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Randomized Controlled Trial
. 2022 Nov 1;7(11):1091-1099.
doi: 10.1001/jamacardio.2022.3032.

Complete Revascularization vs Culprit Lesion-Only Percutaneous Coronary Intervention for Angina-Related Quality of Life in Patients With ST-Segment Elevation Myocardial Infarction: Results From the COMPLETE Randomized Clinical Trial

Shamir R Mehta  1 , Jia Wang  1 , David A Wood  2 , John A Spertus  3 , David J Cohen  4   5 , Roxana Mehran  6 , Robert F Storey  7 , Philippe Gabriel Steg  8 , Natalia Pinilla-Echeverri  1 , Tej Sheth  1 , Kevin R Bainey  9 , Sripal Bangalore  10 , Warren J Cantor  11 , David P Faxon  12 , Laurent J Feldman  8 , Sanjit S Jolly  1 , Vijay Kunadian  13 , Shahar Lavi  14 , Jose Lopez-Sendon  15 , Mina Madan  16 , Raul Moreno  15 , Sunil V Rao  17 , Josep Rodés-Cabau  18 , Goran Stankovic  19 , Shrikant I Bangdiwala  1 , John A Cairns  2 ; COMPLETE Trial Investigators
Collaborators, Affiliations
Randomized Controlled Trial

Complete Revascularization vs Culprit Lesion-Only Percutaneous Coronary Intervention for Angina-Related Quality of Life in Patients With ST-Segment Elevation Myocardial Infarction: Results From the COMPLETE Randomized Clinical Trial

Shamir R Mehta et al. JAMA Cardiol. .

Abstract

Importance: In patients with multivessel coronary artery disease (CAD) presenting with ST-segment elevation myocardial infarction (STEMI), complete revascularization reduces major cardiovascular events compared with culprit lesion-only percutaneous coronary intervention (PCI). Whether complete revascularization also improves angina-related health status is unknown.

Objective: To determine whether complete revascularization improves angina status in patients with STEMI and multivessel CAD.

Design, setting, and participants: This secondary analysis of a randomized, multinational, open label trial of patient-reported outcomes took place in 140 primary PCI centers in 31 countries. Patients presenting with STEMI and multivessel CAD were randomized between February 1, 2013, and March 6, 2017. Analysis took place between July 2021 and December 2021.

Interventions: Following PCI of the culprit lesion, patients with STEMI and multivessel CAD were randomized to receive either complete revascularization with additional PCI of angiographically significant nonculprit lesions or to no further revascularization.

Main outcomes and measures: Seattle Angina Questionnaire Angina Frequency (SAQ-AF) score (range, 0 [daily angina] to 100 [no angina]) and the proportion of angina-free individuals by study end.

Results: Of 4041 patients, 2016 were randomized to complete revascularization and 2025 to culprit lesion-only PCI. The mean (SD) age of patients was 62 (10.7) years, and 3225 (80%) were male. The mean (SD) SAQ-AF score increased from 87.1 (17.8) points at baseline to 97.1 (9.7) points at a median follow-up of 3 years in the complete revascularization group (score change, 9.9 [95% CI, 9.0-10.8]; P < .001) compared with an increase of 87.2 (18.4) to 96.3 (10.9) points (score change, 8.9 [95% CI, 8.0-9.8]; P < .001) in the culprit lesion-only group (between-group difference, 0.97 points [95% CI, 0.27-1.67]; P = .006). Overall, 1457 patients (87.5%) were free of angina (SAQ-AF score, 100) in the complete revascularization group compared with 1376 patients (84.3%) in the culprit lesion-only group (absolute difference, 3.2% [95% CI, 0.7%-5.7%]; P = .01). This benefit was observed mainly in patients with nonculprit lesion stenosis severity of 80% or more (absolute difference, 4.7%; interaction P = .02).

