Use of Fondaparinux Off-Label or Approved Anticoagulants for Management of Heparin-Induced Thrombocytopenia

Schindewolf, Marc; Steindl, Julia; Beyer‐Westendorf, Jan; Schellong, Sebastian; Dohmen, Pascal M.; Brachmann, Johannes; Madlener, Katharina; Pötzsch, Bernd; Klamroth, Robert; Hankowitz, Johannes; Banik, Norbert; Eberle, Sonja; Müller, Markus; Kropff, Stefan; Lindhoff-Last, Edelgard

doi:10.1016/j.jacc.2017.09.1099

Cited by 62 publications

(47 citation statements)

References 49 publications

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“…The remaining nine studies were included in this review15, 16, 17, 18, 19, 20, 21, 22, 23 (Table 1). …”

Section: Resultsmentioning

confidence: 99%

“…The SRA was used to confirm HIT in all patients in two studies,15, 16 and in selected patients in three studies 19, 20, 22. The HIPA was used in one study23; therefore, a total of 68 patients with HIT confirmed by the combination of a functional assay plus moderate/high clinical pretest probability were included in this review. All studies used either a commercial or in‐house ELISA and two studies used additional HIT antibody tests (e.g, ID‐PaGIA) 16, 18.…”

Section: Resultsmentioning

confidence: 99%

“…This discrepancy is not surprising given the larger denominator of treated patients in the current analysis (additional 118 patients). Importantly, this updated review provides reassurance that a larger proportion of patients truly had HIT due to the inclusion of three studies that confirmed HIT with functional assays (64 patients)15, 16, 23 and two others that used the combination of a moderate or high 4Ts score combined with a positive ELISA to confirm HIT (44 patients) 19, 20…”

Section: Discussionmentioning

confidence: 99%

“…With respect to bleeding, it is noteworthy that at least some of the included patients who experienced major bleeds had evidence of renal insufficiency at the time of the event 23. Due to limited clinical details, it is not possible to provide an accurate proportion.…”

Section: Discussionmentioning

confidence: 99%

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Systematic review of fondaparinux for heparin‐induced thrombocytopenia: When there are no randomized controlled trials

Linkins

Warkentin

2018

Research and Practice in Thrombosis and Haemostasis

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BackgroundFondaparinux is commonly used for treatment of heparin‐induced thrombocytopenia (HIT) despite lack of approval for this indication. High quality randomized controlled trials of this agent are unlikely to be forthcoming.ObjectivesThe objective of this systematic review is to update the literature on the efficacy and safety of fondaparinux for treatment of confirmed and probable HIT based on the available evidence.MethodsPrimary articles were identified using Web of Science and PubMed database searches for English‐language studies from January 2006 to November 2017. Selected studies enrolled consecutive adult patients who received fondaparinux as the primary anticoagulant to treat acute HIT; confirmed the diagnosis by serological testing with a serotonin‐release assay; heparin‐induced platelet activation assay or enzyme‐linked immunosorbent assay; provided clinical criteria used to define HIT and reported clinically important outcomes.ResultsA total of 9 studies were identified with 154 HIT positive patients. Ten experienced a new thrombotic event while receiving fondaparinux (6.5%, 95% CI, 3.4 to 11.7%) and 26 experienced major bleeding (16.9%, 95% CI, 11.7 to 23.6%). Mortality due to thrombosis or bleeding was reported in 5 patients (3.2%, 95% CI, 1.2 to 7.6%).ConclusionsFondaparinux appears to be an effective and safe anticoagulant for treatment of acute HIT despite the absence of randomized trials. Caution should exercised when using fondaparinux in patients with renal insufficiency.

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“…The remaining nine studies were included in this review15, 16, 17, 18, 19, 20, 21, 22, 23 (Table 1). …”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Systematic review of fondaparinux for heparin‐induced thrombocytopenia: When there are no randomized controlled trials

Linkins

Warkentin

2018

Research and Practice in Thrombosis and Haemostasis

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“…Schindewolf et al 10 avaliaram o uso de anticoagulação alternativa em pacientes com TIH de intermediário e alto risco (EPW > 4 pontos), demonstrando que o Fondaparinux foi mais efetivo que argatroban, lepirudin e danaparoid na prevenção de complicações trombóticas (11,7% x 0%), prevenção de morte durante internamento hospitalar (14,4% x 0%) e apresentou menor taxa de sangramento (6,3% x 4,8%). Esses resultados, compatíveis com outros estudos na literatura, sugerem benefício no uso do Fondaparinux como anticoagulação alternativa em pacientes com TIH, embora não exista ainda recomendação formal 11 .…”

Section: Tratamento E Manejo Clínicounclassified

Trombocitopenia induzida por heparina: do diagnóstico ao tratamento

Santos

Bezerra

2018

Rev. Med. (São Paulo)

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Santos MAO, Bezerra LS. Trombocitopenia induzida por heparina: do diagnóstico ao tratamento / Heparin induced thrombocytopenia: diagnosis and treatment. Rev Med (São Paulo). 2018 mar.-abr.;97(2):160-4. Diretor Científico do Grupo de RESUMO:A heparina é largamente utilizada na prática clínica como droga anticoagulante. Trombocitopenia induzida por heparina (TIH) é uma síndrome imune-hematológica que resulta na ativação plaquetária decorrente do uso de heparina, com uma incidência em torno de 1 a 6%. Pode ser classificada em tipo I e II, sendo esta mais grave e potencialmente letal. O somatório de achados clínicos e laboratoriais compatíveis com HIT e positividade para anticorpo HIT é necessário para confirmação diagnóstica. A escala de probabilidade de Warkentin auxilia no diagnóstico de TIH, com alto valor preditivo negativo. Uma abordagem adequada incluindo a suspensão precoce da heparina é mandatória. O esquema de anticoagulação alternativa se faz necessário, com preferência pelo uso dos inibidores diretos da trombina. O uso de fondaparinux nesse contexto mostrou benefícios, embora sejam necessários ensaios clínicos randomizados para melhor nível de evidência.Descritores: Trombocitopenia; Trombocitopenia/diagnóstico; Trombocitopenia/terapia; Heparina; Anticogulantes. ABSTRACT:Heparin is the most common anticoagulant drug used in the clinical practice. Heparin-induced thrombocytopenia (HIT) is an immuno-hematologic syndrome that results from platelets activation in patients under heparin therapy. The incidence of HIT is about 1 to 6%. It might be classified in type I and II, this last is potentially lethal. Clinical and laboratorial findings are both mandatory to diagnostic confirmation, as well as positivity for HIT antibody. The Warkentin probability scale helps on HIT diagnosis and has a high negative predictive value. A clinical approach that includes heparin discontinuation is mandatory. An alternative anticoagulation therapy must be initiated and the direct inhibitors of thrombin are the preferred drugs. Foundaparinux has showed benefits in this context, although randomized clinical trials are needed for better evidence.

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Comparative effectiveness and safety of anticoagulants for the treatment of heparin‐induced thrombocytopenia

et al. 2021

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Background The effectiveness and safety of non‐heparin anticoagulants for the treatment of heparin‐induced thrombocytopenia (HIT) are not fully established, and the optimal treatment strategy is unknown. In a systematic review and meta‐analysis, we aimed to determine precise rates of platelet recovery, new or progressive thromboembolism (TE), major bleeding, and death for all non‐heparin anticoagulants and to study potential sources of variability. Methods Following a detailed protocol (PROSPERO: CRD42020219027), EMBASE and Medline were searched for all studies reporting clinical outcomes of patients treated with non‐heparin anticoagulants (argatroban, danaparoid, fondaparinux, direct oral anticoagulants [DOAC], bivalirudin, and other hirudins) for acute HIT. Proportions of patients with the outcomes of interest were pooled using a random‐effects model for each drug. The influence of the patient population, the diagnostic test used, the study design, and the type of article was assessed. Results Out of 3194 articles screened, 92 studies with 119 treatment groups describing 4698 patients were included. The pooled rates of platelet recovery ranged from 74% (bivalirudin) to 99% (fondaparinux), TE from 1% (fondaparinux) to 7% (danaparoid), major bleeding from 1% (DOAC) to 14% (bivalirudin), and death from 7% (fondaparinux) to 19% (bivalirudin). Confidence intervals were mostly overlapping, and results were not influenced by patient population, diagnostic test used, study design, or type of article. Discussion Effectiveness and safety outcomes were similar among various anticoagulants, and significant factors affecting these outcomes were not identified. These findings support fondaparinux and DOACs as viable alternatives to conventional anticoagulants for treatment of acute HIT in clinical practice.

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Use of Fondaparinux Off-Label or Approved Anticoagulants for Management of Heparin-Induced Thrombocytopenia

Cited by 62 publications

References 49 publications

Systematic review of fondaparinux for heparin‐induced thrombocytopenia: When there are no randomized controlled trials

Systematic review of fondaparinux for heparin‐induced thrombocytopenia: When there are no randomized controlled trials

Trombocitopenia induzida por heparina: do diagnóstico ao tratamento

Comparative effectiveness and safety of anticoagulants for the treatment of heparin‐induced thrombocytopenia

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