Effectivity and Safety of Different Anticoagulants in Patients With Thromboembolic Antiphospholipid Syndrome
Condition: Antiphospholipid Syndrome; Venous Thromboembolism; Arterial Thromboembolism; Major Bleed
MeSH terms: Thromboembolism; Venous Thromboembolism; Antiphospholipid Syndrome; Syndrome
Study type: Observational

Summary: 
      Retrospective monocentric registry to evaluate the efficacy and safety of different
      anticoagulants in patients with thromboembolic antiphospholipid syndrome
    

Detailed description: 
      Antiphospholipid syndrome is a thrombophilic diathesis characterised by the occurrence of
      recurrent, unprovoked thromboembolic events (arterial, venous, microvascular) in combination
      with the presence of specific APS antibodies.

      A distinction is made between different subtypes of APS. One is the thrombotic
      antiphospholipid syndrome (APS), which is the focus of the registry, and the other is
      obstetric APS, which is characterised by obstetric complications.

      The particular challenge in dealing with APS patients is to establish an adequate therapy
      regime, as some patients suffer from an increased risk of recurrent thrombosis despite
      anticoagulation and/or aggregation inhibition.

      The standard medication for antiphospholipid syndrome is based on the use of vitamin K
      antagonists (VKA). This regimen is essential to follow, especially in high-risk patients with
      positive lupus anticoagulants and/or triple positive antiphospholipid antibodies.

      In 2019, a 'Red Hand Letter' was issued advising against treating APS patients with direct
      oral anticoagulants (DOACs) but so far some studies suggest that alternative anticoagulation
      with DOACs may be beneficial in a selected patient population with a single- or
      double-positive antiphospholipid antibody profile.

      However, the current data on the use of DOAKs in patients with antiphospholipid syndrome is
      still limited. Therefore, the analysis of the patient data available in the investigator's
      specialised coagulation centre in the form of the APSantiCO registry should help to select a
      suitable anticoagulant regimen in everyday clinical practice.

      The clinical and laboratory data required for the creation of the register are already
      available for evaluation in the form of electronic medical records, as the Coagulation Centre
      of the CCB Bethanien Hospital, which was founded in 2015, has been providing outpatient care
      to numerous APS patients for years. The data regarding the recording of recurrent thromboses
      despite anticoagulation and major bleeding under the various anticoagulants are collected
      with the help of a differentiated study of records. In addition, telephone contact is made
      with the patients. The telephone contact takes place within the framework of routine quality
      assurance in order to ensure optimal patient care, since many patients were unable or
      unwilling to attend their semi-annual or annual routine check-ups in the last two years due
      to the COVID 19 pandemic situation.

      In the course of the telephone call, it should therefore be clarified whether a new
      appointment is needed, e.g. in case of a new event under the existing medication since the
      last presentation at the coagulation centre or in case of the occurrence of undesirable side
      effects and bleeding.

      Apart from this telephone call, no patient contact is foreseen.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Consecutive patients with confirmed thromboembolic antiphospholipid-syndrome who need
        anticoagulation and/or aggregation inhibition
      
Keywords: direct oral anticoagulant; vitamin k antagonist; antiphospholipid syndrome; thrombosis; major bleeding