EXAMINATION: EES superior to BMS at 5 years in patients with STEMI

LONDON — The 5-year results of the EXAMINATION trial, presented at the European Society of Cardiology Congress, indicated that an everolimus-eluting stent had superior clinical outcomes to a bare-metal stent in patients with STEMI.

Researchers evaluated the performance of the everolimus-eluting stent (EES; Xience V, Abbott Vascular) compared with a BMS (Multi-Link Vision, Abbott Vascular) in patients with STEMI undergoing primary PCI.

The 5-year endpoints of interest were a patient-oriented endpoint of all-cause death, any recurrent MI or any revascularization, and a device-oriented endpoint of cardiac death, target vessel MI or target lesion revascularization.

Manel Sabaté, MD, PhD, from the department of cardiology at Hospital Clinic Barcelona, Spain, and colleagues also evaluated the individual components of the patient-oriented and device-oriented endpoints, as well as stent thrombosis.

At 5 years, 731 patients from the EES group (mean age, 61 years; 84.4% men) and 727 patients from the BMS group (mean age, 62 years; 81.7% men) were available for analysis.

Rates of the patient-oriented endpoint at 5 years were 21.4% for the EES group and 26% for the BMS group (log-rank P = .03), Sabaté said during the presentation.

“The benefit accrued over time, with a two-point benefit in the first year and a three-point benefit in the subsequent years,” he said.

The difference was driven by all-cause death (EES, 8.8%; BMS, 12%; log-rank P = .04), with a trend toward benefit in revascularization rate (EES, 12.9%; BMS, 16.2%; log-rank P = .06) and no difference in recurrent MI (EES, 5%; BMS; 3.8%; log-rank P = .35).

The 5-year rates of the device-oriented endpoint were 11.9% for the EES vs. 15.5% for the BMS (log-rank P = .04). “Again, the benefit accrued over time, with a trend toward higher benefit in the first year,” Sabaté said.

The benefit was driven by TLR (BMS, 7.6%; EES, 4.5%; log-rank P = .01), and there were no differences in cardiac death or target vessel MI.

EES was associated with a numerical reduction in definite stent thrombosis (1.6% vs. 2.4%; P = .25) and definite or probable stent thrombosis (2% vs. 3.1%; P = .17) at 5 years, according to Sabaté. The benefit occurred primarily in the first year (P for interaction = .02).

“The benefit of EES over BMS was mainly driven [by] reductions in all-cause death and revascularization rates,” he said. “These results lay the foundation for future developments in stent technologies and should be taken as a point of reference for the evaluation of new bioresorbable polymer-based metallic stents or bioresorbable scaffolds in this clinical context.” – by Erik Swain

Reference:

Sabaté M, et al. Clinical Trial Update III: Pharmacology & Therapy. Presented at: European Society of Cardiology Congress; Aug. 29-Sept. 2, 2015; London.

Disclosure: Sabaté reports receiving a research grant and speaker fees from Abbott Vascular.