可降解涂层与不可降解涂层雷帕霉素洗脱支架在急性心肌梗死直接经皮冠状动脉介入治疗中的疗效比较

Efficacy comparison of primary percutaneous coronary intervention with biodegradable polymer- and durable polymer-based sirolimus-eluting stents for patients with acute myocardial infarction

目的 比较可降解涂层雷帕霉素洗脱支架（Excel）与不可降解涂层雷帕霉素洗脱支架（Cypher Select）在急性ST段抬高型心肌梗死直接经皮冠状动脉介入治疗中的有效性和安全性.方法 连续入选的228例急性ST段抬高型心肌梗死患者随机分至Cypher组（113例）和Excel组（115例）.主要终点为术后12个月主要不良心脏事件（包括死亡、心肌梗死和靶血管重建）,次要终点为9个月晚期管腔丢失和支架再狭窄.结果 术后9个月Cypher组和Excel组分别有43例（38.1%）和48例（42.1%）患者接受冠状动脉造影随访,两组支架内晚期管腔丢失[（0.17±0.26）mm比（0.18±0.33）mm,P=0.483]、节段内晚期管腔丢失[（0.19±0.36）mm比（0.20±0.42）mm,P=0.419）和支架内再狭窄（2.3%比2.1%,P=0.937）、节段内再狭窄（4.7%比6.3%,P=0.738）的发生率差异无统计学意义.术后12个月Cypher组和Excel组死亡（3.5%比2.6%,P=0.692）、心肌梗死（1.8%比2.6%,P=0.658）、靶血管重建（1.8%比2.6%,P=0.658）、主要不良心脏事件（5.3%比6.1%,P=0.788）及支架内血栓形成（4.4%比3.5%,P=0.724）的发生率差异无统计学意义.结论 可降解涂层与不可降解涂层雷帕霉素洗脱支架在直接经皮冠状动脉介入治疗急性ST段抬高型心肌梗死中的近期疗效和安全性可能是一致的,其远期效果有待进一步研究.

Objective 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）. Methods 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. Results 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 ） mmvs. （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. Conclusions 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.