XAMI: Second-generation EES noninferior to first-generation SES

The second-generation everolimus-eluting stent was noninferior to the first-generation sirolimus-eluting stent, and superiority for major adverse cardiac events was suggested, according to data from the XAMI trial.

Patients with acute MI (n=625) were randomly assigned (2:1) to receive the second-generation everolimus-eluting stents (EES; Xience V, Abbott Vascular) or first-generation sirolimus-eluting stents (SES; Cypher, Cordis).

The rate of major adverse cardiac events, consisting of cardiac death, nonfatal MI or any target vessel revascularization, at 1 year was higher with older-generation stents (SES, 7.7% vs. EES, 4%). The absolute difference was –3.7% (95% CI, –8.28 to –0.03). The researchers calculated a RR for major adverse cardiac events of 0.52 (95% CI, 0.27-1.00). At 1 year, cardiac mortality was lower with EES (1.5% vs. 2.7%; P=.36).

The incidence of definite and/or probable stent thrombosis at 1 year was also lower with EES (1.2% vs. 2.7%; P=.21). The researchers said the difference in stent thrombosis rates at 30 years was primarily responsible for the difference between the two groups at 1 year.

“Despite the promising low percentage of stent thrombosis, long-term follow-up will have to demonstrate safety, as continuing rates of late stent thrombosis have been reported in first-generation drug-eluting stents during the first few years,” researchers wrote in the study.

The XAMI trial has a planned follow-up of 3 years.