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Bivalirudin versus heparin in patients with or without bail-out GPI use: a pre-specified subgroup analysis from the
Jia Liao1,2, Miaohan Qiu1, Xiaojian Feng3
1State Key Laboratory of Frigid Zone Cardiovascular Disease, Department of Cardiology, General Hospital of Northern Theater Command, Cardiovascular Research Institute, Shenyang, 110016, China.
Insights
Bivalirudin significantly reduced death and bleeding in ST-elevation myocardial infarction patients undergoing primary PCI without glycoprotein IIb/IIIa inhibitors. However, benefits were less clear when bail-out GPI was needed.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- Conflicting data exists on bivalirudin versus heparin anticoagulation in ST-elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI).
- Glycoprotein IIb/IIIa inhibitors (GPI) may confound comparative effectiveness studies.
- The BRIGHT-4 trial aimed to clarify these outcomes.
Purpose of the Study:
- To compare the safety and effectiveness of bivalirudin with a post-PCI high-dose infusion versus heparin monotherapy in STEMI patients undergoing primary PCI.
- To evaluate the impact of bail-out GPI use on these outcomes.
Main Methods:
- A subgroup analysis of the BRIGHT-4 trial involving 6016 STEMI patients randomized to bivalirudin or heparin.
- Patients received either bivalirudin with a post-PCI infusion or heparin monotherapy.
- Glycoprotein IIb/IIIa inhibitors were reserved for bail-out therapy.
Main Results:
- Bail-out GPI use increased the risk of the primary outcome (composite of death or BARC 3-5 bleeding) and all-cause death.
- In patients not requiring GPI, bivalirudin showed significantly lower rates of the primary outcome, all-cause death, and BARC 3-5 bleeding compared to heparin.
- Among patients requiring bail-out GPI, no significant differences in outcomes were observed between bivalirudin and heparin.
Conclusions:
- Bivalirudin with a post-PCI infusion significantly reduced death and major bleeding compared to heparin in STEMI patients undergoing primary PCI without GPI use.
- The benefits of bivalirudin may be diminished in patients requiring bail-out GPI due to thrombotic complications.
Background:
Conflicting results comparing bivalirudin versus heparin anticoagulation in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), in part due to the confounding effect of glycoprotein IIb/IIIa inhibitors (GPI). The aim of the study was to compare the safety and effectiveness of bivalirudin plus a post-PCI high-dose infusion vs heparin with or without bail-out GPI use.
Methods:
We conducted a pre-specified subgroup analysis from the BRIGHT-4 trial that randomized 6016 STEMI patients who underwent primary PCI to receive either bivalirudin plus a post-PCI high-dose infusion for 2-4 h or heparin monotherapy. GPI use was only reserved as bail-out therapy for procedural thrombotic complications. The primary outcome was a composite of all-cause death or Bleeding Academic Research Consortium (BARC) types 3-5 bleeding at 30 days.
Results:
A total of 5250 (87.4%) patients received treatment without GPI while 758 (12.6%) received bail-out GPI. Bail-out GPI use was associated with an increased risk of the primary outcome compared to non-GPI use (5.28% vs. 3.41%; adjusted hazard ratio (aHR), 1.62; 95% confidence interval (CI), 1.13-2.33; P = 0.009) and all-cause death (5.01% vs. 3.12%; aHR, 1.74; 95% CI, 1.20-2.52; P = 0.004) but not in the risk of BARC types 3-5 bleeding (0.53% vs. 0.48%; aHR, 0.90; 95% CI, 0.31-2.66; P = 0.85). Among patients without GPI use, bivalirudin was associated with lower rates of the primary outcome (2.63% vs. 4.21%; aHR, 0.55; 95% CI, 0.39-0.77; P = 0.0005), all-cause death (2.52% vs. 3.74%; aHR, 0.58; 95% CI, 0.41-0.83; P = 0.003), and BARC types 3-5 bleeding (0.15% vs. 0.81%; aHR, 0.19; 95% CI, 0.06-0.57; P = 0.003) compared with heparin. However, among patients requiring bail-out GPI, there were no significant differences observed in the rates of the primary outcome (5.76% vs. 4.87%; aHR, 0.77; 95% CI, 0.36-1.66; P = 0.50; Pinteraction = 0.07) or its individual components between bivalirudin and heparin groups.
Conclusions:
Bivalirudin plus a post-PCI high-dose infusion was associated with significantly reduced 30-day composite rate of all-cause death or BARC types 3-5 bleeding compared with heparin monotherapy in STEMI patients undergoing primary PCI without GPI use. However, these benefits might be less pronounced in patients requiring bail-out GPI due to thrombotic complications during primary PCI.
Trial Registration:
ClinicalTrials.gov NCT03822975.
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