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Randomized Controlled Trial
. 2023 Sep;16(9):e012867.
doi: 10.1161/CIRCINTERVENTIONS.122.012867. Epub 2023 Sep 19.

Complete Revascularization Versus Culprit-Lesion-Only PCI in STEMI Patients With Diabetes and Multivessel Coronary Artery Disease: Results From the COMPLETE Trial

Zardasht Oqab  1   2   3   4 , Vijay Kunadian  5 , David A Wood  6 , Robert F Storey  7 , Sunil V Rao  8 , Roxana Mehran  9 , Natalia Pinilla-Echeverri  1   2   3 , Thenmozhi Mani  1   2   3 , Robert H Boone  6 , Saleem Kassam  10 , Matthias Bossard  11 , Samer Mansour  12 , Warren Ball  13 , Matthew Sibbald  1   2   3 , Nicholas Valettas  1   2   3 , Raul Moreno  14 , Philippe Gabriel Steg  15 , John A Cairns  6 , Shamir R Mehta  1   2   3
Affiliations
Randomized Controlled Trial

Complete Revascularization Versus Culprit-Lesion-Only PCI in STEMI Patients With Diabetes and Multivessel Coronary Artery Disease: Results From the COMPLETE Trial

Zardasht Oqab et al. Circ Cardiovasc Interv. 2023 Sep.

Abstract

Background: In the COMPLETE trial (Complete Versus Culprit-Only Revascularization to Treat Multivessel Disease After Early PCI for STEMI), a strategy of complete revascularization reduced the risk of major cardiovascular events compared with culprit-lesion-only percutaneous coronary intervention in patients presenting with ST-segment-elevation myocardial infarction (STEMI) and multivessel coronary artery disease. Patients with diabetes have a worse prognosis following STEMI. We evaluated the consistency of the effects of complete revascularization in patients with and without diabetes.

Methods: The COMPLETE trial randomized a strategy of complete revascularization, consisting of angiography-guided percutaneous coronary intervention of all suitable nonculprit lesions, versus a strategy of culprit-lesion-only percutaneous coronary intervention (guideline-directed medical therapy alone). In prespecified analyses, treatment effects were determined in patients with and without diabetes on the first coprimary outcome of cardiovascular death or new myocardial infarction and the second coprimary outcome of cardiovascular death, new myocardial infarction, or ischemia-driven revascularization. Interaction P values were calculated to evaluate whether there was a differential treatment effect in patients with and without diabetes.

Results: Of the 4041 patients enrolled in the COMPLETE trial, 787 patients (19.5%) had diabetes. The median HbA1c (glycated hemoglobin) was 7.7% in the diabetes group and 5.7% in the nondiabetes group. Complete revascularization consistently reduced the first coprimary outcome in patients with diabetes (hazard ratio, 0.87 [95% CI, 0.59-1.29]) and without diabetes (hazard ratio, 0.70 [95% CI, 0.55-0.90]), with no evidence of a differential treatment effect (interaction P=0.36). Similarly, for the second coprimary outcome, no differential treatment effect (interaction P=0.27) of complete revascularization was found in patients with diabetes (hazard ratio, 0.61 [95% CI, 0.43-0.87]) and without diabetes (hazard ratio, 0.48 [95% CI, 0.39-0.60]).

Conclusions: Among patients presenting with STEMI and multivessel disease, the benefit of complete revascularization over a culprit-lesion-only percutaneous coronary intervention strategy was consistent regardless of the presence or absence of diabetes.

Keywords: acute coronary syndrome; coronary artery disease; diabetes; ischemia; myocardial infarction; percutaneous coronary intervention.

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Conflict of interest statement

Disclosures Dr Mehta reports grants from Canadian Institute of Health Research, grants from AstraZeneca and Boston Scientific, during the conduct of the study. Dr Mehran reports grants and other from Abbott, grants and other from Abiomed, grants and other from Applied Therapeutics, grants and other from Arena, grants from AstraZeneca, grants and other from Bayer, grants and other from Biosensors, grants, personal fees and other from Boston Scientific, grants and other from CardiaWave, grants from CellAegis, grants from CERC, grants and other from Chiesi, grants and other from Concept Medical, grants and other from CSL Behring, grants and other from DSI, grants from Insel Gruppe AG, grants and other from Medtronic, other from Novartis, grants from OrbusNeich, grants and other from Philips, grants from Transverse Medical, grants from Zoll, personal fees from California Institute for Regenerative Medicine (CIRM), personal fees from Cine-Med Research, personal fees from Janssen, personal fees from WebMD, personal fees from SCAI, other from AM Pharma, other from Alleviant Medical, other from CeloNova BioSciences, other from Duke University, other from Humacyte, from Idorsia Pharmaceuticals, personal fees from AMA, other from Biotronik, other from Elixir Medical, other from STEL, other from ControlRad, other from CRF, other from ACC, outside the submitted work. Dr Storey reports personal fees from Bayer, personal fees from Bristol-Myers Squibb/Pfizer, grants and personal fees from AstraZeneca, grants and personal fees from Thromboserin, grants and personal fees from Glycardial Diagnostics, personal fees from Portola, personal fees from Medscape, grants and personal fees from Cytosorbents, personal fees from Intas Pharmaceuticals, personal fees from Hengrui, personal fees from Sanofi Aventis, personal fees from Idorsia, personal fees from PhaseBio, personal fees from Alnylam, personal fees from CSL-Behring, personal fees from Novartis, personal fees from Chiesi, outside the submitted work. Dr Pinilla-Echeverri reports grants from Boston Scientific, grants from AstraZeneca, grants from Canadian Institutes of Health Research, grants from Population Health Research Institute, during the conduct of the study; personal fees from Abbott, personal fees from Philips, personal fees from Conavi, personal fees from Novartis, outside the submitted work. Dr Moreno reports other from Abbott Vascular, other from Boston Scientific, other from Biosensors, other from Biotronik, other from Medtronic Inc., other from Daiichi-Sankyo, other from AMGEN, other from AstraZeneca, other from Edwards Lifesciences, other from Terumo, other from Philips, other from Cardinal Health, outside the submitted work. Dr Steg reports grants and personal fees from Amarin, personal fees from Amgen, personal fees and nonfinancial support from AstraZeneca, grants and personal fees from Bayer, personal fees from Bristol-Myers Squibb, personal fees from Boehringer Ingelheim, personal fees from Idorsia, personal fees from Novartis, personal fees from Novo Nordisk, personal fees from Pfizer, personal fees from Sanofi/Lexicon, grants and personal fees from Servier, personal fees from Myokardia, grants and personal fees from Sanofi, personal fees from Regeneron, personal fees from Phase Bio, outside the submitted work. Dr Cairns reports grants from Boston Scientific, grants from Astra Zeneca, grants from CIHR, during the conduct of the study; personal fees from Abbott, personal fees from Bayer, personal fees from BMS Pfizer, outside the submitted work. Dr Sibbald reports grants from Abbott Vascular and Phillips. The remainder of authors have nothing to disclose.

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