PMID- 33810894 OWN - NLM STAT- MEDLINE DCOM- 20211124 LR - 20211124 IS - 1879-114X (Electronic) IS - 0149-2918 (Linking) VI - 43 IP - 5 DP - 2021 May TI - Efficacy and Safety of Bivalirudin During Percutaneous Coronary Intervention in Chronic Total Occlusion: A Retrospective Study. PG - 844-851 LID - S0149-2918(21)00112-0 [pii] LID - 10.1016/j.clinthera.2021.03.004 [doi] AB - PURPOSE: Bivalirudin as a thrombin inhibitor is proven to have a low risk of bleeding during percutaneous coronary intervention (PCI). Some evidence indicates comparable effectiveness and safety between bivalirudin and unfractionated heparin (UFH). Although bivalirudin during PCI offers more clinical and safety benefits to patients with chronic total occlusion (CTO), mostly via radial access, this has not been confirmed. The objective of this study was to examine the efficacy and safety of bivalirudin during percutaneous coronary intervention (PCI) in patients with CTO. METHODS: This trial used a retrospective cohort study design. Medical information from 736 patients with CTO who underwent PCI with bivalirudin or UFH at the First Affiliated Hospital of Zhengzhou University from July 2019 to September 2020 was extracted and analyzed. The primary end point was the 30-day incidence of net adverse clinical events (NACEs), and the secondary end point was the major adverse cardiovascular events (MACEs), which were related to safety and efficacy, respectively. Other end points incorporated each component of the primary outcome, target vessel revascularization, and stent thrombosis. Clinical and procedural characteristics at baseline were adjusted by using a logistic regression model. FINDINGS: Overall, 71.5% of patients with CTO used the radial approach. Both groups exhibited nonsignificant differences in the majority of baseline characteristics. The bivalirudin group was associated with a significant reduction in NACEs (12.9% vs 21.5%; P = 0.002) and major bleeding (2.5% vs 8.0%; P = 0.001) versus the UFH group at the end of the 30-day follow-up. The incidence of MACEs, myocardial infarction, death, stroke, stent thrombosis, and target vessel revascularization did not differ significantly between the 2 groups. Moreover, the bivalirudin group also reported a lower incidence of NACEs in the prespecified subgroups. IMPLICATIONS: Bivalirudin exhibited comparative efficacy but superior safety compared with UFH among patients with CTO undergoing PCI. Chinese Clinical Trial Registry: ChiCTR2000034771. CI - Copyright (c) 2021 Elsevier Inc. All rights reserved. FAU - Zhang, Yanghui AU - Zhang Y AD - Department of Cardiology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China. Electronic address: zyanghui0211@163.com. FAU - Zhang, Yahao AU - Zhang Y AD - Department of Cardiology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China. Electronic address: zhyh626@163.com. FAU - Chang, Chao AU - Chang C AD - Department of Cardiology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China. Electronic address: chch125@163.com. FAU - Yan, Shumei AU - Yan S AD - Department of Cardiology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China. Electronic address: 1035228605@qq.com. FAU - Chen, Zheng AU - Chen Z AD - Department of Cardiac Surgery, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China. Electronic address: zdchenzheng@163.com. FAU - Zhang, Lishuai AU - Zhang L AD - Department of Cardiology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China. Electronic address: 18031864231@163.com. FAU - Chen, Kui AU - Chen K AD - Department of Cardiology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China. Electronic address: fccchenk@zzu.edu.cn. FAU - Liu, Guizhi AU - Liu G AD - Department of Cardiology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China. Electronic address: 15838023091@163.com. LA - eng PT - Journal Article DEP - 20210331 PL - United States TA - Clin Ther JT - Clinical therapeutics JID - 7706726 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 MH - Anticoagulants MH - Antithrombins/adverse effects MH - Heparin MH - Hirudins/adverse effects MH - Humans MH - Peptide Fragments/adverse effects MH - *Percutaneous Coronary Intervention/adverse effects MH - Recombinant Proteins MH - Retrospective Studies MH - Treatment Outcome OTO - NOTNLM OT - Bivalirudin OT - chronic total occlusion OT - percutaneous coronary intervention OT - unfractionated heparin COIS- Disclosures The authors have indicated that they have no conflicts of interest regarding the content of this article. EDAT- 2021/04/04 06:00 MHDA- 2021/11/25 06:00 CRDT- 2021/04/03 05:28 PHST- 2021/01/03 00:00 [received] PHST- 2021/03/04 00:00 [revised] PHST- 2021/03/09 00:00 [accepted] PHST- 2021/04/04 06:00 [pubmed] PHST- 2021/11/25 06:00 [medline] PHST- 2021/04/03 05:28 [entrez] AID - S0149-2918(21)00112-0 [pii] AID - 10.1016/j.clinthera.2021.03.004 [doi] PST - ppublish SO - Clin Ther. 2021 May;43(5):844-851. doi: 10.1016/j.clinthera.2021.03.004. Epub 2021 Mar 31.