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Bivalirudin Versus Heparin Monotherapy in ST-Segment-Elevation Myocardial Infarction

James, Stefan ; Koul, Sasha LU ; Andersson, Jonas ; Angerås, Oskar ; Bhiladvala, Pallonji LU ; Calais, Fredrik ; Danielewicz, Mikael ; Fröbert, Ole ; Grimfjärd, Per and Götberg, Matthias LU , et al. (2021) In Circulation. Cardiovascular Interventions 14(12). p.008969-008969
Abstract

BACKGROUND: Bivalirudin was not superior to unfractionated heparin in patients with myocardial infarction (MI) treated with percutaneous coronary intervention and no planned use of GPI (glycoprotein IIb/IIIa inhibitors) in contemporary clinical practice of radial access and potent P2Y12-inhibitors in the VALIDATE-SWEDEHEART randomized clinical trial (Bivalirudin Versus Heparin in STEMI and NSTEMI Patients on Modern Antiplatelet Therapy-Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies Registry). METHODS: In this prespecified separately powered subgroup analysis, we included patients with ST-segment-elevation MI undergoing primary percutaneous coronary... (More)

BACKGROUND: Bivalirudin was not superior to unfractionated heparin in patients with myocardial infarction (MI) treated with percutaneous coronary intervention and no planned use of GPI (glycoprotein IIb/IIIa inhibitors) in contemporary clinical practice of radial access and potent P2Y12-inhibitors in the VALIDATE-SWEDEHEART randomized clinical trial (Bivalirudin Versus Heparin in STEMI and NSTEMI Patients on Modern Antiplatelet Therapy-Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies Registry). METHODS: In this prespecified separately powered subgroup analysis, we included patients with ST-segment-elevation MI undergoing primary percutaneous coronary intervention with the primary composite end point of all-cause death, MI, or major bleeding event within 180 days. RESULTS: Among the 6006 patients enrolled in the trial, 3005 patients with ST-segment-elevation MI were randomized to receive bivalirudin or heparin. The mean age was 66.8 years. According to protocol recommendations, 87% were treated with potent oral P2Y12-inhibitors before start of angiography and radial access was used in 90%. GPI was used in 51 (3.4%) and 74 (4.9%) of patients randomized to receive bivalirudin and heparin, respectively. The primary end point occurred in 12.5% (187 of 1501) and 13.0% (196 of 1504; hazard ratio [HR], 0.95 [95% CI, 0.78-1.17], P=0.64) with consistent results in all major subgroups. All-cause death occurred in 3.9% versus 3.9% (HR, 1.00 [0.70-1.45], P=0.98), MI in 1.7% versus 2.2% (HR, 0.76 [0.45-1.28], P=0.30), major bleeding in 8.3% versus 8.0% (HR, 1.04 [0.81-1.33], P=0.78), and definite stent thrombosis in 0.5% versus 1.3% (HR, 0.42 [0.18-0.96], P=0.04). CONCLUSIONS: In patients with ST-segment-elevation MI undergoing primary percutaneous coronary intervention with radial access and receiving current recommended treatments with potent P2Y12-inhibitors rate of the composite of all-cause death, MI, or major bleeding was not lower in those randomized to receive bivalirudin as compared with heparin. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02311231.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
bivalirudin, heparin, myocardial infarction, stent, thrombosis
in
Circulation. Cardiovascular Interventions
volume
14
issue
12
pages
008969 - 008969
publisher
American Heart Association
external identifiers
  • pmid:34903034
  • scopus:85122903628
ISSN
1941-7632
DOI
10.1161/CIRCINTERVENTIONS.120.008969
language
English
LU publication?
yes
id
fd90a3d9-1aa3-4d69-b16d-143e93dd93c1
date added to LUP
2022-03-10 15:07:22
date last changed
2024-05-02 07:30:42
@article{fd90a3d9-1aa3-4d69-b16d-143e93dd93c1,
  abstract     = {{<p>BACKGROUND: Bivalirudin was not superior to unfractionated heparin in patients with myocardial infarction (MI) treated with percutaneous coronary intervention and no planned use of GPI (glycoprotein IIb/IIIa inhibitors) in contemporary clinical practice of radial access and potent P2Y12-inhibitors in the VALIDATE-SWEDEHEART randomized clinical trial (Bivalirudin Versus Heparin in STEMI and NSTEMI Patients on Modern Antiplatelet Therapy-Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies Registry). METHODS: In this prespecified separately powered subgroup analysis, we included patients with ST-segment-elevation MI undergoing primary percutaneous coronary intervention with the primary composite end point of all-cause death, MI, or major bleeding event within 180 days. RESULTS: Among the 6006 patients enrolled in the trial, 3005 patients with ST-segment-elevation MI were randomized to receive bivalirudin or heparin. The mean age was 66.8 years. According to protocol recommendations, 87% were treated with potent oral P2Y12-inhibitors before start of angiography and radial access was used in 90%. GPI was used in 51 (3.4%) and 74 (4.9%) of patients randomized to receive bivalirudin and heparin, respectively. The primary end point occurred in 12.5% (187 of 1501) and 13.0% (196 of 1504; hazard ratio [HR], 0.95 [95% CI, 0.78-1.17], P=0.64) with consistent results in all major subgroups. All-cause death occurred in 3.9% versus 3.9% (HR, 1.00 [0.70-1.45], P=0.98), MI in 1.7% versus 2.2% (HR, 0.76 [0.45-1.28], P=0.30), major bleeding in 8.3% versus 8.0% (HR, 1.04 [0.81-1.33], P=0.78), and definite stent thrombosis in 0.5% versus 1.3% (HR, 0.42 [0.18-0.96], P=0.04). CONCLUSIONS: In patients with ST-segment-elevation MI undergoing primary percutaneous coronary intervention with radial access and receiving current recommended treatments with potent P2Y12-inhibitors rate of the composite of all-cause death, MI, or major bleeding was not lower in those randomized to receive bivalirudin as compared with heparin. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02311231.</p>}},
  author       = {{James, Stefan and Koul, Sasha and Andersson, Jonas and Angerås, Oskar and Bhiladvala, Pallonji and Calais, Fredrik and Danielewicz, Mikael and Fröbert, Ole and Grimfjärd, Per and Götberg, Matthias and Henareh, Loghman and Ioanes, Dan and Jensen, Jens and Linder, Rikard and Lindroos, Pontus and Omerovic, Elmir and Panayi, Georgios and Råmunddal, Truls and Sarno, Giovanna and Ulvenstam, Anders and Völtz, Sebastian and Wagner, Henrik and Wikström, Helena and Östlund, Ollie and Erlinge, David}},
  issn         = {{1941-7632}},
  keywords     = {{bivalirudin; heparin; myocardial infarction; stent; thrombosis}},
  language     = {{eng}},
  number       = {{12}},
  pages        = {{008969--008969}},
  publisher    = {{American Heart Association}},
  series       = {{Circulation. Cardiovascular Interventions}},
  title        = {{Bivalirudin Versus Heparin Monotherapy in ST-Segment-Elevation Myocardial Infarction}},
  url          = {{http://dx.doi.org/10.1161/CIRCINTERVENTIONS.120.008969}},
  doi          = {{10.1161/CIRCINTERVENTIONS.120.008969}},
  volume       = {{14}},
  year         = {{2021}},
}