Bivalirudin Presents a Favorable Safety Profile Regarding Adverse Drug Reactions, Thrombocytopenia, and Bleeding in Chinese Patients With High Bleeding Risk Undergoing Percutaneous Coronary Intervention: A Prospective, Multi-Center, Intensive Monitoring Study
BackgroundThis study aimed to comprehensively explore the occurrence and risk factors for adverse events (AEs) and adverse drug reactions (ADRs) (especially for thrombocytopenia and bleeding) in Chinese patients with high bleeding risk (older adults, or complicated with diabetes mellitus or renal fu...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2022-06-01
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| Series: | Frontiers in Cardiovascular Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fcvm.2022.821322/full |
| _version_ | 1797840073174024192 |
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| author | Xiaoping Peng Zhenyong Li Dunheng Li Zhongyin Li Zhaohua Lu Caidong Luo Zheng Ji |
| author_facet | Xiaoping Peng Zhenyong Li Dunheng Li Zhongyin Li Zhaohua Lu Caidong Luo Zheng Ji |
| author_sort | Xiaoping Peng |
| collection | DOAJ |
| description | BackgroundThis study aimed to comprehensively explore the occurrence and risk factors for adverse events (AEs) and adverse drug reactions (ADRs) (especially for thrombocytopenia and bleeding) in Chinese patients with high bleeding risk (older adults, or complicated with diabetes mellitus or renal function impairment) undergoing percutaneous coronary intervention (PCI) with bivalirudin as an anticoagulant.MethodsA total of 1,226 patients with high bleeding risk who received PCI with bivalirudin as an anticoagulant from 27 Chinese medical centers were enrolled in this prospective, multi-center, intensive monitoring study. AEs, ADRs, thrombocytopenia, and bleeding were collected from admission to 72 h post-bivalirudin administration; subsequently, patients were followed up on the 30th day with the safety data collected as well.ResultsAdverse events were observed in 198 (16.2) patients, among which severe AEs occurred in 16 (1.3%) patients. Meanwhile, bivalirudin-related ADRs were reported in 66 (5.4%) patients, among which 5 (0.4%) patients experienced bivalirudin-related severe ADRs. Besides, thrombocytopenia and bleeding occurred in 45 (3.7%) and 19 (1.5%) patients, respectively. The subsequent multivariate logistic analysis revealed that age >75 years [p = 0.017, odds ratio (OR) = 1.856] and spontaneous coronary artery dissection (SCAD) (p = 0.030, OR = 2.022) were independently related to higher ADR risk; SCAD (p = 0.017, OR = 2.426) was independently correlated with higher thrombocytopenia risk, while radial artery access (p = 0.015, OR = 0.352) was independently correlated with lower thrombocytopenia risk; and the administration of bivalirudin preoperatively or intraoperatively (p = 0.013, OR = 5.097) was independently associated with higher bleeding risk.ConclusionBivalirudin presents a favorable safety profile regarding ADRs, thrombocytopenia, and bleeding in Chinese patients with high bleeding risk undergoing PCI. |
| first_indexed | 2024-04-09T16:08:34Z |
| format | Article |
| id | doaj.art-5626749da52f437ebb33f2a2a2103db2 |
| institution | Directory Open Access Journal |
| issn | 2297-055X |
| language | English |
| last_indexed | 2024-04-09T16:08:34Z |
| publishDate | 2022-06-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Cardiovascular Medicine |
| spelling | doaj.art-5626749da52f437ebb33f2a2a2103db22023-04-24T15:06:44ZengFrontiers Media S.A.Frontiers in Cardiovascular Medicine2297-055X2022-06-01910.3389/fcvm.2022.821322821322Bivalirudin Presents a Favorable Safety Profile Regarding Adverse Drug Reactions, Thrombocytopenia, and Bleeding in Chinese Patients With High Bleeding Risk Undergoing Percutaneous Coronary Intervention: A Prospective, Multi-Center, Intensive Monitoring StudyXiaoping Peng0Zhenyong Li1Dunheng Li2Zhongyin Li3Zhaohua Lu4Caidong Luo5Zheng Ji6Department of Cardiovascular, The First Affiliated Hospital of Nanchang University, Nanchang, ChinaDepartment of Cardiology, Xuzhou Central Hospital, Xuzhou, ChinaDepartment of Cardiology, Tai’an First People’s Hospital, Tai’an, ChinaDepartment of Cardiovascular, Puyang Oilfield General Hospital, Puyang, ChinaDepartment of Cardiology, Wuzhou People’s Hospital, Wuzhou, ChinaDepartment of Cardiology, Mianyang Central Hospital, Mianyang, ChinaFirst Department of Cardiology, Tangshan Worker’s Hospital, Tangshan, ChinaBackgroundThis study aimed to comprehensively explore the occurrence and risk factors