EINSTEIN-PE
Oral Rivaroxaban for the Treatment of Symptomatic Pulmonary Embolism
Patient / Population Intervention / Exposition Vergleich Endpunkt
In 4,832 patients with acute symptomatic pulmonary embolism, single-drug oral rivaroxaban was non-inferior for recurrent venous thromboembolism and halved major bleeding compared with enoxaparin followed by a vitamin K antagonist.
N
4.832
Design
Open-label, event-driven non-inferiority RCT
Endpunkt
Symptomatic recurrent venous thromboembolism
Relevanz
2
Ergebnis2.1 % vs 1.8 % (HR 1.12; 95 % CI 0.75–1.68; p=0.003 for non-inferiority). Major bleeding 1.1 % vs 2.2 % (HR 0.49; 95 % CI 0.31–0.79; p=0.003).
The EINSTEIN-PE Investigators. N Engl J Med. 2012;366(14):1287-1297. 10.1056/NEJMoa1113572
Diskussion & Kritik
Open-label, and haemodynamically unstable patients were excluded, so it says nothing about high-risk PE. It is the trial that made a single-drug oral regimen with no parenteral lead-in possible and, with major bleeding halved, drives the preference for a DOAC over a VKA.