Author + information
- Received September 28, 2014
- Accepted October 8, 2014
- Published online January 1, 2015.
- Eliano Pio Navarese, MD, PhD∗,†,‡∗ (, )
- Volker Schulze, MD†,‡,
- Felicita Andreotti, MD, PhD‡,§,
- Mariusz Kowalewski, MD‡,‖,
- Michalina Kołodziejczak, MD‡,¶,
- David E. Kandzari, MD#,
- Tienush Rassaf, MD, PhD†,‡,
- Bartosz Gorny, MD‡,§,
- Maximilian Brockmeyer, MD†,‡,
- Christian Meyer, MD, PhD†,‡,
- Sergio Berti, MD∗∗∗,
- Jacek Kubica, MD, PhD‡,¶,
- Malte Kelm, MD†,‡ and
- Marco Valgimigli, MD, PhD††
- ∗Invasive Cardiology, National Research Council Institute of Clinical Physiology, Pisa, Italy
- †Department of Internal Medicine, Division of Cardiology, Pulmonology and Vascular Medicine, Heinrich-Heine-University, Düsseldorf, Germany
- ‡Systematic Investigation and Research on Interventions and Outcomes (SIRIO) MEDICINE Research Network, Poland and Germany
- §Department of Cardiovascular Science, Catholic University, Rome, Italy
- ‖Department of Cardiology, 10th Military Research Hospital and Polyclinic, Bydgoszcz, Poland
- ¶Department of Cardiology and Internal Medicine, Nicolaus Copernicus University, Bydgoszcz, Poland
- #Piedmont Heart Institute, Atlanta, Georgia
- ∗∗Cardiothoracic Department, Heart Hospital, Fondazione Toscana Gabriele Monasterio, Massa, Italy
- ††Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands
- ↵∗Reprint requests and correspondence:
Dr. Eliano Pio Navarese, National Research Council of Clinical Physiology, Invasive Cardiology, Moruzzi 1, Pisa 56124, Italy.
Objectives The aim of this meta-analysis was to compare the 30-day safety and efficacy of bivalirudin with those of heparin with or without routine administration of a glycoprotein IIb/IIIa inhibitor (GPI) in patients with acute coronary syndrome (ACS).
Background Bivalirudin has been a mainstay of anticoagulation in patients with ACS compared with heparin. The extent to which trial results have been affected by the coadministration of heparin with a GPI, however, remains unclear.
Methods A total of 13 randomized, controlled trials involving 24,605 patients were included.
Results There was no significant difference in 30-day mortality or myocardial infarction rate with bivalirudin compared with heparin with or without routine GPI administration. A reduction of 30-day major bleeding was observed with bivalirudin compared with heparin that was significant when GPI was routinely administered (odds ratio [OR]: 0.52, 95% confidence interval [CI]: 0.45 to 0.60), p < 0.001) but not with provisionally administered GPI (OR: 0.66, 95% CI: 0.33 to 1.32; p = 0.24). The occurrence of stent thrombosis (ST) at 30 days was significantly increased with bivalirudin compared with heparin plus routinely administered GPI (OR: 1.67, 95% CI: 1.13 to 2.45, p = 0.02), but not compared with heparin plus provisionally administered GPI (OR: 2.08, 95% CI: 0.35 to 12.32, p = 0.42). The rate of acute ST (≤24 h), however, was almost 4.5-fold higher with bivalirudin compared with heparin with or without GPI, whereas the rate of subacute ST (24 h to 30 days) did not differ significantly.
Conclusions Overall, bivalirudin in ACS patients is associated with a significant reduction of major bleeding compared with heparin plus routinely administered GPI, but with a marked increase in ST rates compared with heparin with or without GPI.
Dr. Valgimigli has received honoraria for lectures and for serving on the Advisory Boards of Merck, Iroko, Eli Lilly, Medtronic, The Medicines Company, Eli Lilly, and Daiichi Sankyo; and has received research grants from Merck, Iroko, Eli Lilly, and Medtronic. Dr. Andreotti has received honoraria for lectures and for serving on the advisory boards of Amgen, Bayer, Boehringer Ingelheim, BMS-Pfizer, Daiichi Sankyo, and Eli Lilly. Dr. Kandzari has received research/grant support and consulting honoraria from Medtronic and Boston Scientific; and has received research/grant support from Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received September 28, 2014.
- Accepted October 8, 2014.
- 2015 American College of Cardiology Foundation