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EXAMINATION: Xience V performed better than bare metal stents in PCI patients
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European Society of Cardiology Congress 2011
A second-generation everolimus-eluting stent, performed well and was safer in patients undergoing primary percutaneous coronary intervention for STEMI compared with a bare metal stent, new study results indicated.
The EXAMINATION trial was a randomized controlled study that compared a Xience V everolimus-eluting stent (EES; Abbott Vascular) with a cobalt-chromium bare metal stent (BMS) in 1,498 patients undergoing primary PCI for STEMI. Patients were included if they had STEMI less than 12 hours after the onset of symptoms, rescue PCI after failed thrombolysis, PCI indicated less than 24 hours after effective thrombolysis, and STEMI after 12 to 48 hours after the onset of symptoms. All-cause death, any recurrent MI, and any repeat revascularization at 1-year follow-up were the composite of the primary endpoint. Results of the trial were presented at the European Society of Cardiology Congress 2011 in Paris.
According to the study, the main coronary risk factors included: smoking (72.2%); hypertension (48.4%); diabetes (17.2%); dyslipidemia (43.8%); and family history (16.4%). Target lesion was located most often (43.6%) in the right coronary artery, followed by the left anterior descending artery (40.6%). Of the patients included, 84.6% had STEMI less than 12 hours after onset of symptoms, 6.5% were rescue PCI, 2.3% were PCI early after successful thrombolysis, and 6.5% had STEMI after 12 to 48 hours. Each group had a 3.5% all-cause death rate and any MI rate of 2% in BMS vs. 1.3% in EES. At 1-year follow-up, definite and definite/probable stent thrombosis were significantly lower with EES vs. BMS, and the primary endpoint was 13.9% for the BMS group and 11.9% for the EES group.
“These are the first ‘real world’ results we have from a randomized trial about the performance of the new generation drug-eluting stents in the high-risk context of STEMI,” said Manel Sabate, MD, chief of the cardiology unit at the Clinic Hospital in Barcelona, Spain. “We can be reassured over any concerns about stent thrombosis.”
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Disclosure: The EXAMINATION trial received a grant from Abbott.
EXAMINATION raises the hypothesis that polymer-covered stents are more blood-compatible and less thrombotic than naked metallic struts. Very late stent thrombosis relates to polymer tissue compatibility. Although a rigorous trial discussant will appropriately state that this should not be the case, EXAMINATION will likely influence interventional practice. With the use of newer DES, and this specific brand in particular, physicians will feel less concerned about early safety of DES in the setting of STEMI.
– William Wijns, MD
Co-director, Cardiovascular Center,
O.L.V.Z., Aalst, Belgium
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