Clinical outcomes in patients with ST-segment elevation myocardial infarction treated with everolimus-eluting stents versus bare-metal stents (EXAMINATION): 5-year results of a randomised trial.
- Sabaté M University Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain. Electronic address: masabate@clinic.ub.es.
- Brugaletta S University Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
- Cequier A University Hospital of Bellvitge, Barcelona, Spain.
- Iñiguez A Hospital do Meixoeiro, Vigo, Spain.
- Serra A University Hospital of Sant Pau, Barcelona, Spain.
- Jiménez-Quevedo P University Hospital San Carlos, Madrid, Spain.
- Mainar V Hospital General of Alicante, Alicante, Spain.
- Campo G University Hospital Ferrara, Ferrara, Italy.
- Tespili M University Hospital Bolognini Seriate, Bergamo, Italy.
- den Heijer P Amphia Ziekenhuis, Breda, Netherlands.
- Bethencourt A Hospital Son Espases, Palma de Mallorca, Spain.
- Vazquez N Hospital Juan Canalejo, A Coruña, Spain.
- van Es GA Cardialysis, Rotterdam, Netherlands.
- Backx B Cardialysis, Rotterdam, Netherlands.
- Valgimigli M Erasmus MC, Rotterdam, Netherlands; University Hospital of Bern, Inselhospital, Bern, Switzerland.
- Serruys PW International Centre of Circulatory Health, Imperial College London, London, UK.
- 2015-11-02
Published in:
- Lancet (London, England). - 2016
Aged
Cause of Death
Drug-Eluting Stents
Endpoint Determination
Europe
Everolimus
Female
Follow-Up Studies
Humans
Kaplan-Meier Estimate
Male
Metals
Myocardial Infarction
Myocardial Revascularization
Patient Outcome Assessment
Prospective Studies
Single-Blind Method
Stents
Thrombosis
English
BACKGROUND
Data for the safety and efficacy of new-generation drug-eluting stents at long-term follow-up, and specifically in patients with ST-segment elevation myocardial infarction, are scarce. In the EXAMINATION trial, we compared everolimus-eluting stents (EES) with bare-metal stents (BMS) in an all-comer population with ST-segment elevation myocardial infarction. In this study, we assessed the 5-year outcomes of the population in the EXAMINATION trial.
METHODS
In the multicentre EXAMINATION trial, done in Italy, Spain, and the Netherlands, patients with ST-segment elevation myocardial infarction were randomly assigned in a 1:1 ratio to receive EES or BMS. The random allocation schedule was computer-generated and central randomisation (by telephone) was used to allocate patients in blocks of four or six, stratified by centre. Patients were masked to treatment assignment. At 5 years, we assessed the combined patient-oriented outcome of all-cause death, any myocardial infarction, or any revascularisation. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00828087.
FINDINGS
1498 patients were randomly assigned to receive either EES (n=751) or BMS (n=747). At 5 years, complete clinical follow-up data were obtained for 731 patients treated with EES and 727 treated with BMS (97% of both groups). The patient-oriented endpoint occurred in 159 (21%) patients in the EES group versus 192 (26%) in the BMS group (hazard ratio 0·80, 95% CI 0·65-0·98; p=0·033). This difference was mainly driven by a reduced rate of all-cause mortality (65 [9%] vs 88 [12%]; 0·72, 0·52-0·10; p=0·047).
INTERPRETATION
Our findings should be taken as a point of reference for the assessment of new bioresorbable polymer-based metallic stents or bioresorbable scaffolds in patients with ST-segment elevation myocardial infarction.
FUNDING
Spanish Heart Foundation.
Data for the safety and efficacy of new-generation drug-eluting stents at long-term follow-up, and specifically in patients with ST-segment elevation myocardial infarction, are scarce. In the EXAMINATION trial, we compared everolimus-eluting stents (EES) with bare-metal stents (BMS) in an all-comer population with ST-segment elevation myocardial infarction. In this study, we assessed the 5-year outcomes of the population in the EXAMINATION trial.
METHODS
In the multicentre EXAMINATION trial, done in Italy, Spain, and the Netherlands, patients with ST-segment elevation myocardial infarction were randomly assigned in a 1:1 ratio to receive EES or BMS. The random allocation schedule was computer-generated and central randomisation (by telephone) was used to allocate patients in blocks of four or six, stratified by centre. Patients were masked to treatment assignment. At 5 years, we assessed the combined patient-oriented outcome of all-cause death, any myocardial infarction, or any revascularisation. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00828087.
FINDINGS
1498 patients were randomly assigned to receive either EES (n=751) or BMS (n=747). At 5 years, complete clinical follow-up data were obtained for 731 patients treated with EES and 727 treated with BMS (97% of both groups). The patient-oriented endpoint occurred in 159 (21%) patients in the EES group versus 192 (26%) in the BMS group (hazard ratio 0·80, 95% CI 0·65-0·98; p=0·033). This difference was mainly driven by a reduced rate of all-cause mortality (65 [9%] vs 88 [12%]; 0·72, 0·52-0·10; p=0·047).
INTERPRETATION
Our findings should be taken as a point of reference for the assessment of new bioresorbable polymer-based metallic stents or bioresorbable scaffolds in patients with ST-segment elevation myocardial infarction.
FUNDING
Spanish Heart Foundation.
- Language
-
- English
- Open access status
- green
- Identifiers
-
- DOI 10.1016/S0140-6736(15)00548-6
- PMID 26520230
- Persistent URL
- https://folia.unifr.ch/global/documents/278646
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