论文部分内容阅读
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 coating sirolimus-eluting stent (TIVOLI stent) in patients with coronary atherosclerotic heart disease. METHODS: This prospective, multicenter clinical study comparing TIVOLI and ENDEAVOR zotarolimus-eluting stents (ENDEAVOR stent) was performed to demonstrate that TIVOLI stents are not inferior to ENDEAVOR stents in terms of late stent loss in stents. A total of 324 patients (168 in the TIVOLI group and 156 in the ENDEAVOR group) were enrolled in 12 centers in China. A maximum of two coronary lesions were placed in each stent with a lesion length ≤40 mm and a reference vessel diameter of 2.25-4.00 mm. The primary endpoint was late stent loss in the stent as determined by coronary angiography at 240 days postoperatively. The secondary end point was the clinical outcome of 1-3 years after surgery, including major adverse cardiac events (cardiac death, myocardial infarction or target lesion revascularization) and stent thrombosis. Results: In the TIVOLI group, the late lumen loss and stent restenosis were lower in the stent and stent segments than in the ENDEAVOR group (P <0.05 ~ 0.01). The target rate of revascularization in TIVOLI group was lower than that in ENDEAVOR group one, two and three years after operation (P <0.05 ~ 0.01). The incidence of major adverse cardiac events in TIVOLI group tended to be lower than those in ENDEAVOR group at 1, 2 and 3 years after operation, but the difference was not statistically significant (P> 0.05). Conclusion: TIVOLI stent is better than ENDEAVOR stent in the late stage of 8 months after operation. The incidence of angiographic defined restenosis and 3-year target lesion revascularization at 8 months after operation is low. There was no significant difference between the two groups in the incidence of major cardiac adverse events at 3 years.