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.
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
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.


CONCLUSIONS
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.


BACKGROUND
trialregister.nl NTR1108.
van der Schaaf
René J
RJ
Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
Claessen
Bimmer E
BE
Hoebers
Loes P
LP
Verouden
Niels J
NJ
Koolen
Jacques J
JJ
Suttorp
Maarten J
MJ
Barbato
Emanuele
E
Bax
Matthijs
M
Strauss
Bradley H
BH
Olivecrona
Göran K
GK
Tuseth
Vegard
V
Glogar
Dietmar
D
Råmunddal
Truls
T
Tijssen
Jan G
JG
Piek
Jan J
JJ
Henriques
José P S
JP
D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation; D002317:Cardiovascular Agents / Q000008:administration & dosage; D002908:Chronic Disease; D002985:Clinical Protocols; D054059:Coronary Occlusion / Q000150:complications / Q000503:physiopathology / Q000628:therapy*; D054855:Drug-Eluting Stents; D005060:Europe; D000068338:Everolimus; D006801:Humans; D008279:Magnetic Resonance Imaging; D009200:Myocardial Contraction; D009203:Myocardial Infarction / Q000150:complications / Q000503:physiopathology / Q000628:therapy*; D009864:Ontario; D011446:Prospective Studies; D011474:Prosthesis Design; D020127:Recovery of Function; D012107:Research Design; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives; D013318:Stroke Volume; D013997:Time Factors; D016896:Treatment Outcome; D016277:Ventricular Function, Left
D002317:Cardiovascular Agents; D000068338:Everolimus; D020123:Sirolimus