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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.

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

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  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

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