Division of Cardiology, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.
Int J Cardiol. 2011 Mar 3;147(2):253-7. doi: 10.1016/j.ijcard.2009.09.466. Epub 2009 Sep 26.
Meta-analysis of randomized trials showed superior efficacy and similar safety of drug-eluting stent over bare-metal stent in acute ST-elevation myocardial infarction (STEMI) patients. However, long-term relative outcomes of sirolimus- (SES) vs. paclitaxel-eluting stent (PES) have not been fully evaluated in randomized studies. This study compared long-term safety and efficacy of these two stents in STEMI.
A total of 308 STEMI patients were randomly treated with SES (n = 154) or PES (n = 154). Three-year clinical outcomes were assessed. Primary outcome of interest was incidence of major adverse cardiac events (MACE) including death, myocardial infarction (MI), stent thrombosis or target vessel revascularization (TVR). Secondary outcome of interest was occurrence of very late stent thrombosis.
Both groups had similar baseline characteristics. During follow-up, there was no difference between the two groups in terms of death (6.5% for SES and 10.4% for PES, p = 0.22), MI (2.6% vs. 3.9%, p = 0.75), stent thrombosis (1.9% vs. 3.2%, p = 0.72), TVR (3.9% vs. 8.4%, p = 0.15) and MACE (12.3% vs. 18.8%, p = 0.12). Eight patients in overall population had stent thrombosis: definite 3, probable 1, and possible 4. Cumulative incidence of stent thrombosis was gradually increased; 0.6% at 30 days, 0.6% at 1 year, 1.6% at 2 years, and 2.6% at 3 years. Very late stent thrombosis, definite or probable, occurred in 0.6% for both.
Among non-selected STEMI patients who underwent primary angioplasty, both SES and PES might be safe and SES showed similar three-year clinical outcomes compared to PES.
随机试验的荟萃分析显示，药物洗脱支架在急性 ST 段抬高型心肌梗死（STEMI）患者中的疗效优于裸金属支架，且安全性相当。然而，在随机研究中尚未充分评估西罗莫司洗脱支架（SES）与紫杉醇洗脱支架（PES）的长期相对结局。本研究比较了这两种支架在 STEMI 中的长期安全性和疗效。
共 308 例 STEMI 患者随机接受 SES（n = 154）或 PES（n = 154）治疗。评估 3 年临床结局。主要观察终点为主要不良心脏事件（MACE）发生率，包括死亡、心肌梗死（MI）、支架血栓形成或靶血管血运重建（TVR）。次要观察终点为迟发支架血栓形成的发生情况。
两组患者基线特征相似。随访期间，SES 组和 PES 组的死亡率（SES 组为 6.5%，PES 组为 10.4%，p = 0.22）、MI 发生率（SES 组为 2.6%，PES 组为 3.9%，p = 0.75）、支架血栓形成发生率（SES 组为 1.9%，PES 组为 3.2%，p = 0.72）、TVR 发生率（SES 组为 3.9%，PES 组为 8.4%，p = 0.15）和 MACE 发生率（SES 组为 12.3%，PES 组为 18.8%，p = 0.12）均无差异。总体人群中有 8 例患者发生支架血栓形成：明确支架血栓形成 3 例，可能支架血栓形成 1 例，很可能支架血栓形成 4 例。支架血栓形成的累积发生率逐渐增加；30 天为 0.6%，1 年为 0.6%，2 年为 1.6%，3 年为 2.6%。明确或可能的迟发支架血栓形成在两组中均为 0.6%。
在接受直接经皮冠状动脉介入治疗的非选择性 STEMI 患者中，SES 和 PES 均可能是安全的，SES 与 PES 相比，在 3 年的临床结局方面无差异。
