Newer generation everolimus-eluting stents perform better than bare metal stents in patients having primary percutaneous coronary interventional for ST elevation myocardial infarction (STEMI), according to results of the EXAMINATION trial reported at the European Congress of Cardiology congress.
Although a non-significant trend was found for the primary endpoint of patient-oriented outcome – death, any myocardial infarction and any repeat revascularisation – statistically significant benefits were shown for the secondary performance endpoints of freedom from target vessel and lesion revascularisation and from stent thrombosis.
Historically there has been a prejudice against using drug-eluting stents in STEMI populations due to concerns about adherence to anticoagulation therapy. Thus, in the investigator-initiated EXAMINATION (Evaluation of Xience V stent in acute myocardial infarction) trial, Manel Sabate and colleagues from the University Hospital Clinic, Barcelona, Spain, assessed the safety and performance of the Xience V everolimus-eluting stent (Abbott Vascular) against a cobalt chromium bare metal stent.
Nearly 1,500 STEMI patients having primary percutaneous coronary intervention were randomised 1:1 to receive a drug-eluting stent (n=751) or bare metal stent (n=747). The trial involved eight centres in Spain, two in The Netherlands and two in Italy.
Results at one year showed that 88% of patients receiving the everolimus-eluting stent were free of the primary endpoint (death, myocardial infarction and revascularisation) versus 85.6% receiving the bare metal stent (p=0.16).
In terms of secondary endpoints, freedom from target vessel revascularisation was 96.1% for the everolimus-eluting stent and 93% for the bare metal stent (p=0.007). The occurrence of definite/probable stent thrombosis was 0.9% for the everolimus-eluting stent versus 2.5 % for the bare metal stent (p=0.01).
Study presenter Sabate said: “These are the first real-world results we have from a randomised trial investigating the performance of new generation drug-eluting stent in the high-risk context of STEMI, and I think we can be reassured over any concerns about stent thrombosis.”
Commenting, Gabriel Steg from the Centre Hospitalier Bichaut-Claude Bernard in Paris, said: “These results are very convincing and may result in guideline changes with respect to use of drug eluting stents in STEMI.”
Steg added: “While the study does not completely address the issue of compliance to dual antiplatelet therapy, the fact that 70% of presenting patients received these stents and complied with antiplatelet therapy is encouraging.”