Post-Procedural Bivalirudin Infusion at Full or Low Regimen in Patients With Acute Coronary Syndrome
Giuseppe Gargiulo1, Greta Carrara2, Enrico Frigoli3
1Department of Cardiology, Bern University Hospital, Bern, Switzerland; Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.
Insights
Prolonged bivalirudin infusion after percutaneous coronary intervention (PCI) in acute coronary syndrome (ACS) patients did not significantly change primary outcomes. However, a full-dose post-PCI bivalirudin regimen improved outcomes compared to no infusion or low-dose regimens.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- The clinical utility of extended bivalirudin infusion post-percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) patients, including those with ST-segment elevation, remains uncertain.
- Current guidelines offer limited clarity on optimal bivalirudin dosing strategies in this patient population.
Purpose of the Study:
- To evaluate the efficacy and safety of full-dose versus low-dose post-PCI bivalirudin regimens in ACS patients.
- To compare different bivalirudin infusion strategies following PCI in patients with or without ST-segment elevation.
Main Methods:
- The MATRIX program randomized ACS patients to receive bivalirudin with or without a post-PCI infusion.
- Infusion regimens included a full dose (1.75 mg/kg/h for ≤4 h) or a reduced dose (0.25 mg/kg/h for ≤6 h) at the operator's discretion.
- The primary endpoint was a composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events at 30 days.
Main Results:
- No significant difference in the primary outcome was observed between patients who received post-PCI bivalirudin and those who did not, across both ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation acute coronary syndromes (NSTE-ACS).
- However, multivariable and propensity score analyses indicated that a full-dose post-PCI bivalirudin regimen was associated with a significant reduction in the primary endpoint compared to a low-dose regimen.
- The full-dose regimen demonstrated consistent outcome improvements across ACS types compared to no post-PCI infusion or heparin use.
Conclusions:
- In ACS patients, the presence or absence of post-PCI bivalirudin infusion did not significantly alter the primary endpoint.
- A full-dose post-PCI bivalirudin regimen was associated with improved clinical outcomes compared to no infusion, low-dose infusion, or heparin.
- These findings suggest a potential benefit of optimized, higher-dose bivalirudin infusions in specific ACS patient subgroups.
Background:
The value of prolonged bivalirudin infusion after percutaneous coronary intervention (PCI) in acute coronary syndrome (ACS) patients with or without ST-segment elevation remains unclear.
Objectives:
The purpose of this study was to assess efficacy and safety of a full or low post-PCI bivalirudin regimen in ACS patients with or without ST-segment elevation.
Methods:
The MATRIX program assigned bivalirudin to patients without or with a post-PCI infusion at either a full (1.75 mg/kg/h for ≤4 h) or reduced (0.25 mg/kg/h for ≤6 h) regimen at the operator's discretion. The primary endpoint was the 30-day composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events (composite of all-cause death, myocardial infarction, or stroke, or major bleeding).
Results:
Among 3,610 patients assigned to bivalirudin, 1,799 were randomized to receive and 1,811 not to receive a post-PCI bivalirudin infusion. Post-PCI full bivalirudin was administered in 612 (ST-segment elevation myocardial infarction [STEMI], n = 399; non-ST-segment elevation acute coronary syndromes [NSTE-ACS], n = 213), whereas the low-dose regimen was administered in 1,068 (STEMI, n = 519; NSTE-ACS, n = 549) patients. The primary outcome did not differ in STEMI or NSTE-ACS patients who received or did not receive post-PCI bivalirudin. However, full compared with low bivalirudin regimen remained associated with a significant reduction of the primary endpoint after multivariable (rate ratio: 0.21; 95% CI: 0.12 to 0.35; p < 0.001) or propensity score (rate ratio: 0.16; 95% CI: 0.09 to 0.26; p < 0.001) adjustment. Full post-PCI bivalirudin was associated with improved outcomes consistently across ACS types compared with the no post-PCI infusion or heparin groups.
Conclusions:
In ACS patients with or without ST-segment elevation, the primary endpoint did not differ with or without post-PCI bivalirudin infusion but a post-PCI full dose was associated with improved outcomes when compared with no or low-dose post-PCI infusion or heparin (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX [MATRIX]; NCT01433627).
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