PMID- 27838271 OWN - NLM STAT- MEDLINE DCOM- 20171025 LR - 20181014 IS - 1876-7605 (Electronic) IS - 1936-8798 (Linking) VI - 9 IP - 23 DP - 2016 Dec 12 TI - Use and Effectiveness of Bivalirudin Versus Unfractionated Heparin for Percutaneous Coronary Intervention Among Patients With ST-Segment Elevation Myocardial Infarction in the United States. PG - 2376-2386 LID - S1936-8798(16)31546-1 [pii] LID - 10.1016/j.jcin.2016.09.020 [doi] AB - 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. CI - Copyright A(c) 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. FAU - Secemsky, Eric A AU - Secemsky EA AD - Division of Cardiology, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts; Smith Center for Outcomes Research in Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts. FAU - Kirtane, Ajay AU - Kirtane A AD - Division of Cardiology, Department of Medicine, and Center for Interventional Vascular Therapy, Columbia University, New York, New York. FAU - Bangalore, Sripal AU - Bangalore S AD - Division of Cardiology, Department of Medicine, New York University School of Medicine, New York, New York. FAU - Jovin, Ion S AU - Jovin IS AD - Division of Cardiology, Department of Medicine, Virginia Commonwealth University, Richmond, Virginia. FAU - Shah, Rachit M AU - Shah RM AD - Division of Cardiology, Department of Medicine, Virginia Commonwealth University, Richmond, Virginia. FAU - Ferro, Enrico G AU - Ferro EG AD - Harvard Medical School, Boston, Massachusetts. FAU - Wimmer, Neil J AU - Wimmer NJ AD - Division of Cardiology, Department of Medicine, Christiana Care Health System, Newark, Delaware. FAU - Roe, Matthew AU - Roe M AD - Duke Clinical Research Institute, Duke University, Durham, North Carolina. FAU - Dai, Dadi AU - Dai D AD - Duke Clinical Research Institute, Duke University, Durham, North Carolina. FAU - Mauri, Laura AU - Mauri L AD - Harvard Medical School, Boston, Massachusetts; Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts. FAU - Yeh, Robert W AU - Yeh RW AD - Harvard Medical School, Boston, Massachusetts; Smith Center for Outcomes Research in Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts. Electronic address: ryeh@bidmc.harvard.edu. LA - eng PT - Comparative Study PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20161109 PL - United States TA - JACC Cardiovasc Interv JT - JACC. Cardiovascular interventions JID - 101467004 RN - 0 (Anticoagulants) RN - 0 (Antithrombins) RN - 0 (Hirudins) RN - 0 (Peptide Fragments) RN - 0 (Platelet Aggregation Inhibitors) RN - 0 (Recombinant Proteins) RN - 9005-49-6 (Heparin) RN - TN9BEX005G (bivalirudin) SB - IM CIN - JACC Cardiovasc Interv. 2016 Dec 12;9(23):2387-2389. PMID: 27838264 MH - Aged MH - Anticoagulants/adverse effects/*therapeutic use MH - Antithrombins/adverse effects/*therapeutic use MH - Comparative Effectiveness Research MH - Coronary Thrombosis/etiology/prevention & control MH - Drug Utilization Review MH - Female MH - Hemorrhage/chemically induced MH - Heparin/adverse effects/*therapeutic use MH - Hirudins/adverse effects MH - Hospital Mortality MH - Humans MH - Male MH - Middle Aged MH - Peptide Fragments/adverse effects/*therapeutic use MH - *Percutaneous Coronary Intervention/adverse effects/mortality MH - Platelet Aggregation Inhibitors/therapeutic use MH - Practice Patterns, Physicians'/*trends MH - Recombinant Proteins/adverse effects/therapeutic use MH - Registries MH - Risk Factors MH - ST Elevation Myocardial Infarction/diagnostic imaging/mortality/*therapy MH - Time Factors MH - Treatment Outcome MH - United States OTO - NOTNLM OT - ST-segment elevation myocardial infarction OT - bivalirudin OT - bleeding OT - mortality OT - percutaneous coronary intervention EDAT- 2016/11/14 06:00 MHDA- 2017/10/27 06:00 CRDT- 2016/11/14 06:00 PHST- 2016/08/23 00:00 [received] PHST- 2016/09/08 00:00 [revised] PHST- 2016/09/08 00:00 [accepted] PHST- 2016/11/14 06:00 [pubmed] PHST- 2017/10/27 06:00 [medline] PHST- 2016/11/14 06:00 [entrez] AID - S1936-8798(16)31546-1 [pii] AID - 10.1016/j.jcin.2016.09.020 [doi] PST - ppublish SO - JACC Cardiovasc Interv. 2016 Dec 12;9(23):2376-2386. doi: 10.1016/j.jcin.2016.09.020. Epub 2016 Nov 9.