Rivaroxaban nella trombosi venosa profonda e nell embolia polmonare il single drug approach. Claudio Ferri. Università dell Aquila

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1 Capri Conference 2.0 Capri 28/29 Marzo 2014 nella trombosi venosa profonda e nell embolia polmonare il single drug approach Claudio Ferri Università dell Aquila Cattedra e Scuola di Medicina Interna Dipartimento MeSVA UOC di Medicina Interna e Nefrologia Ospedale San Salvatore

2 DVT and pulmonary embolism 1. Vascular damage (Endothelial) 2. Abnormal blood flow (Stasis) 3. Hypercoagulability (Trombophilia) Rudolph Carl Virchow ( )

3 DVT and pulmonary embolism Pulmonary Embolism Migration Embolization Thrombus DVT

4 DVT and pulmonary embolism: Meta-analysis (8 studies, patients), modified DVT incidence = 1-2 cases per persons per year VKA 3-folds increment bleedings -85% recurrence 5-folds reduction PE Intracranial bleedings about 8% of major bleedings (mortality about 46%)

5 Direct Thrombin inhibition XIIa XIa VIIa Tissue factor IXa Xa II Factor IIa (thrombin) Dabigatran

6 Direct Thrombin inhibition Major bleeding (HR 0.52; 95% CI, 0.27 to 1.02; p<0.001) Recurrent venous thromboembolism (HR 1.44; 95% CI, 0.78 to 2.64; P=0.01 for noninferiority). Major or clinically relevant bleeding (HR 0.54) Schulman S et al. N Engl J Med Feb 21;368(8):

7 Direct Factor Xa inhibition XIIa XIa IXa Xa Factor II (prothrombin) VIIa Apixaban Edoxaban Betrixaban.. Tissue factor Fibrinogen Fibrin clot

8 Agnelli G et al (Amplify Investigators). N Engl J Med. 2013;369(9): doi: /NEJMoa Efficacy Outcomes Direct Factor Xa inhibition - Apixaban Apixaban n=2609 Enoxaparin/ Warfarin n=2635 First recurrent VTE or VTErelated death, n (%) 59 (2.3) 71 (2.7) 0.84 ( ) < Noninferiority Index event: DVT 38/1698 (2.2) 47/1736 (2.7) 0.83 ( ) Index event: PE DVT 21/900 (2.3) 23/886 (2.6) 0.90 ( ) VTE or CV-related death, n (%) VTE or all-cause death, n (%) 61 (2.3) 77 (2.9) 0.80 ( ) 84 (3.2) 104 (4.0) 0.82 ( )

9 Direct Factor Xa inhibition - Apixaban Agnelli G et al (Amplify Investigators). N Engl J Med. 2013;369(9): doi: /NEJMoa

10 Direct Factor Xa inhibition - Edoxaban Edoxaban Warfarin (HR 0.89; 95% CI, 0.70 to 1.13; P<0.001 for noninferiority) Overall On-Rx TTR : 63.5% Number at Risk: Edoxaban Overall Warfarin Overall Edoxaban On-tx Warfarin On-tx The Hokusai-VTE Investigators. N Engl J Med 2013

11 Direct Factor Xa inhibition - Edoxaban Outcome First major or clinically relevant non-major bleeding, n (%) Major bleeding, n (%) Fatal Non-fatal in critical sites Non-fatal in non-critical sites Edoxaban (N=4118) Warfarin (N=4122) Relative risk (95% CI) 349 (8.5) 423 (10.3) 0.81 ( ) * 56 (1.4) 2 (<0.1) 13 (0.3) 41 (1.0) 66 (1.6) 10 (0.2) 25 (0.6) 33 (0.8) 0.84 ( ) # Clinically relevant non-major bleeding, n (%) 298 (7.2) 368 (8.9) 0.80 ( ) * Any bleeding, n (%) 895 (21.7) 1056 (25.6) 0.82 ( ) * P=0.004, # P=0.35, P<0.001 for superiority The Hokusai-VTE Investigators. N Engl J Med 2013

12 Reimbursement Apixaban Dabigatran - Conditio sine qua non: Any NV-AF Apixaban and Dabigatran - Only permanent NV-AF Conditio sine qua non: >65 years Apixaban Any age Dabigatran and Group 1. Eligibility: CHA 2 DS 2 -VASC >1 Dabigatran, > 3 Apixaban, >3 HAS Bled > 3 Apixaban, Dabigatran, Group 2. Eligibility : TTR last 6 months < 70% Apixaban and Dabigatran, < 60% Group 3. Eligibility: VKA treatment is not feasible due to any problem related to INR blood sampling-control : DVT treatment and prevention of DVT recurrence and PE after DVT (adults)

13 Record 2: Extended thromboprophylaxis with rivaroxaban compared with short-term thromboprophylaxis with low molecular weight heparin after total hip arthroplasty Double blind R S U R G E R Y Evening before surgery 10 mg od 6 8 hours post-surgery 6 8 hours post-surgery Enoxaparin 40 mg od Oral placebo Mandatory bilateral venography F O L L O W U P Day 1 Day 36±4 Day 65+5 Inclusion criteria Patients aged 18 years, scheduled to undergo elective THR Major exclusion criteria Active bleeding or high risk of bleeding Significant liver disease Anticoagulant therapy that could not be stopped Use of HIV-protease inhibitors

14 Incidence (%) Record 2 - Results 10 8 Total VTE 10 mg once daily Enoxaparin 40 mg once daily 6 Major VTE % Symptomatic VTE RRR 78.9% RRR 87.8% RRR 80.1% 2.0% 5.1% 0.6% 1.2% 0.2% 0.1% 0.1% Major bleeding

