Almalla Mohammad, Schröder Jörg W, Pross Verena, Marx Nikolaus, Hoffmann Rainer
Department of Cardiology, Medical Clinic I, University Hospital RWTH Aachen, Aachen, Germany.
Coron Artery Dis. 2013 Mar;24(2):165-70. doi: 10.1097/MCA.0b013e32835c8fb2.
First-generation drug-eluting stents have been proven to be very effective for the treatment of bare-metal stent in-stent restenosis (BMS ISR). Efficacy of second-generation drug-eluting stents in this setting remains less well defined. This study compared 3-year clinical outcomes after treatment of BMS ISR using second-generation everolimus-eluting stents (EES) to first-generation paclitaxel-eluting stents (PES) or sirolimus-eluting stents (SES).
This was a retrospective observational study. A total of 264 consecutive patients with BMS ISR underwent percutaneous coronary intervention using EES (75 patients), PES (95 patients), or SES (94 patients) from 2003 to 2009. The primary endpoint of the study was survival free of major adverse cardiac events (MACE) at 3 years. Secondary endpoints were survival free of need for revascularization of the target lesion and definite stent thrombosis. Clinical follow-up could be obtained in 99% of patients.
Baseline clinical and angiographic parameters were comparable between the three groups. MACE at the 3-year follow-up were 27, 30, and 27%, for the EES, PES, and SES groups, respectively (P=0.874). The target lesion revascularization rates for EES, PES, and SES groups were 15, 20, and 23%, respectively (P=0.429). Rates of definite stent thrombosis at the 3-year follow-up were comparable between the three groups at 0, 2.1, and 1.0%, respectively (P=0.437). Rates of myocardial infarction and death were also similar between the three groups. Diabetes mellitus was the only independent predictor of MACE at the 3-year follow-up (odds ratio=1.14, 95% confidence interval 1.00-1.30; P=0.038), whereas renal insufficiency was the only independent predictor for death (odds ratio=1.10, 95% confidence interval 0.850-1.274; P=0.011).
Second-generation EES is as effective and safe as the first-generation PES or SES in the treatment of BMS ISR. Diabetes mellitus is the only independent predictor for MACE at the long-term follow-up.
第一代药物洗脱支架已被证明在治疗裸金属支架内再狭窄（BMS ISR）方面非常有效。第二代药物洗脱支架在这种情况下的疗效仍不太明确。本研究比较了使用第二代依维莫司洗脱支架（EES）与第一代紫杉醇洗脱支架（PES）或西罗莫司洗脱支架（SES）治疗BMS ISR后的3年临床结局。
这是一项回顾性观察研究。2003年至2009年，共有264例连续的BMS ISR患者接受了经皮冠状动脉介入治疗，其中75例使用EES，95例使用PES，94例使用SES。该研究的主要终点是3年时无主要不良心脏事件（MACE）的生存率。次要终点是无靶病变血运重建需求和明确的支架血栓形成的生存率。99%的患者可获得临床随访。
三组之间的基线临床和血管造影参数具有可比性。EES、PES和SES组在3年随访时的MACE发生率分别为27%、30%和27%（P = 0.874）。EES、PES和SES组的靶病变血运重建率分别为15%、20%和23%（P = 0.429）。三组在3年随访时明确的支架血栓形成率分别为0%、2.1%和1.0%，具有可比性（P = 0.437）。三组之间的心肌梗死和死亡率也相似。糖尿病是3年随访时MACE的唯一独立预测因素（比值比 = 1.14，95%置信区间1.00 - 1.30；P = 0.038），而肾功能不全是死亡的唯一独立预测因素（比值比 = 1.10，95%置信区间0.850 - 1.274；P = 0.011）。
在治疗BMS ISR方面，第二代EES与第一代PES或SES一样有效和安全。糖尿病是长期随访时MACE的唯一独立预测因素。
