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. 2023 Jul 31;24(8):218.
doi: 10.31083/j.rcm2408218. eCollection 2023 Aug.

One-Year Safety and Effectiveness of Bivalirudin versus Heparin in Patients Undergoing Elective Percutaneous Coronary Intervention

Jiawen Li  1 , Yulong Li  1 , Shuhong Su  2 , Zhifang Wang  2 , Haiwei Liu  3 , Weixian Yang  1 , Shubin Qiao  1 , Yuejin Yang  1 , Bo Xu  1 , Runlin Gao  1 , Jinqing Yuan  1 , Xueyan Zhao  1
Affiliations

One-Year Safety and Effectiveness of Bivalirudin versus Heparin in Patients Undergoing Elective Percutaneous Coronary Intervention

Jiawen Li et al. Rev Cardiovasc Med. .

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.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Fig. 1.
Fig. 1.
Flow chart. BARC, Bleeding Academic Research Consortium; UFH, unfractionated heparin; GPI, glycoprotein IIb/IIIa inhibitors; MACCE, major adverse cardiac and cerebrovascular events; NACE, net adverse clinical events.
Fig. 2.
Fig. 2.
Subgroup analyses of bleeding. UFH, unfractionated heparin; GPI, glycoprotein IIb/IIIa inhibitors; CI, confidence interval.
See this image and copyright information in PMC

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