2011 Jun 15;107(12):1757-62. doi: 10.1016/j.amjcard.2011.02.330. Epub 2011 Apr 15.
Compared to paclitaxel-eluting stents (PESs) and sirolimus-eluting stents (SESs), a paucity of data exists regarding the clinical outcome of everolimus-eluting stents (EESs) in unselected patients with the entire spectrum of obstructive coronary artery disease. The present study cohort included 6,615 consecutive patients at Washington Hospital Center who underwent coronary artery stent implantation with EESs (n = 519), PESs (n = 2,036), or SESs (n = 4,060). Patients who received bare metal stents, zotarolimus-eluting stents, or 2 different drug-eluting stent types were excluded. The analyzed clinical end points were death, death or Q-wave myocardial infarction, target lesion revascularization (TLR), target vessel revascularization, definite stent thrombosis, and major adverse cardiac events, defined as the composite of death, Q-wave myocardial infarction, or TLR at 1 year. The groups were well matched for the conventional risk factors for coronary artery disease, except for systemic hypertension, which differed among the groups. The unadjusted end points for EESs and PESs were death (4.5% vs 7.1%; p = 0.03), TLR (3.4% vs 4.6%; p = 0.24), target vessel revascularization (5.6% vs 7.1%; p = 0.46), death or Q-wave myocardial infarction (4.5% vs 7.4%; p = 0.02), and definite stent thrombosis (0.0% vs 0.7%; p = 0.09). The unadjusted end points for EES and SES were death (4.5% vs 5.2%; p = 0.45), TLR (3.4% vs 5.8%; p = 0.3), target vessel revascularization (5.6% vs 8.6%; p = 0.05), death or Q-wave myocardial infarction (4.5% vs 5.4%; p = 0.39), and definite stent thrombosis (0.0% vs 1.08%; p = 0.003). The rates of major adverse cardiac events were similar among the 3 groups. After multivariate analysis, the rate of death or Q-wave myocardial infarction between the EES and PES groups was no longer significant (hazard ratio 1.14, 95% confidence interval 0.59 to 2.20, p = 0.70). In conclusion, the results of the present study suggest the use of EES in routine clinical practice is both safe and effective but offers no clinically relevant advantage in terms of hard end points compared to PES or SES.
与紫杉醇洗脱支架（PESs）和西罗莫司洗脱支架（SESs）相比，在患有整个阻塞性冠状动脉疾病谱的未经选择的患者中，关于依维莫司洗脱支架（EESs）的临床结局的数据很少。本研究队列包括在华盛顿医院中心接受 EES（n = 519）、PES（n = 2,036）或 SES（n = 4,060）冠状动脉支架植入的 6615 例连续患者。排除了接受裸金属支架、佐他莫司洗脱支架或 2 种不同药物洗脱支架类型的患者。分析的临床终点为死亡、死亡或 Q 波心肌梗死、靶病变血运重建（TLR）、靶血管血运重建、明确支架血栓形成和主要不良心脏事件，定义为 1 年时死亡、Q 波心肌梗死或 TLR 的复合终点。除了各组之间存在差异的全身性高血压外，这些组在冠心病的常规危险因素方面匹配良好。EES 和 PES 的未经调整的终点为死亡（4.5%比 7.1%；p = 0.03）、TLR（3.4%比 4.6%；p = 0.24）、靶血管血运重建（5.6%比 7.1%；p = 0.46）、死亡或 Q 波心肌梗死（4.5%比 7.4%；p = 0.02）和明确支架血栓形成（0.0%比 0.7%；p = 0.09）。EES 和 SES 的未经调整的终点为死亡（4.5%比 5.2%；p = 0.45）、TLR（3.4%比 5.8%；p = 0.3）、靶血管血运重建（5.6%比 8.6%；p = 0.05）、死亡或 Q 波心肌梗死（4.5%比 5.4%；p = 0.39）和明确支架血栓形成（0.0%比 1.08%；p = 0.003）。3 组之间主要不良心脏事件的发生率相似。多变量分析后，EES 组和 PES 组之间死亡或 Q 波心肌梗死的发生率不再显著（风险比 1.14，95%置信区间 0.59 至 2.20，p = 0.70）。总之，本研究结果表明，EES 在常规临床实践中的使用既安全又有效，但与 PES 或 SES 相比，在硬终点方面没有临床相关优势。
