Major bleeding with vitamin K antagonists or direct oral anticoagulants in real-life

Cecilia Becattini, Laura Franco, Jan Beyer-Westendorf, Luca Masotti, Cinzia Nitti, Simone Vanni, Giorgia Manina, Sergio Cattinelli, Roberto Cappelli, Rodolfo Sbrojavacca, Fulvio Pomero, Sandra Marten, Giancarlo Agnelli

Research output: Contribution to journalArticle

26 Citations (Scopus)

Abstract

Background Limited data are available on major bleeding (MB) occurring during treatment with vitamin K (VKAs) or direct oral anticoagulants (DOACs) outside clinical trials. Methods Patients hospitalized for MB while on treatment with VKAs or DOACs were included in a multicenter study to compare clinical presentation, management and outcome of bleeding. The primary study outcome was death at 30 days. Results Between September 2013 and September 2015, 806 patients were included in the study, 76% on VKAs and 24% on DOACs. MB was an intracranial hemorrhage in 51% and 21% patients on VKAs or DOACs, respectively (Odds Ratio [OR] 3.79; 95% confidence interval [CI] 2.59–5.54) a gastrointestinal bleeding in 46% and 25% patients on DOACs and VKAs, respectively (OR 2.62; 95% CI 1.87–3.68). Death at 30 days occurred in 130 patients (16%), 18% and 9% of VKA and DOAC patients (HR 1.95; 95% CI 1.19–3.22, p = 0.008). The rate of death at 30 days was similar in VKA and DOAC patients with intracranial hemorrhage (26% and 24%; HR 1.05, 95% CI 0.54–2.02) and gastrointestinal bleeding (11% and 7%; HR 1.46, 95% CI 0.57–3.74) and higher in VKA than DOAC patients with other MBs (10% and 3%; HR 3.42, 95% CI 0.78–15.03). Conclusions Admission for ICH is less frequent for DOAC patients compared with VKA patients. Admission for gastrointestinal MB is more frequent for DOAC as compared to VKA patients. Mortality seems lower in patients with MBs while on DOACs than VKAs but this finding varies across different types of MBs.

Original languageEnglish
Pages (from-to)261-266
Number of pages6
JournalInternational Journal of Cardiology
Volume227
DOIs
Publication statusPublished - Jan 15 2017
Externally publishedYes

Fingerprint

Vitamin K
Anticoagulants
Hemorrhage
Confidence Intervals
Intracranial Hemorrhages
Odds Ratio
Mortality
Multicenter Studies
Outcome Assessment (Health Care)
Clinical Trials

Keywords

  • Anticoagulants
  • Apixaban
  • Dabigatran
  • Intracranial hemorrhage
  • Major bleeding
  • Rivaroxaban

ASJC Scopus subject areas

  • Medicine(all)
  • Cardiology and Cardiovascular Medicine

Cite this

Becattini, C., Franco, L., Beyer-Westendorf, J., Masotti, L., Nitti, C., Vanni, S., ... Agnelli, G. (2017). Major bleeding with vitamin K antagonists or direct oral anticoagulants in real-life. International Journal of Cardiology, 227, 261-266. https://doi.org/10.1016/j.ijcard.2016.11.117

Major bleeding with vitamin K antagonists or direct oral anticoagulants in real-life. / Becattini, Cecilia; Franco, Laura; Beyer-Westendorf, Jan; Masotti, Luca; Nitti, Cinzia; Vanni, Simone; Manina, Giorgia; Cattinelli, Sergio; Cappelli, Roberto; Sbrojavacca, Rodolfo; Pomero, Fulvio; Marten, Sandra; Agnelli, Giancarlo.

In: International Journal of Cardiology, Vol. 227, 15.01.2017, p. 261-266.

Research output: Contribution to journalArticle

Becattini, C, Franco, L, Beyer-Westendorf, J, Masotti, L, Nitti, C, Vanni, S, Manina, G, Cattinelli, S, Cappelli, R, Sbrojavacca, R, Pomero, F, Marten, S & Agnelli, G 2017, 'Major bleeding with vitamin K antagonists or direct oral anticoagulants in real-life', International Journal of Cardiology, vol. 227, pp. 261-266. https://doi.org/10.1016/j.ijcard.2016.11.117
Becattini, Cecilia ; Franco, Laura ; Beyer-Westendorf, Jan ; Masotti, Luca ; Nitti, Cinzia ; Vanni, Simone ; Manina, Giorgia ; Cattinelli, Sergio ; Cappelli, Roberto ; Sbrojavacca, Rodolfo ; Pomero, Fulvio ; Marten, Sandra ; Agnelli, Giancarlo. / Major bleeding with vitamin K antagonists or direct oral anticoagulants in real-life. In: International Journal of Cardiology. 2017 ; Vol. 227. pp. 261-266.
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abstract = "Background Limited data are available on major bleeding (MB) occurring during treatment with vitamin K (VKAs) or direct oral anticoagulants (DOACs) outside clinical trials. Methods Patients hospitalized for MB while on treatment with VKAs or DOACs were included in a multicenter study to compare clinical presentation, management and outcome of bleeding. The primary study outcome was death at 30 days. Results Between September 2013 and September 2015, 806 patients were included in the study, 76{\%} on VKAs and 24{\%} on DOACs. MB was an intracranial hemorrhage in 51{\%} and 21{\%} patients on VKAs or DOACs, respectively (Odds Ratio [OR] 3.79; 95{\%} confidence interval [CI] 2.59–5.54) a gastrointestinal bleeding in 46{\%} and 25{\%} patients on DOACs and VKAs, respectively (OR 2.62; 95{\%} CI 1.87–3.68). Death at 30 days occurred in 130 patients (16{\%}), 18{\%} and 9{\%} of VKA and DOAC patients (HR 1.95; 95{\%} CI 1.19–3.22, p = 0.008). The rate of death at 30 days was similar in VKA and DOAC patients with intracranial hemorrhage (26{\%} and 24{\%}; HR 1.05, 95{\%} CI 0.54–2.02) and gastrointestinal bleeding (11{\%} and 7{\%}; HR 1.46, 95{\%} CI 0.57–3.74) and higher in VKA than DOAC patients with other MBs (10{\%} and 3{\%}; HR 3.42, 95{\%} CI 0.78–15.03). Conclusions Admission for ICH is less frequent for DOAC patients compared with VKA patients. Admission for gastrointestinal MB is more frequent for DOAC as compared to VKA patients. Mortality seems lower in patients with MBs while on DOACs than VKAs but this finding varies across different types of MBs.",
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AU - Becattini, Cecilia

