Combined use of antifibrinolytics and activated prothrombin complex concentrate (aPCC) is not related to thromboembolic events in patients with acquired haemophilia A: data from FAIR Registry

for the FAIR Study Group

Research output: Contribution to journalArticle

Abstract

Antifibrinolytics combined with aPCC are not routinely administered to patients with acquired hemophilia A due to increased thrombotic risk. This association normalizes clot stability, and improves the efficacy of therapy, but can increase the risk of severe side effects. Due to these premises it has always raised doubts and perplexities in the clinics. We now report the data of the “FEIBA® on acquired haemophilia A Italian Registry (FAIR Registry)”, a retrospective-prospective study that included 56 patients. This is the first study that assessed the clinical response of the combination of aPCC and antifibrinolytic agents in patients with acquired haemophilia A. A total of 101 acute bleeds were treated with aPCC. Antifibrinolytic agents were used in the treatment of 39.6% of total bleeds, based on both, a clinical assessment and an evaluation of bleeding. Twenty-five of the 30 patients (57.1%) treated with antifibrinolytic drugs showed serious co-morbidity. Among them, 40% presented severe cardiovascular diseases. All bleeds treated with combined therapy had a shorter duration of treatment (mean reduction 16.3%). All the treated patients presented a good tolerability and no arterial or venous thromboembolic events were reported. In our retrospective registry the combination of antifibrinolytics and aPCC appears safe and effective in the treatment of patients with AHA, especially in the case of severe and life-threatening bleeding, but this hypothesis needs to be confirmed in adequate, larger clinical trials.

Original languageEnglish
JournalJournal of Thrombosis and Thrombolysis
DOIs
Publication statusAccepted/In press - Jan 1 2018

Fingerprint

Antifibrinolytic Agents
Registries
Hemorrhage
Therapeutics
prothrombin complex concentrates
Acquired Factor 8 deficiency
Cardiovascular Diseases
Retrospective Studies
Clinical Trials
Prospective Studies
Morbidity
Pharmaceutical Preparations

Keywords

  • Acquired haemophilia A
  • Activated prothrombin complex concentrate
  • Antifibrinolytics
  • Thromboembolic risk

ASJC Scopus subject areas

  • Hematology
  • Cardiology and Cardiovascular Medicine

Cite this

@article{e1cc976794b542a1be9cda76ee2f9baa,
title = "Combined use of antifibrinolytics and activated prothrombin complex concentrate (aPCC) is not related to thromboembolic events in patients with acquired haemophilia A: data from FAIR Registry",
abstract = "Antifibrinolytics combined with aPCC are not routinely administered to patients with acquired hemophilia A due to increased thrombotic risk. This association normalizes clot stability, and improves the efficacy of therapy, but can increase the risk of severe side effects. Due to these premises it has always raised doubts and perplexities in the clinics. We now report the data of the “FEIBA{\circledR} on acquired haemophilia A Italian Registry (FAIR Registry)”, a retrospective-prospective study that included 56 patients. This is the first study that assessed the clinical response of the combination of aPCC and antifibrinolytic agents in patients with acquired haemophilia A. A total of 101 acute bleeds were treated with aPCC. Antifibrinolytic agents were used in the treatment of 39.6{\%} of total bleeds, based on both, a clinical assessment and an evaluation of bleeding. Twenty-five of the 30 patients (57.1{\%}) treated with antifibrinolytic drugs showed serious co-morbidity. Among them, 40{\%} presented severe cardiovascular diseases. All bleeds treated with combined therapy had a shorter duration of treatment (mean reduction 16.3{\%}). All the treated patients presented a good tolerability and no arterial or venous thromboembolic events were reported. In our retrospective registry the combination of antifibrinolytics and aPCC appears safe and effective in the treatment of patients with AHA, especially in the case of severe and life-threatening bleeding, but this hypothesis needs to be confirmed in adequate, larger clinical trials.",
keywords = "Acquired haemophilia A, Activated prothrombin complex concentrate, Antifibrinolytics, Thromboembolic risk",
author = "{for the FAIR Study Group} and S. Pasca and C. Ambaglio and A. Rocino and C. Santoro and I. Cantori and E. Zanon and S. Siragusa and M. Napolitano and Federici, {A. B.} and L. Mameli and G. Giuffrida and A. Falanga and C. Lodigiani and Santoro, {R. C.}",
year = "2018",
month = "1",
day = "1",
doi = "10.1007/s11239-018-1750-y",
language = "English",
journal = "Journal of Thrombosis and Thrombolysis",
issn = "0929-5305",
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TY - JOUR

