PMID- 28303632 OWN - NLM STAT- MEDLINE DCOM- 20180626 LR - 20191114 IS - 1522-726X (Electronic) IS - 1522-1946 (Print) IS - 1522-1946 (Linking) VI - 90 IP - 5 DP - 2017 Nov 1 TI - The comparative safety and effectiveness of bivalirudin versus heparin monotherapy in patients on dialysis undergoing percutaneous coronary intervention: Insights from the Blue Cross Blue Shield of Michigan cardiovascular consortium. PG - 724-732 LID - 10.1002/ccd.27001 [doi] AB - BACKGROUND: Dialysis patients are at a higher risk of bleeding after percutaneous coronary intervention (PCI); however, due to their exclusion from randomized clinical trials, the optimal antithrombotic regimen for this population remains unknown. We sought to evaluate the comparative safety and effectiveness of bivalirudin monotherapy versus unfractionated heparin (UFH) monotherapy in dialysis patients undergoing PCI. METHODS: We included dialysis patients who underwent PCI in a multicenter registry between January 2010 and September 2015 at 47 Michigan hospitals. We compared in-hospital outcomes between bivalirudin versus UFH; excluding those treated with glycoprotein IIb/IIIa inhibitors. Optimal full matching was used to account for the nonrandom use of these drugs. RESULTS: Of 177,963 patients who underwent PCI, 4,303 (2.4%) were on dialysis. Among those, 1,257 (29.2%) received bivalirudin monotherapy and 2,112 (49.1%) received UFH monotherapy. Patients treated with bivalirudin had fewer comorbidities. After matching, there were no significant differences in outcomes between those who received bivalirudin versus UFH: bleeding (adjusted odds ratio: 0.67; 95% confidence interval: 0.41-1.07; P = 0.093); major bleeding (0.81; 0.19-3.50; P = 0.77); transfusion (1.01; 0.77-1.33; P = 0.96); repeat PCI (0.57; 0.14-2.24; P = 0.42); stent thrombosis (0.56; 0.05-5.83; P = 0.63); and death (0.84; 0.46-1.51; P = 0.55). CONCLUSIONS: We found no significant differences in in-hospital outcomes between bivalirudin and UFH monotherapy among dialysis patients undergoing PCI. Randomized clinical trials are needed to determine the optimal anticoagulant regimen for this population. (c) 2017 Wiley Periodicals, Inc. CI - (c) 2017 Wiley Periodicals, Inc. FAU - Sukul, Devraj AU - Sukul D AD - Department of Internal Medicine, Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan. FAU - Seth, Milan AU - Seth M AD - Department of Internal Medicine, Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan. FAU - Schreiber, Theodore AU - Schreiber T AD - Detroit Medical Center-Cardiovascular Institute, Detroit, Michigan. FAU - Khandelwal, Akshay AU - Khandelwal A AD - Division of Cardiology, Henry Ford Health System, Detroit, Michigan. FAU - Cannon, Louis A AU - Cannon LA AD - McLaren-Northern Michigan Regional Hospital, Petoskey, Michigan. FAU - LaLonde, Thomas A AU - LaLonde TA AD - Department of Cardiovascular Medicine, St. John Hospital and Medical Center, Detroit, Michigan. FAU - Gurm, Hitinder S AU - Gurm HS AUID- ORCID: 0000-0002-1646-0218 AD - Department of Internal Medicine, Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan. AD - Cardiovascular Medicine, VA Ann Arbor Healthcare System, Ann Arbor, Michigan. LA - eng GR - T32 HL007853/HL/NHLBI NIH HHS/United States PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Observational Study DEP - 20170317 PL - United States TA - Catheter Cardiovasc Interv JT - Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions JID - 100884139 RN - 0 (Anticoagulants) RN - 0 (Antithrombins) RN - 0 (Hirudins) RN - 0 (Peptide Fragments) RN - 0 (Recombinant Proteins) RN - 9005-49-6 (Heparin) RN - TN9BEX005G (bivalirudin) SB - IM CIN - Catheter Cardiovasc Interv. 2017 Nov 1;90(5):733-734. PMID: 29105331 MH - Aged MH - Anticoagulants/adverse effects/*therapeutic use MH - Antithrombins/adverse effects/*therapeutic use MH - *Blue Cross Blue Shield Insurance Plans MH - Comparative Effectiveness Research MH - Coronary Artery Disease/complications/diagnostic imaging/*therapy MH - Female MH - Hemorrhage/chemically induced MH - Heparin/adverse effects/*therapeutic use MH - Hirudins/adverse effects MH - Humans MH - Logistic Models MH - Male MH - Michigan MH - Middle Aged MH - Odds Ratio MH - Peptide Fragments/adverse effects/*therapeutic use MH - *Percutaneous Coronary Intervention/adverse effects/instrumentation MH - Propensity Score MH - Recombinant Proteins/adverse effects/therapeutic use MH - Registries MH - *Renal Dialysis/adverse effects MH - Renal Insufficiency, Chronic/complications/diagnosis/physiopathology/*therapy MH - Retrospective Studies MH - Risk Factors MH - Stents MH - Thrombosis/diagnosis/etiology/*prevention & control MH - Time Factors MH - Treatment Outcome PMC - PMC6850212 MID - NIHMS1053101 OTO - NOTNLM OT - anticoagulant OT - chronic kidney disease OT - dialysis OT - outcomes OT - percutaneous coronary intervention COIS- Disclosures: Hitinder S. Gurm receives research funding from Blue Cross Blue Shield of Michigan, the National Institutes of Health and is a consultant for Osprey Medical. None of the authors have any conflicts directly relevant to this study. EDAT- 2017/03/18 06:00 MHDA- 2018/06/27 06:00 PMCR- 2019/11/12 CRDT- 2017/03/18 06:00 PHST- 2017/01/27 00:00 [received] PHST- 2017/02/04 00:00 [accepted] PHST- 2017/03/18 06:00 [pubmed] PHST- 2018/06/27 06:00 [medline] PHST- 2017/03/18 06:00 [entrez] PHST- 2019/11/12 00:00 [pmc-release] AID - 10.1002/ccd.27001 [doi] PST - ppublish SO - Catheter Cardiovasc Interv. 2017 Nov 1;90(5):724-732. doi: 10.1002/ccd.27001. Epub 2017 Mar 17.