ArticlesEverolimus-eluting stent versus bare-metal stent in ST-segment elevation myocardial infarction (EXAMINATION): 1 year results of a randomised controlled trial
Introduction
Percutaneous coronary intervention is the standard of treatment in ST-elevation myocardial infarction (STEMI) when done in experienced centres within adequate time delay after the symptoms onset.1 In this clinical scenario, the use of bare metal stent (BMS) reduced the rate of re-intervention as compared with balloon angioplasty.2, 3, 4, 5, 6, 7 First generation drug-eluting stents have reduced clinical and angiographic restenosis as compared with BMS in both elective and STEMI context.2, 6, 8, 9, 10, 11, 12 However, concerns on safety potentially related to reduced endothelialisation and healing restrained their use especially in the setting of patients with STEMI.13, 14, 15, 16, 17, 18 The long-term follow-up of several pivotal studies showed an increased risk of stent thrombosis after first generation drug-eluting stents implantation in patients with STEMI compared with BMS,4, 19, 20, 21 even if this result has not been confirmed by other studies.10, 12
Second generation everolimus-eluting stent (EES; Xience V; Abbott Vascular, Santa Clara, CA, USA) has been designed with thin (7·8 μm) non-adhesive, durable, biocompatible acrylic polymers and fluorinated copolymer.22 As compared with first generation drug-eluting stents, the second generation everolimus-eluting stent was able to reduce both the restenosis and the thrombosis rates in randomised controlled trials designed in overall elective context.23, 24
The purpose of the EXAMINATION trial was to compare the second generation everolimus-eluting stent with the cobalt chromium balloon expandable Multilink Vision BMS (Abbott Vascular, Santa Clara, CA, USA) having the same metallic platform but not containing any drug or polymer, in a multicentre, randomised, controlled, superiority trial in patients undergoing percutaneous coronary intervention for STEMI.
Section snippets
Patients and study design
This multicentre, multinational, prospective, randomised, single-blind, controlled trial was done in patients with STEMI.
Between Dec 31, 2008, and May 15, 2010, we recruited patients swith STEMI. Inclusion and exclusion criteria were reported elsewhere.25 Briefly, the study had broad inclusion and few exclusion criteria. Any patient presenting with STEMI with the following electrocardiogram criteria: at least 1 mm in two or more standard leads or at least 2 mm in two or more contiguous
Results
From 2149 patients screened in the centres, 1504 patients were initially recruited, of whom six withdrew consent after randomisation (figure 1). 1498 patients were randomly assigned to receive either an EES (751 patients) or a BMS (747 patients). As a result, this cohort of patients represented 70% of all STEMI presenting at the recruiting centres during the study period. Reasons for non-randomisation of the patient were: impossibility to obtain informed consent (152 [23%] of 645),
Discussion
This is the first trial comparing the use of EES, with the conventional BMS in the setting of STEMI (panel). This trial did not show the previously anticipated superiority of EES in the global patient-oriented primary endpoint. The rates of all-cause death or recurrent myocardial infarction were similar in the two groups whereas a small difference in favour of EES was noted for the need of any revascularisation. The recorded low rate of events in the control group might be related to the
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