T1 - Combined use of antifibrinolytics and activated prothrombin complex concentrate (aPCC) is not related to thromboembolic events in patients with acquired haemophilia A

T2 - data from FAIR Registry

AU - for the FAIR Study Group

AU - Pasca, S.

AU - Ambaglio, C.

AU - Rocino, A.

AU - Santoro, C.

AU - Cantori, I.

AU - Zanon, E.

AU - Siragusa, S.

AU - Napolitano, M.

AU - Federici, A. B.

AU - Mameli, L.

AU - Giuffrida, G.

AU - Falanga, A.

AU - Lodigiani, C.

AU - Santoro, R. C.

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Antifibrinolytics combined with aPCC are not routinely administered to patients with acquired hemophilia A due to increased thrombotic risk. This association normalizes clot stability, and improves the efficacy of therapy, but can increase the risk of severe side effects. Due to these premises it has always raised doubts and perplexities in the clinics. We now report the data of the “FEIBA® on acquired haemophilia A Italian Registry (FAIR Registry)”, a retrospective-prospective study that included 56 patients. This is the first study that assessed the clinical response of the combination of aPCC and antifibrinolytic agents in patients with acquired haemophilia A. A total of 101 acute bleeds were treated with aPCC. Antifibrinolytic agents were used in the treatment of 39.6% of total bleeds, based on both, a clinical assessment and an evaluation of bleeding. Twenty-five of the 30 patients (57.1%) treated with antifibrinolytic drugs showed serious co-morbidity. Among them, 40% presented severe cardiovascular diseases. All bleeds treated with combined therapy had a shorter duration of treatment (mean reduction 16.3%). All the treated patients presented a good tolerability and no arterial or venous thromboembolic events were reported. In our retrospective registry the combination of antifibrinolytics and aPCC appears safe and effective in the treatment of patients with AHA, especially in the case of severe and life-threatening bleeding, but this hypothesis needs to be confirmed in adequate, larger clinical trials.

AB - Antifibrinolytics combined with aPCC are not routinely administered to patients with acquired hemophilia A due to increased thrombotic risk. This association normalizes clot stability, and improves the efficacy of therapy, but can increase the risk of severe side effects. Due to these premises it has always raised doubts and perplexities in the clinics. We now report the data of the “FEIBA® on acquired haemophilia A Italian Registry (FAIR Registry)”, a retrospective-prospective study that included 56 patients. This is the first study that assessed the clinical response of the combination of aPCC and antifibrinolytic agents in patients with acquired haemophilia A. A total of 101 acute bleeds were treated with aPCC. Antifibrinolytic agents were used in the treatment of 39.6% of total bleeds, based on both, a clinical assessment and an evaluation of bleeding. Twenty-five of the 30 patients (57.1%) treated with antifibrinolytic drugs showed serious co-morbidity. Among them, 40% presented severe cardiovascular diseases. All bleeds treated with combined therapy had a shorter duration of treatment (mean reduction 16.3%). All the treated patients presented a good tolerability and no arterial or venous thromboembolic events were reported. In our retrospective registry the combination of antifibrinolytics and aPCC appears safe and effective in the treatment of patients with AHA, especially in the case of severe and life-threatening bleeding, but this hypothesis needs to be confirmed in adequate, larger clinical trials.

KW - Acquired haemophilia A

KW - Activated prothrombin complex concentrate

KW - Antifibrinolytics

KW - Thromboembolic risk

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U2 - 10.1007/s11239-018-1750-y

DO - 10.1007/s11239-018-1750-y

M3 - Article

AN - SCOPUS:85054321297

JO - Journal of Thrombosis and Thrombolysis

JF - Journal of Thrombosis and Thrombolysis

SN - 0929-5305

ER -