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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 effects of coronary artery angiography (CAG) guidance and intravascular ultrasound (IVUS) guided drug-eluting stent (DES) implantation in the treatment of chronic coronary artery disease (CTO) at random for 12 months. Methods: Totally 230 patients with CTO were enrolled in the CAG guide group (115 cases) and IVUS guide group (115 cases) after successful intervention of CTO. The primary endpoint was CTL vascular late luminal loss (LLL) at 12 months after CAG. The secondary endpoint was major cardiac events (MACE) at 12 months postoperatively, including cardiogenic death, target lesion blood loss Reconstruction (TLR), target vessel revascularization (TVR), myocardial infarction (MI), stent thrombosis (ST). Results: The LLL of IVUS guide group was significantly lower than that of CAG guide group (P <0.05) at 12 months. At 12 months of clinical follow-up, there was no significant difference in the cumulative incidence of MACE between IVUS-guided group and CAG-guided group. There was no significant difference in cardiac death, TLR, TVR, MI between the two groups (P = 0.052) . CONCLUSIONS: IVUS guided DES implanted CTL lesion significantly reduced LLL at 12 months. The STV of IVUS guided group decreased at 12 months of follow-up, while no significant decrease of other MACE.