Shamir R Mehta1, David A Wood2, Brandi Meeks3, Robert F Storey4, Roxana Mehran5, Kevin R Bainey6, Helen Nguyen3, Shrikant I Bangdiwala7, John A Cairns2. 1. Population Health Research Institute, Hamilton, Ontario, Canada; McMaster University, Hamilton, Ontario, Canada; Hamilton Health Sciences, Hamilton, Ontario, Canada. Electronic address: smehta@mcmaster.ca. 2. University of British Columbia, Vancouver, British Columbia, Canada. 3. Population Health Research Institute, Hamilton, Ontario, Canada. 4. Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom. 5. The Zena A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY. 6. Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Alberta, Canada. 7. Population Health Research Institute, Hamilton, Ontario, Canada; McMaster University, Hamilton, Ontario, Canada.
Abstract
A significant proportion of patients with ST-segment elevation myocardial infarction (STEMI) have multivessel coronary artery disease (CAD). Following successful culprit lesion percutaneous coronary intervention (PCI) for STEMI, the question of whether to routinely revascularize non-culprit lesions or manage them conservatively with optimal medical therapy (OMT) alone is a common dilemma facing clinicians. METHODS: COMPLETE is a prospective, randomized, international, multicenter, parallel group, open-label trial with blinded evaluation of outcomes. Following successful PCI (contemporary drug eluting stents recommended) of the culprit lesion for STEMI, a total of 4041 patients from 140 centers in 31 countries were randomized to receive either complete revascularization, consisting of staged PCI of all suitable non-culprit lesions plus optimal medical therapy (OMT), or to culprit lesion-only PCI, consisting of OMT alone. OMT comprises evidence-based therapy for STEMI, including and dual antiplatelet therapy with ticagrelor, HTN and lipid management. All coronary angiograms in the trial are being evaluated in a central angiographic core lab to assess quality and completeness of revascularization. The co-primary outcomes are (1): the composite of CV death or new non-fatal MI and (2 the composite of CV death, new non-fatal MI or ischemia-driven revascularization at a median follow-up of 3 years. CONCLUSIONS: The COMPLETE trial is an international multicenter randomized trial that will help determine whether complete revascularization involving staged PCI of non-culprit lesions improves outcomes in patients with STEMI and multivessel CAD. (clinicaltrials.govNCT01740479).
RCT Entities:
A significant proportion of patients with ST-segment elevation myocardial infarction (STEMI) have multivessel coronary artery disease (CAD). Following successful culprit lesion percutaneous coronary intervention (PCI) for STEMI, the question of whether to routinely revascularize non-culprit lesions or manage them conservatively with optimal medical therapy (OMT) alone is a common dilemma facing clinicians. METHODS: COMPLETE is a prospective, randomized, international, multicenter, parallel group, open-label trial with blinded evaluation of outcomes. Following successful PCI (contemporary drug eluting stents recommended) of the culprit lesion for STEMI, a total of 4041 patients from 140 centers in 31 countries were randomized to receive either complete revascularization, consisting of staged PCI of all suitable non-culprit lesions plus optimal medical therapy (OMT), or to culprit lesion-only PCI, consisting of OMT alone. OMT comprises evidence-based therapy for STEMI, including and dual antiplatelet therapy with ticagrelor, HTN and lipid management. All coronary angiograms in the trial are being evaluated in a central angiographic core lab to assess quality and completeness of revascularization. The co-primary outcomes are (1): the composite of CV death or new non-fatal MI and (2 the composite of CV death, new non-fatal MI or ischemia-driven revascularization at a median follow-up of 3 years. CONCLUSIONS: The COMPLETE trial is an international multicenter randomized trial that will help determine whether complete revascularization involving staged PCI of non-culprit lesions improves outcomes in patients with STEMI and multivessel CAD. (clinicaltrials.govNCT01740479).
Authors: Shamir R Mehta; Jia Wang; David A Wood; John A Spertus; David J Cohen; Roxana Mehran; Robert F Storey; Philippe Gabriel Steg; Natalia Pinilla-Echeverri; Tej Sheth; Kevin R Bainey; Sripal Bangalore; Warren J Cantor; David P Faxon; Laurent J Feldman; Sanjit S Jolly; Vijay Kunadian; Shahar Lavi; Jose Lopez-Sendon; Mina Madan; Raul Moreno; Sunil V Rao; Josep Rodés-Cabau; Goran Stankovic; Shrikant I Bangdiwala; John A Cairns Journal: JAMA Cardiol Date: 2022-09-21 Impact factor: 30.154