Bivalirudin vs Heparin Anticoagulation in STEMI : Confirmation of the BRIGHT-4 Results
Stone, Gregg W. ; Valgimigli, Marco ; Erlinge, David LU
; Han, Yaling
; Steg, Philippe Gabriel
; Stables, Rod H.
; Frigoli, Enrico
; James, Stefan K.
; Li, Yi
and Goldstein, Patrick
, et al.
(2024)
In Journal of the American College of Cardiology
84(16).
p.1512-1524
- Abstract
Background: In the BRIGHT-4 (Bivalirudin With Prolonged Full-Dose Infusion During Primary PCI Versus Heparin Trial-4), anticoagulation with bivalirudin plus a 2- to 4-hour high-dose infusion after percutaneous coronary intervention (PCI) reduced all-cause mortality and bleeding without increasing reinfarction or stent thrombosis compared with heparin alone in patients with ST-segment elevation myocardial infarction (STEMI). These findings require external validation. Objectives: This study sought to determine outcomes of bivalirudin vs heparin anticoagulation during PCI in STEMI. Methods: We performed an individual-patient–data meta-analysis of all large randomized trials of bivalirudin vs heparin in STEMI patients undergoing primary... (More)
Background: In the BRIGHT-4 (Bivalirudin With Prolonged Full-Dose Infusion During Primary PCI Versus Heparin Trial-4), anticoagulation with bivalirudin plus a 2- to 4-hour high-dose infusion after percutaneous coronary intervention (PCI) reduced all-cause mortality and bleeding without increasing reinfarction or stent thrombosis compared with heparin alone in patients with ST-segment elevation myocardial infarction (STEMI). These findings require external validation. Objectives: This study sought to determine outcomes of bivalirudin vs heparin anticoagulation during PCI in STEMI. Methods: We performed an individual-patient–data meta-analysis of all large randomized trials of bivalirudin vs heparin in STEMI patients undergoing primary PCI performed before BRIGHT-4. The primary endpoint was all-cause mortality. Results: Six trials randomizing 15,254 patients were included. Pooled across all regimens of bivalirudin and glycoprotein IIb/IIIa inhibitor (GPI) use, bivalirudin reduced 30-day all-cause mortality (2.5% vs 2.9%; adjusted OR: 0.78; 95% CI: 0.62-0.99), cardiac mortality (adjusted OR: 0.69; 95% CI: 0.54-0.88), and major bleeding (adjusted OR: 0.53; 95% CI: 0.44-0.64) but increased reinfarction (adjusted OR: 1.30; 95% CI: 1.02-1.65) and stent thrombosis (adjusted OR: 1.43; 95% CI: 1.05-1.93) compared with heparin. In 4 trials in which 6,244 patients were randomized to bivalirudin plus a high-dose post-PCI infusion vs heparin without planned GPI use (the BRIGHT-4 regimens), 30-day all-cause mortality occurred in 1.8% vs 2.9% of patients, respectively (adjusted OR: 0.74; 95% CI: 0.48-1.12), and bivalirudin reduced cardiac mortality (adjusted OR: 0.62; 95% CI: 0.39-0.97) and major bleeding (adjusted OR: 0.49; 95% CI: 0.35-0.70), with similar rates of reinfarction (adjusted OR: 0.89; 95% CI: 0.58-1.38) and stent thrombosis (adjusted OR: 0.80; 95% CI: 0.41-1.57). Conclusions: In STEMI patients undergoing primary PCI, bivalirudin with a 2- to 4-hour post-PCI high-dose infusion reduced cardiac mortality and major bleeding without an increase in ischemic events compared with heparin monotherapy with provisional GPI use, confirming the BRIGHT-4 results.
(Less)
- author
- Stone, Gregg W.
; Valgimigli, Marco
; Erlinge, David
LU
; Han, Yaling
; Steg, Philippe Gabriel
; Stables, Rod H.
; Frigoli, Enrico
; James, Stefan K.
; Li, Yi
and Goldstein, Patrick
, et al. (More)
- Stone, Gregg W.
; Valgimigli, Marco
; Erlinge, David
LU
; Han, Yaling
; Steg, Philippe Gabriel
; Stables, Rod H.
; Frigoli, Enrico
; James, Stefan K.
