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Trials
Published in: Trials 1/2010

Open Access 01-12-2010 | Study protocol

Rationale and design of EXPLORE: a randomized, prospective, multicenter trial investigating the impact of recanalization of a chronic total occlusion on left ventricular function in patients after primary percutaneous coronary intervention for acute ST-elevation myocardial infarction

Authors: René J van der Schaaf, Bimmer E Claessen, Loes P Hoebers, Niels J Verouden, Jacques J Koolen, Maarten J Suttorp, Emanuele Barbato, Matthijs Bax, Bradley H Strauss, Göran K Olivecrona, Vegard Tuseth, Dietmar Glogar, Truls Råmunddal, Jan G Tijssen, Jan J Piek, José PS Henriques, EXPLORE investigators

Published in: Trials | Issue 1/2010

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Abstract

Background

In the setting of primary percutaneous coronary intervention, patients with a chronic total occlusion in a non-infarct related artery were recently identified as a high-risk subgroup. It is unclear whether ST-elevation myocardial infarction patients with a chronic total occlusion in a non-infarct related artery should undergo additional percutaneous coronary intervention of the chronic total occlusion on top of optimal medical therapy shortly after primary percutaneous coronary intervention. Possible beneficial effects include reduction in adverse left ventricular remodeling and preservation of global left ventricular function and improved clinical outcome during future coronary events.

Methods/Design

The Evaluating Xience V and left ventricular function in Percutaneous coronary intervention on occLusiOns afteR ST-Elevation myocardial infarction (EXPLORE) trial is a randomized, prospective, multicenter, two-arm trial with blinded evaluation of endpoints. Three hundred patients after primary percutaneous coronary intervention for ST-elevation myocardial infarction with a chronic total occlusion in a non-infarct related artery are randomized to either elective percutaneous coronary intervention of the chronic total occlusion within seven days or standard medical treatment. When assigned to the invasive arm, an everolimus-eluting coronary stent is used. Primary endpoints are left ventricular ejection fraction and left ventricular end-diastolic volume assessed by cardiac Magnetic Resonance Imaging at four months. Clinical follow-up will continue until five years.

Discussion

The ongoing EXPLORE trial is the first randomized clinical trial powered to investigate whether recanalization of a chronic total occlusion in a non-infarct related artery after primary percutaneous coronary intervention for ST-elevation myocardial infarction results in a better preserved residual left ventricular ejection fraction, reduced end-diastolic volume and enhanced clinical outcome.

Trial registration

trialregister.nl NTR1108.
Appendix
Available only for authorised users
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Metadata
Title
Rationale and design of EXPLORE: a randomized, prospective, multicenter trial investigating the impact of recanalization of a chronic total occlusion on left ventricular function in patients after primary percutaneous coronary intervention for acute ST-elevation myocardial infarction
Authors
René J van der Schaaf
Bimmer E Claessen
Loes P Hoebers
Niels J Verouden
Jacques J Koolen
Maarten J Suttorp
Emanuele Barbato
Matthijs Bax
Bradley H Strauss
Göran K Olivecrona
Vegard Tuseth
Dietmar Glogar
Truls Råmunddal
Jan G Tijssen
Jan J Piek
José PS Henriques
EXPLORE investigators
Publication date
01-12-2010
Publisher
BioMed Central
Published in
Trials / Issue 1/2010
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-11-89

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