Second-generation everolimus-eluting stents versus first-generation sirolimus-eluting stents in acute myocardial infarction: 1-year results of the randomized xami (xiencev stent vs. cypher stent in primary PCI for acute myocardial infarction) trial
JACC Cardiovascular Interventions, 07/31/2012
Hofma SH et al. – In this all–comer, randomized, multicenter AMI trial, second–generation everolimus–eluting stents (EES) was noninferior to sirolimus–eluting stents (SES), and superiority for MACE was suggested. ST rate in EES at 1–year was low, but long–term follow–up and larger studies will have to show whether very late ST rates will also be improved in newer drug–eluting stents (DES).Methods
- A total of 625 patients with AMI were randomized (2:1) to receive EES or SES in the XAMI (XienceV Stent vs Cypher Stent in Primary PCI for Acute Myocardial Infarction) trial.
- Primary endpoint was major adverse cardiac events (MACE) at 1 year consisting of cardiac death, nonfatal AMI, or any target vessel revascularization.
- The study was powered for noninferiority of EES.
- Secondary endpoints comprised ST rates and MACE rate up to 3 years.
- The MACE rate was 4.0% for EES and 7.7% for SES; the absolute difference was –3.7% (95% confidence interval: –8.28 to –0.03; p = 0.048) and relative risk was 0.52 (95% confidence interval: 0.27 to 1.00).
- One–year cardiac mortality was low at 1.5% for EES versus 2.7% for SES (p = 0.36), and 1–year incidence of definite and/or probable ST was 1.2% for EES versus 2.7% for SES (p = 0.21).