Bivalirudin versus heparin in ST and non-ST-segment elevation myocardial infarction-Outcomes at two yearsDept. of Cardiology, Danderyd, Karolinska University, Stockholm, Sweden.
PCI-Unit at Karlstad Hospital, Karlstad, Sweden.
Dept. of Cardiology, Mälarsjukhuset, Eskilstuna, Sweden.
Dept. of Cardiology, Linköping University Hospital, Linköping, Sweden.
Dept. of Cardiology, Karolinska Hospital, Karolinska University, Stockholm, Sweden.
Dept. of Cardiology, Helsingborg Lasarett, Helsingborg, Sweden.
Dept. of Cardiology, Skaraborgs Hospital, Skövde, Sweden.
Dept. of Clinical Science and Education, Södersjukhuset, Karolinska Institute, Unit of Cariology, Capio St Görans Sjukhus, Stockholm, Sweden.
Dept. of Cardiology Södersjukhuset AB, Stockholm, Sweden.
Dept. of Cardiology, Södra Älvsborgs sjukhus, Borås, Sweden.
Dept. of Cardiology, Kristianstad Hospital, Kristianstad, Sweden.
Dept. of Cardiology, Östersund Hospital, Östersund, Sweden.
Dept. of Medical Sciences, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
Dept. of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.
Dept. of Cardiology, Sahlgrenska University, Gothenburg, Sweden.
Dept. of Cardiology, Örebro University, Faculty of Health, Örebro, Sweden.
Dept. of Cardiology, Örebro University, Faculty of Health, Örebro, Sweden.
Dept. of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.
Dept. of Cardiology, Umeå University, Umeå, Sweden.
Dept. of Cardiology, Sahlgrenska University, Gothenburg, Sweden.
Dept. of Medical Sciences, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
Dept. of Medical Sciences, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
Dept. of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.
Dept. of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.
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2024 (English)In: Cardiovascular Revascularization Medicine, ISSN 1553-8389, E-ISSN 1878-0938, Vol. 66, p. 43-50Article in journal (Refereed) Published
Abstract [en]
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.
Place, publisher, year, edition, pages
Elsevier, 2024. Vol. 66, p. 43-50
Keywords [en]
Bivalirudin, Myocardial infarction, PCI, Unfractionated heparin
National Category
Cardiology and Cardiovascular Disease
Identifiers
URN: urn:nbn:se:oru:diva-112920DOI: 10.1016/j.carrev.2024.03.025ISI: 001313865900001PubMedID: 38575449Scopus ID: 2-s2.0-85189659388OAI: oai:DiVA.org:oru-112920DiVA, id: diva2:1849924
Funder
Swedish Heart Lung FoundationSwedish Research CouncilAstraZenecaSwedish Foundation for Strategic Research2024-04-092024-04-092025-02-10Bibliographically approved