Post-Procedural Bivalirudin Infusion at Full or Low Regimen in Patients With Acute Coronary Syndrome
Giuseppe GargiuloGreta CarraraEnrico FrigoliSergio LeonardiPascal VranckxGianluca CampoFerdinando VarbellaPaolo CalabròTiziana ZaroDavide BartoliniCarlo BriguoriGiuseppe AndòMaurizio FerrarioUgo LimbrunoSalvatore ColangeloPaolo SganzerlaFilippo RussoMarco Stefano NazzaroGiovanni EspositoGiuseppe FerranteAndrea SantarelliGennaro SardellaStephan WindeckerMarco Valgimigli
Why the study?
The value of prolonged bivalirudin infusion after PCI in ACS patients with or without ST-segment elevation remained unclear.
Does post-PCI bivalirudin infusion reduce the 30-day composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events in ACS patients undergoing PCI?
Structured PICO
Does post-PCI bivalirudin infusion reduce the 30-day composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events in ACS patients undergoing PCI?
P
Population
3,610 patients with acute coronary syndrome (ACS) with or without ST-segment elevation undergoing percutaneous coronary intervention (PCI)
I
Intervention
Post-PCI bivalirudin infusion at full regimen (1.75 mg/kg/h for ≤4 h) or low regimen (0.25 mg/kg/h for ≤6 h)
C
Comparator
No post-PCI bivalirudin infusion or heparin
O
Outcome
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)composite
A full-dose post-PCI bivalirudin infusion is associated with improved clinical outcomes compared to no or low-dose infusion in patients with ACS.
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Post-PCI bivalirudin did not reduce the composite outcome of ischemic and bleeding outcomes, including stent thrombosis risk, as compared to no post-PCI bivalirudin infusion.”
AAAnonymous ACC Journal Scan ReviewerACC Journal Scan reviewer
“Results need to be interpreted with caution in the context of the main analysis being negative. Determination of low- or full-dose bivalirudin infusion was left at the discretion of the operator and may have resulted in selection bias, which cannot be adjusted for. In addition, the presence of less bleeding with full- compared to low-dose bivalirudin post-PCI infusion is counterintuitive and suggests persistent confounding factors.”
Implication
Do not alter post-PCI bivalirudin practice; leaves open optimal dose/duration pending dedicated randomized trials.
Abstract
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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Cite This Study
Gargiulo et al. (2019) studied this question.