Design and rationale of the COMPLETE trial: A randomized, comparative effectiveness study of complete versus culprit-only percutaneous coronary intervention to treat multivessel coronary artery disease in patients presenting with ST-segment elevation myocardial infarction

Mehta, Shamir R.; Wood, David A.; Meeks, Brandi; Storey, Robert F.; Mehran, Roxana; Bainey, Kevin R.; Nguyen, Helen; Bangdiwala, Shrikant, I; Cairns, John A.; COMPLETE Trial Steering Comm Inves


Introduction 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.

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Título según WOS: ID WOS:000478778600018 Not found in local WOS DB
Título de la Revista: AMERICAN HEART JOURNAL
Volumen: 215
Fecha de publicación: 2019
Página de inicio: 157
Página final: 166


Notas: ISI