双对吻挤压与经典挤压技术治疗冠状动脉分叉病变的前瞻性、随机、多中心研究

目的 比较双对吻挤压(DK crush)和经典挤压技术治疗冠状动脉分叉病变的临床效果.方法 311例真性分叉病变患者随机分入DK crush组(n=155)和经典挤压组(n=156),随访时间8个月.一级及二级终点分别为主要心脏不良事件(MACE,包括心肌梗死、心原性死亡和靶病变血运重建)和血管直径再狭窄及晚期丢失.结果 DK crush组糖尿病患者较多.经典挤压组及DKcrush组最终对吻扩张(FKBI)成功率分别为76%和100%(P＜0.001).DK crush术式的不足包括造影剂用量大(P=0.04)、球囊数量多(P＜0.01)、手术时间长(P＜0.001),但是对吻扩张不满意率显著减少(27.6%比6.3%,P＜0.01).临床随访率为100%,冠状动脉造影随访率为82%.经典挤压组累计再狭窄率为32.3%,而DK crush组为20.3%(P=0.01),经典挤压组分支血管再狭窄率高(24.4%比12.3%,P=0.01),而两组间主干血管再狭窄率差异无统计学意义.经典挤压组术后8个月时的累计MACE发生率为24.4%(FKBI失败组为35.9%,FKBI成功组为19.7%),显著高于DK crush组(11.4%,P=0.02).经典挤压组血栓栓塞率为3.2%(FKBI失败组为5.1%,FKBI成功组为1.7%),而DK crush组为1.3%(P＞0.05).经典挤压组术后8个月时无靶病变血运重建生存率为75.4%(FKBI失败组为71.2%,FKBI成功组为77.6%),而DK crush组为89.5%(P=0.002).结论 DK crush可能是治疗冠状动脉分叉病变的较佳术式.

Comparison of DK crush with classical crush technique with drug-eluting stents for the treatment of coronary bifurcation lesions from DKCRUSH-1 study

Objective To determine independent factors correlated with clinical effects of DK crush and classical crush technique with drug-eluting stents on bifurcation lesions.Methods 311 patients with bifurcation lesions were randomized to classical(C,n=156)or double kissing(DK)crush(n=155)stent implantation group.The primary endpoints included major adverse cardiac events(MACE).Results Final kissing balloon inflation(FKBI)success rate was 76%in C and 100%in DK groups(P＜0.001).Dkcrush procedure was characterized by lower unsatisfactory FKBI rate(27.6%VS.6.3%,P＜0.01).Clinical follow-up was available in 100%and angiographic follow-up in 82%patients.The overall restenosi srate was 32.3%in C and 20.3%in DK groups(P=0.01).respectively.Cumulative 8-month MACE was 35.9%in without-FKBI and 19.7%in with-FKBI sub-groups,and 11.4%in DK group(P=0.02).The incidence of stent thrombosis was 3.2%in C group (5.1%without VS.1.7%with FKBI)and 1.3%in Dkgroup(P＞0.05).The predictive factors of MACE included minimal side branch stent lumen diameter and lack of DK crush technique.Conclusion DK crush technique is an alternative of double stenting techniquesin terms of improvement of restenosis and clinical outcomes.