Newer generation everolimus drug eluting stents (DES) perform better than bare metal stents (BMS) in patients having primary PCI for ST elevation MI (STEMI), according to results of the EXAMINATION trial reported yesterday.
Although a non-significant trend was found for the primary endpoint of patient-oriented outcome - death, any MI 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 DES in STEMI populations due to concerns about adherence to anticoagulation therapy. Thus, in this investigator-initiated EXAMINATION (Evaluation of Xience V stent in Acute Myocardial INfArCTION) trial, Dr Manel Sabate and colleagues from the University Hospital Clinic, Barcelona, assessed the safety and performance of the XIENCE V everolimus DES against the cobalt chromium bare metal stent.
Almost 1500 STEMI patients having primary PCI were randomised 1:1 to receive the DES (n=751) and the BMS (n=747). The multicentre 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 (a composite of all-cause death, any MI and any revascularisation) versus 85.6% receiving the eluting BMS (P=0.16).
However, results for the secondary endpoints, which related more to the performance of the stent, proved more striking. Freedom from target vessel revascularisation was 96.1% for the everolimus stent and 93% for the BMS (P=0.007). The occurrence of definite/probable stent thrombosis was 0.9% for the everolimus stent versus 2.5 % for the BMS (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 DES in the high-risk context of STEMI, and I think we can be reassured over any concerns about stent thrombosis.”
Commenting, Professor 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 doesn’t 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.”