Li Qiang, Wang Le-feng, Yang Xin-chun, Ge Yong-gui, Wang Hong-shi, Li Wei-ming, Xu Li, Ni Zhu-hua, Xia Kun
Heart Center, Chaoyang Hospital, Capital Medical University, Beijing 100020, China.
Zhonghua Xin Xue Guan Bing Za Zhi. 2010 Oct;38(10):886-90.
This prospective random control study was performed to compare the efficacy and safety of primary percutaneous coronary intervention (PCI) with biodegradable polymer (Excel) and with durable polymer (Cypher Select) sirolimus-eluting stents in patients with acute ST-elevation myocardial infarction (STEMI).
Consecutive patients with STEMI underwent primary PCI were randomly divided into Cypher group (n = 113) and Excel group (n = 115). The primary endpoints were major adverse cardiac events (MACE, including death, reinfarction and target vessel revascularization) within 12 months. The second endpoints included late luminal loss and restenosis at 9 months.
Angiographic follow-up data at 9 months were available in 43 (38%) patients in Cypher group and 48 (42%) in Excel group. The rates of in-stent restenosis and in-segment restenosis were 2.3% vs. 2.1% (P = 0.937) and 4.7% vs. 6.3% (P = 0.738), respectively. The late luminal loss of in-stent and in-segment were (0.17 ± 0.26) mm vs. (0.18 ± 0.33) mm (P = 0.483) and (0.19 ± 0.36) mm vs. (0.20 ± 0.42) mm (P = 0.419), respectively. There were no significant differences in death (3.5% vs. 2.6%, P = 0.692), reinfarction (1.8% vs. 2.6%, P = 0.658), target vessel revascularization (1.8% vs. 2.6%, P = 0.658), MACE (5.3% vs. 6.1%, P = 0.788) or stent thrombosis (4.4% vs. 3.5%, P = 0.692) at 12 months between Cyper group and Excel group.
Excel and Cypher Select stents may have similar mid-term efficacy and safety in patients with STEMI treated with primary PCI.Further investigation is warranted to validate the long-term efficacy and safety.
本前瞻性随机对照研究旨在比较生物可降解聚合物（Excel）涂层与耐用聚合物（Cypher Select）涂层西罗莫司洗脱支架在急性ST段抬高型心肌梗死（STEMI）患者中进行直接经皮冠状动脉介入治疗（PCI）的疗效和安全性。
连续入选接受直接PCI的STEMI患者，随机分为Cypher组（n = 113）和Excel组（n = 115）。主要终点为12个月内的主要不良心脏事件（MACE，包括死亡、再梗死和靶血管血运重建）。次要终点包括9个月时的晚期管腔丢失和再狭窄。
Cypher组43例（38%）、Excel组48例（42%）患者获得了9个月时的血管造影随访数据。支架内再狭窄率和节段内再狭窄率分别为2.3% 对2.1%（P = 0.937）和4.7% 对6.3%（P = 0.738）。支架内和节段内的晚期管腔丢失分别为（0.17±0.26）mm对（0.18±0.33）mm（P = 0.483）和（0.19±0.36）mm对（0.20±0.42）mm（P = 0.419）。Cypher组和Excel组在12个月时的死亡（3.5%对2.6%，P = 0.692）、再梗死（1.8%对2.6%，P = 0.658）、靶血管血运重建（1.8%对2.6%，P = 0.658）、MACE（5.3%对6.1%，P = 0.788）或支架血栓形成（4.4%对3.5%，P = 0.692）方面均无显著差异。
对于接受直接PCI治疗的STEMI患者，Excel和Cypher Select支架可能具有相似的中期疗效和安全性。有必要进行进一步研究以验证其长期疗效和安全性。
