Author + information
- Received September 14, 2018
- Revision received December 3, 2018
- Accepted December 10, 2018
- Published online February 18, 2019.
- Giuseppe Gargiulo, MD, PhDa,b,
- Greta Carrara, Statc,
- Enrico Frigoli, MDa,
- Sergio Leonardi, MD, MHSd,
- Pascal Vranckx, MD, PhDe,
- Gianluca Campo, MD, PhDf,g,
- Ferdinando Varbella, MDh,
- Paolo Calabrò, MD, PhDi,
- Tiziana Zaro, MDj,
- Davide Bartolini, MDk,
- Carlo Briguori, MD, PhDl,
- Giuseppe Andò, MD, PhDm,
- Maurizio Ferrario, MDd,
- Ugo Limbruno, MDn,
- Salvatore Colangelo, MDo,
- Paolo Sganzerla, MDp,
- Filippo Russo, MDq,
- Marco Stefano Nazzaro, MD, PhDr,
- Giovanni Esposito, MD, PhDb,
- Giuseppe Ferrante, MD, PhDs,
- Andrea Santarelli, MDt,
- Gennaro Sardella, MDu,
- Stephan Windecker, MDa and
- Marco Valgimigli, MD, PhDa,∗ (, )@vlgmrc@UniBern
- aDepartment of Cardiology, Bern University Hospital, Bern, Switzerland
- bDepartment of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy
- cAdvice Pharma Group, Milan, Italy
- dDipartimento CardioToracoVascolare, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
- eDepartment of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium & Faculty of Medicine and Life Sciences Hasselt University, Hasselt, Belgium
- fCardiovascular Institute, Azienda Ospedaliero-Universitaria di Ferrara, Cona (FE), Italy
- gMaria Cecilia Hospital, GVM Care and Research, Cotignola (RA), Italy
- hCardiology Unit, Ospedali Riuniti di Rivoli, ASL Torino 3, Turin, Italy
- iDivision of Cardiology, Department of Cardiothoracic Sciences, University of Campania “Luigi Vanvitelli,” Naples, Italy
- jA.O. Ospedale Civile di Vimercate (MB), Vimercate, Italy
- kDepartment of Cardiology, ASL3 Ospedale Villa Scassi, Genoa, Italy
- lClinica Mediterranea, Naples, Italy
- mAzienda Ospedaliera Universitaria Policlinico “Gaetano Martino,” University of Messina, Messina, Italy
- nUO Cardiologia, Azienda USL Toscana Sudest, Grosseto, Italy
- oInterventional Cardiology, San Giovanni Bosco Hospital, Torino, Italy
- pASST Bergamo ovest, Ospedale di Treviglio (BG), Italy
- qAzienda Ospedaliera Sant'Anna, Como, Italy
- rSan Camillo-Forlanini, Roma, Italy
- sHumanitas Research Hospital, Rozzano Milano, Italy
- tCardiovascular Department, Infermi Hospital, Rimini, Italy
- uPoliclinico Umberto I, “Sapienza” University of Rome, Rome, Italy
- ↵∗Address for correspondence:
Dr. Marco Valgimigli, Department of Cardiology, Bern University Hospital, CH-3010 Bern, Switzerland.
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).
The trial was sponsored by the Società Italiana di Cardiologia Invasiva (GISE, a nonprofit organization), which received grant support from The Medicines Company and TERUMO. This substudy did not receive any direct or indirect funding. Dr. Gargiulo has received research grant support from the Cardiopath PhD program. Dr. Vranckx has received consulting fees from AstraZeneca and The Medicines Company during the study; and has received speaking or consulting fees from Bayer HealthCare, Terumo, and Daiichi-Sankyo outside of the submitted work. Dr. Campo has received research grants from AstraZeneca, Boston Scientific, and Abbott Vascular outside of this work. Dr. Varbella has received personal fees from AstraZeneca, Eli Lilly, and Bayer; has received other support from Biosensors; has received grants from Medtronic, Kardia SRL, and Boston Scientific outside of the submitted work; and has received lecture fees for Advisory Board participation from AstraZeneca, Daichi-Sankyo, Bayer, Pfizer, Boehringer Ingelheim, Servier, Amgen, Novartis, Sanofi, and Biotronik. Dr. Andò has received nonfinancial support from Terumo during the conduct of the study; has received personal fees from Daiichi-Sankyo, AstraZeneca, Menarini, Pfizer, Philips, and Bayer; and has received nonfinancial support from Bayer, Boehringer Ingelheim, Chiesi, and Philips outside of the submitted work. Dr. Limbruno has received personal fees from The Medicines Company, AstraZeneca, Lilly, Boston Scientific, Biotronik, and Merck outside of the submitted work. Dr. Windecker’s institution has received research contracts from Abbott, Amgen, Boston Scientific, Biotronik, Medtronic, Edwards Lifesciences, St. Jude, and Terumo. Dr. Valgimigli has received grants from The Medicines Company and Terumo during the conduct of the study; has received grants and personal fees from AstraZeneca; has received nonfinancial support from The Medicines Company; and has received personal fees from The Medicines Company, Terumo, St. Jude Vascular, Alvimedica, Abbott Vascular, and Correvio outside of the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.
- Received September 14, 2018.
- Revision received December 3, 2018.
- Accepted December 10, 2018.
- 2019 American College of Cardiology Foundation
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