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Published on: May 28, 2019
Bivalirudin plus a high-dose infusion versus heparin monotherapy in patients with ST-segment elevation myocardial
Yi Li1, Zhenyang Liang1, Lei Qin2
1General Hospital of Northern Theater Command, Shenyang, China.
Insights
Bivalirudin anticoagulation significantly reduced mortality and major bleeding in ST-segment elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (PCI). This approach proved safer and more effective than heparin monotherapy in the BRIGHT-4 trial.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Pharmacology
Background:
- Conflicting results exist from previous trials comparing bivalirudin and heparin for ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI).
- Different pharmacological regimens used in prior studies may have contributed to these conflicting outcomes.
- This study aimed to compare bivalirudin with a specific post-PCI high-dose infusion regimen against heparin monotherapy, based on prior evidence of optimal safety and efficacy balance.
Purpose of the Study:
- To evaluate the efficacy and safety of bivalirudin with a post-PCI high-dose infusion compared to unfractionated heparin monotherapy in STEMI patients undergoing primary PCI.
- To determine the impact of these anticoagulation strategies on the composite endpoint of all-cause mortality or major bleeding (BARC types 3-5) at 30 days.
Main Methods:
- The BRIGHT-4 trial was an investigator-initiated, open-label, randomized controlled trial involving 6016 STEMI patients undergoing primary PCI.
- Patients received either bivalirudin with a post-PCI high-dose infusion (2-4 hours) or unfractionated heparin monotherapy.
- The primary endpoint was a composite of all-cause mortality or Bleeding Academic Research Consortium (BARC) types 3-5 bleeding at 30 days.
Main Results:
- Bivalirudin significantly reduced the 30-day composite rate of all-cause mortality or BARC types 3-5 bleeding compared to heparin (3.06% vs 4.39%).
- All-cause mortality was lower in the bivalirudin group (2.96% vs 3.92%), and BARC types 3-5 bleeding was significantly reduced (0.17% vs 0.80%).
- Bivalirudin also showed a significant reduction in stent thrombosis compared to heparin (0.37% vs 1.10%).
Conclusions:
- In STEMI patients undergoing primary PCI, predominantly with radial artery access, bivalirudin with a post-PCI high-dose infusion is superior to heparin monotherapy.
- This regimen significantly lowers the 30-day composite rate of mortality or major bleeding.
- Bivalirudin demonstrates a favorable safety and efficacy profile in this patient population.
Background:
Previous randomised trials of bivalirudin versus heparin in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) have reported conflicting results, in part because of treatment with different pharmacological regimens. We designed a large-scale trial examining bivalirudin with a post-PCI high-dose infusion compared with heparin alone, the regimens that previous studies have shown to have the best balance of safety and efficacy.
Methods:
BRIGHT-4 was an investigator-initiated, open-label, randomised controlled trial conducted at 87 clinical centres in 63 cities in China. Patients with STEMI undergoing primary PCI with radial artery access within 48 h of symptom onset who had not received previous fibrinolytic therapy, anticoagulants, or glycoprotein IIb/IIIa inhibitors were randomly assigned (1:1) to receive bivalirudin with a post-PCI high-dose infusion for 2-4 h or unfractionated heparin monotherapy. There was no masking. Glycoprotein IIb/IIIa inhibitor use was reserved for procedural thrombotic complications in both groups. The primary endpoint was a composite of all-cause mortality or Bleeding Academic Research Consortium (BARC) types 3-5 bleeding at 30 days. This trial is registered with ClinicalTrials.gov (NCT03822975), and is ongoing.
Findings:
Between Feb 14, 2019, and April 7, 2022, a total of 6016 patients with STEMI undergoing primary PCI were randomly assigned to receive either bivalirudin plus a high-dose infusion after PCI (n=3009) or unfractionated heparin monotherapy (n=3007). Radial artery access was used in 5593 (93·1%) of 6008 patients. Compared with heparin monotherapy, bivalirudin reduced the 30-day rate of the primary endpoint (132 events [4·39%] in the heparin group vs 92 events [3·06%] in the bivalirudin group; difference, 1·33%, 95% CI 0·38-2·29%; hazard ratio [HR] 0·69, 95% CI 0·53-0·91; p=0·0070). All-cause mortality within 30 days occurred in 118 (3·92%) heparin-assigned patients and in 89 (2·96%) bivalirudin-assigned patients (HR 0·75; 95% CI 0·57-0·99; p=0·0420), and BARC types 3-5 bleeding occurred in 24 (0·80%) heparin-assigned patients and five (0·17%) bivalirudin-assigned patients (HR 0·21; 95% CI 0·08-0·54; p=0·0014). There were no significant differences in the 30-day rates of reinfarction, stroke, or ischaemia-driven target vessel revascularisation between the groups. Within 30 days, stent thrombosis occurred in 11 (0·37%) of bivalirudin-assigned patients and 33 (1·10%) of heparin-assigned patients (p=0·0015).
Interpretation:
In patients with STEMI undergoing primary PCI predominantly with radial artery access, anticoagulation with bivalirudin plus a post-PCI high-dose infusion for 2-4 h significantly reduced the 30-day composite rate of all-cause mortality or BARC types 3-5 major bleeding compared with heparin monotherapy.
Funding:
Chinese Society of Cardiology Foundation (CSCF2019A01), and a research grant from Jiangsu Hengrui Pharmaceuticals.
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