Author + information
- Received August 23, 2016
- Revision received September 8, 2016
- Accepted September 8, 2016
- Published online December 12, 2016.
- Eric A. Secemsky, MD, MSca,b,c,
- Ajay Kirtane, MD, SMd,
- Sripal Bangalore, MD, MHAe,
- Ion S. Jovin, MDf,
- Rachit M. Shah, MBBSf,
- Enrico G. Ferro, BSb,
- Neil J. Wimmer, MD, MScg,
- Matthew Roe, MD, MHSh,
- Dadi Dai, PhDh,
- Laura Mauri, MD, MScb,i and
- Robert W. Yeh, MD, MScb,c,∗ ()
- aDivision of Cardiology, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts
- bHarvard Medical School, Boston, Massachusetts
- cSmith Center for Outcomes Research in Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts
- dDivision of Cardiology, Department of Medicine, and Center for Interventional Vascular Therapy, Columbia University, New York, New York
- eDivision of Cardiology, Department of Medicine, New York University School of Medicine, New York, New York
- fDivision of Cardiology, Department of Medicine, Virginia Commonwealth University, Richmond, Virginia
- gDivision of Cardiology, Department of Medicine, Christiana Care Health System, Newark, Delaware
- hDuke Clinical Research Institute, Duke University, Durham, North Carolina
- iDivision of Cardiovascular Medicine, Department of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts
- ↵∗Reprint requests and correspondence:
Dr. Robert W. Yeh, Smith Center for Outcomes Research in Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, 375 Longwood Ave, MASCO 4, Boston, Massachusetts 02215.
Objectives The purpose of this study was to describe temporal trends and determine the comparative effectiveness of bivalirudin versus unfractionated heparin (UFH) during percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI).
Background Several clinical trials have compared the safety and effectiveness of bivalirudin versus UFH during PCI for STEMI, but results have been conflicting.
Methods Trends in anticoagulant use were examined among 513,775 PCIs for STEMI from July 2009 through December 2014 within the National Cardiovascular Data Registry CathPCI Registry. We conducted an instrumental variable analysis comparing bivalirudin with UFH, using operator preference for bivalirudin as the instrument. We used a test of mediation to determine the extent to which differences in outcomes between anticoagulants were due to differences in use of glycoprotein IIb/IIIa inhibitors (GPI). Primary outcomes were in-hospital bleeding and mortality.
Results Bivalirudin use increased from 2009 through 2013, followed by a new decline. GPIs were used in 74.7% of UFH PCIs versus 26.5% of bivalirudin PCIs. In unadjusted analyses, bivalirudin was associated with decreased bleeding (risk difference [RD]: -4.2%; p < 0.001) and mortality (RD: -0.84%; p < 0.001). After instrumental variable analyses, bivalirudin remained associated with less bleeding (RD: -3.75%; p < 0.001), but not mortality (RD: -0.10%; p = 0.280). The higher rate of GPI use with UFH was responsible for more than one-half of bivalrudin’s bleeding reduction (GPI-adjusted RD: -1.57%; p < 0.001). Bleeding reductions were negligible for transradial PCI (RD: -0.11%; p = 0.842).
Conclusions The use of bivalirudin during STEMI has decreased. Bivalirudin was associated with reduced bleeding and no mortality difference. The bleeding reduction with bivalirudin was largely explained by the greater use of GPIs with UFH.
- percutaneous coronary intervention
- ST-segment elevation myocardial infarction
This research was supported by the American College of Cardiology Foundation's National Cardiovascular Data Registry. Dr. Kirtane receives grants to institution from Boston Scientific, Abbott Vascular, Medtronic, Abiomed, St. Jude Medical, Eli Lilly, and GlaxoSmithKline. Dr. Bangalore is on the advisory board of The Medicines Company. Dr. Roe has received research funding from Eli Lilly, Sanofi, Daiichi-Sankyo, Janssen Pharmaceuticals, Ferring Pharmaceuticals, AstraZeneca, American College of Cardiology, American Heart Association, and the Familial Hypercholesterolemia Foundation; and he provides consulting or has received honoraria from PriMed, AstraZeneca, Boehringer Ingelheim, Merck, Amgen, Myokardia, Eli Lilly, Daiichi-Sanyko, and Elsevier Publishers. Dr. Mauri has received grants to institution from Abbott, Boston Scientific, Medtronic Vascular, Eli Lilly, Daiichi-Sankyo, Biotronik, Boehringher-Ingelheim, Sanofi, and Bristol-Myers Squibb; and provides consulting to Medtronic Vascular, AstraZeneca, St. Jude Medical, Biotronik, Boehringher-Ingelheim, and Eli Lilly. Dr. Yeh has received research funding from Abiomed and Boston Scientific; and is a consultant and serves on advisory boards for Abbott Vascular and Boston Scientific. All other authors reported that they have no relationships relevant to the contents of this article to disclose.
- Received August 23, 2016.
- Revision received September 8, 2016.
- Accepted September 8, 2016.
- 2016 American College of Cardiology Foundation