Vignali Luigi, Saia Francesco, Belotti Laura Maria Beatrice, Solinas Emilia, Guastaroba Paolo, Rubboli Andrea, Manari Antonio, Mehran Roxana, Ardissino Diego, De Palma Rossana
Division of Cardiology, Azienda Ospedaliero-Universitaria, Parma, Italy.
Catheter Cardiovasc Interv. 2015 Apr;85(5):797-806. doi: 10.1002/ccd.25675. Epub 2014 Oct 14.
The aim of this study was to compare long-term clinical outcomes in patients treated with new-generation drug-eluting stent (DES) or early-generation DES in a real-world registry.
New-generation DESs have proved to be more effective and safer than early-generation DES in randomized trials. However, the effects of new-generation DES versus early-generation DES in everyday clinical practice deserve further verification.
A propensity-score and inverse-probability weighted analysis of 5,332 patients undergoing DES implantation (2,557 new-generation and 2,775 early-generation) between January 1, 2007 and June 30, 2011 was performed, with a median follow-up of 3 years. We assessed the incidence of major adverse cardiovascular events (MACE: all-cause death, nonfatal myocardial infarction [MI], and target vessel revascularization [TVR]), and angiographic stent thrombosis (ST) during follow-up.
At 3-years, new-generation DES in comparison with early-generation DES were associated with a reduced risk of MI (5% versus 7.4%, hazard ratio [HR]=0.65, 95% confidence interval [CI]=0.51-0.82, P=0.0004) and angiographic ST (0.5% vs. 1.1%, HR=0.35, 95% CI 0.17-0.72, P=0.004), whereas, the risk of TVR (10.9% vs. 13.5%; HR 0.99, 95% CI 0.84-1.16, P=0.99) and overall MACE was not significantly different (19.2% vs. 22.4%, HR=0.94, 95% CI=0.83-1.07, P=0.35).
Our data from a large all-comers multicenter registry confirm that, in comparison with early-generation DES, the use of new-generation DES is associated with similar efficacy and increased long-term safety, because of a reduced risk of ST and MI.
本研究旨在比较在真实世界注册研究中接受新一代药物洗脱支架(DES)或第一代DES治疗的患者的长期临床结局。
在随机试验中,新一代DES已被证明比第一代DES更有效、更安全。然而,新一代DES与第一代DES在日常临床实践中的效果值得进一步验证。
对2007年1月1日至2011年6月30日期间接受DES植入的5332例患者(2557例新一代和2775例第一代)进行倾向评分和逆概率加权分析,中位随访时间为3年。我们评估了随访期间主要不良心血管事件(MACE:全因死亡、非致死性心肌梗死[MI]和靶血管血运重建[TVR])的发生率以及血管造影支架血栓形成(ST)情况。
在3年时,与第一代DES相比,新一代DES与MI风险降低相关(5%对7.4%,风险比[HR]=0.65,95%置信区间[CI]=0.51 - 0.82,P = 0.0004)以及血管造影ST风险降低(0.5%对1.1%,HR = 0.35,95% CI 0.17 - 0.72,P = 0.004),而TVR风险(10.9%对13.5%;HR 0.99,95% CI 0.84 - 1.16,P = 0.99)和总体MACE无显著差异(19.2%对22.4%,HR = 0.94,95% CI = 0.83 - 1.07,P = 0.35)。
我们来自大型多中心注册研究的数据证实,与第一代DES相比,新一代DES的使用具有相似的疗效且长期安全性增加,因为ST和MI风险降低。