Di Lorenzo Emilio, Sauro Rosario, Capasso Michele, Lanni Francesca, Lanzillo Tonino, Carbone Giannignazio, Manganelli Fiore, Palmieri Vittorio, Serino Vincenzo, Pagliuca Maria Rosaria, Rosato Giuseppe, Suryapranata Harry, De Luca Giuseppe
Division of Cardiology, "S.G. Moscati", Avellino, Italy.
Department of Cardiology, UMC St Radboud, Nijmegen, The Netherlands.
Int J Cardiol. 2016 Jan 1;202:177-82. doi: 10.1016/j.ijcard.2015.08.123. Epub 2015 Aug 16.
Several concerns have emerged about the higher risk of very late stent thrombosis (ST) with first generation drug-eluting stent (DES), especially in ST-segment elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (PCI). New generation DES have demonstrated reduction in ST at mid-term follow-up, however no data are available on long-term follow-up. Therefore, the aim of this study was to report long-term results of the RACES-MI trial conducted to compare Everolimus-Eluting Stent (EES) vs Sirolimus-Eluting Stent (SES) in patients undergoing primary PCI.
The RACES-MI trial enrolled consecutive STEMI patients admitted within 12h of symptom onset, undergoing primary PCI with stent implantation at a tertiary center with 24-hour primary PCI capability, who were randomly assigned to SES or EES. Primary endpoint of this analysis is major adverse cardiac events (MACE) at long-term follow-up. Secondary endpoints are 1) death; 2) reinfarction; 3) definite or probable ST; 4) target-vessel revascularization (TVR) at long-term follow-up.
From April 2007 to May 2009 500 patients with STEMI were randomized to EES (n=250) or SES (n=250). No difference was observed between the groups either in baseline clinical characteristics, in the number of implanted stent or total stent length per patient. However, a larger reference diameter was observed with SES (3.35±0.51 mm vs 3.25±0.51 mm, p=0.001), whereas patients randomized to EES received Gp IIb-IIIa inhibitors more often (54.4% vs 42.4%, p=0.006). At long-term follow-up (2132±528 days), EES was associated with a significant reduction in MACE (23.8 vs 34.1%, adjusted p=0.028), ST (2.5% vs 7.7%, adjusted p=0.009), without any difference in death (8.7% vs 11.4%, adjusted p=0.47), reMI (9.3% vs 13.1%; adjusted p=0.18) and TVR (8.6% vs 12.3%, adjusted p=0.31).
This study shows that among STEMI patients undergoing primary PCI EES, as compared to SES, is associated with significant reduction in MACE and ST at long-term follow-up.
对于第一代药物洗脱支架（DES）发生极晚期支架内血栓形成（ST）的较高风险已出现了一些担忧，尤其是在接受经皮冠状动脉介入治疗（PCI）的ST段抬高型心肌梗死（STEMI）患者中。新一代DES在中期随访中已显示出ST发生率降低，然而尚无长期随访数据。因此，本研究的目的是报告RACES-MI试验的长期结果，该试验旨在比较接受直接PCI的患者中依维莫司洗脱支架（EES）与西罗莫司洗脱支架（SES）。
RACES-MI试验纳入症状发作12小时内入院、在具备24小时直接PCI能力的三级中心接受支架植入直接PCI的连续STEMI患者，将其随机分配至SES或EES组。本分析的主要终点是长期随访时的主要不良心脏事件（MACE）。次要终点为：1）死亡；2）再梗死；3）明确或很可能的ST；4）长期随访时的靶血管血运重建（TVR）。
从2007年4月至2009年5月，500例STEMI患者被随机分为EES组（n = 250）或SES组（n = 250）。两组在基线临床特征、植入支架数量或每位患者的总支架长度方面均未观察到差异。然而，SES组的参考直径更大（3.35±0.51 mm对3.25±0.51 mm，p = 0.001），而随机分配至EES组的患者更常接受糖蛋白IIb/IIIa抑制剂治疗（54.4%对42.4%，p = 0.006）。在长期随访（2132±528天）时，EES组MACE显著降低（23.8%对34.1%，校正p = 0.028），ST发生率降低（2.5%对7.7%，校正p = 0.009），而在死亡（8.7%对11.4%，校正p = 0.47）、再梗死（9.3%对13.1%；校正p = 0.18）和TVR（8.6%对12.3%，校正p = 0.31）方面无差异。
本研究表明，在接受直接PCI的STEMI患者中，与SES相比，EES在长期随访时可使MACE和ST显著降低。
