第二代药物洗脱支架治疗无保护左主干病变的疗效及安全性分析

First-versus second-generation drug-eluting stents for unprotected left main coronary artery disease

目的探讨第二代药物洗脱支架（DES）置入治疗无保护左主干（ULM）病变患者的疗效及安全性。方法回顾性研究南京医科大学附属南京医院诊断为ULM病变并接受DES治疗的患者216例。接受第一代DES的患者121例为F组,接受第二代DES的患者95例为S组。患者术后常规服用阿司匹林100 mg,每日一次;氯吡格雷150 mg,每日一次（维持至少1年）。主要研究终点为主要不良心血管事件（MACE）,包括心源性死亡、非致死性心肌梗死和再次靶血管血运重建（TVR）;次要终点为12个月时定量冠状动脉造影（CAG）参数。结果在（342±23）d随访期内,总体复合MACE 22例（10.2%）,主要构成为TVR 16例（7.4%）。S组复合MACE为5.3%显著低于F组14.0%（χ2=4.491,P=0.034,RR 2.669,95%CI 1.022~6.975）。S组复合MACE的减少主要表现为TVR减少（χ2=4.465,P=0.035,RR 3.402,95%CI 0.998~11.60）。随访血管造影再狭窄F组与S组分别为17例（14.5%）和8例（8.4%）,差异无统计学意义（χ2=1.647,P=0.199）。血管内超声提示的晚期获得性支架贴壁不良于F组和S组分别为7例（5.8%）和1例（1.1%）,F组有增加趋势,但差异无统计学意义（χ2=3.342,P=0.068）。结论与第一代DES相比较,使用第二代DES治疗ULM病变MACE发生率低,主要表现为TVR减少;第二代DES治疗ULM病变具有更好的疗效和安全性。

Objective To compare the safety and efficacy of first- versus second-generation DESs for the treatment of unprotected left main（ ULM） coronary artery disease. Methods This was a retrospective study of consecutive de novo ULM lesions, treated with either second-generation DES[zotarolimus-eluting stent（ ZES） and the everolimus-eluting stent（ EES） ] or first-generation DES[sirolimus-eluting stents（ SES） ] between April 2010 and March 2013. Results Patients with secondgeneration DES were found to have less major adverse cardiac events（ MACE）（ 5. 3% vs. 14. 0%,P = 0. 034） as well as lower target vessel revascularization（ TVR） rates（ 10. 2% vs. 3. 7%,P = 0. 035） at about 1-year follow-up. Angiographic restenosis occurred in 8. 4% of patients in the second-generation group and 14. 5% in the SES group（ P = 0. 199）. There was a trend towards first-generation DES to be associated with more late-acquired stent malappositions as assessed by intravascular ultrasound when compared to second-generation DES yet without statitiscal significance（ 5. 8% vs. 1. 1%,P = 0. 068）. Conclusions Our results suggest that the use of second-generation DES for the treatment of ULM lesions is associated with better clinical outcomes as compared to first-generation DES,mainly due to a lower need for repeat revascularization.