6/28/23, 9:51 PM EINSTEIN-PE Pathway Feedback Search Clinical Topics Home Studies EINSTEIN PE EINSTEIN PE Disease Disease Deep vein thrombosis Pulmonary embolism Trial question Is rivaroxaban noninferior to standard therapy for the treatment of symptomatic PE? Study design Multi-center Open label RCT Population Characteristics of study participants 47.0% female N = 4832 53.0% male 4832 patients (2276 female, 2556 male) Inclusion criteria: patients who had acute symptomatic PE with or without deep vein thrombosis Key exclusion criteria: thrombectomy, vena cava filter placed, contraindication listed in the local labeling of enoxaparin, warfarin, or acenocoumarol, a CrCl < 30 mL/min, acute hepatitis, chronic active hepatitis, or cirrhosis, bacterial endocarditis, active bleeding or a high risk of bleeding Interventions N=2419 rivaroxaban (15 mg BID for 3 weeks, followed by 20 mg once daily) N=2413 vitamin K antagonists (enoxaparin followed by an adjusted-dose vitamin K antagonist) Primary outcome Symptomatic recurrent venous thromboembolism 2.1 % 2.1 https://web.pathway.md/studies/rec3a5FqyimsctZQW 1/2 6/28/23, 9:51 PM EINSTEIN-PE Pathway 1.8 1.6 % 1.1 % Difference not exceeding nonferiority margin 0.5 % 0.0 % Rivaroxaban Vitamin K antagonists Difference not exceeding nonferiority margin in symptomatic recurrent VTE (2.1% vs. 1.8%; HR 1.12, 95% CI 0.75 to 1.68) Secondary outcomes No significant difference in net clinical benefit; VTE plus major bleeding (3.4% vs. 4%; HR 0.85, 95% CI 0.63 to 1.14) Safety outcomes No significant differences in major or clinically relevant nonmajor bleeding (10.3% vs. 11.4%, p=0.23; HR 0.90, 95% CI 0.76-1.07) and other adverse events. Significant differences in major bleeding (1.1% vs. 2.2%, p = 0.003; HR 0.49, 95% CI 0.31- 0.79). Conclusion In patients who had acute symptomatic PE with or without deep vein thrombosis, rivaroxaban was noninferior to vitamin K antagonists with respect to symptomatic recurrent VTE. Reference EINSTEIN-PE Investigators, Buller HR, Prins MH et al. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012 Apr 5;366(14):1287-97. Open reference URL https://web.pathway.md/studies/rec3a5FqyimsctZQW 2/2