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Updated: Dec 26, 2025

Interventional Diagnostic Procedure: A Practical Guide for the Assessment of Coronary Vascular Function
Published on: March 15, 2022
Antithrombotic regimens for percutaneous coronary intervention of the left main coronary artery: The EXCEL trial
Sorin J Brener1, Nicholas J Lembo2,3, David E Kandzari4
1NewYork-Presbyterian Brooklyn Methodist Hospital, New York, New York, USA.
Insights
Bivalirudin use during left main coronary artery percutaneous coronary intervention (PCI) increased early adverse events and bleeding compared to heparin. Five-year outcomes were similar, with no difference in stent thrombosis.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Optimal antithrombotic strategy for left main coronary artery (LMCA) percutaneous coronary intervention (PCI) is debated.
- LMCA PCI patients are underrepresented in major clinical trials.
Purpose of the Study:
- To compare the outcomes of bivalirudin versus heparin in patients undergoing LMCA PCI.
- To evaluate the impact of glycoprotein IIb/IIIa inhibitor (GPI) use on LMCA PCI outcomes.
Main Methods:
- Analysis of the randomized EXCEL trial PCI cohort (n=928).
- Comparison of bivalirudin versus heparin treatment groups.
- Assessment of primary composite endpoint (death, MI, stroke) at 30 days and 5 years.
- Evaluation of major bleeding and stent thrombosis rates.
Main Results:
- Bivalirudin use was associated with higher 30-day (7.2% vs 3.8%) and 5-year (26.3% vs 19.9%) composite endpoint rates compared to heparin (p=0.02 for both).
- Major bleeding was more frequent with bivalirudin (4.1% vs 1.3%, p=0.008).
- No significant difference in stent thrombosis was observed between groups.
Conclusions:
- Procedural bivalirudin use in LMCA PCI was linked to increased periprocedural myocardial infarction and 30-day adverse events without reducing bleeding.
- Five-year outcomes were comparable between bivalirudin and heparin.
- Glycoprotein IIb/IIIa inhibitors were infrequently used and did not impact clinical outcomes.
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.
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