Post-Procedural Bivalirudin Infusion at Full or Low Regimen in Patients With Acute Coronary Syndrome
Giuseppe Gargiulo, Greta Carrara, Enrico Frigoli, Sergio Leonardi, Pascal Vranckx, Gianluca Campo, Ferdinando Varbella, Paolo Calabrò, Tiziana Zaro, Davide Bartolini, Carlo Briguori, Giuseppe Andò, Maurizio Ferrario, Ugo Limbruno, Salvatore Colangelo, Paolo Sganzerla, Filippo Russo, Marco Stefano Nazzaro, Giovanni Esposito, Giuseppe Ferrante, Andrea Santarelli, Gennaro Sardella, Stephan Windecker, Marco Valgimigli, Giuseppe Gargiulo, Greta Carrara, Enrico Frigoli, Sergio Leonardi, Pascal Vranckx, Gianluca Campo, Ferdinando Varbella, Paolo Calabrò, Tiziana Zaro, Davide Bartolini, Carlo Briguori, Giuseppe Andò, Maurizio Ferrario, Ugo Limbruno, Salvatore Colangelo, Paolo Sganzerla, Filippo Russo, Marco Stefano Nazzaro, Giovanni Esposito, Giuseppe Ferrante, Andrea Santarelli, Gennaro Sardella, Stephan Windecker, Marco Valgimigli
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).
Keywords: MATRIX; NSTE-ACS; STEMI; acute coronary syndrome; bivalirudin dose; bivalirudin duration.
Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed