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Bivalirudin versus Heparin Monotherapy in Myocardial Infarction.
David Erlinge1, Elmir Omerovic1, Ole Fröbert1
1From the Department of Cardiology, Clinical Sciences, Lund University, Lund (D.E., P.B., A.L., T.T., M.G., F.S., S.K.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (E.O., D.I., T.R., O.A.), the Department of Cardiology, Faculty of Health, Örebro University, Örebro (O.F., T.K., L.Z.), the Department of Cardiology, Danderyd Hospital (R.L.), and the Department of Cardiology, Karolinska University Hospital (L.H.), Karolinska Institutet, the Department of Cardiology, Capio St. Görans Hospital (J.J., P.L.), and the Department of Cardiology, Södersjukhuset AB (M.A.), Stockholm, PCI-Unit at Karlstad Hospital, Karlstad (M.D.), the Department of Cardiology, Mälarsjukhuset, Eskilstuna (M.H.), the Department of Cardiology, Linköping University Hospital, Linköping (E.S.), the Department of Cardiology, Helsingborg Lasarett, Helsingborg (H. Wagner), the Department of Cardiology, Halmstad Hospital, Halmstad (P.H.), the Department of Cardiology, Falun Hospital, Falun (I.S.), the Department of Cardiology, Skaraborgs Hospital, Skövde (J.S.), the Department of Internal Medicine, Västmanlands Sjukhus, Västerås (P.G.), the Department of Cardiology, Södra Älvsborgs Sjukhus, Borås (L.R.), the Department of Cardiology, Sunderby Sjukhus, Luleå (J.H.), the Department of Cardiology, Kristianstad Hospital, Kristianstad (H. Wikström), the Department of Cardiology, Östersund Hospital, Östersund (A.U.), the Department of Cardiology, Sundsvall Hospital, Sundsvall (B. Lindvall), the Department of Cardiology, Umeå University, Umeå (J.A., P.E.), and the Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala (O.Ö., B. Lagerqvist, C.H., L.W., S.J.) - all in Sweden.
In patients undergoing percutaneous coronary intervention for myocardial infarction, bivalirudin was not found to be superior to heparin monotherapy. The study compared these anticoagulants in patients receiving potent P2Y12 inhibitors, finding similar rates of major adverse events.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Current practice for acute myocardial infarction (AMI) with percutaneous coronary intervention (PCI) involves radial-artery access and potent P2Y12 inhibitors, but optimal anticoagulation strategy remains unclear.
- The comparative efficacy of bivalirudin versus heparin in this specific patient population is not well-established.
Purpose of the Study:
- To compare the efficacy and safety of bivalirudin versus heparin in patients with ST-segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) undergoing PCI.
- To evaluate a composite endpoint of death, myocardial infarction, or major bleeding within 180 days.
Main Methods:
- A multicenter, randomized, registry-based, open-label clinical trial.
- 6006 patients (3005 STEMI, 3001 NSTEMI) received potent P2Y12 inhibitors and were randomized to bivalirudin or heparin during PCI, predominantly via radial access.
- Primary endpoint: composite of death, myocardial infarction, or major bleeding at 180 days.
Main Results:
- No significant difference in the primary endpoint between bivalirudin and heparin groups (12.3% vs 12.8%, HR 0.96; P=0.54).
- Rates of myocardial infarction (2.0% vs 2.4%), major bleeding (8.6% vs 8.6%), and death (2.9% vs 2.8%) were similar.
- Definite stent thrombosis occurred in 0.4% with bivalirudin and 0.7% with heparin (HR 0.54; P=0.09).
Conclusions:
- Bivalirudin monotherapy was not associated with a lower rate of death, myocardial infarction, or major bleeding compared to heparin in patients undergoing PCI for myocardial infarction.
- The findings were consistent across STEMI and NSTEMI subgroups and other major patient categories.
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