Pulmonary vascular disease & thromboembolism
Early discharge and home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban: an international multicentre single-arm clinical trial
Authors' conclusion
Early discharge and home treatment with rivaroxaban is effective and safe in carefully selected patients with acute low-risk PE.
Study context
- Population
- Patients with acute low-risk PE (no haemodynamic instability, RV dysfunction or intracardiac thrombi, or serious comorbidities)interim analysis
- Participants
- 525 patients
- Primary endpoint
- Symptomatic recurrent VTE or PE-related death
- Follow-up
- Within 3 months of enrolment
Methodological detailsprospective, multicentre, investigator initiated, prespecified interim analysis, 7 countries, Enrolment May 2014 through June 2018, consecutive patients
- Prospective
- Multicentre
- Investigator initiated
- Prespecified interim analysis
- 7 countries
- Enrolment May 2014 through June 2018, consecutive patients
Primary result
As reported in the abstract
3 months
Symptomatic non-fatal venous thromboembolism (VTE) recurrence (525 patients in interim analysis)
3 (0.6%); one-sided upper 99.6% CI 2.1%
Further findings
- Cancer-related deaths
- 2 (0.4%)
Safety
- Major bleeding (safety population, n = 519)
- 6 (1.2%)
Original publication
Early discharge and home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban: an international multicentre single-arm clinical trial. Eur Heart J. Published 23 May 2019. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →