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Bivalirudin versus heparin in ST and non-ST-segment elevation myocardial infarction—Outcomes at two years

Omerovic, Elmir ; James, Stefan ; Råmundal, Truls ; Fröbert, Ole ; Linder, Rikard ; Danielewicz, Mikael ; Hamid, Mehmet ; Pagonis, Christos ; Henareh, Loghman and Wagner, Henrik LU , et al. (2024) In Cardiovascular Revascularization Medicine
Abstract

Background: The registry-based randomized VALIDATE-SWEDEHEART trial (NCT02311231) compared bivalirudin vs. heparin in patients undergoing percutaneous coronary intervention (PCI) for myocardial infarction (MI). It showed no difference in the composite primary endpoint of death, MI, or major bleeding at 180 days. Here, we report outcomes at two years. Methods: Analysis of primary and secondary endpoints at two years of follow-up was prespecified in the study protocol. We report the study results for the extended follow-up time here. Results: In total, 6006 patients were enrolled, 3005 with ST-segment elevation MI (STEMI) and 3001 with Non-STEMI (NSTEMI), representing 70 % of all eligible patients with these diagnoses during the study.... (More)

Background: The registry-based randomized VALIDATE-SWEDEHEART trial (NCT02311231) compared bivalirudin vs. heparin in patients undergoing percutaneous coronary intervention (PCI) for myocardial infarction (MI). It showed no difference in the composite primary endpoint of death, MI, or major bleeding at 180 days. Here, we report outcomes at two years. Methods: Analysis of primary and secondary endpoints at two years of follow-up was prespecified in the study protocol. We report the study results for the extended follow-up time here. Results: In total, 6006 patients were enrolled, 3005 with ST-segment elevation MI (STEMI) and 3001 with Non-STEMI (NSTEMI), representing 70 % of all eligible patients with these diagnoses during the study. The primary endpoint occurred in 14.0 % (421 of 3004) in the bivalirudin group compared with 14.3 % (429 of 3002) in the heparin group (hazard ratio [HR] 0.97; 95 % confidence interval [CI], 0.85–1.11; P = 0.70) at one year and in 16.7 % (503 of 3004) compared with 17.1 % (514 of 3002), (HR 0.97; 95 % CI, 0.96–1.10; P = 0.66) at two years. The results were consistent in patients with STEMI and NSTEMI and across major subgroups. Conclusions: Until the two-year follow-up, there were no differences in endpoints between patients with MI undergoing PCI and allocated to bivalirudin compared with those allocated to heparin. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02311231.

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organization
publishing date
type
Contribution to journal
publication status
in press
subject
keywords
Bivalirudin, Myocardial infarction, PCI, Unfractionated heparin
in
Cardiovascular Revascularization Medicine
publisher
Elsevier
external identifiers
  • pmid:38575449
  • scopus:85189659388
ISSN
1553-8389
DOI
10.1016/j.carrev.2024.03.025
language
English
LU publication?
yes
id
411f333d-d533-45c4-b3ad-a9276ffd0a47
date added to LUP
2024-04-24 15:18:10
date last changed
2024-06-19 20:25:36
@article{411f333d-d533-45c4-b3ad-a9276ffd0a47,
  abstract     = {{<p>Background: The registry-based randomized VALIDATE-SWEDEHEART trial (NCT02311231) compared bivalirudin vs. heparin in patients undergoing percutaneous coronary intervention (PCI) for myocardial infarction (MI). It showed no difference in the composite primary endpoint of death, MI, or major bleeding at 180 days. Here, we report outcomes at two years. Methods: Analysis of primary and secondary endpoints at two years of follow-up was prespecified in the study protocol. We report the study results for the extended follow-up time here. Results: In total, 6006 patients were enrolled, 3005 with ST-segment elevation MI (STEMI) and 3001 with Non-STEMI (NSTEMI), representing 70 % of all eligible patients with these diagnoses during the study. The primary endpoint occurred in 14.0 % (421 of 3004) in the bivalirudin group compared with 14.3 % (429 of 3002) in the heparin group (hazard ratio [HR] 0.97; 95 % confidence interval [CI], 0.85–1.11; P = 0.70) at one year and in 16.7 % (503 of 3004) compared with 17.1 % (514 of 3002), (HR 0.97; 95 % CI, 0.96–1.10; P = 0.66) at two years. The results were consistent in patients with STEMI and NSTEMI and across major subgroups. Conclusions: Until the two-year follow-up, there were no differences in endpoints between patients with MI undergoing PCI and allocated to bivalirudin compared with those allocated to heparin. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02311231.</p>}},
  author       = {{Omerovic, Elmir and James, Stefan and Råmundal, Truls and Fröbert, Ole and Linder, Rikard and Danielewicz, Mikael and Hamid, Mehmet and Pagonis, Christos and Henareh, Loghman and Wagner, Henrik and Stewart, Jason and Jensen, Jens and Lindros, Pontus and Robertsson, Lotta and Wikström, Helena and Ulvenstam, Anders and Bhiladval, Pallonji and Tödt, Tim and Ioanes, Dan and Kellerth, Thomas and Zagozdzon, Leszek and Götberg, Matthias and Andersson, Jonas and Angerås, Oskar and Östlund, Ollie and Held, Claes and Koul, Sasha and Erlinge, David}},
  issn         = {{1553-8389}},
  keywords     = {{Bivalirudin; Myocardial infarction; PCI; Unfractionated heparin}},
  language     = {{eng}},
  publisher    = {{Elsevier}},
  series       = {{Cardiovascular Revascularization Medicine}},
  title        = {{Bivalirudin versus heparin in ST and non-ST-segment elevation myocardial infarction—Outcomes at two years}},
  url          = {{http://dx.doi.org/10.1016/j.carrev.2024.03.025}},
  doi          = {{10.1016/j.carrev.2024.03.025}},
  year         = {{2024}},
}