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Randomized Controlled Trial
. 2024 Dec 10;84(24):2335-2346.
doi: 10.1016/j.jacc.2024.07.065.

Major Bleeding and Mortality After Revascularization of Left Main Disease

Gennaro Giustino  1 , Joseph F Sabik 3rd  2 , Patrick W Serruys  3 , John D Puskas  4 , Dimitri Karmpaliotis  5 , David E Kandzari  6 , Marie-Claude Morice  7 , Michael Ragosta 3rd  8 , Zixuan Zhang  9 , Ovidiu Dressler  9 , Bjorn Redfors  9 , Ori Ben-Yehuda  10 , Samin K Sharma  11 , Arie Pieter Kappetein  12 , Gregg W Stone  13
Affiliations
Randomized Controlled Trial

Major Bleeding and Mortality After Revascularization of Left Main Disease

Gennaro Giustino et al. J Am Coll Cardiol. .

Abstract

Background: The incidence and prognostic impact of major bleeding (MB) after percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) for left main coronary artery disease (LMCAD) are unknown.

Objectives: The goal of this study was to investigate the rates and outcomes of MB after LMCAD revascularization.

Methods: In the EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial, 1,905 patients with unprotected LMCAD were randomized to undergo PCI (n = 948) or CABG (n = 957) and followed up for 5 years. MB was defined as TIMI major or minor bleeding, BARC (Bleeding Academic Research Consortium) types 3 to 5 bleeding, or any overt bleeding requiring blood transfusion. The association between MB and subsequent mortality was assessed in time-adjusted Cox regression models.

Results: At 5 years, 217 patients (11.4%) had at least 1 MB event. Rates of 5-year MB were 7.9% after PCI vs 14.8% after CABG (OR: 0.48; 95% CI: 0.36-0.65; P < 0.0001). However, in-hospital MB was lower after PCI (3.8% vs 13.5%; OR: 0.25; 95% CI: 0.17-0.37), whereas postdischarge MB was lower after CABG (4.5% vs 2.0%; OR: 2.33; 95% CI: 1.33-3.09; Pinteraction < 0.0001). All 41 postdischarge MB events after PCI occurred in patients receiving dual antiplatelet therapy. MB events within 5 years were associated with a higher subsequent risk of all-cause mortality (adjusted HR: 2.71; 95% CI: 1.95-3.77; P < 0.0001), whether in-hospital or postdischarge (Pinteraction = 1.00) and after both PCI and CABG (Pinteraction = 0.95), driven both by increased cardiovascular and non-cardiovascular mortality.

Conclusions: In the EXCEL trial, CABG resulted in higher 5-year rates of all MB and in-hospital MB, although postdischarge MB was more frequent after PCI. MB after both procedures was associated with increased cardiovascular and noncardiovascular mortality within 5 years. (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776).

Keywords: bleeding; coronary artery bypass grafting; left main coronary artery; percutaneous coronary intervention; prognosis.

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Conflict of interest statement

Funding Support and Author Disclosures The EXCEL trial was funded by Abbott Vascular. Dr Giustino is a consultant and proctor for Edwards Lifesciences. Dr Sabik has served as a consultant for Medtronic, Edwards, and Sorin; and has served on the advisory board for Medtronic Cardiac Surgery. Dr Serruys has served as a consultant for Abbott, Biosensors, Medtronic, Micell Technologies, SINOMED, Philips/Volcano, Xeltis, and HeartFlow. Dr Kandzari has received consulting honoraria and research/grant support from Medtronic, Biotronik, and Boston Scientific. Dr Stone has received speaker honoraria from Medtronic, Pulnovo, Infraredx, Abiomed, Amgen, and Boehringer Ingelheim; has served as a consultant to Abbott, Daiichi-Sankyo, Ablative Solutions, CorFlow, CardioMech, Robocath, Miracor, Vectorious, Apollo Therapeutics, Elucid Bio, VALFIX, TherOx, HeartFlow, Neovasc, Ancora, Occlutech, Impulse Dynamics, Adona Medical, Millennia Biopharma, Oxitope, Cardiac Success, HighLife, and Elixir; and has equity/options from Ancora, Cagent, Applied Therapeutics, BioStar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, VALFIX, and Xenter. Dr Stone’s employer, Mount Sinai Hospital, receives research grants from Abbott, Abiomed, BioVentrix, Cardiovascular Systems Inc, Philips, Biosense Webster, Shockwave, Vascular Dynamics, Pulnovo, and V-Wave. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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