Efficacy and safety of bivalirudin during percutaneous coronary intervention in high‐bleeding‐risk elderly patients with chronic total occlusion: A prospective randomized controlled trial
| العنوان: | Efficacy and safety of bivalirudin during percutaneous coronary intervention in high‐bleeding‐risk elderly patients with chronic total occlusion: A prospective randomized controlled trial |
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| المؤلفون: | Chun-yu Fan, Hong-wei Zhao, Xiao-jiao Zhang, Cheng-fu Wang, Yong Wang, De-feng Luo, Guo-ning Yu, Yu Zhu, Bo Luan, Ai-jie Hou |
| المصدر: | Catheterization and Cardiovascular Interventions. 93:825-831 |
| بيانات النشر: | Wiley, 2019. |
| سنة النشر: | 2019 |
| مصطلحات موضوعية: | Male, China, medicine.medical_specialty, Time Factors, medicine.medical_treatment, Myocardial Infarction, Hemorrhage, 030204 cardiovascular system & hematology, Risk Assessment, Total occlusion, Antithrombins, law.invention, 03 medical and health sciences, Percutaneous Coronary Intervention, 0302 clinical medicine, Randomized controlled trial, Risk Factors, law, medicine, Humans, Bivalirudin, Radiology, Nuclear Medicine and imaging, Prospective Studies, 030212 general & internal medicine, Aged, Heparin, business.industry, Coronary Thrombosis, Incidence (epidemiology), Age Factors, Anticoagulants, Percutaneous coronary intervention, General Medicine, Hirudins, Middle Aged, Peptide Fragments, Progression-Free Survival, Recombinant Proteins, Surgery, Coronary Occlusion, Chronic Disease, Conventional PCI, Female, Cardiology and Cardiovascular Medicine, business, Mace, medicine.drug |
| الوصف: | 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. |
| تدمد: | 1522-726X 1522-1946 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::511c5a32d6d6f8d5f401a8885cacdc86 https://doi.org/10.1002/ccd.28087 |
| حقوق: | CLOSED |
| رقم الأكسشن: | edsair.doi.dedup.....511c5a32d6d6f8d5f401a8885cacdc86 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 1522726X 15221946 |
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