Elsevier

The Lancet

Volume 380, Issue 9852, 27 October–2 November 2012, Pages 1482-1490
The Lancet

Articles
Everolimus-eluting stent versus bare-metal stent in ST-segment elevation myocardial infarction (EXAMINATION): 1 year results of a randomised controlled trial

https://doi.org/10.1016/S0140-6736(12)61223-9Get rights and content

Summary

Background

Everolimus-eluting stent (EES) reduces the risk of restenosis in elective percutaneous coronary intervention. However, the use of drug-eluting stent in patients with ST-segment elevation myocardial infarction (STEMI) is still controversial. Data regarding the performance of second-generation EES in this setting are scarce. We report the 1-year result of the EXAMINATION (clinical Evaluation of the Xience-V stent in Acute Myocardial INfArcTION) trial, comparing EES with bare-metal stents (BMS) in patients with STEMI.

Methods

This multicentre, prospective, randomised, all-comer controlled trial was done in 12 medical centres in three countries. Between Dec 31, 2008, and May 15, 2010, we recruited patients with STEMI up to 48 h after the onset of symptoms requiring emergent percutaneous coronary intervention. Patients were randomly assigned (ratio 1:1) to receive EES or BMS. Randomisation was in blocks of four or six patients, stratified by centre and centralised by telephone. Patients were masked to treatment. The primary endpoint was the patient-oriented combined endpoint of all-cause death, any recurrent myocardial infarction, and any revascularisation at 1 year and was analysed by intention to treat. The secondary endpoints of the study included the device-oriented combined endpoint of cardiac death, target vessel myocardial infarction or target lesion revascularisation, and rates of all cause or cardiac death, recurrent myocardial infarction, target lesion or target vessel revascularisation, stent thrombosis, device and procedure success, and major and minor bleeding. This trial is registered with ClinicalTrials.gov, number NCT00828087.

Findings

Of the 1504 patients randomised, 1498 patients were randomly assigned to receive EES (n=751) or BMS (n=747). The primary endpoint was similar in both groups (89 [11·9%] of 751 patients in the EES group vs 106 [14·2%] of 747 patients in the BMS group; difference −2·34 [95% CI −5·75 to 1·07]; p=0·19). Device-oriented endpoint (44 [5·9%] in the EES group vs 63 [8·4%] in the BMS group; difference −2·57 [95% CI −5·18 to 0·03]; p=0·05) did not differ between groups, although rates of target lesion and vessel revascularisation were significantly lower in the EES group (16 [2·1%] vs 37 [5·0%], p=0·003, and 28 [3·7%] vs 51 [6·8%], p=0·0077, respectively). Rates of all cause (26 [3·5%] for EES vs 26 [3·5%] for BMS, p=1·00) or cardiac death (24 [3·2%] for EES vs 21 [2·8%] for BMS, p=0·76) or myocardial infarction (10 [1·3%] vs 15 [2·0%], p=0·32) did not differ between groups. Stent thrombosis rates were significantly lower in the EES group (4 [0·5%] patients with definite stent thrombosis in the EES group vs 14 [1·9%] in the BMS group and seven [0·9%] patients with definite or probable stent thrombosis in the EES group vs 19 [2·5%] in the BMS group, both p=0·019). Although device success rate was similar between groups, procedure success rate was significantly higher in the EES group (731 [97·5%] vs 705 [94·6%]; p=0·0050). Finally, Bleeding rates at 1 year were comparable between groups (29 [3·9%] patients in the EES group vs 39 [5·2%] in the BMS group; p=0·19).

Interpretation

The use of EES compared with BMS in the setting of STEMI did not lower the patient-oriented endpoint. However, at the stent level both rates of target lesion revascularisation and stent thrombosis were reduced in recipients of EES.

Funding

Spanish Heart Foundation.

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

References (38)

  • A Kaltoft et al.

    Long-term outcome after drug-eluting versus bare-metal stent implantation in patients with ST-segment elevation myocardial infarction: 3-year follow-up of the randomized DEDICATION (Drug Elution and Distal Protection in Acute Myocardial Infarction) Trial

    J Am Coll Cardiol

    (2010)
  • D Planer et al.

    Comparison of everolimus- and paclitaxel-eluting stents in patients with acute and stable coronary syndromes: pooled results from the SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) Trials

    JACC Cardiovasc Interv

    (2011)
  • PN Ruygrok et al.

    Does angiography six months after coronary intervention influence management and outcome? Benestent II Investigators

    J Am Coll Cardiol

    (1999)
  • P Libby et al.

    Inflammation in atherosclerosis: from pathophysiology to practice

    J Am Coll Cardiol

    (2009)
  • E Kedhi et al.

    Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial

    Lancet

    (2010)
  • T Palmerini et al.

    Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis

    Lancet

    (2012)
  • W Wijns et al.

    Guidelines on myocardial revascularization: the task force on myocardial revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)

    Eur Heart J

    (2010)
  • C Spaulding et al.

    Sirolimus-eluting versus uncoated stents in acute myocardial infarction

    N Engl J Med

    (2006)
  • GJ Laarman et al.

    Paclitaxel-eluting versus uncoated stents in primary percutaneous coronary intervention

    N Engl J Med

    (2006)
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