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Antithrombotic regimens for percutaneous coronary intervention of the left main coronary artery: The EXCEL trial
Author(s) -
Brener Sorin J.,
Lembo Nicholas J.,
Kandzari David E.,
Sabaté Manel,
Gershlick Anthony H.,
Banning Adrian P.,
Buszman Paweł E.,
Kosmidou Ioanna,
Simonton Charles A.,
Morice MarieClaude,
BenYehuda Ori,
Dressler Ovidiu,
Zhang Zixuan,
Sabik Joseph F.,
Kappetein Arie Pieter,
Serruys Patrick W.,
Stone Gregg W.
Publication year - 2021
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.28858
Subject(s) - bivalirudin , medicine , conventional pci , percutaneous coronary intervention , cardiology , myocardial infarction , heparin , antithrombotic , clinical endpoint , stroke (engine) , stent , randomized controlled trial , mechanical engineering , engineering
Objectives We compared the effect of bivalirudin or heparin and use or nonuse of glycoprotein IIb/IIIa inhibitors (GPI) on the outcome of left main coronary artery (LMCA) percutaneous coronary intervention (PCI) in the randomized EXCEL trial. Background The optimal antithrombotic regimen to support PCI of the LMCA remains controversial because of low representation of this subset in clinical trials. Methods The PCI cohort ( n = 928) in EXCEL was divided according to bivalirudin versus heparin antithrombin treatment and compared for the primary composite endpoint of death, myocardial infarction (MI), or stroke at 30 days and 5 years. RESULTS Bivalirudin was used in 319 patients (34.4%). The composite endpoint at 30 days occurred in 7.2% versus 3.8% bivalirudin and heparin patients, respectively, p = .02; at 5 years, the composite endpoint occurred in 26.3% versus 19.9% bivalirudin and heparin patients, respectively, p = .02. Major bleeding was more frequent in bivalirudin patients (4.1% versus 1.3%, p = .008). There were no differences in stent thrombosis between the groups. Bivalirudin use was an independent predictor of the 30‐day composite endpoint (OR 2.88, 95% CI 1.28–6.48, p = .01) but not of the 5‐year composite endpoint (OR 1.30, 95% CI 0.84–2.02, p = .23). GPI use was infrequent ( n = 67, 7.2%) and was not associated with adverse outcomes. Conclusion Among patients undergoing LMCA PCI in the EXCEL trial, procedural use of bivalirudin was associated with greater rates of periprocedural MI and the 30‐day composite endpoint without reducing bleeding complications. Five‐year outcomes were similar. GPIs were used infrequently and were not associated with clinical outcomes.