Your browser doesn't support javascript.
loading
Effectiveness and outcome of management strategies for dabigatran- or warfarin-related major bleeding events.
Majeed, Ammar; Hwang, Hun-Gyu; Eikelboom, John W; Connolly, Stuart; Wallentin, Lars; Feuring, Martin; Brueckmann, Martina; Noack, Herbert; Yusuf, Salim; Schulman, Sam.
Afiliação
  • Majeed A; Coagulation Unit, Hematology Center, Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden; Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden. Electronic address: ammar.majeed@karolinska.se.
  • Hwang HG; Department of Medicine, Soonchunhyang University Gumi's Hospital, North Kyungsang Province, South Korea.
  • Eikelboom JW; Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada.
  • Connolly S; Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada.
  • Wallentin L; Uppsala Clinical Research Center and Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
  • Feuring M; Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany.
  • Brueckmann M; Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany; Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany.
  • Noack H; Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany.
  • Yusuf S; Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada.
  • Schulman S; Coagulation Unit, Hematology Center, Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden; Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada; Department of Medicine, McMaster University and Thrombosis and Atheroscleros
Thromb Res ; 140: 81-88, 2016 Apr.
Article em En | MEDLINE | ID: mdl-26908016
ABSTRACT

BACKGROUND:

Strategies used for the management of dabigatran-related major bleeding events (MBEs), and their effectiveness have not been systematically evaluated.

METHODS:

Reports on 1034 individuals experiencing 1121 MBEs (696 on dabigatran, and 425 on warfarin) in 5 phase III randomized controlled trials were assessed independently by two investigators.

RESULTS:

MBEs were managed either by drug discontinuation only (37%), or drug discontinuation with either transfusion of only red cell concentrates (38%), or plasma (23%). Few MBEs (2%) were treated with coagulation factor concentrates. The effectiveness of the management was assessed as good in significantly larger proportion of MBEs on dabigatran (91%) than on warfarin (84%, odds ratio [OR] 1.68; 95% confidence interval [CI], 1.14-2.49), which was consistent with the lower 30-day mortality (OR (OR 0.66; 95% CI, 0.44-1.00)). The effectiveness of bleeding management in non-traumatic bleeding was better in patients with dabigatran than with warfarin (OR 1.82; 95% CI, 1.18-2.79) but was similar in traumatic bleeding (OR 0.75; 95% CI, 0.25-2.30). The relative effectiveness of management of bleeding and 30-day mortality rates across other key subgroups of patients or sites of bleeding, the use of platelet inhibitors, age-, sex- and renal function subgroups, were comparable in MBEs on dabigatran or warfarin.

CONCLUSION:

Despite the unavailability of a specific antidote at the time of these studies, bleeding in patients receiving dabigatran was managed in the overwhelming majority of patients without coagulation factor concentrates, with comparable or superior effectiveness and lower 30-day mortality rates versus those who bleed while receiving warfarin.
Assuntos
Palavras-chave

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Varfarina / Dabigatrana / Hemorragia / Anticoagulantes Tipo de estudo: Clinical_trials Limite: Aged / Aged80 / Female / Humans / Male Idioma: En Ano de publicação: 2016 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Varfarina / Dabigatrana / Hemorragia / Anticoagulantes Tipo de estudo: Clinical_trials Limite: Aged / Aged80 / Female / Humans / Male Idioma: En Ano de publicação: 2016 Tipo de documento: Article