EXAMINATION: STEMI Patients Fare Better at 5 Years With EES vs BMS
LONDON, England—In STEMI patients, everolimus-eluting stents (EES) provide superior outcomes compared with BMS, according to 5-year findings from the EXAMINATION trial presented September 1, 2015, at the European Society of Cardiology Congress. The difference was driven by reductions in mortality and TLR.
“STEMI represents both the paradigm of a thrombotic milieu and a challenging clinical scenario to test new intracoronary devices,” said researcher Manel Sabaté, MD, PhD, of University Hospital Sant Pau (Barcelona, Spain). Although 2014 guidelines recommend the use of second-generation DES in the context of STEMI, he said, there is still a lack of long-term follow-up data on the topic.
The EXAMINATION trial, which most recently published 2-year results, randomized STEMI patients undergoing emergent PCI within 48 hours of symptom onset to Xience V EES (n = 751) or Multi-link Vision BMS (n = 747; both Abbott Vascular). Due the study’s all-comers design, 70% of all STEMI patients at 12 participating centers were enrolled.
At 5 years, full data were available for 97.3% of the original cohort. Dual antiplatelet therapy use dropped off sharply as planned after 1 year, with approximately 9% of patients in each group continuing therapy at 5 years.
Cumulative 5-year risk of the patient-oriented endpoint (all-cause death, MI, or revascularization) was lower for the EES group than for the BMS group. In particular, the advantage stemmed from decreased mortality and a trend toward less revascularization, while recurrent MI rates were similar (table 1).
Landmark analysis indicated that the overall benefit in terms of the patient-oriented endpoint was not significant before 1 year but grew between 1 and 5 years (log-rank P = .18 and .08, respectively).
The device-oriented endpoint (cardiac death, target-vessel MI, or TLR) also favored EES, with the advantage seen mainly during the first year after treatment (log-rank P value = .05 vs 0.38 in years 1 through 5). Here, the difference resulted from a reduction in TLR, while rates of cardiac death and target-vessel MI were comparable in both groups (table 2).
Definite stent thrombosis rates at 5 years were 2.4% for BMS and 1.6% for EES (P = .25). Rates of definite/probable stent thrombosis were 3.1% and 2.0%, respectively (P = .17). Landmark analysis showed that in the first year of follow-up, EES offered lower risk of definite/probable stent thrombosis compared with BMS (0.9% vs 2.6%; P = .01), but rates with the 2 devices were similar between 1 and 5 years (P = .27).
“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,” Dr. Sabaté concluded.
Session moderator Barbara Casadei, MD, DPhil, of John Radcliffe Hospital (Oxford, England), pointed out that there were no reductions in cardiac death or MI, asking, “So, to be provocative, why conclude that the drug-eluting stent is having extra-cardiovascular beneficial effects in these patients?”
The mortality difference was “striking,” Dr. Sabaté said.
“I have checked the noncardiac cause of death in the patients,” he continued. “Half of them were due to cancer, of course not related to any stent whatsoever, but there were 30% of patients in whom death was related to infection. One may argue, and this is just a hypothesis, but it could be due to infections being caught during hospitalization or rehospitalization.”
Sabaté M. Everolimus-eluting stents versus bare-metal stents in ST-segment elevation myocardial infarction: five-year results of the EXAMINATION trial. Presented at: European Society of Cardiology Congress; September 1, 2015; London, England.
- Dr. Sabaté reports receiving consulting/speaker fees from Abbott.