摘要
目的:评价冠状动脉粥样硬化性心脏病患者成功置入TIVOLI生物可降解涂层西罗莫司洗脱支架(简称TIVOLI支架)的有效性和安全性。方法:本研究为比较TIVOLI支架和ENDEAVOR佐他莫司洗脱支架(简称ENDEAVOR支架)的前瞻性、多中心临床研究,以证实TIVOLI支架在支架内晚期管腔丢失方面并不劣于ENDEAVOR支架。在中国12家中心共纳入324例患者(TIVOLI组168例;ENDEAVOR组156例),每例患者最多两处冠状动脉病变置入支架,病变长度≤40 mm,参考血管直径2.25～4.00 mm。主要终点为术后240天冠状动脉造影确定的支架内晚期管腔丢失。次级终点为术后1～3年的临床预后,包括主要心脏不良事件(心脏性死亡、心肌梗死或靶病变血运重建)和支架内血栓形成。结果:TIVOLI组支架内和支架节段内晚期管腔丢失、支架内再狭窄率均低于ENDEAVOR组,差异均有统计学意义(P<0.05～0.01)。TIVOLI组靶病变血运重建率术后1、2、3年均低于ENDEAVOR组,差异均有统计学意义(P<0.05～0.01)。TIVOLI组主要心脏不良事件发生率术后1、2、3年比ENDEAVOR组有更低的趋势,但差异无统计学意义(P>0.05)。结论:TIVOLI支架术后8个月晚期管腔丢失优于ENDEAVOR支架,术后8个月造影界定的再狭窄和3年靶病变血运重建的发生率均较低。3年主要心脏不良事件发生率方面两组差异无统计学意义。
Objective ：To evaluate the efficacy and safety of TIVOLI biodegradable polymer coated sirolimus-eluting stents （TIVOLI stents）, in treating coronary artery disease（CAD） patients. Methods ：We conducted a prospective multicenter clinical trial to demonstrate the no-inferiority of TIVOLI stents to Endeavor zotalimus-eluting stents（ Endeavor stentts） in late lumen loss. Our work included two groups as TIVOLI group, n = 168 and EN- DEAVOR group, n = 156. The primary end point was angiographie in-stent late lumen loss at 240 days. The secondary end point was 1 - 3 years clinical follow-up of major adverse cardiac events （MACE） as cardiac death, myocardial infarction, target lesion revascularization（TLR） and in-stent thrombosis. Results： The angiographie late lumen loss at 240 days in TIVOL/group was lower than that in Endeavor group,P〈0. 05 -001. The 1 -3 years post-operational TLR in TIVOLI group were all lower than those in Endeavor group ,P〈O. 05 - 001. Conclusion ： TIVOL stents was superior to Endeavor stents in terms of late lumen loss at 240 days after stent implantation, it also had lower in-stent re-stenosis rate and lower TLR at 3 years after stent implantation.
出处
《中国循环杂志》
CSCD
北大核心
2012年第5期334-337,共4页
Chinese Circulation Journal
