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Clinical Studies – Targeting Acute and Chronic Thromboembolic Disorders
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HoT-PE: Early discharge and home treatment of patients with low-risk PE with Xarelto

Major Studies

 
Background

  • PE is a frequent cause of mortality worldwide, with a wide spectrum of severity requiring risk assessment to define the appropriate management strategy
  • One of the most challenging tasks is to identify apparently stable patients whose risk is ‘sufficiently low’ to permit early discharge and ambulatory treatment
  • The HoT-PE trial was designed to address the ongoing change of the paradigm in PE care

Objective

  • To investigate whether early discharge and ambulatory treatment with Xarelto is effective and safe in patients with low-risk PE

Study design

  • A prospective, multicentre, single-arm, phase III study

HoT-PE Study

Endpoints

Primary efficacy outcome

  • Symptomatic recurrent VTE , or PE related death within 3 months of enrolment

Safety outcomes

  • Major bleeding

  • Clinically relevant non-major bleeding

  • Serious adverse events

Secondary efficacy outcomes

  • All-cause mortality

  • Number of re-hospitalisations due to PE or bleeding event

 

Key Findings

  • The primary efficacy outcome of recurrent VTE occurred in 3 of 525 patients in the ITT population (0.6%; P<0.0001)

  • All 3 of these cases presented as non-fatal PE

  • Major bleeding occurred in 6 of 519 patients in the safety population (1.2%)

  • Clinically relevant non-major bleeding occurred in 31 of 519 patients in the safety population (6.0%)

  • No deaths related to PE were reported during the study

     

 

PE , pulmonary embolism; RV, right ventricular; SPC, summary of product characteristics; VTE , venous thromboembolism.

* Additional exclusion criteria included: pain requiring parenteral administration of analgesic agents; non-compliance or inability to adhere to treatment or follow-up visits; lack of family environment or support system; and contraindications to Xarelto as per the SPC.

† Reduction of the maintenance dose to 15 mg OD was possible at the discretion of the treating physician. of cancer in the previous <6 months, or recurrent or metastatic cancer other than fully treated basal cell or squamous cell carcinoma of the skin.

 

PP-XAR-ALL-1825-1

    • 1
      Barco S, et al. Eur Heart J. 2020;41:509–518.
    • a
      Pulmonary embolism (= PE). A potentially fatal condition caused by a blood clot blocking a vessel in the lung: usually the clot originates from a DVT in the legs. PE can result in permanent lung damage. 
    • b
      Venous thromboembolism (= VTE). A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.