Clinical Studies – Targeting Acute and Chronic Thromboembolic Disorders
HoT-PE: Early discharge and home treatment of patients with low-risk PE with Xarelto
Background1
- 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
Objective1
- To investigate whether early discharge and ambulatory treatment with Xarelto is effective and safe in patients with low-risk PE
Study design1
- A prospective, multicentre, single-arm, phase III study
Endpoints1
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 findings1
- 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.
PP-XAR-ALL-1825-1
References
- Barco S, et al. Eur Heart J. 2020;41:509–518. Barco S, et al. Eur Heart J. 2020;41:509–518. Return to content
