ST段抬高心肌梗死应用国产西罗莫司洗脱支架与金属裸支架的对比研究Initial results of home-made sirolimus eluting stent (Firebird DES stent) versus bare metal stent in ST segment elevation myocardial infarction (FIBISTEMI Trial)
高海,颜红兵,朱小玲,李南,艾辉,李世英,杨铎,王健,孙晓东,慈维萍
摘要(Abstract):
目的评估在ST段抬高心肌梗死(STEMI)患者应用国产西罗莫司洗脱支架的安全性和有效性。方法将1年内连续入选STEMI的患者随机分为国产西罗莫司洗脱(火鸟)支架组或金属裸支架(BMS)组。对所有患者连续临床随访6个月,术后6个月常规行冠状动脉造影。试验主要终点是术后6个月靶病变区晚期管腔丢失(LLL),次要终点包括支架内血栓发生率和主要心脏不良事件(MACE)。结果试验前6个月共入选85例患者。国产西罗莫司(火鸟)支架组42例,平均年龄58·1岁。BMS组43例,平均年龄59·8岁。两组6个月血管造影随访率分别为47·6%和44·2%。6个月随访结果显示,国产西罗莫司(火鸟)支架组死亡率、靶血管重建率(TVR)和MACE分别为2·4%,0%和2·4%,BMS组相应为4·7%,31·6%和25·6%(P<0·05)。BMS组有1例发生支架内亚急性血栓。定量冠状动脉造影结果显示,国产西罗莫司(火鸟)支架组支架内平均LLL为0·18mm,BMS组为0·72mm。结论与BMS比较,国产西罗莫司(火鸟)支架能够有效降低STEMI患者6个月死亡率、TVR和MACE发生率,其急性或亚急性支架血栓发生率低。
关键词(KeyWords): 心肌梗死;支架;西罗莫司
基金项目(Foundation):
作者(Author): 高海,颜红兵,朱小玲,李南,艾辉,李世英,杨铎,王健,孙晓东,慈维萍
参考文献(References):
- [1]Keeley EC,Boura JA,Grines CL.Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction:a quantitiative reviewof23randomised trials.Lancet,2003,261:13-20.
- [2]颜红兵,朱小玲,柯元南,等.常规开展直接冠状动脉介入治疗的5年总结.中华急诊医学杂志,2005,14:64-67.
- [3]Moses JW,Leon MB,Popma JJ,et al.Sirolimus-elutingstents verus standard stentsin patients withstenosisin a native coronary arteries.NEngl J Med,2003,349:1315-1323.
- [4]Stone GW,Ellis SG,Cox DA,et al.Apolymer-based,paclitaxel-eluting stent in patients with coronary artery disease.NEngl J Med,2004;350:221-231.
- [5]Lemos PA,Saia F,Hofman SH,et al.Short and long termclinical benefit of sirolimus-eluting stents compared to conventional bare stents for patients with acute myocardiol infarction.J Am Coll Cardiol,2004,43:704-708.
- [6]Hofma SH,van der Giessen WJ,van Dalen BM,et al.Indication of long-term endothelial dysfunction after sirolimus-eluting stent implantation.Eur Heart J,2006,27:166-170.
- [7]Babinska A,Markell MS,Salifu MO,et al.Enhancement of human platelet aggregation and secretion induced by rapamycin.Nephrol Dial Transplant,1998,13:3153-3159.
- [8]Steffel J,Latini RA,Akhmedov A,et al.Rapamycin,but not FK-506,increases endothelial tissue factor expression:implications for drug-eluting stent design.Circulation,2005,112:2002-2011.
- [9]Guagliumi G,Farb A,Musumeci G,et al.Imagesin cardiovascular medicine.Sirolimus-eluting stent implantedin human coronary artery for16months:pathological findings.Circulation,2003,107:1340-1341.
- [10]Nebeker JR,Virmani R,Bennet CL,et al.Hypersensitivity cases associated with drug-eluting coronary stents:a review of available cases from the Research on Adverse Drug Events and Reports(RADAR)project.J AmColl Cardiol,2006,47:175-181.
- [11]Hofma SH,Ong AT,Aoki J,et al.One year clinical followup of paclitaxel elutingstentsfor acute myocardial infarction compared with sirolimus eluting stents.Heart,2005,91:1176-1180.
- [12]Weber F,Schneider H,Schwarz C,et al.Sirolimus-eluting stents for percutaneous coronary intervention in acute myocardial infarction lesson froma case-controlled comparison of bard metal versus drug-eluting stents in thrombus-laden lesions.Z Kardiol,2004,93:938-943.
- [13]Cheneau E,Rhs SW,Kuchulakanti PK,et al.Impact of sirolimus-eluting stents on outcomes of patients treated for acute myocardial infarction by primary angioplasty.Catheter Cardiovasc Interv,2005,65:469-472.
- [14]Saia F,Lemos PA,Lee CH,et al.Sirolimus-eluting stent implantation in ST-elevation acute myocardial infarction:a clinical and angiographic study.Circulation,2003,108:1927-1929.
- [15]Margheri M,Giglioli C,Comeglio M,et al.Early outcome after paclitaxel-eluting stents in patients with acute and subacute myocardial infarction.Aclinical study.Ita Heart J,2004,5:536-540.
- [16]Valgimigli M,Percoco G,Malagutti P,et al.Tirofiban and sirolimus-eluting stents vs abciximab and bare-metal stents for acute myocardial infarction:a randomized trial.JAMA,2005,293:2109-2117.