Related Experiment Video
Updated: Apr 4, 2026
Interventional Diagnostic Procedure: A Practical Guide for the Assessment of Coronary Vascular Function
Published on: March 15, 2022
Bivalirudin or Unfractionated Heparin in Acute Coronary Syndromes
Marco Valgimigli1, Enrico Frigoli, Sergio Leonardi
1From the Swiss Cardiovascular Center Bern, Bern University Hospital (M.V.), Clinical Trials Unit and Institute of Social and Preventive Medicine (M.R., D.H.), and Institute of Primary Health Care (P.J.), University of Bern, Bern, Switzerland; Thoraxcenter, Erasmus Medical Center, Rotterdam (M.V.), and Isala Klinieken, Zwolle (A.H.) - both in the Netherlands; EUSTRATEGY Association, Forli (E.F.), Unità Operativa Complessa Cardiologia, Dipartimento CardioToracoVascolare, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L., A.R.), Cardiology Unit, Ospedali Riuniti di Rivoli (A.G., F.V.), and San Giovanni Bosco Hospital (R.G., G.B.), Turin, Division of Cardiology, Department of Cardiothoracic Sciences, Second University of Naples (P.C.), Department of Advanced Biomedical Sciences, Division of Cardiology, Federico II University of Naples (G.E.), and Clinica Mediterranea (C.B.), Naples, Azienda Ospedaliera Ospedale Civile di Vimercate, Desio (S.G.), Department of Cardiology, ASL3 Ospedale Villa Scassi (P.R.), and IRCCS Azienda Ospedaliera Universitaria San Martino (A.Z.), Genoa, Azienda Ospedaliera Universitaria Policlinico Gaetano Martino, University of Messina, Messina (G.A.), Unità Operativa Cardiologia, ASL 9 Grosseto, Grosseto (U.L.), Azienda Ospedaliera Ospedale Treviglio-Caravaggio, Treviglio (P.S.), Azienda Ospedaliera Sant'Anna, Como (F.R.), University Hospital Maggiore della Carita, Novara (A.L.), Ospedale Fatebenefratelli, Milan (B.C.), Casa di Cura Villa Verde, Taranto (A.A.), Ospedale Sirai-Carbonia, Carbonia (S.I.), IRCCS Humanitas, Rozzano (P.P.), Cardiovascular Department, Infermi Hospital, Rimini (A.S.), Policlinico Umberto I, Sapienza University of Rome (G.S.), and Interventional Cardiology Unit, Sandro Pertini Hospital Rome (S.R.), Rome, Azienda Ospedaliera Ospedale di Desio, Desio (S.T.), Policlinico San Marco, Zingonia (N.C.), and Mater Salutis Hospital, Legnago (P.T.) - all in Italy; Sahlgrenska University Hospital, Göteborg, Sweden (E.O.); Hospi
Insights
Bivalirudin did not significantly reduce major adverse cardiovascular events or net adverse clinical events compared to unfractionated heparin in acute coronary syndrome patients undergoing percutaneous coronary intervention. Post-PCI bivalirudin infusion also showed no significant benefit.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- Conflicting evidence exists regarding the efficacy and safety of bivalirudin in percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS).
- This study addresses the need for clear evidence on bivalirudin's role in ACS management.
Purpose of the Study:
- To compare the efficacy and safety of bivalirudin versus unfractionated heparin in patients with ACS undergoing PCI.
- To evaluate the benefit of a post-PCI bivalirudin infusion compared to no infusion.
Main Methods:
- A randomized trial involving 7213 patients with ACS planned for PCI.
- Patients received either bivalirudin or unfractionated heparin.
- A subgroup of bivalirudin recipients were further randomized to receive or not receive a post-PCI infusion.
Main Results:
- Bivalirudin did not significantly lower the rates of major adverse cardiovascular events (MACE) or net adverse clinical events (NACE) compared to unfractionated heparin.
- Post-PCI bivalirudin infusion did not significantly reduce the composite outcome of urgent target-vessel revascularization, definite stent thrombosis, or NACE.
Conclusions:
- Bivalirudin is not superior to unfractionated heparin in reducing MACE or NACE in ACS patients undergoing PCI.
- A post-PCI bivalirudin infusion does not offer significant clinical benefits in this patient population.
Background:
Conflicting evidence exists on the efficacy and safety of bivalirudin administered as part of percutaneous coronary intervention (PCI) in patients with an acute coronary syndrome.
Methods:
We randomly assigned 7213 patients with an acute coronary syndrome for whom PCI was anticipated to receive either bivalirudin or unfractionated heparin. Patients in the bivalirudin group were subsequently randomly assigned to receive or not to receive a post-PCI bivalirudin infusion. Primary outcomes for the comparison between bivalirudin and heparin were the occurrence of major adverse cardiovascular events (a composite of death, myocardial infarction, or stroke) and net adverse clinical events (a composite of major bleeding or a major adverse cardiovascular event). The primary outcome for the comparison of a post-PCI bivalirudin infusion with no post-PCI infusion was a composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events.
Results:
The rate of major adverse cardiovascular events was not significantly lower with bivalirudin than with heparin (10.3% and 10.9%, respectively; relative risk, 0.94; 95% confidence interval [CI], 0.81 to 1.09; P=0.44), nor was the rate of net adverse clinical events (11.2% and 12.4%, respectively; relative risk, 0.89; 95% CI, 0.78 to 1.03; P=0.12). Post-PCI bivalirudin infusion, as compared with no infusion, did not significantly decrease the rate of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events (11.0% and 11.9%, respectively; relative risk, 0.91; 95% CI, 0.74 to 1.11; P=0.34).
Conclusions:
In patients with an acute coronary syndrome, the rates of major adverse cardiovascular events and net adverse clinical events were not significantly lower with bivalirudin than with unfractionated heparin. The rate of the composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events was not significantly lower with a post-PCI bivalirudin infusion than with no post-PCI infusion. (Funded by the Medicines Company and Terumo Medical; MATRIX ClinicalTrials.gov number, NCT01433627.).
Related Concept Videos
01:30Anticoagulant Drugs: Low-Molecular-Weight Heparins
01:29Venous Thrombosis III: Interprofessional Care
01:28Acute Coronary Syndrome IV: Interprofessional Care
01:30Acute Coronary Syndrome I: Introduction
01:27Coronary Artery Disease V: Interprofessional Care
01:18Anticoagulant Drugs: Vitamin K Antagonists and Direct Oral Anticoagulants
Warfarin, a prominent vitamin K antagonist family member, exerts its effect by inhibiting the enzyme VKORC1 (vitamin K epoxide reductase complex 1). By hindering this enzyme, warfarin...