Background During primary percutaneous coronary intervention (PCI), a concurrent chronic total occlusion (CTO) is found in 10% of patients with ST-elevation myocardial infarction (STEMI). Long-term benefits of CTO-PCI have been suggested; however, randomised data are lacking. Our aim was to determine mid-term and long-term clinical outcome of CTO-PCI versus CTO-No PCI in patients with STEMI with a concurrent CTO.
Methods The Evaluating Xience and left ventricular function in PCI on occlusiOns afteR STEMI (EXPLORE) was a multicentre randomised trial that included 302 patients with STEMI after successful primary PCI with a concurrent CTO. Patients were randomised to either CTO-PCI or CTO-No PCI. The primary end point of the current study was occurrence of major adverse cardiac events (MACE): cardiac death, coronary artery bypass grafting and MI. Other end points were 1-year left ventricular function (LVF); LV-ejection fraction and LV end-diastolic volume and angina status.
Results The median long-term follow-up was 3.9 (2.1–5.0) years. MACE was not significantly different between both arms (13.5% vs 12.3%, HR 1.03, 95% CI 0.54 to 1.98; P=0.93). Cardiac death was more frequent in the CTO-PCI arm (6.0% vs 1.0%, P=0.02) with no difference in all-cause mortality (12.9% vs 6.2%, HR 2.07, 95% CI 0.84 to 5.14; P=0.11). One-year LVF did not differ between both arms. However, there were more patients with freedom of angina in the CTO-PCI arm at 1 year (94% vs 87%, P=0.03).
Conclusions In this randomised trial involving patients with STEMI with a concurrent CTO, CTO-PCI was not associated with a reduction in long-term MACE compared to CTO-No PCI. One-year LVF was comparable between both treatment arms. The finding that there were more patients with freedom of angina after CTO-PCI at 1-year follow-up needs further investigation.
Clinical trial registration EXPLORE trial number NTR1108 www.trialregister.nl.
- percutaneous coronary intervention
- acute coronary syndromes
- chronic coronary disease
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Contributors All authors attributed to the conception, design, critical revision and final approval of this manuscript. JE and LPH performed statistical analyses. JE interpreted the data and drafted the manuscript under supervision of senior authors JPSH, JGT and LPH.
Funding This investigator-initiated study was funded by the Academic Medical Center in combination with a research grant from Abbott Vascular.
Competing interests JPSH has received grants from Abbott Vascular during the conduct of the study; and has received grants from B. Braun, Abiomed and Biotronik outside the submitted work. RJvdS has received grants from Abbott Vascular, Biotronik and Biosensors; has received personal fees from Biotronik and Boston Scientific; has been a consultant for Biotronik and has received speakers fees from OrbusNeich, Boston Scientific and Asahi Intecc outside the submitted work. TR has been a proctor for Boston Scientific.
Patient consent Obtained.
Ethics approval The EXPLORE trial was approved by the central Medical Ethics Review Committee (METC) of the Academic Medical Center of Amsterdam (The Netherlands) and by all local ethics committees involved.
Provenance and peer review Not commissioned; externally peer reviewed.
Collaborators The following investigators and research coordinators participated in the EXPLORE trial (total number of patients recruited): Academisch Medisch Centrum, Amsterdam (78)—JPS Henriques, JJ Piek, RJ De Winter, KT Koch, MM Vis, J Baan, JJ Wykrzykowska, EM Scheunhage; Sahlgrenska University Hospital, Gothenburg, Sweden (61)—T Råmunddal, D Ioanes, EL Pommer; North Estonia Medical Center, Estonia (41)—P Laanmets, M Tamm; Onze Lieve Vrouwe Gasthuis. Amsterdam, The Netherlands (30)—RJ van der Schaaf, T Slagboom, G Amoroso, V Stolk; Haukeland University Hospital, Bergen, Norway (29)—E Eriksen, V Tuseth, LM Moldestad; Haga ziekenhuis, Den Haag, The Netherlands (17)—M Bax, CE Schotborgh, C de Jonge-Scheen; St. Antonius Ziekenhuis, Nieuwegein, The Netherlands (11)—MJ Suttorp, M Bosschaert, C Feirabend; Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium (9)— E Barbato, H Batjoens; Sunnybrook Health Sciences Center, Toronto, Canada (9)—BH Strauss, P Reilly; VUMC, Amsterdam, The Netherlands (8)—KM Marques, EJ Verduyn; Quebec Heart-Lung Institute-Quebec, Canada (4)—O Bertrand; Amphia Ziekenhuis, Breda, The Netherlands (4)—M Meuwissen, M Baas; Maasstad ziekenhuis, Rotterdam, The Netherlands (2)—M van der Ent, AF Haan; Catharina Ziekenhuis, Eindhoven, The Netherlands (1)—J Koolen, L van Leur. Trial Steering Committee—JPS Henriques (PI), RJ van der Schaaf (co-PI), JGP Tijssen. EXPLORE study coordinators—LP Hoebers, J Elias, IM van Dongen; Clinical Adjudication Committee—M Meuwissen, HR Michels; Monitoring—C Dille, Cordinamo, Weeze, The Netherlands; Clinical Cardiac Imaging Core Laboratory—R Nijveldt, R Kooistra, JC Tuinenburg. Clinfact, Leiden, The Netherlands; Angiographic Adjudication Committee—P Agostoni, G van Houwelingen; Syntax score Adjudication Corelab—Cardialysis, Rotterdam, The Netherlands.
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