TAP技术与必要性支架术处理冠状动脉分叉病变的疗效对比

Randomized study on T stenting and small protrusion technique versus simple stenting for patients with coronary artery bifurcation lesions and with big size side branch

目的对比分析TAP技术与必要性支架术在处理边支大于2．0mm冠状动脉分叉病变的临床效果。方法将患者随机分为必要性支架组和TAP组。入选病例的冠状动脉造影均证实为MEDINA（1，1，1）型分叉病变，主支血管参考直径≥2．5mm，边支血管参考直径≥2．0mm。主要研究终点：术后12个月主要不良心血管事件的发生率和支架血栓发生率。次要终点包括：术后8个月冠状动脉造影随访再狭窄率、手术操作时间、曝光时间、对比剂用量、手术操作成功率、手术相关心肌梗死。结果TAP组均完成最终对吻球囊扩张。12个月随访结果显示，TAP组主要不良心血管事件和必要性支架组差异无统计学意义（13．0％比12．1％，P〉0．05）。两组均发生1例支架血栓事件。TAP组与必要性支架组术后24h操作相关心肌梗死发生率差异无统计学意义（8．7％比5．2％，P〉0．05）。两组在手术时间、X线曝光时间、对比剂用量差异无统计学意义。8个月冠状动脉造影结果显示，必要性支架组边支开口再狭窄明显高于TAP组（17．1％比3．8％，P〈0．05），总体再狭窄率两组差异无统计学意义。结论TAP技术在处理大分支冠状动脉分叉病变的有效性及长期安全性方面不亚于必要性支架术。

Objective To explore the feasibility and safety of T stenting and small protrusion（TAP） technique and compare the efficacy with simple stenting in patients with coronary bifurcation lesions and with big size side branch. Methods A total of 142 eligible patients were recruited and 127 patients completed the study （ simple stenting group 58 and TAP technique group 69）. Results Major adverse cardiovascular event rate was similar at 12 months follow up between the groups （ TAP technique group 13.0% versus simple stenting group 12. 1% , P 〉 0.05 ）. The rate of procedural-related myocardial infarction, procedure and fluoroscopy time, contrast volumes were also similar between 2 groups （ all P 〉 0. 05 ）. At 8 months, coronary angiography revealed that the restenosis rate of the ostium of side branch in TAP group was significantly lower than that of simple stenting group（ 17.1% versus 3.8% ,P 〈 0. 05 ）. Overall restennosis rate was similar between the groups （ P 〉 0. 05 ）. Conclusion Both TAP technique and simple stenting are feasible and effective strategies for treating patients with bifurcation lesions.