for adverse events (AEs) and adverse drug reactions (ADRs) (especially for thrombocytopenia and bleeding) in Chinese patients with high bleeding risk (older adults, or complicated with diabetes mellitus or renal function impairment) undergoing percutaneous coronary intervention (PCI) with bivalirudin as an anticoagulant.MethodsA total of 1,226 patients with high bleeding risk who received PCI with bivalirudin as an anticoagulant from 27 Chinese medical centers were enrolled in this prospective, multi-center, intensive monitoring study. AEs, ADRs, thrombocytopenia, and bleeding were collected from admission to 72 h post-bivalirudin administration; subsequently, patients were followed up on the 30th day with the safety data collected as well.ResultsAdverse events were observed in 198 (16.2) patients, among which severe AEs occurred in 16 (1.3%) patients. Meanwhile, bivalirudin-related ADRs were reported in 66 (5.4%) patients, among which 5 (0.4%) patients experienced bivalirudin-related severe ADRs. Besides, thrombocytopenia and bleeding occurred in 45 (3.7%) and 19 (1.5%) patients, respectively. The subsequent multivariate logistic analysis revealed that age >75 years [p = 0.017, odds ratio (OR) = 1.856] and spontaneous coronary artery dissection (SCAD) (p = 0.030, OR = 2.022) were independently related to higher ADR risk; SCAD (p = 0.017, OR = 2.426) was independently correlated with higher thrombocytopenia risk, while radial artery access (p = 0.015, OR = 0.352) was independently correlated with lower thrombocytopenia risk; and the administration of bivalirudin preoperatively or intraoperatively (p = 0.013, OR = 5.097) was independently associated with higher bleeding risk.ConclusionBivalirudin presents a favorable safety profile regarding ADRs, thrombocytopenia, and bleeding in Chinese patients with high bleeding risk undergoing PCI.https://www.frontiersin.org/articles/10.3389/fcvm.2022.821322/fullbivalirudinpercutaneous coronary interventionhigh bleeding risk patientsadverse events and adverse drug reactionsthrombocytopenia and bleeding |
| spellingShingle | Xiaoping Peng Zhenyong Li Dunheng Li Zhongyin Li Zhaohua Lu Caidong Luo Zheng Ji Bivalirudin Presents a Favorable Safety Profile Regarding Adverse Drug Reactions, Thrombocytopenia, and Bleeding in Chinese Patients With High Bleeding Risk Undergoing Percutaneous Coronary Intervention: A Prospective, Multi-Center, Intensive Monitoring Study Frontiers in Cardiovascular Medicine bivalirudin percutaneous coronary intervention high bleeding risk patients adverse events and adverse drug reactions thrombocytopenia and bleeding |
| title | Bivalirudin Presents a Favorable Safety Profile Regarding Adverse Drug Reactions, Thrombocytopenia, and Bleeding in Chinese Patients With High Bleeding Risk Undergoing Percutaneous Coronary Intervention: A Prospective, Multi-Center, Intensive Monitoring Study |
| title_full | Bivalirudin Presents a Favorable Safety Profile Regarding Adverse Drug Reactions, Thrombocytopenia, and Bleeding in Chinese Patients With High Bleeding Risk Undergoing Percutaneous Coronary Intervention: A Prospective, Multi-Center, Intensive Monitoring Study |
| title_fullStr | Bivalirudin Presents a Favorable Safety Profile Regarding Adverse Drug Reactions, Thrombocytopenia, and Bleeding in Chinese Patients With High Bleeding Risk Undergoing Percutaneous Coronary Intervention: A Prospective, Multi-Center, Intensive Monitoring Study |
| title_full_unstemmed | Bivalirudin Presents a Favorable Safety Profile Regarding Adverse Drug Reactions, Thrombocytopenia, and Bleeding in Chinese Patients With High Bleeding Risk Undergoing Percutaneous Coronary Intervention: A Prospective, Multi-Center, Intensive Monitoring Study |
| title_short | Bivalirudin Presents a Favorable Safety Profile Regarding Adverse Drug Reactions, Thrombocytopenia, and Bleeding in Chinese Patients With High Bleeding Risk Undergoing Percutaneous Coronary Intervention: A Prospective, Multi-Center, Intensive Monitoring Study |
| title_sort | bivalirudin presents a favorable safety profile regarding adverse drug reactions thrombocytopenia and bleeding in chinese patients with high bleeding risk undergoing percutaneous coronary intervention a prospective multi center intensive monitoring study |
| topic | bivalirudin percutaneous coronary intervention high bleeding risk patients adverse events and adverse drug reactions thrombocytopenia and bleeding |
| url | https://www.frontiersin.org/articles/10.3389/fcvm.2022.821322/full |
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