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. 2023 Jul 1;8(7):631-639.
doi: 10.1001/jamacardio.2023.1177.

Percutaneous Coronary Intervention vs Coronary Artery Bypass Graft Surgery for Left Main Disease in Patients With and Without Acute Coronary Syndromes: A Pooled Analysis of 4 Randomized Clinical Trials

Prakriti Gaba  1 , Evald H Christiansen  2 , Per H Nielsen  2 , Sabina A Murphy  1 , Patrick T O'Gara  1   3 , Peter K Smith  4 , Patrick W Serruys  5 , A Pieter Kappetein  6 , Seung-Jung Park  7 , Duk-Woo Park  7 , Gregg W Stone  8 , Joseph F Sabik  9 , Marc S Sabatine  1   3 , Niels R Holm  2 , Brian A Bergmark  1
Affiliations

Percutaneous Coronary Intervention vs Coronary Artery Bypass Graft Surgery for Left Main Disease in Patients With and Without Acute Coronary Syndromes: A Pooled Analysis of 4 Randomized Clinical Trials

Prakriti Gaba et al. JAMA Cardiol. .

Abstract

Importance: Patients with left main coronary artery disease presenting with an acute coronary syndrome (ACS) represent a high-risk and understudied subgroup of patients with atherosclerosis.

Objective: To assess clinical outcomes after PCI vs CABG in patients with left main disease with vs without ACS.

Design, setting, and participants: Data were pooled from 4 trials comparing PCI with drug-eluting stents vs CABG in patients with left main disease who were considered equally suitable candidates for either strategy (SYNTAX, PRECOMBAT, NOBLE, and EXCEL). Patients were categorized as presenting with or without ACS. Kaplan-Meier event rates through 5 years and Cox model hazard ratios were generated, and interactions were tested. Patients were enrolled in the individual trials from 2004 through 2015. Individual patient data from the trials were pooled and reconciled from 2020 to 2021, and the analyses pertaining to the ACS subgroup were performed from March 2022 through February 2023.

Main outcomes and measures: The primary outcome was death through 5 years. Secondary outcomes included cardiovascular death, spontaneous myocardial infarction (MI), procedural MI, stroke, and repeat revascularization.

Results: Among 4394 patients (median [IQR] age, 66 [59-73] years; 3371 [76.7%] male and 1022 [23.3%] female) randomized to receive PCI or CABG, 1466 (33%) had ACS. Patients with ACS were more likely to have diabetes, prior MI, left ventricular ejection fraction less than 50%, and higher SYNTAX scores. At 30 days, patients with ACS had higher all-cause death (hazard ratio [HR], 3.40; 95% CI, 1.81-6.37; P < .001) and cardiovascular death (HR, 3.21; 95% CI, 1.69-6.08; P < .001) compared with those without ACS. Patients with ACS also had higher rates of spontaneous MI (HR, 1.70; 95% CI, 1.25-2.31; P < .001) through 5 years. The rates of all-cause mortality through 5 years with PCI vs CABG were 10.9% vs 11.5% (HR, 0.93; 95% CI, 0.68-1.27) in patients with ACS and 11.3% vs 9.6% (HR, 1.19; 95% CI, 0.95-1.50) in patients without ACS (P = .22 for interaction). The risk of early stroke was lower with PCI vs CABG (ACS: HR, 0.39; 95% CI, 0.12-1.25; no ACS: HR, 0.35; 95% CI, 0.16-0.75), whereas the 5-year risks of spontaneous MI and repeat revascularization were higher with PCI vs CABG (spontaneous MI: ACS: HR, 1.74; 95% CI, 1.09-2.77; no ACS: HR, 3.03; 95% CI, 1.94-4.72; repeat revascularization: ACS: HR, 1.57; 95% CI, 1.19-2.09; no ACS: HR, 1.90; 95% CI, 1.54-2.33), regardless of ACS status.

Conclusion and relevance: Among largely stable patients undergoing left main revascularization and with predominantly low to intermediate coronary anatomical complexity, those with ACS had higher rates of early death. Nonetheless, rates of all-cause mortality through 5 years were similar with PCI vs CABG in this high-risk subgroup. The relative advantages and disadvantages of PCI vs CABG in terms of early stroke and long-term spontaneous MI and repeat revascularization were consistent regardless of ACS status.

