Long-term results of the randomized comparison of everolimus-eluting stents and sirolimus-eluting stent in patients with ST elevation myocardial infarction (RACES-MI trial)

Background: 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. Methods: The RACES-MI trial enrolled consecutive STEMI patients admitted within 12 h 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. Results: 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). Conclusions: 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.