AU - Franco, Laura

AU - Beyer-Westendorf, Jan

AU - Masotti, Luca

AU - Nitti, Cinzia

AU - Vanni, Simone

AU - Manina, Giorgia

AU - Cattinelli, Sergio

AU - Cappelli, Roberto

AU - Sbrojavacca, Rodolfo

AU - Pomero, Fulvio

AU - Marten, Sandra

AU - Agnelli, Giancarlo

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N2 - Background Limited data are available on major bleeding (MB) occurring during treatment with vitamin K (VKAs) or direct oral anticoagulants (DOACs) outside clinical trials. Methods Patients hospitalized for MB while on treatment with VKAs or DOACs were included in a multicenter study to compare clinical presentation, management and outcome of bleeding. The primary study outcome was death at 30 days. Results Between September 2013 and September 2015, 806 patients were included in the study, 76% on VKAs and 24% on DOACs. MB was an intracranial hemorrhage in 51% and 21% patients on VKAs or DOACs, respectively (Odds Ratio [OR] 3.79; 95% confidence interval [CI] 2.59–5.54) a gastrointestinal bleeding in 46% and 25% patients on DOACs and VKAs, respectively (OR 2.62; 95% CI 1.87–3.68). Death at 30 days occurred in 130 patients (16%), 18% and 9% of VKA and DOAC patients (HR 1.95; 95% CI 1.19–3.22, p = 0.008). The rate of death at 30 days was similar in VKA and DOAC patients with intracranial hemorrhage (26% and 24%; HR 1.05, 95% CI 0.54–2.02) and gastrointestinal bleeding (11% and 7%; HR 1.46, 95% CI 0.57–3.74) and higher in VKA than DOAC patients with other MBs (10% and 3%; HR 3.42, 95% CI 0.78–15.03). Conclusions Admission for ICH is less frequent for DOAC patients compared with VKA patients. Admission for gastrointestinal MB is more frequent for DOAC as compared to VKA patients. Mortality seems lower in patients with MBs while on DOACs than VKAs but this finding varies across different types of MBs.

AB - Background Limited data are available on major bleeding (MB) occurring during treatment with vitamin K (VKAs) or direct oral anticoagulants (DOACs) outside clinical trials. Methods Patients hospitalized for MB while on treatment with VKAs or DOACs were included in a multicenter study to compare clinical presentation, management and outcome of bleeding. The primary study outcome was death at 30 days. Results Between September 2013 and September 2015, 806 patients were included in the study, 76% on VKAs and 24% on DOACs. MB was an intracranial hemorrhage in 51% and 21% patients on VKAs or DOACs, respectively (Odds Ratio [OR] 3.79; 95% confidence interval [CI] 2.59–5.54) a gastrointestinal bleeding in 46% and 25% patients on DOACs and VKAs, respectively (OR 2.62; 95% CI 1.87–3.68). Death at 30 days occurred in 130 patients (16%), 18% and 9% of VKA and DOAC patients (HR 1.95; 95% CI 1.19–3.22, p = 0.008). The rate of death at 30 days was similar in VKA and DOAC patients with intracranial hemorrhage (26% and 24%; HR 1.05, 95% CI 0.54–2.02) and gastrointestinal bleeding (11% and 7%; HR 1.46, 95% CI 0.57–3.74) and higher in VKA than DOAC patients with other MBs (10% and 3%; HR 3.42, 95% CI 0.78–15.03). Conclusions Admission for ICH is less frequent for DOAC patients compared with VKA patients. Admission for gastrointestinal MB is more frequent for DOAC as compared to VKA patients. Mortality seems lower in patients with MBs while on DOACs than VKAs but this finding varies across different types of MBs.

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KW - Apixaban

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KW - Intracranial hemorrhage

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KW - Rivaroxaban

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