LA TERAPIA DEL TROMBOEMBOLISMO VENOSO

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1 LA TERAPIA DEL TROMBOEMBOLISMO VENOSO Pavia 13 giugno 2014 Domenico Prisco SOD Patologia Medica AOU Careggi, Firenze DMSC, Università di Firenze

2 Pharmacological VTE TREATMENT - UFH - LMWHs - Fondaparinux - VKAs - Aspirin - New anticoagulants (dabigatran, rivaroxaban, apixaban, edoxaban) - Thrombolysis Non pharmacological - Surgery (embolectomy, thrombectomy) - Interventional radiology (mechanical fragmentation, thrombosuction) - IVCFs Imberti, Th Res, 2012

3 Treatment of VTE (DVT & PE): current practice Thrombolysis LMWH Fondaparinux Unfractionated heparin Initial treatment vitamin K antagonists INR or Long term-treatment Extended* treatment 5 days at least 3 months indefinite* * With re-assessment of the individual risk-benefit at periodic intervals Agnelli & Becattini, N Engl J Med 2010

4 Treatment for pulmonary embolism Adam Torbicki Arnaud Perrier S Konstantinides Giancarlo Agnelli Nazareno Galié Piotr Pruszczyk

5 Embolia polmonare: scelta del trombolitico Nessun agente o regime di trattamento ha mostrato superiorità in termini di efficacia Alteplasi è comunque l unico agente trombolitico approvato dalla Food and Drug Adminstration per il trattamento dell embolia polmonare massiva.

6 Alteplasi ed embolia polmonare emodinamicamente instabile Al momento della decisione di intraprendere la terapia sospendere la somministrazione di eparina ed ottenere aptt di base. Intraprendere infusione continua di Alteplasi (100 mg in 2 ore). La somministrazione di boli non ha mostrato vantaggi rispetto al regime di infusione continua (Sors H et al; Chest 1994). Al termine infusione misurare di nuovo aptt aptt < 80 secondi: riprendere infusione di eparina senza bolo. aptt > 80 secondi: effettuare nuovo controllo in 4 ore. La somministrazione loco-regionale mediante catetere in arteria polmonare non ha mostrato vantaggi rispetto a quella sistemica in accordo ai risultati idi un singolo trial (Verstraete et al; Circ. 1988)

7 Controindicazioni alla terapia fibrinolitica Controindicazioni assolute: Stroke emorragico o di origine sconosciuta Stroke ischemico nei precedenti 6 mesi Danno o neoplasia del sistema nervoso centrale Recente trauma maggiore/ chirurgia maggiore/ trauma cranico (nelle precedenti 3 settimane) Sanguinamento gastrointestinale nell ultimo mese Sanguinamento noto Le controindicazioni considerate assolute possono diventare relative in un paziente con alto rischio di EP con indicazione al trattamento immediato

8 Risk stratification-driven clinical management Clinical features Shock or sustained hypotension: - systolic BP<90mmHg - pressure drop of 40 mmhg >15 minutes Hemodynamically unstable Proceed to thrombolysis or surgery or catheter embolectomy Hemodynamically stable Stratify for adverse outcome Markers of RV Dysfunction Echocardiography MDCT BNP levels Injury Troponin All Absent Continue anticoagulation and consider early discharge or home treatment Dysfunction or injury Continue anticoagulation Medical ward admission Dysfunction & Injury present Consider ICU admission and/or thrombolysis in patients at low bleeding risk

9 International, multicenter study aimed at assessing the efficacy and safety of TNK versus placebo in patients with acute pulmonary embolism, normal blood pressure and right ventricle overload

10 PEITHO study

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13 FASI E SCOPI DEL TRATTAMENTO DELLA TVP PROSSIMALE Antithrombotic Therapy for VTE Disease. Kearon C et al, Chest 2012; 141(2)(Suppl):e419S e494s Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Fase iniziale: prevenire estensione trombosi ed embolia Lungo termine: prevenire recidive precoci Estesa: prevenire recidive tardive/non correlate all'evento iniziale

