冠状动脉造影和血管内超声引导药物洗脱支架植入治疗冠状动脉慢性闭塞病变远期效果的对比研究

The long-term effects of angiography-guided versus IVUS-guided drug-eluting stent implantation for patients with chronic total coronary occlusion lesion

目的:随机对比研究冠状动脉造影(CAG)引导和血管内超声(IVUS)引导药物洗脱支架(DES)植入治疗冠状动脉慢性闭塞病变(CTO)12个月的临床效果。方法:230例CTO病变患者,成功介入开通CTO病变后随机入选CAG引导组(115例)和IVUS引导组(115例)。主要终点为术后12个月复查CAG时CTO血管晚期管腔丢失值(LLL),次要终点为术后12个月的主要心脏不良事件(MACE),包括心源性死亡、靶病变血运重建(TLR)、靶血管血运重建(TVR)、心肌梗死(MI)、支架内血栓(ST)。结果:12个月CAG复查时IVUS引导组LLL显著低于CAG引导组(P<0.05)。临床随访12个月时,IVUS引导组累计MACE发生率与CAG引导组无显著性差异;心源性死亡、TLR、TVR、MI两组无显著性差异,但ST有降低趋势(P=0.052)。结论:IVUS引导DES植入治疗CTO病变显著降低12个月的LLL;随访12个月,IVUS引导组ST有降低趋势,其他MACE无显著性下降。

Objective：To compare the clinical outcomes at 12 months follow-up between angiography-guided and IVUS-guided drug-eluting stent（DES）implantation in patients with chronic total coronary occlusion（CTO）.Method：A total of 230 patients with CTO,which was successfully recanalized and predilated with balloon,were enrolled and randomised to be treated with DES either guided by IVUS（n=115）or angiography（n=115）.The primary endpoint was late lumen loss（LLL）at 12-month angiographic follow-up after index procedure.The secondary endpoint included MACE,and its components of cardiac death,TLR,TVR,MI,and ST at 12 months follow-up.Result：The LLL in the IVUS guidance group was considerably lower than that in the angiography guidance group at 12months（P〈0.05）.There was no significant difference in the rate of MACE comparing IVUS guidance versus angiography guidance,similar results were found in cardiac death,TLR,TVR,MI;ST had lower tendency（P=0.052）.Conclusion：IVUS guided DES implantation is associated with considerably lower LLL in patients with CTO lesions at 12 months follow-up.In the IVUS guidance group,there is no significant lower MACE events,but a tendency of ST depression at the 12 months follow-up.