Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
JACC Cardiovasc Interv. 2009 Dec;2(12):1219-26. doi: 10.1016/j.jcin.2009.09.014.
The aim of this study was to evaluate the efficacy and safety of unrestricted everolimus-eluting stent (EES) implantation in a contemporary cohort of real-world patients.
The randomized SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions) trials have evaluated the performance of EES, resulting in their approval by the Food and Drug Administration, but data regarding unselected usage, including off-label indications are lacking.
Consecutive patients treated with EES (either PROMUS, Boston Scientific Corp., Natick, Massachusetts, or XIENCE-V, Abbott Vascular Devices, Santa Clara, California) between October 2006 and February 2008 were analyzed. End points were cardiac death, myocardial infarction (MI), ischemic-driven target lesion revascularization (TLR), stent thrombosis (ST), and major adverse cardiac events (MACE) (a composite of cardiac death, MI, TLR) during follow-up.
We identified 345 patients (573 lesions) treated with EES. The majority of patients (71.9%) were treated for > or =1 off-label or untested indication. Clinical follow-up was completed in 99%. At a median follow-up of 378 days (interquartile range 334 to 473), MACE occurred in 36 (10.6%) patients, TLR in 27 (7.9%), MI in 7 (2.1%), and cardiac death in 7 (2.1%). Definite and probable ST was observed in 3 (0.9%) cases. Off-label EES implantation was not associated with a statistically significant increased risk of MACE (12.2% vs. 6.3%, p = 0.17), TLR (9.3% vs. 4.2%, p = 0.18), or ST (0.8% vs. 1.1%, p = 1.0). On multivariable analysis, previous bypass surgery (p = 0.002) and diabetes (p = 0.03) were associated with MACE.
In unrestricted daily practice, EES were implanted predominantly for off-label indications and associated with a relative low rate of MACE and TLR.
本研究旨在评估在当代真实世界患者人群中，无限制依维莫司洗脱支架（EES）植入的疗效和安全性。
随机 SPIRIT（评价依维莫司洗脱冠状动脉支架系统 XIENCE V 在治疗新发病变的患者中的临床疗效）试验已经评估了 EES 的性能，这导致了其被食品和药物管理局批准，但缺乏关于未经选择的使用（包括超适应证）的数据。
分析了 2006 年 10 月至 2008 年 2 月期间连续接受 EES（波士顿科学公司的 Promus 或雅培血管设备公司的 XIENCE-V）治疗的患者。终点事件包括随访期间的心脏死亡、心肌梗死（MI）、缺血驱动的靶病变血运重建（TLR）、支架血栓形成（ST）和主要不良心脏事件（MACE）（心脏死亡、MI、TLR 的复合终点）。
共纳入 345 例（573 处病变）接受 EES 治疗的患者。大多数患者（71.9%）接受了 >或=1 种超适应证或未经试验的适应证治疗。99%的患者完成了临床随访。在中位随访 378 天（四分位距 334-473）期间，36 例（10.6%）患者发生 MACE，27 例（7.9%）发生 TLR，7 例（2.1%）发生 MI，7 例（2.1%）发生心脏死亡。确定和可能的 ST 发生在 3 例（0.9%）患者中。超适应证 EES 植入与 MACE（12.2%比 6.3%，p = 0.17）、TLR（9.3%比 4.2%，p = 0.18）或 ST（0.8%比 1.1%，p = 1.0）发生率无统计学显著差异。多变量分析显示，既往旁路手术（p = 0.002）和糖尿病（p = 0.03）与 MACE 相关。
在不受限制的日常实践中，EES 主要植入于超适应证的病变，且 MACE 和 TLR 发生率相对较低。
