One-Year Safety and Effectiveness of Bivalirudin versus Heparin in Patients Undergoing Elective Percutaneous Coronary Intervention
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Updated: Jun 18, 2025
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Published on: March 15, 2022
Jiawen Li1, Yulong Li1, Shuhong Su2
1Department 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.
Insights
Bivalirudin use in elective percutaneous coronary intervention (PCI) significantly reduced net adverse clinical events (NACE) and bleeding compared to unfractionated heparin (UFH). This improved safety profile was observed without increasing major adverse cardiovascular and cerebrovascular events (MACCE).
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- Bivalirudin's role in primary percutaneous coronary intervention (PCI) is established, but its long-term safety and efficacy in elective PCI require further evaluation.
- Unfractionated heparin (UFH) is a common anticoagulant used during PCI, often in conjunction with glycoprotein IIb/IIIa inhibitors (GPI).
Purpose of the Study:
- To assess the long-term safety and efficacy of bivalirudin compared to UFH in patients undergoing elective PCI.
- To determine the impact of bivalirudin on net adverse clinical events (NACE) and bleeding complications.
Main Methods:
- A comparative study involving 957 patients treated with bivalirudin and 1713 patients treated with UFH (with or without GPI).
- Primary endpoint: NACE (composite of death, myocardial infarction, revascularization, stent thrombosis, stroke, and bleeding).
- Secondary endpoints: bleeding events and major adverse cardiovascular and cerebrovascular events (MACCE).
Main Results:
- One-year follow-up revealed lower rates of NACE (HR: 0.75, p=0.021) and bleeding (HR: 0.58, p=0.045) in the bivalirudin group compared to the UFH group.
- No significant difference in MACCE was observed between the two groups.
- Bleeding risk reduction with bivalirudin was more pronounced when compared to UFH with GPI (p=0.001).
Conclusions:
- Bivalirudin is a safe and effective anticoagulant for elective PCI, demonstrating reduced NACE and bleeding risks.
- The observed benefits of bivalirudin, particularly in bleeding reduction, are significant and support its use in this patient population.
- The comparative advantage of bivalirudin over UFH in reducing bleeding is influenced by the concomitant use of GPIs.
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.
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