国产无聚合物紫杉醇微孔载药支架与雷帕霉素涂层支架对比治疗急性心肌梗死

Domestic polymer-free paclitaxel-eluting stent and polymer-based rapamycin-eluting stent for the treatment of acute myocardial infarction: a comparison study

目的比较国产无聚合物紫杉醇微孔载药支架(垠艺支架)与雷帕霉素涂层支架(乐普支架)在治疗急性心肌梗死患者中的临床安全性及有效性。方法 2010年1月—2012年1月收治急性心肌梗死患者115例,根据植入支架类型不同分为垠艺支架组45例和乐普支架组70例,观察两组基本临床情况、冠状动脉病变特征、基本介入技术指标及围术期情况。术后随访,对比两组支架内血栓形成、主要心血管不良事件发生率。结果两组患者术中发生无复流、心律紊乱等并发症的差异无统计学意义(P>0.05)等。随访1年,垠艺组支架内再狭窄1例,乐普组2例,均行再次球囊扩张及支架植入,但组间差异无统计学意义(P>0.05)。术后均无急性、亚急性或晚期支架内血栓事件发生,无致命性心肌梗死,无心源性死亡。结论紫杉醇微孔载药支架与国产雷帕霉素药物洗脱支架在治疗急性心肌梗死时具有相同的近、中期临床疗效和安全性。

Objective To evaluate the safety and efficacy of domestic polymer-free paclitaxel-eluting microporous stents （YINYI） in comparison with polymer-based rapamycin-eluting stents （Partner） in treating patients with acute myocardial infarction. Methods During the period from Jan. 2010 to Jan. 2012, a total of 115 patients with acute myocardial infarction were admitted to the hospital. According to the stent used in treatment, the patients were divided into YINYI group （n = 45） and Partner group （n = 70）. The basic clinical conditions, the pathologic characteristics of coronary artery lesion, the percutaneous coronary intervention results and the related situation during perioperative period were analyzed. All the patients were followed up for one year. The in- stent thrombosis and the incidence of major adverse cardiac events, including cardiac death, myocardial infarction and target lesion revascularization, were compared between the two groups. Results No reflow or arrhythmia occurred during the procedure in patients of both groups. During one- year follow- up period, in- stent restenosis was seen in one patient of YINYI group and two patients of Partner group （P 〉 0.05）, and balloon dilatation together with stent implantation had to be carried again in these three patients. No acute, subacute or late stent thrombosis was observed, and no fatal myocardial infarction or cardiogenic death occurred in both groups. Conclusion In treating acute myocardial infarction, domestic polymer-free paclitaxel-eluting microporous stents carry the similar short-to-mid term efficacy and safety as polymer-based rapamycin-eluting stents do.（J Intervent Radiol, 2013, 22： 458-460）