The HoT-PE trial was a prospective, international, multicentre, single-arm phase 4 trial with 3-month follow-up (plus 1-year follow-up for survival). Primary outcome was recurrent symptomatic venous thromboembolism (VTE), or death due to recurrent PE, within 3 months of enrolment. A total of 525 patients with objectively confirmed PE within 24 hours of presentation were enrolled. These patients received the first dose of rivaroxaban 15 mg twice daily in the hospital and continued for 3 weeks after discharge, followed by rivaroxaban once daily 20 mg, or 15 mg in select patients for at least 3 months. The mean age of patients was 56.7 years, 45.7% were female, 98.5% were white, and 6.2% had active cancer.
The primary efficacy outcome of recurrent symptomatic VTE or fatal PE within 3 months occurred in 0.6% of the intent-to-treat population (these 3 events were all cases of recurrent PE). Furthermore, 2.3% of patients were hospitalised as a result of suspected recurrent PE or bleeding. Safety outcomes showed low rates of adverse events, such as major bleeding (6/519 patients), any clinically relevant bleeding (31/519 patients), and at least one serious adverse event (8/519 patients). There were 2 deaths during the trial; these were both caused by advanced cancer. These findings support selecting of appropriate PE patients for ambulatory treatment with a direct oral anticoagulant, which helps to reduce hospital-related complications and rationalise the use of healthcare resources.
1. Konstantinides SV, et al. Abstract 402-16. ACC 2019, 16-18 March, New Orleans, USA.
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