14 TERAPIA INIZIALE DELLA TVP PROSSIMALE: QUALE FARMACO E COME? 6 opzioni: con monitoraggio: Eparina non frazionata (ENF) EV o SC (fino agli anni 90) senza monitoraggio: ENF SC Eparine a basso peso molecolare (EBPM) SC Fondaparinux SC (dagli anni 2000) Rivaroxaban per OS: senza monitoraggio (2010)

15 TERAPIA INIZIALE DELLA TVP PROSSIMALE: DOVE? Tipo di farmaco, via di somministrazione, necessità di monitoraggio può condizionare scelta tra ricovero ospedaliero vs. gestione a domicilio

16 Initial and long term treatment of VTE 5-7 days UFH LMWH UFH Monitor APTT ( x control) Fondaparinux 4-5 days Warfarin Monitor INR ( ) Monitor INR ( ) start 3-6 months Kearon, Chest, 2008

17 Real-life treatment of acute VTE: RIETE registry Treatment PE±DVT Isolated DVT p (n=20,543) (n=21,283) Thrombolytics 0.9% 0.1% <0.001 UFH 12% 2.9% <0.001 LMWH 85% 95% <0.001 Fondaparinux 1.3% 1.6% VKA 73% 67% <0.001 Lecumberri R et al Thromb Haemost 2013

18 TERAPIA INIZIALE DELLA TVP PROSSIMALE: Antithrombotic Therapy for VTE Disease. Kearon C et al, Chest 2012; 141(2)(Suppl):e419S e494s Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines NB: se edema e dolore severi, può essere necessario ritardare deambulazione

19 TERAPIA INIZIALE DELLA TVP PROSSIMALE: Antithrombotic Therapy for VTE Disease. Kearon C et al, Chest 2012; 141(2)(Suppl):e419S e494s Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Compression stockings with ankle pressure of 30 to 40 mm Hg and a lower pressure higher up the leg (ie, graduated pressure) should be started as soon as feasible after starting anticoagulant therapy (within 2 weeks).

20 Venous thromboembolic diseases: the management of venous thromboembolic diseases and the role of thrombophilia testing. National Clinical Guideline Centre - June 2012 National Institute of Clinical Excellence Contraindications:

21 Blood. 2012;119: CES-related side effects (ie, itching, erythema, or allergic reaction) developed in 55 (40.7%) of the 135 patien allocated to the thigh-length CES and in 36 (27.3%) of thos randomized to the below-knee group (P =.017), and led to premature discontinuation of their use in 29 (21.5%) and 18 (13.6% patients, respectively (P =0.11).

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26 Vitamin K antagonists major drawbacks Unpredictable response Narrow therapeutic window (INR range 2-3) Routine coagulation monitoring Frequent dose adjustments Warfarin therapy has several limitations that make it difficult to use in practice Slow onset/offset of action Numerous food-drug interactions Numerous drug-drug interactions Risk of Bleeding Complications

27 Features of novel oral anticoagulants Dabigatran 1 Rivaroxaban 1,2 Apixaban 1,3 Edoxaban 4-6 Target IIa (thrombin) Xa Xa Xa Hours to Cmax CYP metabolism None 32% Minimal <4% Bioavailability 6% 80% 60% 62% Transporters P-gp P-gp/BCRP P-gp/ BCRP P-gp Protein binding 35% 93% 87% 50% Half-life h (BD) 7-11 h (QD/BD) 8-15 h (BD) 8-10 h (QD) Renal elimination 80%* 33% # 25% # 35% # BCRP, breast cancer resistance protein CYP, cytochrome P450; P-gp, P-glycoprotein NR, not reported * Of absorbed substance # Of ingested substance 1. Eriksson et al. Clin Pharmacokinet 2009;48:1-22; 2. Xarelto [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; 2011; 3. ELIQUIS Summary of Product Characteristics. Bristol Myers Squibb/Pfizer EEIG, UK; 4. Ruff et al. Hot Topics in Cardiology 2009;18:1-32; 5. Matsushima et al. Am Assoc Pharm Sci 2011; abstract; 6. Ogata et al. J Clin Pharmacol 2010;50:743-53

28 Treatment of acute VTE with new anticoagulants: possible options Start with standard parenteral drugs (i.e. LMWHs) for the initial therapy before the new compound Start therapy with an intensive regimen of the new compound for the first weeks ( single drug approach )

29 Acute VTE treatment Phase III Clinical Program Overview THRIVE Ximelagatran VAN GOGH Idraparinux CASSIOPEA * Idrabiotaparinux RECOVER, * RECOVER II * AMPLIFY Dabigatran Apixaban HOKUSAI * Edoxaban EINSTEIN PE EINSTEIN DVT Rivaroxaban * INITIAL PARENTERAL TREATMENT

30 Acute VTE treatment Phase III Clinical Program Overview THRIVE * VAN GOGH * CASSIOPEA Ximelagatran Idraparinux Idrabiotaparinux RECOVER, RECOVER II AMPLIFY * Dabigatran Apixaban HOKUSAI EINSTEIN PE * EINSTEIN DVT * Edoxaban Rivaroxaban * SINGLE DRUG APPROACH

31 Estimated cumulative risk (%) Cumulative incidence (%) Rationale for intensified initial treatment in phase III VTE treatment studies Evidence of early recurrent VTE in THRIVE study with ximelagatran Ximelagatran 36 mg bid 1 Enoxaparin 1 mg/kg bid 5 20 days/ warfarin (INR ) Time after randomization (days) Evidence of early recurrent VTE in the van Gogh PE study with idraparinux Days Idraparinux 2.5 mg once weekly Standard therapy* Early separation of the curves indicates the need for intensified anticoagulant treatment in the acute phase *Heparin followed by an adjusted-dose VKA for either 3 or 6 months 1. Fiessinger J-N et al. JAMA The van Gogh Investigators. N Engl J Med 2007

32 NOAC VTE: study designs RE-COVER I 1 EINSTEIN-DVT 3 AMPLIFY 5 Hokusai-VTE 6 RE-COVER II 2 EINSTEIN-PE 4 Study drug Dabigatran Rivaroxaban Apixaban Edoxaban Study design* Double-blind Open-label Double-blind Double-blind Pre-randomization heparin NR <48 hrs <36 hrs <48 hrs Heparin lead-in At least 5 days None None At least 5 days Dose 150 mg BID 15 mg BID x 3 wk then 20 mg QD 10 mg BID x 7 d then 5 mg BID 60 mg QD 30 mg QD Dose reduction NONE NONE NONE 18% Randomized population 2, , ,400 8,292 2, ,833 4 Treatment duration 6 months Pre-specified 3, 6, 12 months 6 months Flexible 3 to 12 months *Comparator was warfarin in each case Dose was halved to 30 mg in patients perceived to be at higher risk for bleeding by predefined criteria NR=not reported 1. Schulman et al. N Engl J Med 2009;361: ; 2. Schulman et al. Blood 2011;118:Abstract EINSTEIN Investigators. N Engl J Med 2010;363: ; 4. EINSTEIN PE Investigators. N Engl J Med 2012;366: Agnelli et al. N Engl J Med doi: /nejmoa ; 6. The Hokusai-VTE Investigators. N Engl J Med 2013

33 RE-COVER 1# (Dabigatran) EINSTEIN DVT 2 (Rivaroxaban) EINSTEIN PE 3 (Rivaroxaban) AMPLIFY 4 (Apixaban) Hokusai- VTE 5 (Edoxaban) Patients, N Age (yrs) Female (%) Creatinine clearance <50 ml/min (%) NOAC VTE trials: Baseline characteristics NR DVT (%) PE±DVT (%) Unprovoked (%) NR Cancer (%) Previous VTE NR=not reported; # RECOVER II is still only available as an abstract and therefore is not included in the table Data from Hokusai-VTE are for history of cancer; active cancer was observed in 2.4% of patients overall 1. Schulman et al. N Engl J Med 2009;361: EINSTEIN Investigators. N Engl J Med 2010;363: ; 3. EINSTEIN PE Investigators. N Engl J Med 2012;366: Agnelli et al. N Engl J Med 2013;369: ; 5. The Hokusai-VTE Investigators. N Engl J Med 2013

34 RE-COVER I 1 EINSTEIN-DVT 2 EINSTEIN-PE 3 AMPLIFY 4 Hokusai-VTE 5-7 Drug Dabigatran Rivaroxaban Rivaroxaban Apixaban Edoxaban Treatment duration (%) 3 months 6 months * 6-12 months 12 months NOAC VTE trials: Baseline characteristics Mean treatment duration, days 1 dose heparin prior to randomization (%) Adherence to therapy >80% (%) <180 NR 215 < NR * For Hokusai-VTE duration was 3 to 6 months 40% of patients in Hokusai-VTE reaching 12 months is included within 61% of patients reaching 6-12 months NR= Not Reported 1. Schulman et al. N Engl J Med 2009;361: ; 2. EINSTEIN Investigators. N Engl J Med 2010;363: EINSTEIN PE Investigators. N Engl J Med 2012;366: ; 4. Agnelli et al. N Engl J Med doi: /nejmoa The Hokusai-VTE Investigators. N Engl J Med 2013; 6. Raskob et al. J Thromb Haemost 2013;11: ; 7. Daiichi Sankyo, data on file.

35 Patients (%) Phase III VTE trials recurrent VTE * ** 2.4% 2.1% 2.1% 3.0% ** 2.1% 1.8% * 2.3% 2.7% 3.2% 3.5% # 1.6% 1.9% All NOACs were non-inferior to warfarin Follow up period: *6 months **3, 6 or 12 months 12 months regardless of treatment duration #3 to 12 months (ontreatment analysis) Overall On-treatment 1. Schulman et al. N Engl J Med 2009;361: EINSTEIN Investigators. N Engl J Med 2010;363: ; 3. EINSTEIN PE Investigators. N Engl J Med 2012;366: Agnelli et al. N Engl J Med 2013;369: ; 5. The Hokusai-VTE Investigators. N Engl J Med 2013; e-pub ahead of print

36 Patients (%) Phase III VTE trials safety Major or clinically relevant non-major bleeding P= % NOAC Warfarin 8.1% 8.1% 10.3% 11.4% P< % P= % 10.3% 5.6% 4.3% 1. Schulman et al. N Engl J Med 2009;361: EINSTEIN Investigators. N Engl J Med 2010;363: ; 3. EINSTEIN PE Investigators. N Engl J Med 2012;366: Agnelli et al. N Engl J Med 2013;369: ; 5. The Hokusai-VTE Investigators. N Engl J Med 2013; e-pub ahead of print

37 Patients (%) Phase III VTE trials safety Major bleeding NOAC Warfarin P= % 1.9% P< % 1.6% 1.6% 1.4% 1.2% 1.1% 0.8% 0.6% 1. Schulman et al. N Engl J Med 2009;361: EINSTEIN Investigators. N Engl J Med 2010;363: ; 3. EINSTEIN PE Investigators. N Engl J Med 2012;366: Agnelli et al. N Engl J Med 2013;369: ; 5. The Hokusai-VTE Investigators. N Engl J Med 2013; e-pub ahead of print

38 Effectiveness and safety of NOACs as compared with VKAs in the treatment of acute symptomatic VTE: a systematic review and metaanalysis Efficacy outcomes Van Der Tulle, J Thromb Haemost, 2014

39 Effectiveness and safety of NOACs as compared with VKAs in the treatment of acute symptomatic VTE: a systematic review and meta-analysis Safety outcomes NNH for Major Bleeding 149 Van Der Tulle, J Thromb Haemost, 2014

40 ACCP 2012 Treatment of VTE 2012

41 Cumulative incidence of recurrent DVT and/or PE Recurrence rates in patients with unprovoked vs secondary VTE Prandoni et al, Haematologica 2007

42 Annualized recurrence rates after a first episode of venous thromboembolism Transient risk factor: 3.3% per patient-year 0.7% with a surgical risk factor (95% CI 0-1.5%) 4.2% with a non-surgical risk factor (95% CI %) Unprovoked VTE: 7.4% per patient-year (95% CI %) Iorio et al Arch Intern Med 2010

43 Possible strategies in pts with a previous unprovoked VTE Prolonged OAT in all (many pts treated unnecessarily; complications) Prolonged, low intensity OAT in all pts (less effective, complications non completely avoided) Prolonged treatment with new, low risk drugs (for the future?) Identify those pts who are at higher/lower risk Thrombophilia Persistence of residual vein thrombosis D-dimer test

