氮氧化钛生物有效性支架与雷帕霉素药物洗脱支架临床应用比较

Efficacy comparison between Titanium nitric-oxide biological active stent and sirolimus-eluting stent in clinical practice

目的：对比研究氮氧化钛生物有效性支架（Titan2-BAS）与雷帕霉素药物洗脱支架（sirolimus-eluting stent,SES）在冠状动脉血运重建方面的临床疗效.方法：141例冠心病患者,根据植入的支架不同分为A组（Titan2-BAS）87例,B组（SES）54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治疗1~3 mo,B组至少12 mo.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：①A组病变内径（3.1±0.4）mm,长度为（24±3）mm,B组病变内径（3.0±0.5）mm,长度为（22±4）mm,两组无显著差异（P〉0.05）.②A组146处〉75%狭窄病变共植入Ti-tan2-BAS 168枚,1枚支架未能通过病变（RCA）,通过率99.3%;B组86处病变共植入SES94枚,通过率100%,两组无显著差异（P〉0.05）.③随访1~17 mo,平均5.8 mo.两组均无死亡病例;A组无急、晚期血栓.B组1例术后2 d出现支架内血栓;A组1例术后3 mo行靶血管重建,B组无靶血管重建;两组MACE发生率无显著差异（P〉0.05）.结论：在本研究样品量情况下,Titan2-BAS与SES在冠脉血运重建方面的近期及远期疗效相近,Titan2不增加MACE发生率.

AIM：To compare the efficacy of Titanium nitric-oxide biological active stents（Titan2-BAS） in clinical practice of coronary revascularization compared with sirolimus-eluting stent（SES）.METHODS：A total of 141 patients with coronary artery diseases were enrolled.Based on the different stents,87 patients were enrolled in group A treated with Titanium nitric-oxide biological active stent and other 54 patients enrolled in group B treated with 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 12 months.The stent delivery success rate,incidence of early in-stent thrombosis and MACE（death,acute myocardial infarction,and target vessel revascularization） in follow-up were analyzed in both groups.RESULTS：①The reference vessel diameter is（3.1±0.4） mm and lesion length is（24±3） mm in group A,while it is（3.0±0.5） mm and（22±4） mm long respectively in group B.There is no significant difference between the 2 groups（P〉0.05）.②In group A,168 Titan2-BAS were implanted in 147 lesions with stenosis 〉75%,1 stent failed to cross the lesion,the delivery success rate is 99.3%.In group B,94 units of SES were implanted in 86 lesions,the delivery success rate is 100%.There is no significant difference between the 2 groups（P〉0.05）.③The follow-up period was from 1 to 17 months,with an average of 5.8 months.No death case found in both groups.There is no acute or late in-stent thrombosis in group A.One patient in group B was found in-stent thrombosis 2 d after the procedure.One patient underwent revascularization 3 months after the procedure in group A,while no revascularization in group B.In summary,there was no significant difference on MACE between the 2 groups（P〉0.05）.CONCLUSION：The present data suggest that Titan2-BAS is comparable with SES in short-term and long-term efficacy in coronary revascularization.Compared to SES,Titan2-BAS did not show an increase in MACE.