15 Record 1: Oral rivaroxaban compared with subcutaneous enoxaparin for extended thromboprophylaxis after total hip arthroplasty Double blind R S U R 6 8 hours post-surgery G E 6 8 hours post-surgery R Y Evening before surgery 10 mg od Enoxaparin 40 mg od Mandatory bilateral venography Day 1 Day 36±4 F O L L O W U P Up to Day 65 Inclusion criteria Patients aged 18 years, scheduled to undergo elective THR Major exclusion criteria Last dose, day before venography Active bleeding or high risk of bleeding Significant liver disease Anticoagulant therapy that could not be stopped Use of HIV-protease inhibitors

16 Incidence (%) Record 1 - Results 5 4 Total VTE RRR 70% 10 mg once daily Enoxaparin 40 mg once daily Major VTE RRR 88% Symptomatic VTE Major bleeding 0 3.7% 1.1% 2.0% 0.2% 0.5% 0.3% 0.1% 0.3%

17 Clinical programme overview: 50,000 patients to be enrolled VTE prevention after major orthopaedic surgery VTE prevention in hospitalized medically ill patients Phase II ODIXa-HIP1 ODIXa-HIP2 ODIXa-KNEE ODIXa-OD-HIP Phase III RECORD1 RECORD2 RECORD3 RECORD4 VTE treatment Stroke prevention in atrial fibrillation Secondary prevention of acute coronary syndromes ODIXa-DVT EINSTEIN-DVT EINSTEIN-DVT EINSTEIN-PE EINSTEIN-EXT Japanese Phase III study

18 EINSTEIN DVT: Primary outcome by subgroups No. events (n/n) Enox/V KA (n/n) 36/1,731 51/1,718 HR (95% CI) 0.68 (0.44 to 1.04) Outcome Enoxaparin/VKA HR Net clinical benefit: primary efficacy outcome + major bleeding EINSTEIN DVT: Net clinical benefit and total mortality n/n (%) n/n (%) (95% CI) 51/1,731 (2.9) 73/1,718 (4.2) 0.67 ( ) Total mortality 38/1,731 (2.2) 49/1,718 (2.9) 0.67 ( ) Cardiovascular events 12/1,718 (0.7) 14/1,711 (0.8) 0.79 ( ) EINSTEIN Investigators. N Engl J Med (26):

19 EINSTEIN PE: study design 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 Predefined treatment period of 3, 6, or 12 months Day 1 Day 21 Objectively confirmed PE ± DVT N=4833 R 15 mg bid 20 mg od Enoxaparin bid for at least 5 days, 30-day poststudy treatment period plus VKA INR 2.5 (range ) Primary efficacy outcome: first recurrent VTE Principal safety outcome: first major or nonmajor clinically relevant bleeding

20 EINSTEIN PE: Primary efficacy (N=2419) Enoxaparin/VKA (N=2413) n (%) n (%) First symptomatic recurrent VTE 50 (2.1) 44 (1.8) Recurrent DVT 18 (0.7) 17 (0.7) Recurrent DVT + PE 0 2 (<0.1) Non-fatal PE 22 (0.9) 19 (0.8) Fatal PE/unexplained death where PE cannot be ruled out 10 (0.4) 6 (0.2) HR * superior p=0.57 for superiority (two-sided) non-inferior p= for non-inferiority (one-sided) inferior *Potential relative risk increase <68.4%; absolute risk difference 0.24% ( 0.5 to 1.02)

21 Cumulative event rate (%) EINSTEIN PE: principal safety outcome major or non-major clinically relevant bleeding 15 Enoxaparin/VKA 14 N= EINSTEIN PE: 9 8 N= Enoxaparin/VKA HR (95% CI) 5 n/n (%) n/n (%) p-value / / ( ) 2 (10.3) (11.4) p= Time to event (days) Number of patients at risk Enoxaparin/VKA Safety population

22 Cumulative event rate (%) EINSTEIN PE: major bleeding 3.0 n/n (%) Enoxaparin/VKA n/n (%) HR (95% CI) p-value /2412 (1.1) 52/2405 (2.2) 0.49 ( ) p= Enoxaparin/VKA N= N=2412 Safety population Time to event (days) Number of patients at risk Enoxaparin/VKA

23 Percentage Compliance/adherence rates in mixed therapeutic areas P < among dose schedules Claxton AJ, Clin Ther 2001,23,8:

24 DVT costs - ITALY DVT treatment Drugs (7 months) INR monitoring (7 months) TOTAL LMWE/VKA Acute phase (10 days) Post-acute phase Only LMWE EBPM: enoxaparina; dosaggio medio: 100 UI axa/kg di peso corporeo BID; per un adulto di 70 Kg: costo medio/die: 9.22 (prezzo massimo di cessione al SSN) Fase acuta: enoxaparina + warfarin Fase post-acuta: solo warfarin; dosaggio medio: 5mg/die; costo medio/die: 0.07 Il costo della terapia con rivaroxaban è stato calcolato assumendo 2,2 (costo medio europeo dei prezzi in Germania, UK, Danimarca, Spagna, Francia, Irlanda, Belgio, Austria) I costi del monitoraggio dell INR per warfarin sono stati calcolati sulla base delle tariffe nazionali/regionali e assumendo una frequenza del controllo da 11 visite (1 visita ogni 20 giorni) a 30 visite visita alla settimana).

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