IMR Press / RCM / Volume 24 / Issue 8 / DOI: 10.31083/j.rcm2408218
Open Access Original Research
One-Year Safety and Effectiveness of Bivalirudin versus Heparin in Patients Undergoing Elective Percutaneous Coronary Intervention
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1 Department of Cardiology, 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, 100037 Beijing, China
2 Department of Cardiology, Xinxiang Central Hospital, 453000 Xinxiang, Henan, China
3 Department of Cardiology, Northern Theatre General Hospital, 110016 Shenyang, Liaoning, China
*Correspondence: zhao_xueyan@sina.com (Xueyan Zhao); jqyuanfw@163.com (Jinqing Yuan)
Rev. Cardiovasc. Med. 2023, 24(8), 218; https://doi.org/10.31083/j.rcm2408218
Submitted: 3 December 2022 | Revised: 21 February 2023 | Accepted: 28 February 2023 | Published: 31 July 2023
(This article belongs to the Section Cardiovascular Drugs)
Copyright: © 2023 The Author(s). Published by IMR Press.
This is an open access article under the CC BY 4.0 license.
Abstract

Background: Bivalirudin reduces ischemic and hemorrhagic events in patients undergoing primary percutaneous coronary intervention (PCI), but the safety and efficacy for such individuals are unclear. Our aim was to evaluate the long-term safety and efficacy of bivalirudin in patients undergoing elective PCI. Methods: We examined 957 patients with bivalirudin anticoagulation and 1713 patients with unfractionated heparin (UFH) anticoagulation with and without glycoprotein IIb/IIIa inhibitors (GPI). The primary endpoint was net adverse clinical events (NACE), a composite of death, myocardial infarction, revascularization, stent thrombosis, stroke, and bleeding. The secondary endpoints were bleeding and major adverse cardiovascular and cerebrovascular events (MACCE). Results: In one year of follow-up, 307 (11.5%) NACEs, 72 (2.7%) bleedings, and 249 (9.3%) MACCEs occurred. Statistically, patients with bivalirudin anticoagulation had less NACE [hazard ratio (HR): 0.75, 95% confidence interval (CI): 0.58–0.96, p = 0.021] and bleeding (HR: 0.58, 95% CI: 0.34–0.99, p = 0.045) but not less MACCE, than did those with UFH anticoagulation. Furthermore, the risk of bleeding in the bivalirudin group was lower than in the UFH with GPI group (p = 0.001) but not lower than in the group of UFH without GPI (p = 0.197). Conclusions: In patients who undergo elective PCI, the use of bivalirudin significantly decreased the risk of NACE and bleeding without increasing the risk of MACCE; the reduction of bleeding risk with bivalirudin was mainly attributed to the presence of GPIs in the UFH group.

Keywords
bivalirudin
elective percutaneous coronary intervention
glycoprotein IIb/IIIa inhibitors
unfractionated heparin
Funding
2020-I2M-C&T-B-052/CAMS Innovation Fund for Medical Sciences
NCRC2020013/National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences
2020CB012/Young and middle-aged talents in the XPCC Science and Technology Project
BJUHFCSOARF201801-06/CS Optimizing Antithrombotic Research Fund
Figures
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