Han Ya-Ling, Zhang Jian, Li Yi, Wang Shou-Li, Jing Quan-Min, Yi Xian-Hua, Ma Ying-Yan, Luan Bo, Wang Geng, Wang Bin
Department of Cardiology, Shenyang Northern Hospital, Shenyang, Liaoning 110016, China.
Chin Med J (Engl). 2009 Mar 20;122(6):643-7.
There are limited data on the efficacy of drug-eluting stents (DES) for treatment of chronic total occlusions (CTO). The aim of the study was to evaluate the long-term clinical outcomes of DES implantation for CTO compared with bare-metal stent (BMS) implantation.
Between June 1995 and December 2006, a total of 1184 patients with successful recanalization of at least one de novo CTO lesion were consecutively registered, including 660 (55.7%) who underwent DES and 524 (44.3%) who underwent BMS implantation. All patients were followed up for up to 5 years for occurrence of major adverse cardiac events (MACE). Long-term survival rates were estimated with the Kaplan-Meier method.
Baseline clinical and angiographic characteristics were comparable between the two groups except that patients in the DES group received longer dual antiplatelet therapy ((7.4 +/- 2.5) months vs (1.7 +/- 0.8) months, P < 0.001). Average follow-up periods were (4.7 +/- 0.89) and (3.2 +/- 1.3) years for the BMS and DES groups, respectively. There was no significant difference in 5-year survival rates between the two groups (90.3% for DES group vs 89.6% for BMS group, Log-rank P = 0.38), but the 5-year target vessel revascularization (TVR)-free survival rate in the DES group was significantly higher than that in the BMS group (81.6% vs 73.5%, Log-rank P < 0.001). The cumulative MACE-free survival in the DES group was also significantly higher than that in the BMS group (80.6% vs 71.5%, Log-rank P < 0.001). The rates of re-admission caused by cardiovascular disease (27.0% vs 37.8%, P < 0.001) and the need for bypass surgery were significantly lower in the DES group (1.5% vs 3.4%, P < 0.05). By multivariable analysis, DES implantation could significantly lower the long-term MACE risk of PCI for CTO patients (HR: 0.492; 95% CI 0.396 - 0.656, P < 0.001). Left ventricular ejection fraction < 50% and elderly (> or = 65 years) were identified as independent predictors of long-term MACE during follow-up.
This study demonstrates the long-term (up to 5 years) efficacy of DES for treatment of CTO, which is superior to BMS implantation in reducing the rates of TVR and MACE, as well as the need of re-admission and bypass surgery.
关于药物洗脱支架(DES)治疗慢性完全闭塞病变(CTO)疗效的数据有限。本研究的目的是评估与裸金属支架(BMS)植入相比,DES植入治疗CTO的长期临床结局。
1995年6月至2006年12月,共连续登记了1184例至少成功再通一处初发CTO病变的患者,其中660例(55.7%)接受了DES植入,524例(44.3%)接受了BMS植入。所有患者均随访长达5年,观察主要不良心脏事件(MACE)的发生情况。采用Kaplan-Meier法估计长期生存率。
两组患者的基线临床和血管造影特征具有可比性,但DES组患者接受双联抗血小板治疗的时间更长((7.4±2.5)个月 vs (1.7±0.8)个月,P<0.001)。BMS组和DES组的平均随访时间分别为(4.7±0.89)年和(3.2±1.3)年。两组的5年生存率无显著差异(DES组为90.3%,BMS组为89.6%,Log-rank检验P=0.38),但DES组的5年无靶血管重建(TVR)生存率显著高于BMS组(81.6% vs 73.5%,Log-rank检验P<0.001)。DES组的累积无MACE生存率也显著高于BMS组(80.6% vs 71.5%,Log-rank检验P<0.001)。DES组因心血管疾病导致的再次入院率(27.0% vs 37.8%,P<0.001)和旁路手术需求显著更低(1.5% vs 3.4%,P<0.05)。通过多变量分析,DES植入可显著降低CTO患者PCI的长期MACE风险(HR:0.492;95%CI 0.396 - 0.656,P<0.001)。左心室射血分数<50%和老年患者(≥65岁)被确定为随访期间长期MACE的独立预测因素。
本研究证明了DES治疗CTO的长期(长达5年)疗效,在降低TVR和MACE发生率以及再次入院和旁路手术需求方面优于BMS植入。