PMID- 37776692 OWN - NLM STAT- MEDLINE DCOM- 20231128 LR - 20231128 IS - 1878-0334 (Electronic) IS - 1871-4021 (Linking) VI - 17 IP - 10 DP - 2023 Oct TI - One-year clinical outcomes of bivalirudin versus unfractionated heparin in patients with type 2 diabetes undergoing elective percutaneous coronary intervention. PG - 102858 LID - S1871-4021(23)00154-6 [pii] LID - 10.1016/j.dsx.2023.102858 [doi] AB - BACKGROUND: Patients with diabetes and coronary artery disease have a higher risk of bleeding and thrombotic events. However, data on the safety and efficacy of bivalirudin in these patients undergoing elective percutaneous coronary intervention (PCI) are lacking. METHODS: 1152 patients undergoing elective PCI anticoagulated with bivalirudin and 10,250 patients anticoagulated with unfractionated heparin (UFH) (with or without glycoprotein IIb/IIIa inhibitors [GPI]) were performed propensity-score matching method. The thrombotic endpoint was major adverse cardiovascular and cerebrovascular events (MACCE). The bleeding endpoint was according to the Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding. RESULTS: Finally, 376 (bivalirudin group) and 878 (UFH group) patients with type 2 diabetes (T2D) were enrolled. After one-year follow-up, there were 130 (10.4%) MACCE and 27 (2.2%) bleeding events occurred. Multivariate COX regression analysis showed no significant difference for MACCE between bivalirudin group and UFH group (P > 0.05). Further analysis showed that there was a reduction in the risk of myocardial infarction (MI) between two groups (Hazard ratio [HR] = 0.199, 95% confidence interval [CI]: 0.047-0.845, P = 0.029), but not in the risk of death, revascularization, stent thrombosis or stroke (all P > 0.05). As for BARC 2, 3 or 5 bleeding, no significant difference was found between two groups (P > 0.05). CONCLUSIONS: Although diabetes is considered a high-risk factor for poor prognosis, compared with UFH (with or without GPI), bivalirudin did not increase the risk of MACCE and even decreased the risk of MI in patients with T2D undergoing elective PCI, while the risk of bleeding was similar between two groups. CI - Copyright (c) 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved. FAU - Li, Yulong AU - Li Y AD - National Clinical Research Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 167 Beilishi Road, Xicheng District, Beijing, 100037, China. FAU - Li, Jiawen AU - Li J AD - National Clinical Research Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 167 Beilishi Road, Xicheng District, Beijing, 100037, China. FAU - Guan, Changdong AU - Guan C AD - National Clinical Research Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 167 Beilishi Road, Xicheng District, Beijing, 100037, China. FAU - Su, Shuhong AU - Su S AD - Department of Cardiology, Xinxiang Central Hospital, Xinxiang, 453000, Henan Province, China. FAU - Wang, Zhifang AU - Wang Z AD - Department of Cardiology, Xinxiang Central Hospital, Xinxiang, 453000, Henan Province, China. FAU - Liu, Haiwei AU - Liu H AD - Department of Cardiology, Northern Theatre General Hospital, Shenyang, 110016, Liaoning Province, China. FAU - Yang, Yuejin AU - Yang Y AD - National Clinical Research Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 167 Beilishi Road, Xicheng District, Beijing, 100037, China. FAU - Gao, Runlin AU - Gao R AD - National Clinical Research Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 167 Beilishi Road, Xicheng District, Beijing, 100037, China. FAU - Yuan, Jinqing AU - Yuan J AD - National Clinical Research Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 167 Beilishi Road, Xicheng District, Beijing, 100037, China. Electronic address: jqyuanfw@163.com. FAU - Zhao, Xueyan AU - Zhao X AD - National Clinical Research Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 167 Beilishi Road, Xicheng District, Beijing, 100037, China. Electronic address: zhao_xueyan@sina.com. LA - eng PT - Journal Article DEP - 20230920 PL - Netherlands TA - Diabetes Metab Syndr JT - Diabetes & metabolic syndrome JID - 101462250 RN - 9005-49-6 (Heparin) RN - TN9BEX005G (bivalirudin) RN - 0 (Anticoagulants) RN - 0 (Hirudins) RN - 0 (Peptide Fragments) RN - 0 (Recombinant Proteins) SB - IM MH - Humans MH - Heparin/adverse effects MH - *Percutaneous Coronary Intervention MH - Anticoagulants/adverse effects MH - *Diabetes Mellitus, Type 2/complications/drug therapy/chemically induced MH - Treatment Outcome MH - Hirudins/adverse effects MH - Peptide Fragments/therapeutic use MH - Hemorrhage/chemically induced MH - *Myocardial Infarction MH - Recombinant Proteins/adverse effects OTO - NOTNLM OT - Bivalirudin OT - Bleeding OT - Diabetes OT - Elective percutaneous coronary intervention OT - Major adverse cardiovascular and cerebrovascular events COIS- Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Xueyan Zhao reports article publishing charges was provided by Chinese Academy of Medical Sciences & Peking Union Medical College Fuwai Hospital. EDAT- 2023/10/01 04:44 MHDA- 2023/11/28 06:42 CRDT- 2023/09/30 18:07 PHST- 2023/07/03 00:00 [received] PHST- 2023/09/11 00:00 [revised] PHST- 2023/09/13 00:00 [accepted] PHST- 2023/11/28 06:42 [medline] PHST- 2023/10/01 04:44 [pubmed] PHST- 2023/09/30 18:07 [entrez] AID - S1871-4021(23)00154-6 [pii] AID - 10.1016/j.dsx.2023.102858 [doi] PST - ppublish SO - Diabetes Metab Syndr. 2023 Oct;17(10):102858. doi: 10.1016/j.dsx.2023.102858. Epub 2023 Sep 20.