1 / 8

Oral rivaroxaban alone for the treatment of symptomatic pulmonary embolism: the EINSTEIN PE study

Oral rivaroxaban alone for the treatment of symptomatic pulmonary embolism: the EINSTEIN PE study. Harry R Büller on behalf of the EINSTEIN Investigators. Disclosures for Harry R Büller. EINSTEIN PE: study design. Predefined treatment period of 3, 6, or 12 months. Day 1. Day 21.

aquila-mendoza
Télécharger la présentation

Oral rivaroxaban alone for the treatment of symptomatic pulmonary embolism: the EINSTEIN PE study

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Oral rivaroxaban alone for the treatment of symptomatic pulmonary embolism: the EINSTEIN PE study Harry R Büller on behalf of the EINSTEIN Investigators

  2. Disclosures for Harry R Büller

  3. EINSTEIN PE: study design Predefined treatment period of 3, 6, or 12 months Day 1 Day 21 Objectively confirmed PE ± DVT 30-day post-study treatment period Rivaroxaban Rivaroxaban N=4833 15 mg bid 20 mg od R Enoxaparin bid for at least 5 days, plus VKA INR 2.5 (range 2.0–3.0) • Primary efficacy outcome: first recurrent VTE • Principal safety outcome: first major or non­major clinically relevant bleeding Randomized, open-label, event-driven, non-inferiority study Up to 48 hours’ heparins/fondaparinux treatment permitted before study entry 88 primary efficacy outcomes needed Non-inferiority margin: 2.0

  4. Patient flow Rivaroxaban Enoxaparin/VKA 2420 2413 2419 2413 2412 2405 2224 2238 66 118 10 8 Randomized (N=4833) ITT population Safety population* Per-protocol population Withdrawal of consent Lost to follow-up *As treated

  5. EINSTEIN PE: primary efficacy outcome analysis HR 1.12 0.75 1.68* 0 1.00 2.00 Rivaroxaban superior Rivaroxaban non-inferior Rivaroxaban inferior p=0.57 for superiority (two-sided) P=0.0026 for non-inferiority (one-sided) *Potential relative risk increase <68.4%; absolute risk difference 0.24% (–0.5 to 1.02)

  6. EINSTEIN PE: principal safety outcome –major or non-major clinically relevant bleeding 15 14 13 12 11 10 9 8 7 6 5 4 3 2 1 0 0 30 60 90 120 150 180 210 240 270 300 330 360 Enoxaparin/VKA N=2405 Rivaroxaban N=2412 Cumulative event rate (%) Time to event (days) Safety population

  7. EINSTEIN PE: major bleeding 3.0 2.5 2.0 1.5 1.0 0.5 0.0 0 30 60 90 120 150 180 210 240 270 300 330 360 Enoxaparin/VKA N=2405 Cumulative event rate (%) Rivaroxaban N=2412 Time to event (days) Safety population

  8. EINSTEIN PE: conclusions • In patients with acute symptomatic PE with or without DVT, rivaroxaban showed: • Non-inferiority to LMWH/VKA for efficacy: HR=1.12 (0.75–1.69); pnon-inferiority=0.0026 for non-inferiority margin of 2.0 • Similar findings for principal safety outcome: HR=0.90 (0.76–1.07); p=0.23 • Superiority for major bleeding: HR=0.49 (0.31–0.79) p=0.0032 • Consistent efficacy and safety results irrespective of age, body weight, gender, kidney function and cancer • No evidence for liver toxicity

More Related