44 Risk of Recurrence n=222 (> 500) (< 500; n=377) Palareti et al, Circulation 2003

45 (Palareti et al., NEJM 2006;335:1780-9)

46 Systematic review: D-dimer to predict recurrent disease after stopping anticoagulant therapy for unprovoked venous thromboembolism Verhovsek M, Douketis JD, Yi Q, Shrivastava S, Tait RC, Baglin T, Poli D, Lim W. Author, reference Palareti, 2003 Eichinger, 2003 Palareti, 2006 Shrivastava, 2006 positive D-dimer post-anticoagulation Vs negative D-dimer post-anticoagulation Patients, n Recurrent VTE Annualized risk (95%CI) (4.3,10.3) (3.4,5.6) (5.9,15.9) (0.0,24.1) Tait, (7.7, 21.1) Baglin, (5.2,12.2) Poli, (5.6,15.9) Pooled (5.8,11.9)* Patients, n Recurrent VTE N (%) Annualized risk (95%CI) (1.0,4.5) (1.5,4.4) (2.6,6.1) (0.0,8.7) (0.1,7.6) (1.5,8.1) (1.4,6.1) (2.7,4.3)** Ann Intern Med 2008

47 Cumulative hazard of recurrence combining Ddimer with sex and hormone therapy Douketis et al, Ann Int Med 2010

48 Gli algoritmi

49 Clinical decision rule to identify patients at low risk(*) of recurrent venous thromboembolism after 5 7 months of oral anticoagulant therapy Men Women Predictive values always long-term anticoagulation score Post-thrombotic signs (hyperpigmentation, edema or redness in either leg) 1 D-Dimer level 250 μg/l 1 Body mass index 30 kg/m2 1 Age 65 yr 1 (*)Low-risk 1 Rodger M et al. CMAJ, 2008

50 Predictive values Points (according to nomogram) sex males 60 females 0 Localization of distal 0 VTE Proximal DVT 70 PE 90 D-dimer levels continous Low-risk 180 points (according to nomogram) 4.4% (95% CI 2.7%-6.2%) Circulation, 2010

51 Predictive values Elevated D-dimer levels 1 months after stopping VKA score 2 Age < 50 years 1 Male sex 1 Women assuming oral contraceptives -2 The DASH score varies between -2 to 4, identifying patients at low risk of recurrence when the score is 1. Tosetto A et al. JTH, 2012

52 Gli studi di management

53 PERCORSO DIAGNOSTICO-TERAPEUTICO DEI SOGGETTI ARRUOLATI: VALUTAZIONE SU BASE CLINICA- STRUMENTALE (CUS E/O ECOCARDIOGRAMMA) Tutti i pazienti inclusi (con TVP e/o EP) CUS bilaterale degli arti inferiori (V. femorale comune all inguine, la femorale superficiale a metà coscia e la poplitea nel cavo popliteo fino alla triforcazione) Se in almeno uno dei punti suddetti dell arto sintomatico permane un residuo trombotico (> 4 mm): proseguire TAO per un totale di almeno 12 mesi Al termine di almeno 12 mesi di TAO CUS ripetuta; qualsiasi siano i risultati i paz avviati alla fase successiva

54 Prevalence of first-time ever D-dimer above the predefined cut-off levels after VKA withdrawal Blood, in press

55 Total screened patients n = 2458 Excluded for pre-specified criteria n = 442 DD neg 52,3% DD pos reassume VKA 36,9% DD pos refuse VKA 10,8% Candidate to extended VKA treatment n = 606 Candidate to short VKA treatment n = 353 Eligible for the study n = 1057 Excluded for various reasons # n = 47 Patients included in the analysis n = 1010 Patients with always negative DD (no VKAs) n = 528 (52.3%) (VTE idiopathic = 377) (Associated with WRF = 151) Patients with positive DD - resumed VKAs n = 373 (36.9%) (VTE idiopathic = 311) (Associated with WRF = 62) - refused VKAs n = 109 (10.8%) (VTE idiopathic = 83) (Associated with WRF = 26) Blood, in press

56 Kaplan Meier Cumulative Event Rates for recurrent VTE in patients with persistently negative D-dimer results in whom anticoagulation was definitively stopped (dotted line) and in those with positive D-dimer results who refused to resume anticoagulation (continuous line) Blood, in press

