氮氧化钛生物有效性支架与生物可降解雷帕霉素药物洗脱支架长期临床对比研究

Long term clinical comparison between Titanium nitric oxide biological availability stent and biodegradable polymer coated sirolimus-eluting stent

目的对比研究氮氧化钛生物有效性支架（Titan2-BAS）与生物可降解雷帕霉素药物洗脱支架（Excel支架）在冠状动脉血运重建方面的临床疗效。方法 162例冠心病患者,根据植入的支架不同分为A组（Titan2-BAS）88例,B组（Excel）74例,均采用经桡动脉或尺动脉途径冠脉血运重建。A组阿司匹林与氯吡格雷双联抗血小板治疗1~3个月,B组至少6个月,此后长期单用阿司匹林。计算A、B两组支架病变的通过率、早期支架内血栓发生率及随访MACE发生率（指死亡、急性心肌梗死、靶血管重建等）。结果 （1）A组141处〉75%狭窄病变共植入Ti-tan2-BAS支架152枚,1枚支架未能通过病变（RCA）,通过率99.3%;B组114处病变共植入Excel支架120枚,通过率100%,两组差异无统计学意义（P〉0.05）。（2）随访10~18个月,平均13.8个月。两组均无死亡病例;A、B两组均无急、晚期血栓;A组1例术后6个月行靶血管重建,B组无靶血管重建;综合以上,两组MACE发生率差异无统计学意义（P〉0.05）。结论在本研究样品量情况下,Titan2-BAS与Excel支架在冠脉血运重建方面的近期及远期疗效相近。

Objectives To compare the clinical efficacy of Titanium nitric-oxide biological availability stents（Titan2-BAS） with biodegradable polymer coated sirolimus eluting stents（Excel） in practice of coronary revascularization.Methods 162 patients with coronary heart diseases were enrolled.Based on the different stents,88 patients were enrolled in group A treated with Titanium nitric oxide biological availability stent and other 74 patients enrolled in group B treated with biodegradable polymer coated sirolimus eluting stents.All the stents were implanted through either radial or ulnar artery approach.Patients in group A were administered with aspirin and clopidogrel for 1 to 3 months,while patients in group B for at least 6 months.Late aspirin for long term secondary prevention was reasonable.The stent delivery success rate,incidence of early in stent thrombosis and MACE（death,acute myocardial infarction and target vessel revascularization） in follow up was analyzed in both groups.Results（1）In group A,152 Titan2-BAS were implanted in 141 lesions with stenosis 75%,1 stent failed to cross the lesion,the delivery success rate was 99.3%.In group B,120 Excel were implanted in 114 lesions,the delivery success rate was 100%.There was no significant difference between the two groups（P0.05）.（2）After 10~18（average 13.8） months follow-ups,no death,no acute or late in stent thrombosis case was found in both groups.1 patient underwent revascularization at 6 months after the operation in group A,while no revascularization in group B.In summary,there was no significant difference on MACE between the two groups（P0.05）.Conclusions The present data suggest that Titan2-BAS is comparable with Excel in short term and long term efficacy in coronary revascularization.