FIREBIRD雷帕霉素洗脱支架与TAXUS紫杉醇洗脱支架成功置入后长期临床结果观察:单中心、大规模注册研究

摘要

Objective;To compare the long-term clinical outcome in patients with successfully implanted FIREBIRD sirolimus-eluting stents ( SES) and TAXUS paclitaxel-eluting stents (PES) in clinical practice.rnMethods:A total of 3 110 patients who successfully underwent elective drug eluting stents implantation in our hospital from April 2004 to October 2006 were retrospectively studied. The patients were divided into two groups as FIREBIRD SES group, n = 2 274 and TAXUS PES group,n = 836. The clinical outcome follow-up included death,myocardial infarction,thrombosis,target lesion revascularization(TLR) ,target vessel revascularization(TVR) and major adverse cardiac events( MACE) at 30 days,l year and 2 years after the procedure. Cox' s proportional-hazards models were performed to assess relative risks of all outcomes before and after the propensity match between two groups.rnResults:Before propensity match,FIREBIRD SES group had lower risk of TLR( HR 0. 381,95% CI 0. 262 ~0. 541) ,TVR ( HR 0. 512 ,95% CI 0. 383 ~ 0. 681) and MACE ( HR 0. 527,95% CI 0. 410 ~ 0. 677 ) than those in TAXUS PES group. After propensity match,FIREBIRD SES group also had lower risk of TLR( HR 0. 330,95% CI 0. 188 -0.578) ,TVR( HR 0. 412,95% CI 0. 263 ~ 0. 643 ) , and MACE( HR 0. 476,95% CI 0. 332 ~ 0. 681) than those in TAXUS PES group.rnConclusion: Compared with TAXUS PES, the patients with FIREBIRD SES implantation could have lower risk of TLR, TVR and MACE in clinical practice.%目的:比较成功置入FIREBIRD雷帕霉素洗脱支架与TAXUS紫杉醇洗脱支架后长期临床观察结果.方法:本研究入选了2004-04至2006-10期间,在我院择期置入FIREBIRD雷帕霉素洗脱支架与TAXUS紫杉醇洗脱支架共计3 110例患者,并按置入支架的种类分为FIREBIRD组(2 274例)和TAXUS组(836例).临床随访资料包括术后30天、1年和2年的死亡、心肌梗死、支架内血栓形成、靶病变血运重建、靶血管血运重建和主要心脏不良事件.本研究通过COX比例风险模型比较了倾向性评分匹配前后两组间的2年临床随访结果.结果:两组倾向性评分匹配前COX比例风险模型分析显示FIREBIRD组靶病变血运重建(风险比0.381,95%可信区间0.262～0.541)、靶血管血运重建(风险比 0.512,95%可信区间 0.383～0.681)以及主要心脏不良事件(风险比 0.527,95%可信区间0.410～0.677)的风险低于TAXUS组.经过倾向性评分匹配后COX比例风险模型分析仍显示FIREBIRD组靶病变血运重建(风险比 0.330,95%可信区间0.188～0.578)、靶血管血运重建(风险比 0.412,95%可信区间 0.263～0.643)以及主要心脏不良事件(风险比0.476,95%可信区间0.332～0.681)的风险低于TAXUS组.结论:与TAXUS紫杉醇洗脱支架相比,置入FIREBIRD雷帕霉素洗脱支架可降低靶病变血运重建、靶血管血运重建及主要心脏不良事件发生的风险.