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

Elmir Omerovic; Stefan James; Truls Råmundal; Ole Fröbert; Rikard Linder; Mikael Danielewicz; Mehmet Hamid; Christos Pagonis; Loghman Henareh; Henrik Wagner; Jason Stewart; Jens Jensen; Pontus Lindros; Lotta Robertsson; Helena Wikström; Anders Ulvenstam; Pallonji Bhiladval; Tim Tödt; Dan Ioanes; Thomas Kellerth; Leszek Zagozdzon; Matthias Götberg; Jonas Andersson; Oskar Angerås; Ollie Östlund; Claes Held; Sasha Koul; David Erlinge

doi:10.1016/j.carrev.2024.03.025

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

Elmir Omerovic^*, Stefan James, Truls Råmundal, Ole Fröbert, Rikard Linder, Mikael Danielewicz, Mehmet Hamid, Christos Pagonis, Loghman Henareh, Henrik Wagner, Jason Stewart, Jens Jensen, Pontus Lindros, Lotta Robertsson, Helena Wikström, Anders Ulvenstam, Pallonji Bhiladval, Tim Tödt, Dan Ioanes, Thomas KellerthLeszek Zagozdzon, Matthias Götberg, Jonas Andersson, Oskar Angerås, Ollie Östlund, Claes Held, Sasha Koul, David Erlinge

^*Corresponding author for this work

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

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. 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.

Original language	English
Journal	Cardiovascular Revascularization Medicine
Volume	66
Pages (from-to)	43-50
Number of pages	8
ISSN	1553-8389
DOIs	https://doi.org/10.1016/j.carrev.2024.03.025
Publication status	Published - Sept 2024
Externally published	Yes

Keywords

Bivalirudin
Myocardial infarction
PCI
Unfractionated heparin

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10.1016/j.carrev.2024.03.025

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Omerovic, E., James, S., Råmundal, T., Fröbert, O., Linder, R., Danielewicz, M., Hamid, M., Pagonis, C., Henareh, L., Wagner, H., Stewart, J., Jensen, J., Lindros, P., Robertsson, L., Wikström, H., Ulvenstam, A., Bhiladval, P., Tödt, T., Ioanes, D., ... Erlinge, D. (2024). Bivalirudin versus heparin in ST and non-ST-segment elevation myocardial infarction—Outcomes at two years. Cardiovascular Revascularization Medicine, 66, 43-50. https://doi.org/10.1016/j.carrev.2024.03.025

@article{9cb503f1b7b5435aa4af9d63d48bbef0,

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

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. 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.",

keywords = "Bivalirudin, Myocardial infarction, PCI, Unfractionated heparin",

author = "Elmir Omerovic and Stefan James and Truls R{\aa}mundal and Ole Fr{\"o}bert and Rikard Linder and Mikael Danielewicz and Mehmet Hamid and Christos Pagonis and Loghman Henareh and Henrik Wagner and Jason Stewart and Jens Jensen and Pontus Lindros and Lotta Robertsson and Helena Wikstr{\"o}m and Anders Ulvenstam and Pallonji Bhiladval and Tim T{\"o}dt and Dan Ioanes and Thomas Kellerth and Leszek Zagozdzon and Matthias G{\"o}tberg and Jonas Andersson and Oskar Anger{\aa}s and Ollie {\"O}stlund and Claes Held and Sasha Koul and David Erlinge",

note = "Publisher Copyright: {\textcopyright} 2024 Elsevier Inc.",

year = "2024",

month = sep,

doi = "10.1016/j.carrev.2024.03.025",

language = "English",

volume = "66",

pages = "43--50",

journal = "Cardiovascular Revascularization Medicine",

issn = "1553-8389",

publisher = "Elsevier Inc.",

}

Omerovic, E, James, S, Råmundal, T, Fröbert, O, Linder, R, Danielewicz, M, Hamid, M, Pagonis, C, Henareh, L, Wagner, H, Stewart, J, Jensen, J, Lindros, P, Robertsson, L, Wikström, H, Ulvenstam, A, Bhiladval, P, Tödt, T, Ioanes, D, Kellerth, T, Zagozdzon, L, Götberg, M, Andersson, J, Angerås, O, Östlund, O, Held, C, Koul, S & Erlinge, D 2024, 'Bivalirudin versus heparin in ST and non-ST-segment elevation myocardial infarction—Outcomes at two years', Cardiovascular Revascularization Medicine, vol. 66, pp. 43-50. https://doi.org/10.1016/j.carrev.2024.03.025

Bivalirudin versus heparin in ST and non-ST-segment elevation myocardial infarction—Outcomes at two years. / Omerovic, Elmir; James, Stefan; Råmundal, Truls et al.
In: Cardiovascular Revascularization Medicine, Vol. 66, 09.2024, p. 43-50.

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

TY - JOUR

T1 - Bivalirudin versus heparin in ST and non-ST-segment elevation myocardial infarction—Outcomes at two years

AU - Omerovic, Elmir

AU - James, Stefan

AU - Råmundal, Truls

AU - Fröbert, Ole

AU - Linder, Rikard

AU - Danielewicz, Mikael

AU - Hamid, Mehmet

AU - Pagonis, Christos

AU - Henareh, Loghman

AU - Wagner, Henrik

AU - Stewart, Jason

AU - Jensen, Jens

AU - Lindros, Pontus

AU - Robertsson, Lotta

AU - Wikström, Helena

AU - Ulvenstam, Anders

AU - Bhiladval, Pallonji

AU - Tödt, Tim

AU - Ioanes, Dan

AU - Kellerth, Thomas

AU - Zagozdzon, Leszek

AU - Götberg, Matthias

AU - Andersson, Jonas

AU - Angerås, Oskar

AU - Östlund, Ollie

AU - Held, Claes

AU - Koul, Sasha

AU - Erlinge, David

PY - 2024/9

Y1 - 2024/9

N2 - 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.

AB - 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.

KW - Bivalirudin

KW - Myocardial infarction

KW - PCI

KW - Unfractionated heparin

UR - http://www.scopus.com/inward/record.url?scp=85189659388&partnerID=8YFLogxK

U2 - 10.1016/j.carrev.2024.03.025

DO - 10.1016/j.carrev.2024.03.025

M3 - Journal article

C2 - 38575449

AN - SCOPUS:85189659388

SN - 1553-8389

VL - 66

SP - 43

EP - 50

JO - Cardiovascular Revascularization Medicine

JF - Cardiovascular Revascularization Medicine

ER -

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

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Keywords

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