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

Jul 23, 2012
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Authors:
Hofma SH, Brouwer J, Velders MA, et al.
Citation:
J Am Coll Cardiol 2012;60:381-387.
Summary By:
Debabrata Mukherjee, MD, FACC

Study Questions:

What is the comparative efficacy and safety of second-generation everolimus-eluting stents (EES) with first-generation sirolimus-eluting stents (SES) in primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI)?

Methods:

A total of 625 patients with AMI were randomized (2:1) to receive EES or SES in the XAMI trial (XienceV Stent vs. Cypher Stent in Primary PCI for Acute Myocardial Infarction). 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 stent thrombosis (ST) rates and MACE rate up to 3 years. Kaplan-Meier survival estimates were used to compare time to the first occurrence of MACE, with pair-wise differences assessed by using the log-rank test.

Results:

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, 0.27-1.00). 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).

Conclusions:

The authors concluded that second-generation EES was noninferior to SES, and superiority for MACE was suggested.

Perspective:

This contemporary, all-comer, randomized multicenter AMI trial reports low MACE rates at 1 year with the use of DES in primary PCI in AMI. Although not powered for superiority, the second-generation EES displayed a significantly lower MACE rate than the first-generation SES, proving noninferiority and suggesting possible superiority. ST rate in EES was very low, but longer-term follow-up and larger studies are indicated to assess whether the reported ST rates beyond 1 year will also be improved with EES.

Keywords: Myocardial Infarction, Sirolimus, Stents, Percutaneous Coronary Intervention


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