August 31, 2011 — Results of a recent randomized controlled study show the drug-eluting stent Xience V performs well in patients having primary percutaneous coronary intervention (PCI) for ST elevation myocardial infarction (STEMI). It also has a better safety profile than that of bare metal stents.
The EXAMINATION (Evaluation of Xience-V stent in Acute Myocardial INfArcTION) trial was crafted with an "all-comers" design to evaluate the stent in the complex setting of STEMI; it also served provide data that may be applicable to the real world population.
Manel Sabate, M.D., said the first generation drug-eluting stents (DES) had been evaluated in randomized controlled trials in the setting of STEMI, with positive results overall. However, he added, most of these trials lacked "good generalizability" to real world circumstances because of their highly selected inclusion/exclusion criteria. Moreover, no safety and efficacy data exist for the new generation of DES in this high-risk group of patients with STEMI. The all-comers design of the trial applied wide inclusion and few exclusion criteria, "which may result in a more representative sample of the target population".
The study was an investigator-initiated, multi-center, multinational trial involving 1,498 STEMI patients randomized to either a Xience V stent (everolimus-eluting) or cobalt chromium bare metal stent. The primary endpoint was a composite of all-cause death, any recurrent myocardial infarction and any repeat revascularization at one-year follow-up. Individual components of the primary endpoint and stent thrombosis were the main secondary endpoints. Patients included in the trial represented up to 70 percent of all STEMI patients being attended in the centers during the recruitment period, reflecting the "real world" nature of the design.
Results presented during the Hot Line session at the European Society of Cardiology in Paris. It included 98 percent of patients with one-year follow-up data. There was a non-significant trend towards benefit with the Xience-V stent by virtue of a lower rate of new revascularizations during follow-up as compared to the bare metal stents.
In terms of safety, the rates of definite and definite/probable stent thrombosis at one-year follow-up were significantly lower with the Xience V stent as compared to the bare metal stent; this accounted for 0.5 percent (definite) and 0.9 percent (definite or probable) at one year with Xience V and 1.9 percent and 2.6 percent with the bare metal stent (both p=0.01).
"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 Sabate, "and I think we can be reassured over any concerns about stent thrombosis."
For more information: www.escardio.org