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XAMI: Second-generation EES comparable to first-generation SES
Three-year follow-up of the XAMI trial demonstrated a low rate of cardiac events among patients with acute MI regardless of random assignment to a second-generation everolimus-eluting stent or first-generation sirolimus-eluting stent.
The all-comers, randomized, multicenter XAMI trial was designed to evaluate the long-term efficacy and safety of the second-generation everolimus-eluting stent (EES; Xience V, Abbott Vascular) compared with the first-generation sirolimus-eluting stent (SES; Cypher, Cordis). The trial included 625 patients with acute MI who were randomly assigned to the EES or SES in a 2:1 ratio.
The primary endpoint was a composite of nonfatal acute MI, cardiac mortality or target vessel revascularization at 1 year. Follow-up was planned for 3 years.
At 3 years, the primary endpoint occurred in 8% of patients assigned the EES vs. 10.5% assigned the SES (P = .3). The researchers also reported no significant difference between the groups in the individual components of the primary endpoint. The rate of cardiac mortality was 2.5% with the EES vs. 2.7% with the SES (P= .86), nonfatal MI was 2.5% vs. 3.2% (P = .62), TVR was 4.3% vs. 5.9% (P = .36), target lesion revascularization was 2.5% vs. 1.8% (P = .78) and definite/probable stent thrombosis was 1% vs. 0.5% (P = .6).
Less than 0.5% of patients were using dual antiplatelet therapy at 3-year follow-up. The rate of DAPT use was not different between the groups.
“The XAMI trial showed very reassuring low event rates after primary PCI using DES, but the significantly lower MACE rate in EES at 1-year follow-up was not sustained at 3 years,” the researchers wrote. “The fear of increased very late stent thrombosis has limited the use of DES in MI patients in recent years. The long-term outcomes of this and other trials show that the use of second-generation DES, like EES in acute MI patients, is highly effective and safe up to at least 3 years of follow-up.”
Disclosure: Several researchers report financial ties with Abbott Vascular, AstraZeneca, Boston Scientific, Daiichi Sankyo, Eli Lilly, Iroko Cardio, St. Jude Medical, Terumo and The Medicines Company.