; Li, Yi
; Goldstein, Patrick
; Mehran, Roxana
; Mehdipoor, Ghazaleh
; Crowley, Aaron
; Chen, Shmuel
; Redfors, Björn
; Snyder, Clayton
; Zhou, Zhipeng
and Bikdeli, Behnood
(Less)
- organization
- publishing date
- 2024-10
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- anticoagulation, bleeding, mortality, myocardial infarction, prognosis
- in
- Journal of the American College of Cardiology
- volume
- 84
- issue
- 16
- pages
- 13 pages
- publisher
- Elsevier
- external identifiers
-
- pmid:39384262
- scopus:85204925927
- ISSN
- 0735-1097
- DOI
- 10.1016/j.jacc.2024.07.045
- language
- English
- LU publication?
- yes
- id
- bb871d4e-0ecc-4725-89cd-02d2d74fb9ec
- date added to LUP
- 2025-01-09 15:24:56
- date last changed
- 2025-07-11 20:06:00
@article{bb871d4e-0ecc-4725-89cd-02d2d74fb9ec,
abstract = {{<p>Background: In the BRIGHT-4 (Bivalirudin With Prolonged Full-Dose Infusion During Primary PCI Versus Heparin Trial-4), anticoagulation with bivalirudin plus a 2- to 4-hour high-dose infusion after percutaneous coronary intervention (PCI) reduced all-cause mortality and bleeding without increasing reinfarction or stent thrombosis compared with heparin alone in patients with ST-segment elevation myocardial infarction (STEMI). These findings require external validation. Objectives: This study sought to determine outcomes of bivalirudin vs heparin anticoagulation during PCI in STEMI. Methods: We performed an individual-patient–data meta-analysis of all large randomized trials of bivalirudin vs heparin in STEMI patients undergoing primary PCI performed before BRIGHT-4. The primary endpoint was all-cause mortality. Results: Six trials randomizing 15,254 patients were included. Pooled across all regimens of bivalirudin and glycoprotein IIb/IIIa inhibitor (GPI) use, bivalirudin reduced 30-day all-cause mortality (2.5% vs 2.9%; adjusted OR: 0.78; 95% CI: 0.62-0.99), cardiac mortality (adjusted OR: 0.69; 95% CI: 0.54-0.88), and major bleeding (adjusted OR: 0.53; 95% CI: 0.44-0.64) but increased reinfarction (adjusted OR: 1.30; 95% CI: 1.02-1.65) and stent thrombosis (adjusted OR: 1.43; 95% CI: 1.05-1.93) compared with heparin. In 4 trials in which 6,244 patients were randomized to bivalirudin plus a high-dose post-PCI infusion vs heparin without planned GPI use (the BRIGHT-4 regimens), 30-day all-cause mortality occurred in 1.8% vs 2.9% of patients, respectively (adjusted OR: 0.74; 95% CI: 0.48-1.12), and bivalirudin reduced cardiac mortality (adjusted OR: 0.62; 95% CI: 0.39-0.97) and major bleeding (adjusted OR: 0.49; 95% CI: 0.35-0.70), with similar rates of reinfarction (adjusted OR: 0.89; 95% CI: 0.58-1.38) and stent thrombosis (adjusted OR: 0.80; 95% CI: 0.41-1.57). Conclusions: In STEMI patients undergoing primary PCI, bivalirudin with a 2- to 4-hour post-PCI high-dose infusion reduced cardiac mortality and major bleeding without an increase in ischemic events compared with heparin monotherapy with provisional GPI use, confirming the BRIGHT-4 results.</p>}},
author = {{Stone, Gregg W. and Valgimigli, Marco and Erlinge, David and Han, Yaling and Steg, Philippe Gabriel and Stables, Rod H. and Frigoli, Enrico and James, Stefan K. and Li, Yi and Goldstein, Patrick and Mehran, Roxana and Mehdipoor, Ghazaleh and Crowley, Aaron and Chen, Shmuel and Redfors, Björn and Snyder, Clayton and Zhou, Zhipeng and Bikdeli, Behnood}},
issn = {{0735-1097}},
keywords = {{anticoagulation; bleeding; mortality; myocardial infarction; prognosis}},
language = {{eng}},
number = {{16}},
pages = {{1512--1524}},
publisher = {{Elsevier}},
series = {{Journal of the American College of Cardiology}},
title = {{Bivalirudin vs Heparin Anticoagulation in STEMI : Confirmation of the BRIGHT-4 Results}},
url = {{http://dx.doi.org/10.1016/j.jacc.2024.07.045}},
doi = {{10.1016/j.jacc.2024.07.045}},
volume = {{84}},
year = {{2024}},
}