国产替罗非班联合生物可降解支架Excel治疗急性冠脉综合征的安全性和疗效

目的 评估国产替罗非班联合生物可降解支架Excel治疗急性冠脉综合征(ACS)的安全性和近、远期疗效.方法 301例ACS患者分为Excel组、Cypher组和裸金属支架(BMS)组.Excel组100例接受Excel支架植入术,Cypher组102例接受Cypher支架植入术,裸金属支架组99例接受裸金属支架植入术,3组均于术中和术后使用替罗非班.替罗非班的给药方法:首先给予负荷量10 μg/kg,3 min内静注完毕,之后以0.15μg/(kg·min)的速度微量泵持续静点48 h.比较3组支架植入后安全性和有效性,观察支架植入后TIMI血流、出血并发症、血小板、血红蛋白、红细胞压积变化、心绞痛发生率、急性或亚急性血栓及主要不良心脏事件(MACE)(包括心源性死亡、非致死性心肌梗死、靶病变再次血运重建术)等,并于1个月、6个月、12个月进行门诊及电话随访,观察比较心绞痛发生率、MACE发生率及再住院率.结果 Excel组、Cypher组和裸金属支架组比较,3组术前患者年龄、性别、冠心病的危险因素、左室射血分数、靶病变的部位、血小板计数、血红蛋白、红细胞压积差异均无统计学意义.3组手术成功率均为100%,TIMI血流均为Ⅲ级,术后均无严重的出血并发症如脑卒中和上消化道大出血等,出血并发症、血小板计数、血红蛋白、红细胞压积3组间差异均无统计学意义,3组发生急性血栓分别为0例、1例和1例(0 vs.0.98%vs.1.01%),3组急性支架内急性支架内血栓发生率差异均无统计学意义(P>0.05).术后1个月、6个月随访3组心绞痛发生率、亚急性支架内血栓发生率、MACE的发生率、再住院率差异均无统计学意义(P>0.05);12个月随访Excel组、Cypher与BMS组比较,心绞痛发生率、MACE的发生率、晚期支架内血栓发生率、再住院率差异均有统计学意义(P<0.05).结论 国产替罗非班联合生物可降解支架Excel治疗ACS具有预防急性和亚急性及晚期支架内血栓的作用,具有较好的安全性和有效性,有良好的近期和远期疗效.

The safety and therapeutic efficacy for application of biodegradable stent excel with biodegradble polymer combined with firofiban in patients with acute coronary syndrom

Objective To evaluate the safety, and the brief-and prolongedterm therapeutic efficacy for im- plantation of biodegradable stent Excel combined with Tirofiban made in China into patients with acute coronary syndrome(ACS). Method A total of 301 patients were divided into Excel group (n = 100), Cypher group (n =102) and bare metal stem(BMS) (n = 99). The Tirofiban used in three groups was administered intravenously during and after operation.The loading dose of Tirofiban was 10 μg/kg given within 3 min followed by a Tirofiban intravenous maintenance infusion in 0.15 μg/(kg·min) with micro pump for 48 hours. Safety and efficacy were compared among three groups after stents implantation by the observation of TIMI flow, complication of bleeding, changes of platelet count, haematoglobin and hematocrit, incidence of angina, acute and subacute thrombosis inner stent and major adverse cardiac events (MACE) (cardiac death, nonfatal myocardial infarction and target ves-sel revascularization). Follow-up information got from out-patient clinic and telephone call including incidence of angina, MACE and rehospitalization were comapared sucessively 1 month, 6 monthes and 12 monthes after dis- charge. Results Among there groups,there were no significant differences in demographics,and physical and lab-oratory findings before treatment. Successful rate of implantation was 100 percent and the TIMI flow of class Ⅲ was found in all patients. There was no complication of stroke and massive hemorrhage of gastrointestinal tract, and no significant differences in complication of bleeding, platelet count, hemoglobin and hematocrit after implantation. Incidence rates of acute thrombosis were 0, 0.98 and 1.01 percent in three groups, and there was no significant difference in acute thrombosis inner stent among three groups (P >0.05). The rates of angina, sub.acute stent thrombosis, MACE and rehospitalization among three groups had no differences at 1 month and 6 monthes follow-up (P > 0.05), but significant differences were not found until 12 monthes follow-up (P < 0.05). Conclusions Drug-eluting stent Excel with biodegradable polymer combined with Tirofiban made in China implanted in patients with ACS were capable of preventing acute and later thrombosis inner stent. This procedure had favourable safety, and brief-term and proionge-term therapeutic efficacy.