EES Decrease Restenosis, TVR vs. BMS in Non-STEMI

Patients with non-STEMI who receive second-generation stents that elute everolimus have less restenosis and clinically driven target vessel revascularization (TVR) compared with those receiving bare-metal stents (BMS), according to findings presented this week at TCT 2014. Researchers also observed trends toward reductions in MACE and stent thrombosis with the everolimus-eluting stent (EES).

Using data from the ELISA DES program, Wouter S. Remkes, MD, of Isala Klinieken in Zwolle, the Netherlands, and colleagues investigated the efficacy profile of an EES (Xience V, Abbott Vascular) in patients with non-STEMI in comparison to a cobalt chromium BMS with the same stent frame design.

The ELISA DES program included the ELISA-3 trial (n=542) and the ELISA-3 prospective registry (n=488). In the ELISA-3 trial, high-risk patients with non-STEMI were randomly assigned to early or late intervention if they presented with evidence of extensive myocardial ischemia on ECG, elevated biomarkers and/or age older than 65 years; patients deemed suitable for PCI underwent a second randomization to EES (n=82) or BMS (n=89) and had follow-up angiography at 9 months. The ELISA-3 prospective registry enrolled low-risk patients with non-STEMI who did not meet the high-risk inclusion criteria; these patients were also randomly assigned EES (n=147) or BMS (n=149) but did not undergo follow-up angiography.

The primary endpoint of the ELISA-3 angiographic substudy was restenosis at 9 months. Angiographic follow-up data showed a significantly larger minimal luminal diameter with the EES and a significant difference in binary stenosis (see Figure). Baseline characteristics in the substudy did not differ by treatment arm. Most patients were male, and mean age was approximately 68 years.

Remkes also presented findings from a pooled analysis of 467 matched patients from the ELISA-3 trial and prospective registry. Two-year incidence of stent thrombosis and MACE, including all-cause death, MI or TVR, were the prespecified secondary endpoints. At 2 years, patients assigned to BMS had a higher rate of clinically driven TVR compared to those assigned to EES at 9.1% vs. 4% (P=.03).

“There was a trend toward a lower incidence of MACE and stent thrombosis with the EES compared to BMS,” Remkes said. At 2 years, the rate of MACE was 12.5% in the pooled EES group vs. 15.2% in the pooled BMS group (P=.41), and the rate of stent thrombosis was 1.3% in the EES group and 3% in the BMS group (P=.34).

Until now, “no studies have compared EES vs. its BMS counterpart in the setting of non-STEMI, and the efficacy of these stents as compared to BMS had not been evaluated previously,” he said. “This study gives an indication that EES [are] safe and reduce restenosis and possibly, subsequently, target vessel revascularization.”

However, he noted several limitations of the study, including insufficient power to show superiority of EES and to detect differences in clinical outcome.

Disclosures:

• Remkes reports no relevant conflicts of interest.