Key result
Bivalirudin linked to ~41% lower 30-day NACE risk versus heparin in PCI.
Why the study?
Bivalirudin is considered safer than other anticoagulants such as heparin, but relevant safety data in Chinese patients undergoing PCI were unclear.
Does bivalirudin reduce net adverse clinical events compared with heparin in Chinese patients undergoing percutaneous coronary intervention?
Cohort (n=2,377)
No
Does bivalirudin reduce net adverse clinical events compared with heparin in Chinese patients undergoing percutaneous coronary intervention?
In Chinese patients undergoing PCI, bivalirudin was associated with a lower 30-day risk of net adverse clinical events and bleeding compared to heparin, without a significant difference in major adverse cardiac and cerebral events.
Bivalirudin was associated with fewer net adverse events in Chinese PCI patients; hypothesis-generating and should not change practice without randomized confirmation.
Bivalirudin, as a direct thrombin inhibitor, is considered to be safer compared with other anticoagulants, such as heparin; however, relevant data in China are unclear. The present study aimed to compare the safety of bivalirudin and heparin as anticoagulants in Chinese patients who underwent percutaneous coronary intervention (PCI). In the present study, 2,377 patients with ST-segment elevation myocardial infarction (STEMI), unstable angina, non-STEMI or stable coronary artery disease who underwent primary PCI while receiving bivalirudin or heparin (low molecular weight heparin or unfractionated heparin) were reviewed, and then analyzed as the bivalirudin group (n=944) and heparin group (n=1,433). The net adverse clinical events (NACEs) within 30 days were obtained, which were defined as major adverse cardiac and cerebral events (MACCEs) + Bleeding Academic Research Consortium (BARC) grade 2-5 bleeding events. Compared with the heparin group, the incidence of NACEs was reduced in the bivalirudin group (9.3 vs. 13.4%; P=0.003). However, no discrepancy was found in the incidence of MACCEs between the groups (5.9 vs. 7.6%; P=0.116). Moreover, the incidences of BARC 2-5 (4.8 vs. 8.7%; P<0.001) and BARC 3-5 bleeding events (1.9 vs. 4.4%; P=0.001) were decreased in the bivalirudin group compared with the heparin group. Following adjustment using multivariate logistic regression analysis, bivalirudin treatment (vs. heparin treatment) was independently associated with lower risks of NACEs [odds ratio (OR), 0.587; P<0.001], MACCEs (OR, 0.689; P=0.041) and BARC 2-5 (OR, 0.459; P<0.001) and 3-5 bleeding events (OR, 0.386; P=0.002). Overall, the present study demonstrated that bivalirudin decreased the risks of NACEs and bleeding events compared with heparin in Chinese patients who undergo PCI. However, further validation is required.
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Chai et al. (2023) conducted a cohort in Coronary artery disease undergoing percutaneous coronary intervention (n=2,377). Bivalirudin vs. Heparin (low molecular weight heparin or unfractionated heparin) was evaluated on Net adverse clinical events (NACEs) within 30 days (OR 0.587, 95% CI 0.437-0.788, p=<0.001). Bivalirudin significantly reduced the incidence of 30-day net adverse clinical events compared to heparin (9.3% vs 13.4%, OR 0.587) in Chinese patients undergoing percutaneous coronary intervention.
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