57 Primary outcomes and major bleeding events in the DULCIS study Normal DD, no anticoagulation (n. 506; 821 yr) Altered DD, anticoagulation refused (n. 109; 171 yr) Altered DD, anticoagulation resumed (n. 373; 601 yr) Outcomes no. (%; CI) Incidence % pt/yr % (CI) Major bleeding no. (%;CI) Incidence % pt/yr % (CI) 23 (4.5%; ) 2.8% ( ) 0 15 (13.8%; ) 8.8% ( ) 0 4 (1.1%; ) 0.7% ( ) 14* (3.7%; ) 2.3% ( ) (* = 1 fatal) Blood in pressi

58 Extended treatment of VTE Three studies comparing ODIs with placebo in patients who stopped anticoagulant treatment RE-SONATE (150 mg bid as in RECOVER) EINSTEIN EXTENSION (20 mg od as in EINSTEIN) AMPLIFY EXTENSION (5 mg bid or 2.5 mg bid) One study comparing ODI with warfarin REMEDY (150 mg bid as in RECOVER)

59 Phase III VTE_Ext trials recurrent VTE HR 0.19 NNT 14 HR 0.20 NNT 14 HR 0.61 HR 0.08 HR 1.44* *= 95%CI: Einstein Investigators N Engl J Med 2010 Dec 23;363(26): ; 2. Agnelli et al. N Engl J Med c2012. DOI: /NEJMoa ; 3. Schulman et al. N Engl J Med 2013;368:

60 Phase III VTE_Ext trials Major bleeding HR 0.52*** RR 0.49* RR 0.25** P=1.0 95%CI * ** *** : P= Einstein Investigators N Engl J Med 2010 Dec 23;363(26): ; 2. Agnelli et al. N Engl J Med c2012. DOI: /NEJMoa ; 3. Schulman et al. N Engl J Med 2013;368:

61 Phase III VTE_Ext trials CRNMBs HR 0.54 RR 1.29** NNH 200*** RR 1.82 NNH 63*** HR 2.92 *one major bleeding ** 95%CI: *** one major bleeding or CRNMB 1. Einstein Investigators N Engl J Med 2010 Dec 23;363(26): ; 2. Agnelli et al. N Engl J Med c2012. DOI: /NEJMoa ; 3. Schulman et al. N Engl J Med 2013;368:

62 Einstein, Amplify, Remedy, Resonate: EXTENSION Study Indication Patient s (n ) Drug Recurrent VTE# Major bleeding# EINSTEIN EXTENSION Extension VTE 1196 Rivaroxaban 20 mg o.d. 1.3 vs 7.1 P<0.001** 0.7 vs 0 P=0.11* AMPLIFY EXTENSION Extension VTE 2486 Apixaban 2.5 mg b.d. or 5 mg b.d. 3.8 vs 4.2 vs 11.6 P< vs 0.1 vs 0.5 REMEDY Extension VTE 2856 Dabigatran 150 mg b.d. Vs warfarin 1.8 vs 1.3 P=0.03* 0.9 vs 1.8 P=0.058* RRR -31% RESONATE Extension VTE 1343 Dabigatran 150 mg b.d. 0.4 vs 5.6 P<0.0001** 0.3 vs 0 P=0.996* # drugs vs comparator (%) * for non inferiority, ** for superiority major and clinical relevant non major bleeding Imberti, Clinical Appl Thromb, 2013

63 Clinical management of venous thromboembolism before (conventional management) and after (future management) the availability of new oral anticoagulants in this indication Agnelli G, Best Pract & Res Clin Haemat 2013

64 Main conclusions All four NOAs are effective and safe enough to qualify as ideal oral anticoagulants for treatment of patients with acute VTE, including those with clinically stable PE Rivaroxaban and apixaban do not require an initial parenteral treatment, but require a more intensive treatment regimen in the first weeks (3 and 1, respectively) Rivaroxaban (after the first 3 weeks) and edoxaban can be given in once daily administration Low-dose apixaban is promising for the long-term treatment of VTE All of them have limitations for the treatment of patients with severe renal failure and lack an antidote All of them require further investigation in cancer patients and in pregnant women with VTE

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