drugset / Trial / NCT02311231
Bivalirudin vs Heparin in NSTEMI and STEMI in Patients on Modern Antiplatelet Therapy in SWEDEHEART
RandomizedParallel-groupOpen-labelTreatment
Summary
In this trial we test the hypothesis that PCI and bivalirudin is superior to heparin alone (according to local protocol) in reducing death, MI, and major bleeding in patients with NSTEMI or STEMI at 180 days (primary end point), treated with ticagrelor or prasugrel.
Timeline
- Start
- 2014-06
- Primary completion
- 2017-03
- Completion
- 2017-03
Outcome
Missed primary endpoint
paper in the bivalirudin group and in 12.8% (383 of 3002) in the heparin group (hazard ratio, 0.96; 95% confidence interval [CI], 0.83 to 1.10; P=0.54). PMID 28844201 ↗
paper the rate of the composite of death from any cause, myocardial infarction, or major bleeding was not lower among those who received bivalirudin PMID 28844201 ↗
Publications
- Omerovic E, James S, Ramundal T, Frobert O, Linder R, Danielewicz M, Hamid M, Pagonis C, Henareh L, Wagner H, Stewart J, Jensen J, Lindros P, Robertsson L, Wikstrom H, Ulvenstam A, Bhiladval P, Todt T, Ioanes D, Kellerth T, Zagozdzon L, Gotberg M, Andersson J, Angeras O, Ostlund O, Held C, Koul S, Erlinge D. Bivalirudin versus heparin in ST and non-ST-segment elevation myocardial infarction-Outcomes at two years. Cardiovasc Revasc Med. 2024 Sep;66:43-50. doi: 10.1016/j.carrev.2024.03.025. Epub 2024 Mar 26.
- James S, Koul S, Andersson J, Angeras O, Bhiladvala P, Calais F, Danielewicz M, Frobert O, Grimfjard P, Gotberg M, Henareh L, Ioanes D, Jensen J, Linder R, Lindroos P, Omerovic E, Panayi G, Ramunddal T, Sarno G, Ulvenstam A, Voltz S, Wagner H, Wikstrom H, Ostlund O, Erlinge D. Bivalirudin Versus Heparin Monotherapy in ST-Segment-Elevation Myocardial Infarction. Circ Cardiovasc Interv. 2021 Dec;14(12):e008969. doi: 10.1161/CIRCINTERVENTIONS.120.008969. Epub 2021 Dec 14.
- Bergman S, Mohammad MA, James SK, Angeras O, Wagner H, Jensen J, Schersten F, Frobert O, Koul S, Erlinge D. Clinical Impact of Intraprocedural Stent Thrombosis During Percutaneous Coronary Intervention in Patients Treated With Potent P2Y12 inhibitors - a VALIDATE-SWEDEHEART Substudy. J Am Heart Assoc. 2021 Sep 21;10(18):e022984. doi: 10.1161/JAHA.121.022984. Epub 2021 Sep 13.
- Rylance RT, Wagner P, Omerovic E, Held C, James S, Koul S, Erlinge D. Assessing the external validity of the VALIDATE-SWEDEHEART trial. Clin Trials. 2021 Aug;18(4):427-435. doi: 10.1177/17407745211012438. Epub 2021 May 20.
- Jamaly S, Redfors B, Omerovic E, Carlsson L, Karason K. Prognostic significance of BMI after PCI treatment in ST-elevation myocardial infarction: a cohort study from the Swedish Coronary Angiography and Angioplasty Registry. Open Heart. 2021 Feb;8(1):e001479. doi: 10.1136/openhrt-2020-001479.
- Olsson A, Ring C, Josefsson J, Eriksson A, Rylance R, Frobert O, James S, Sparv D, Erlinge D. Patient experience of the informed consent process during acute myocardial infarction: a sub-study of the VALIDATE-SWEDEHEART trial. Trials. 2020 Mar 6;21(1):246. doi: 10.1186/s13063-020-4147-0.
- Wester A, Attar R, Mohammad MA, Andell P, Hofmann R, Jensen J, Szummer K, Erlinge D, Koul S. Impact of Baseline Anemia in Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention: A Prespecified Analysis From the VALIDATE-SWEDEHEART Trial. J Am Heart Assoc. 2019 Aug 20;8(16):e012741. doi: 10.1161/JAHA.119.012741. Epub 2019 Aug 7.
- Erlinge D, Omerovic E, Frobert O, Linder R, Danielewicz M, Hamid M, Swahn E, Henareh L, Wagner H, Hardhammar P, Sjogren I, Stewart J, Grimfjard P, Jensen J, Aasa M, Robertsson L, Lindroos P, Haupt J, Wikstrom H, Ulvenstam A, Bhiladvala P, Lindvall B, Lundin A, Todt T, Ioanes D, Ramunddal T, Kellerth T, Zagozdzon L, Gotberg M, Andersson J, Angeras O, Ostlund O, Lagerqvist B, Held C, Wallentin L, Schersten F, Eriksson P, Koul S, James S. Bivalirudin versus Heparin Monotherapy in Myocardial Infarction. N Engl J Med. 2017 Sep 21;377(12):1132-1142. doi: 10.1056/NEJMoa1706443. Epub 2017 Aug 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bivalirudin | Peptide | 1.75 mg/kg | Intravenous |
| Comparator | Heparin | Other / unclassified | — | Intravenous |