DES Noninferior for Survival Compared with BMS in STEMI
SAN FRANCISCO, CALIF.—Results from the EXAMINATION trial and the DESERT meta-analysis showed that DES were associated with superior outcomes without greater risk in patients with STEMI, according to presentations made Monday morning.
EXAMINATION, conducted at 12 centers in Italy, Spain and the Netherlands, was a randomized, controlled trial comparing outcomes for 751 patients assigned to an everolimus-eluting stent (Xience V, Abbott Vascular) with those of 747 patients assigned to a cobalt-chromium stent (Vision, Abbott Vascular). Eligible patients underwent primary PCI for STEMI within 48 hours after onset of symptoms.
At 1-year, Xience V was comparable to bare-metal stenting for the composite endpoint of all-cause death, any MI or any revascularization (88.0% vs. 85.6%; P=.16)
“There was no significant difference [in the composite endpoint] between the groups,” said Manel Sabaté, MD, PhD, of Thorax Clinic, Barcelona, Spain, presenting the EXAMINATION results. “Xience V was numerically better than the Vision stent, but [there was] no significant difference in this patient-oriented endpoint.”
Sabaté added that results were similarly comparable for the secondary endpoints of cardiac death and recurrent MI, but Xience V showed superior rates of freedom from TLR, TVR and stent thrombosis (see Table 1).
“The use of the Xience V stent in the setting of STEMI resulted in a non-significant reduction in the patient-oriented primary endpoint,” he said. “In terms of stent-oriented endpoints, the Xience V stent significantly reduced the rates of target vessel revascularization and target lesion revascularization and the rates of definite and definite/probable stent thrombosis.”
In DESERT, researchers pooled patient-level data from 11 randomized, controlled trials involving 3,980 primary PCI patients assigned to DES and 2,318 assigned to BMS. Giuseppe De Luca, MD, PhD, chief of interventional cardiology at Eastern Piedmont University in Novara, Italy, said the group reached similar conclusions as the findings in EXAMINATION.
De Luca said that DES were associated with similar rates of death, and stent thrombosis compared with BMS, a slight increase in reinfarction, and significantly reduced target vessel revascularization (see Table 2).
“Among selected patients with STEMI undergoing primary PCI, sirolimus-eluting stents and paclitaxel-eluting stents as compared to BMS are associated with a significant reduction in TVR and TLR within 1 year and at long-term follow-up,” he said during his presentation. “Despite a slightly higher rate of very late reinfarction and stent thrombosis with SES and PES compared to BMS, there were no significant differences in overall or very late mortality, with the point estimate favoring DES in all time periods, providing reassurance of safety.
“There was no difference in deaths between the two groups,” he added. “There was even a trend in favor of DES.”
De Luca cautioned that few patients in the trials had cardiogenic shock, so conclusions from DESERT cannot be extended to all patients undergoing primary PCI for STEMI.
- Dr. De Luca reports receiving speaker and consultant fees from AstraZeneca, Boston Scientific, Cordis, CID, Eli Lilly, Medtronic, Medrad, The Medicine Company, SanofiAventis and Terumo.
- Dr. Sabaté reports receiving consulting fees from Abbott Vascular, AstraZeneca, Cordis, Daiichi Sankyo/Eli Lilly and Medtronic.