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一项比较支架置入术与非体外循环冠状动脉搭桥术治疗左前降支近端严重狭窄的前瞻性随机试验:三年随访

A prospective randomized trial comparing stenting with off-pump coronary surgery for high-grade stenosis in the proximal left anterior descending coronary artery: three-year follow-up.

作者信息

Drenth Derk J, Veeger Nic J G M, Winter Jobst B, Grandjean Jan G, Mariani Massimo A, Boven van Ad J, Boonstra Piet W

机构信息

Thoraxcentre of the Groningen University Hospital, Groningen, The Netherlands.

出版信息

J Am Coll Cardiol. 2002 Dec 4;40(11):1955-60. doi: 10.1016/s0735-1097(02)02536-6.

DOI:10.1016/s0735-1097(02)02536-6
PMID:12475455
Abstract

OBJECTIVES

This study was done to identify the best treatment for an isolated high-grade stenosis of the proximal left anterior descending coronary artery (LAD).

BACKGROUND

Percutaneous transluminal coronary angioplasty with stenting (PCI) and off-pump coronary artery bypass grafting (surgery) are used to treat single-vessel disease of a high-grade stenosis of the proximal LAD. Midterm results of both treatments are compared in this prospective randomized study.

METHODS

In a single-center prospective trial, we randomly assigned 102 patients with a high-grade stenosis of the proximal LAD (American College of Cardiology/American Heart Association classification type B2 or C) to PCI (n = 51) or surgery (n = 51). Primary composite end point was freedom from Major Adverse Cardiac and Cerebrovascular Events (MACCE) at follow-up, including death, myocardial infarction, cerebrovascular accident, and repeat target vessel revascularization (TVR). Secondary end points were angina pectoris class and need for antianginal medication at follow-up. Analysis was by intention-to-treat (ITT) and received treatment (RT).

RESULTS

Mean follow-up time was three years (90% midrange, two to four years). Incidence of MACCE was 23.5% after PCI and 9.8% after surgery; p = 0.07 ITT (24.1% vs. 8.3%; p = 0.04 RT). After surgery a significantly lower angina pectoris class (p = 0.02) and need for antianginal medication (p = 0.01) was found compared to PCI. Target vessel revascularization was 15.7% after PCI and 4.1% after surgery (p = 0.09).

CONCLUSIONS

At three-year follow-up (range, two to four years), a trend in favor of surgery is observed in regard to MACCE-free survival with a significantly lower angina pectoris status and significantly lower need for antianginal medication.

摘要

目的

本研究旨在确定治疗孤立性左前降支冠状动脉(LAD)近端高度狭窄的最佳方法。

背景

经皮冠状动脉腔内血管成形术加支架置入术(PCI)和非体外循环冠状动脉搭桥术(手术)用于治疗LAD近端高度狭窄的单支血管病变。在这项前瞻性随机研究中,对两种治疗方法的中期结果进行了比较。

方法

在一项单中心前瞻性试验中,我们将102例LAD近端高度狭窄(美国心脏病学会/美国心脏协会分类为B2型或C型)的患者随机分为PCI组(n = 51)或手术组(n = 51)。主要复合终点是随访时无主要不良心脑血管事件(MACCE),包括死亡、心肌梗死、脑血管意外和再次靶血管血运重建(TVR)。次要终点是随访时的心绞痛分级和抗心绞痛药物需求。分析采用意向性治疗(ITT)和接受治疗(RT)。

结果

平均随访时间为三年(90%的范围为两年至四年)。PCI术后MACCE发生率为23.5%,手术组为9.8%;ITT分析p = 0.07(24.1%对8.3%;p = 0.04,RT分析)。与PCI相比,手术后心绞痛分级明显更低(p = 0.02),抗心绞痛药物需求明显更低(p = 0.01)。PCI术后靶血管血运重建率为15.7%,手术组为4.1%(p = 0.09)。

结论

在三年随访期(范围为两年至四年),在无MACCE生存方面观察到倾向于手术治疗的趋势,心绞痛状况明显更低,抗心绞痛药物需求明显更低。

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