{
  "abstract": "Background Current international guidelines suggest andexanet alfa (AA) for the management of factor Xa inhibitor-associated intracranial haemorrhage (ICH). However, those recommendations are based on low-quality evidence and there is uncertainty regarding the net clinical benefit of AA.Methods We conducted a systematic review and meta-analysis including available randomised controlled clinical trials (RCTs) and observational studies that investigated efficacy and safety of AA compared with usual care for the treatment of factor Xa inhibitor-associated ICH. Good haemostatic efficacy, defined as haematoma expansion of ≤35% or ≤6 mL, was the primary outcome. Secondary efficacy outcomes were excellent haemostatic efficacy (≤20% haematoma expansion) and good functional outcome (modified Rankin Scale scores 0–3) at follow-up, while safety outcomes were mortality and thrombotic events at follow-up.Results Eighteen studies (1 RCT) were included comprising a total of 1567 patients treated with AA versus 1969 patients receiving usual care. AA was associated with a higher likelihood of good haemostatic efficacy (RR=1.16; 95% CI=1.06 to 1.26) compared with usual care, while excellent haemostatic efficacy (RR=1.04; 95% CI=0.85 to 1.26) and good functional outcome (RR=0.92; 95% CI=0.53 to 1.62) were similar between the two groups. Regarding safety outcomes, similar rates of mortality (RR=0.77; 95% CI=0.56 to 1.04) and thrombotic events (RR=1.20; 95% CI=0.81 to 1.78) were documented.Conclusions The present meta-analysis suggests AA is associated with improved haemostatic efficacy compared with usual care, with no significant differences observed in functional and safety outcomes. These findings indicate that AA may have a role in the management of factor Xa inhibitor-associated ICH, although further high-quality studies are needed to better define its net clinical benefit.",
  "authors": [
    {
      "affiliations": [
        "Second Department of Neurology, “Attikon” University Hospital, National and Kapodistrian University of Athens, Athens, Greece"
      ],
      "name": "Georgios Tsivgoulis"
    },
    {
      "affiliations": [
        "Department of Medicine (Neurology), McMaster University/Population Health Research Institute, Hamilton, Ontario, Canada"
      ],
      "name": "Aristeidis H Katsanos"
    },
    {
      "affiliations": [
        "Neurology and Stroke Unit, Department of Neurosciences, Bufalini Hospital, Cesena, Italy"
      ],
      "name": "Michele Romoli"
    },
    {
      "affiliations": [
        "Department of Neurology, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA"
      ],
      "name": "Amrou Sarraj"
    },
    {
      "affiliations": [
        "Neurology, Ruhr University Bochum, Bochum, Nordrhein-Westfalen, Germany"
      ],
      "name": "Christos Krogias"
    },
    {
      "affiliations": [
        "Second Department of Neurology, AHEPA University General Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece"
      ],
      "name": "Theodoros Karapanayiotides"
    },
    {
      "affiliations": [
        "Second Department of Neurology, “Attikon” University Hospital, National and Kapodistrian University of Athens, Athens, Greece"
      ],
      "name": "Aikaterini Theodorou"
    },
    {
      "affiliations": [
        "Second Department of Neurology, “Attikon” University Hospital, National and Kapodistrian University of Athens, Athens, Greece"
      ],
      "name": "Maria Ioanna Stefanou"
    },
    {
      "affiliations": [
        "Vall d’Hebron Stroke Center, Department of Neurology, Hospital Vall d’Hebron, Barcelona, Catalunya, Spain"
      ],
      "name": "Carlos A Molina"
    },
    {
      "affiliations": [
        "Neurosurgery, National and Kapodistrian University of Athens, Athens, Attica, Greece"
      ],
      "name": "Marios Themistocleous"
    },
    {
      "affiliations": [
        "Departments of Neurology, Klinikum Frankfurt Höchst , Frankfurt and Heidelberg University Hospital, Heidelberg, Germany"
      ],
      "name": "Thorsten Steiner"
    },
    {
      "affiliations": [
        "Department of Medicine (Neurology), McMaster University/Population Health Research Institute, Hamilton, Ontario, Canada"
      ],
      "name": "Ashkan Shoamanesh"
    },
    {
      "affiliations": [
        "Second Department of Neurology, “Attikon” University Hospital, National and Kapodistrian University of Athens, Athens, Greece"
      ],
      "name": "Lina Palaiodimou"
    }
  ],
  "title": "Efficacy and safety of andexanet alfa for factor Xa inhibitor-associated intracranial haemorrhage",
  "uid": "55bba90d-03df-5ca1-a0d9-247ee12a5813"
}