PMID- 30724035 OWN - NLM STAT- MEDLINE DCOM- 20200511 LR - 20200511 IS - 1522-726X (Electronic) IS - 1522-1946 (Linking) VI - 93 IP - S1 DP - 2019 Feb 15 TI - Efficacy and safety of bivalirudin during percutaneous coronary intervention in high-bleeding-risk elderly patients with chronic total occlusion: A prospective randomized controlled trial. PG - 825-831 LID - 10.1002/ccd.28087 [doi] AB - OBJECTIVES: To assess the efficacy and safety of bivalirudin during percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) in high-bleeding-risk elderly patients. BACKGROUND: Bivalirudin reduces PCI-related bleeding; however, its efficacy and safety in patients with CTO, especially elderly patients with a high bleeding risk, remain unclear. METHODS: This single-center prospective randomized controlled trial assigned 123 high-bleeding-risk elderly patients with CTO to either the unfractionated heparin (UFH) group (n = 55) or the bivalirudin group (n = 68). The primary efficacy endpoint was the incidence of major adverse cardiac events (MACEs) during hospitalization and at the 6-month follow-up. The safety endpoint was bleeding or procedure (access)-related complications after PCI. RESULTS: MACE incidence was 17.6% and 20.0% in the bivalirudin and UFH groups, respectively (P = 0.82). Bleeding Academic Research Consortium (BARC) type 1-2 bleeding events during hospitalization were comparable between the groups (UFH: 10.9% vs. bivalirudin: 8.8%, P = 0.77). No BARC type 3-5 bleeding events or severe procedure (access)-related complications (subcutaneous hematoma >5 cm) occurred in either group. At the 6-month follow-up, MACE incidence was comparable between the groups (UFH: 3.6% vs. bivalirudin: 1.5%, P = 0.59). The Kaplan-Meier analysis revealed that MACE-free survival rates were comparable between the groups (P = 0.43). One case of BARC type 3-5 bleeding (fatal intracranial hemorrhage) was observed in the UFH group at the 6-month follow-up. CONCLUSIONS: Bivalirudin and UFH showed comparable efficacy and safety in elderly patients with a high bleeding risk, undergoing PCI for CTO lesions. CI - (c) 2019 Wiley Periodicals, Inc. FAU - Wang, Yong AU - Wang Y AUID- ORCID: 0000-0002-7405-2888 AD - Department of Cardiology, The People's Hospital of China Medical University, The People's Hospital of Liaoning Province, Shenyang, Liaoning, People's Republic of China. FAU - Zhao, Hong-Wei AU - Zhao HW AD - Department of Cardiology, The People's Hospital of China Medical University, The People's Hospital of Liaoning Province, Shenyang, Liaoning, People's Republic of China. FAU - Wang, Cheng-Fu AU - Wang CF AD - Department of Cardiology, The People's Hospital of China Medical University, The People's Hospital of Liaoning Province, Shenyang, Liaoning, People's Republic of China. FAU - Fan, Chun-Yu AU - Fan CY AD - Department of Cardiology, The People's Hospital of China Medical University, The People's Hospital of Liaoning Province, Shenyang, Liaoning, People's Republic of China. FAU - Zhang, Xiao-Jiao AU - Zhang XJ AD - Department of Cardiology, The People's Hospital of China Medical University, The People's Hospital of Liaoning Province, Shenyang, Liaoning, People's Republic of China. FAU - Zhu, Yu AU - Zhu Y AD - Department of Cardiology, The People's Hospital of China Medical University, The People's Hospital of Liaoning Province, Shenyang, Liaoning, People's Republic of China. FAU - Luo, De-Feng AU - Luo DF AD - Department of Cardiology, The People's Hospital of China Medical University, The People's Hospital of Liaoning Province, Shenyang, Liaoning, People's Republic of China. FAU - Yu, Guo-Ning AU - Yu GN AD - Department of Science and Education, The People's Hospital of China Medical University, The People's Hospital of Liaoning Province, Shenyang, Liaoning, People's Republic of China. FAU - Hou, Ai-Jie AU - Hou AJ AD - Department of Cardiology, The People's Hospital of China Medical University, The People's Hospital of Liaoning Province, Shenyang, Liaoning, People's Republic of China. FAU - Luan, Bo AU - Luan B AD - Department of Cardiology, The People's Hospital of China Medical University, The People's Hospital of Liaoning Province, Shenyang, Liaoning, People's Republic of China. LA - eng PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial DEP - 20190205 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 MH - Age Factors MH - Aged MH - Anticoagulants/*administration & dosage/adverse effects MH - Antithrombins/*administration & dosage/adverse effects MH - China/epidemiology MH - Chronic Disease MH - Coronary Occlusion/diagnostic imaging/mortality/*therapy MH - Coronary Thrombosis/epidemiology MH - Female MH - Hemorrhage/chemically induced/*epidemiology/mortality MH - Heparin/*administration & dosage/adverse effects MH - Hirudins/*administration & dosage/adverse effects MH - Humans MH - Male MH - Middle Aged MH - Myocardial Infarction/epidemiology MH - Peptide Fragments/*administration & dosage/adverse effects MH - Percutaneous Coronary Intervention/*adverse effects/mortality MH - Progression-Free Survival MH - Prospective Studies MH - Recombinant Proteins/administration & dosage/adverse effects MH - Risk Assessment MH - Risk Factors MH - Time Factors OTO - NOTNLM OT - complications OT - randomized controlled trial OT - safety OT - treatment efficacy OT - unfractionated heparin EDAT- 2019/02/07 06:00 MHDA- 2020/05/12 06:00 CRDT- 2019/02/07 06:00 PHST- 2018/12/27 00:00 [received] PHST- 2018/12/29 00:00 [accepted] PHST- 2019/02/07 06:00 [pubmed] PHST- 2020/05/12 06:00 [medline] PHST- 2019/02/07 06:00 [entrez] AID - 10.1002/ccd.28087 [doi] PST - ppublish SO - Catheter Cardiovasc Interv. 2019 Feb 15;93(S1):825-831. doi: 10.1002/ccd.28087. Epub 2019 Feb 5.