Trial registration: ClinicalTrials.gov Identifiers: NCT00114972, NCT00422968, NCT01496651, NCT01205776.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Gaba is a member of the TIMI Study Group, which has received grant support through Brigham and Women’s Hospital from Abbott, Amgen, Anthos Therapeutics, AstraZeneca, Bayer HealthCare Pharmaceuticals, Daiichi Sankyo, Eisai, Intarcia, Ionis, MedImmune, Merck, Novartis, Pfizer, Quark Pharmaceuticals, Regeneron Pharmaceuticals, Roche, Siemens Healthcare Diagnostics, The Medicines Company, and Zora Biosciences. Dr Christiansen reported institutional research grants from Abbott, Biosensors, and Boston Scientific and speaker fees from Abbott. Dr Murphy is a member of the TIMI Study Group, which has received grant support through Brigham and Women’s Hospital from Abbott, Amgen, Anthos Therapeutics, AstraZeneca, Bayer HealthCare Pharmaceuticals, Daiichi Sankyo, Eisai, Intarcia, Ionis, MedImmune, Merck, Novartis, Pfizer, Quark Pharmaceuticals, Regeneron Pharmaceuticals, Roche, Siemens Healthcare Diagnostics, The Medicines Company, and Zora Biosciences. Dr Serruys reported consultancy or personal fees from SMT, Novartis, Philips, Xeltis, and Meril Life. Dr Kappetein reported being an employee of Medtronic. Dr S.-J. Park reported grants from Abbott Vascular, Daiichi Sankyo, ChongKunDang Pharm, Daewoong Pharm, and Edwards and personal fees from Abbott Vascular and Edwards, all outside the submitted work. Dr D.-W. Park reported grants from Daiichi Sankyo, ChongKunDang Pharm, Daewoong Pharm, and Abbott Vascular and personal fees from Edwards, Abbott Vascular, and Medtronic, all outside the submitted work. Dr Stone reported speaker honoraria from Medtronic, Pulnovo, Infraredx, Abiomed, and Abbott; serving as a consultant to Daiichi Sankyo, Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Impulse Dynamics, Cardiomech, Gore, Amgen, Adona Medical, Millennia Biopharma, and Oxitope; having equity/options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and Xenter; research support to his employer, Mount Sinai Hospital, from Abbott, Abiomed, Bioventrix, Cardiovascular Systems, Phillips, Biosense-Webster, Shockwave, Vascular Dynamics, Pulnovo and V-wave; and his daughter being an employee at IQVIA. Dr Sabik reported personal fees from Medtronic outside the submitted work and being the North American Surgical Principal Investigator in the EXCEL trial. Dr Sabatine is a member of the TIMI Study Group, which has received grant support through Brigham and Women’s Hospital from Abbott, Amgen, Anthos Therapeutics, AstraZeneca, Bayer HealthCare Pharmaceuticals, Daiichi Sankyo, Eisai, Intarcia, Ionis, MedImmune, Merck, Novartis, Pfizer, Quark Pharmaceuticals, Regeneron Pharmaceuticals, Roche, Siemens Healthcare Diagnostics, The Medicines Company, and Zora Biosciences, and reported consulting for Althera, Amgen, Anthos Therapeutics, AstraZeneca, Beren Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, CVS Caremark, DalCor, Dr Reddy’s Laboratories, Fibrogen, IFM Therapeutics, Intarcia, MedImmune, Merck, Moderna, Novo Nordisk, Precision Biosciences, and Silence Therapeutics outside the submitted work. Dr Holm reported grants from Biosensors during the conduct of the study and grants from Abbott, B Braun, Boston Scientific, and Reva Medical and personal fees from Abbott, Terumo, and Reva Medical outside the submitted work. Dr Bergmark is a member of the TIMI Study Group, which has received grant support through Brigham and Women’s Hospital from Abbott, Amgen, Anthos Therapeutics, AstraZeneca, Bayer HealthCare Pharmaceuticals, Daiichi Sankyo, Eisai, Intarcia, Ionis, MedImmune, Merck, Novartis, Pfizer, Quark Pharmaceuticals, Regeneron Pharmaceuticals, Roche, Siemens Healthcare Diagnostics, The Medicines Company, and Zora Biosciences, and reported grants from Pfizer, Ionis, AstraZeneca, Abbott Vascular and personal fees from Abiomed, Abbott, CSI, Philips, Terumo, Servier, Endovascular Engineering, SpectraWAVE, Janssen, Quark, and Daiichi Sankyo outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Cardiovascular Death in Patients With vs Without Acute Coronary Syndrome (ACS)
Cumulative incidence of cardiovascular death in patients with vs without ACS with comparisons indicated in blue at 30 days, 1 year, and 5 years. HR indicates hazard ratio.
Figure 2.
Figure 2.. Cardiovascular Events in Patients With or Without Acute Coronary Syndrome (ACS) Undergoing Revascularization for Left Main Coronary Artery Disease by Percutaneous Coronary Intervention (PCI) vs Coronary Artery Bypass Graft (CABG) Surgery
HR indicates hazard ratio.
See this image and copyright information in PMC

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