TY - JOUR
T1 - Rationale and design of EXPLORE
T2 - 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
AU - van der Schaaf, René J.
AU - Claessen, Bimmer E.
AU - Hoebers, Loes P.
AU - Verouden, Niels J.
AU - Koolen, Jacques J.
AU - Suttorp, Maarten J.
AU - Barbato, Emanuele
AU - Bax, Matthijs
AU - Strauss, Bradley H.
AU - Olivecrona, Göran K.
AU - Tuseth, Vegard
AU - Glogar, Dietmar
AU - Råmunddal, Truls
AU - Tijssen, Jan G.
AU - Piek, Jan J.
AU - Henriques, José P.S.
N1 - Funding Information:
This study is an investigator-initiated trial, for the greater part funded by the Academic Medical Center-University of Amsterdam. Abbott Vascular has agreed to partly support this trial with a research grant. Abbott Vascular is not allowed to have a representative on the executive committee, steering committee, critical events committee or data safety monitoring board. Furthermore they have no access to the data, nor are they allowed to review potential publications and presentations.
Funding Information:
As principal investigator, J.H. has received a research grant to fund and coordinate this project. All other authors confirm that they have no competing interests to declare.
PY - 2010/9/21
Y1 - 2010/9/21
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=77956692768&partnerID=8YFLogxK
U2 - 10.1186/1745-6215-11-89
DO - 10.1186/1745-6215-11-89
M3 - Article
C2 - 20858263
AN - SCOPUS:77956692768
SN - 1745-6215
VL - 11
JO - Trials
JF - Trials
M1 - 89
ER -