冠状动脉内直接支架置入治疗急性冠状动脉综合征——与传统支架置入方法的随机对比研究

Direct Coronary Stenting in Acute Coronary Syndrome:A Randomized Comparison With Conventional Stenting

目的 :采用与传统支架置入术 (CS)随机对比研究的方法 ,评价冠状动脉 (冠脉 )内直接支架置入术 (DS)治疗急性冠脉综合征相关病变的可行性和安全性。 方法 :将 15 0例急性冠脉综合征患者随机分为DS组和CS组 ,两组的基本临床特征和造影特征及术前治疗无显著差异。实验第一终点是影像学的成功 :支架置入后靶病变残余狭窄 <2 0 % ,心肌梗死溶栓治疗临床试验 (TIMI) 3级血流 ,“无再流或慢血流现象”的减少 ;第二终点为严重并发症发生率和手术操作时间及花费的评价。 结果 :DS组和CS组组间手术成功率无差异 (DS组为 94 7% ,CS组为 96 0 % )。无再流或慢血流现象发生率DS组为 5例 (6 7% ) ,CS组为 4例 (5 3 % ) ,两组间亦无差异 (P =NS)。手术时间、球囊导管及造影剂用量DS组均低于CS组 ,两组比较有极显著差异 (P <0 0 1)。住院期间效果及严重并发症两组间无差异 ;6个月随访结果两组比较亦无显著性差异。 结论 :本随机研究证实了一些回顾性研究的结果 ,DS治疗急性冠脉综合征的相关病变具有可行性和安全性 ,与CS相比较 ,这一策略的突出优点是显著增加效益费用比 ,而对急性并发症特别是“无再流或慢血流”现象的发生无影响。

Objective: To evaluate the feasibility and safety of direct stenting (DS) and to compare it with conventional implantation techniques in acute coronary syndrome (ACS)-related lesions. Methods: Between May 2000 and March 2001, 150 patients with ACS were randomized to either group A (n=75), DS without predilatation, or group B (n = 75), conventional stenting (CS) with predilatation . Baseline clinical and angiographic characteristics before procedure were similar between the two groups. The primary endpoint of the study was angiographic success,which was defined as a residual stenosis<20% associated with a TIMI grade 3 flow and reduction of no-reflow or slow-flow phenomenon. The secondary endpoint was about the major adverse clinical event (MACE) rate in-hospital and at 6 months. Secondary endpoint also included the duration and cost of the procedure. Results: Primary success rate was 94.7% in group A and 96% in group B (p=not significant, NS). No-reflow or slow-flow was observed in 6.7% after DS and in 5.3% after CS (p=NS). The number of balloons used, and doses of contrast agent were significantly different between the two groups (p<0.01). The MACE rate was not different during in-hospital stay and follow-up period between the two groups. Conclusion: This randomized study confirms the promising result of previous studies that direct coronary stenting in selected ACS-related lesions is feasible and safe. The major impact of this strategy is the improvement of the cost-benefit ratio, with little influence on acute complications, especially on the occurrence of no-reflow or slow-flow phenomenon in selected patients with ACS.