Conclusions and relevance: In patients with STEMI and multivessel CAD, complete revascularization resulted in a slightly greater proportion of patients being angina-free compared with a culprit lesion-only strategy. This modest incremental improvement in health status is in addition to the established benefit of complete revascularization in reducing cardiovascular events.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Mehta reported grants from AstraZeneca, Boston Scientific, and Canadian Institutes of Health Research during the conduct of the study and personal fees from Janssen Pharmaceuticals outside the submitted work. Dr Wood reported grants from Edwards Lifesciences, Abbott Vascular, and Medtronic outside the submitted work. Dr Spertus reported grants from Abbott Vascular and American College of Cardiology Foundation outside the submitted work; a patent for copyright to the Kansas City Cardiomyopathy Questionnaire and Peripheral Artery Questionnaire with royalties; grants from Abbott Vascular, Bristol Myers Squibb, and Janssen Pharmaceuticals; personal fees from Bayer, Bristol Myers Squibb, Novartis, Merck, Imbria Pharmaceuticals, Terumo, and United Healthcare; and is a member of the board of directors for Blue Cross Blue Shield of Kansas City outside the submitted work. Dr Cohen reported grants and personal fees from Abbott Vascular, Medtronic, Boston Scientific, and Svelte outside the submitted work. Dr Mehran reported grants from Beth Israel Deaconess, Biosensors, Biotronik, Bristol Myers Squibb, Boston Scientific, CallAegis, Concept Medical, CSL Behring, DSI, Duke University, Humacyte, Idorsa Pharmaceuticals, Insel Gruppe AG, Janssen, Medtronic, Novartis Research, OrbusNeich, Philips, Vivasure, and Zoll, all paid to the institution; grants from Abbott, Abiomed, Applied Therapeutics, Arena, AstraZeneca, Bayer, CardiaWave, CellAegis, CERC, Chiesi, and Transverse Medical; consulted for California Institute for Regenerative Medicine, Cine-Med Research, Janssen, and WebMD; served on the advisory boards of Abbott, Arena, Biotronik, CardiaWave, Chiesi, Concept Medical, Humacyte, Magenta, Novartis, and Philips, all paid to the research institution; served on the board of trustees for the American College of Cardiology (unpaid); served on the Women in Innovations Committee of SCAI; served as faculty for CRF (unpaid); <1% equity of Applied Therapeutics, Elixir Medical, STEL, and Claret Medical (Boston Scientific Corp divested final stock options); and other support from AM Pharma, Alleviant Medical, CeloNova BioSciences, Idorsia Pharmaceuticals, American Medical Association Scientific Advisory Board, and ControlRad outside the submitted work. Dr Storey reported personal fees from AstraZeneca, Alnylam, Bayer, Bristol Myers Squibb/Pfizer, Chiesi, CSL Behring, GlyCardial Diagnostics, Hengrui, Idorsia, Novartis, PhaseBio, Cytosorbents, Sanofi Aventis, Thromboserin, Portola, Medscape, and Intas Pharmaceuticals and institutional research grants from AstraZeneca, GlyCardial Diagnostics, Cytosorbents, and Thromboserin outside the submitted work. Dr Steg reports grants and personal fees from Amarin, Bayer, Servier, and Sanofi; personal fees from Amgen, Bristol Myers Squibb, Boehringer Ingelheim, Idorsia, Novartis, Novo Nordisk, Pfizer, Sanofi/Lexicon, Myokardia, Regeneron, Phase Bio, and Merck; personal fees and nonfinancial support from AstraZeneca; and a patent on alirocumab for cardiovascular risk reduction, assigned to Sanofi, issued outside the submitted work. Dr Pinilla-Echeverri reports grants from Boston Scientific, AstraZeneca, Canadian Institutes of Health Research, and Health Research Institute during the conduct of the study and personal fees from Abbott Vascular, Conavi, Philips, Novartis, and Amgen outside the submitted work. Dr Sheth reported personal fees and grants from Abbott Vascular and Edwards Life Sciences outside the submitted work. Dr Bangalore reported grants from REATA and Abbott Vascular and personal fees from Abbott Vascular, Biotronik, Pfizer, Boston Scientific, and Amgen outside the submitted work. Dr Faxon reports participation on a data safety monitoring board or advisory board for Aegis-CSL112/C5Research-Cleveland Clinic, Agent/Boston Scientific, Apollo/Baim Institute, SMART/Baim Institute, Expand TVR/Baim Institute, and otsVADd/Otsuka and leadership or fiduciary role in other board, society, committee or advocacy group, unpaid for Alliance for a Healthy Generation. Dr Jolly reported grants from Boston Scientific and personal fees from Medtronic outside the submitted work. Dr Lopez-Sendon reported grants from Population Health Research Institute, McMaster University, and Hamilton Health Science during the conduct of the study; grants from Amgen, AstraZeneca, Pfizer, Bayer, Boehringer Ingelheim, and Merck outside the submitted work; and personal fees from Bayer and Menarini outside the submitted work. Dr Moreno reports other support from Abbott Vascular, Boston Scientific, Biosensors, Biotronik, Medtronic, Daiichi-Sankyo, Amgen, AstraZeneca, Edwards Lifesciences, Terumo, Philips, and Cardinal Health outside the submitted work. Dr Cairns reports grants from Boston Scientific, AstraZeneca, CIHR, and Edwards Laboratories during the conduct of the study and grants from AstraZeneca; nonfinancial support from Boston Scientific; and personal fees from Abbott, Bayer, and BMS Pfizer outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Flow Diagram
ITT indicates intention-to-treat; MI, myocardial infarction; OMT, optimal medical therapy; PCI, percutaneous coronary intervention; SAQ, Seattle Angina Questionnaire.
Figure 2.
Figure 2.. Forest Plots of Prespecified Subgroups
The Seattle Angina Questionnaire angina frequency score at final follow-up (A) and proportion of angina-free individuals at study end (B) are reported (median 3 years). LAD indicates left anterior descending coronary artery; PCI, percutaneous coronary intervention.
Figure 3.
Figure 3.. Total Angina Burden From Randomization to Follow-up
ARD indicates absolute risk difference; IDR, ischemia-driven revascularization; MI, myocardial infarction; PCI, percutaneous coronary intervention; UA, unstable angina.
See this image and copyright information in PMC

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