Acute and long-term treatment of VTE. Cecilia Becattini University of Perugia
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1 Acute and long-term treatment of VTE Cecilia Becattini University of Perugia
2 Acute and long-term treatment of VTE The goals The acute PE phase After the acute phase
3 Treatment for VTE Goals of acute treatment Reduce mortality Reduce early recurrences Goals of long-term treatment Complete treatment of acute VTE Reduce recurrences Goals of extended treatment Initial treatment Reduce recurrences in high risk pts Long term-treatment Extended treatment 5 days 3-6 months > 6 months
4 Acute and long-term treatment of VTE The goals The acute phase revascularization filters home-treatment After the acute phase
5 PE: results from large registries short-term mortality ICOPER 11% MAPPET 9% IPER 7% EMPEROR 5% RIETE HD stable patients 3% HD unstable 9%
6 PE: ESC model for risk stratification Eur Heart J 2014
7 2014 ESC model in clinical practice 906 patients with acute symptomatic objectively confirmed PE 30-day Mortality based on risk High Intermediate high Intermediate low Low Becattini et al, Eur Resp J 2016
8 Tenecteplase for intermediate-high risk PE All-cause mortality or hemodynamic collapse within 7 days of randomization Tenecteplase (n=506) Placebo (n=499) n (%) n (%) P value 13 (2.6) 28 (5.6) Meyer G, N Eng J Med 2014 S Konstantinides for the PEITHO Steering Committee. Am Heart J 2012;163:33-38.e1
9 Tenecteplase for intermediate-high risk PE All-cause mortality within 7 days Tenecteplase (n=506) Placebo (n=499) n (%) n (%) P value 6 (1.2) 9 (1.8) 0.43 Hemodynamic collapse within 7 days bleeding 8 (1.6) 25 (5.0) Major 32 (6.3) 6 (1.5) <0.001 Hemorrhagic stroke 10 1 Meyer G, N Eng J Med2014 S Konstantinides for the PEITHO Steering Committee. Am Heart J 2012;163:33-38.e1
10 Ultrasound-facilitated CDT for PE 150 patients with proximal PE and right ventricle dilation at CT preprocedure 48-h p Mean RV/LV diameter ratio Mean PA systolic pressure Mean modified Miller index < < < GUSTO severe bleeding GUSTO moderate bleeding 1 patient (0.5%) 15 patients (10%) Piazza G, JACC 2015
11 Interventional procedures for PE Limited number of controlled studies No evidence of reduction in mortality Risk for peri-procedural complications Long-term benefit of early HD improvement not well established
12 ESC Guidelines: clinical management
13 Vena cava filter for acute PE with DVT Recurrent VTE in patients randomized to vena cava filter implantation plus anticoagulation or anticoagulation alone Cumulative risk HR 1.36, 95% CI filter controls Months since randomization Mismetti P, JAMA 2015
14 Treatment for PE & DVT THRIVE TREATMENT Ximelagatran (26 events) Enoxaparin/warfarin (24 events) 5 95% CI: 0.6%; 1.6% Cumulative risk (%) ITT 2.1% 2.0% Days after randomisation Fiessinger J-N et al. JAMA 2005;293:
15 NOACs in VTE: study design Conventional anticoagulation: Heparin + warfarin Confirmed symptomatic DVT or PE R Treatment period 3, 6 or 12 mo NOA front-load maintaining dose Conventional anticoagulation: Heparin + warfarin Confirmed symptomatic DVT or PE R Treatment period 3, 6 or 12 mo LMWH NOA
16 NOACs vs conventional treatment
17 NOACs: across the VTE spectrum R L
18 PE: anatomical extent of PE as defined in NOACs trials Limited extent 25% of the vasculature of a single lobe Intermediate extent >25% of vasculature of a single lobe or multiple lobes with 25% of entire vasculature Extensive extent multiple lobes with 25% of entire vasculature The Hokusai-VTE Investigators. N Engl J Med 2013
19 Edoxaban in PE patients with increased BNP HR=0,52 HR=0,52 (IC (IC 95%: 0,28 0,98) 0,28 0,98) Pazienti (%) 15/454 30/484 Recidiva di TEV The Hokusai-VTE Investigators. N Engl J Med 2013
20 Treatment NOACs for pulmonary Treatment embolism of PE Study Primary endpoint Event, % (n/n) HR*/RR (95%CI) NOAC Warfarin RECOVER I & II (index PE) VTE/VTE-related death 2.9 (23/795) 3.1 (25/807) 0.93 ( ) EINSTEIN-PE Recurrent VTE 2.1% (50/2419) 1.8% (44/2413) 1.12* ( ) AMPLIFY (Index PE) Recurrent VTE / VTErelated death 2.3% (21/900) 2.6% (23/886) 0.90 ( ) HOKUSAI (Index PE) Recurrent VTE 2.8% (47/1650) 3.9% (65/1669) 0.73* ( ) HOKUSAI (Severe PE) (ProBNP 500 pg/ml) Recurrent VTE 3.3% (15/454) 6.2% (30/485) 0.52* ( )
21 NOACs in pulmonary embolism 5 phase III studies included: 11,539 patients OR 95% CI Recurrent VTE anti-xa anti-iia Major Bleeding* Clinically Relevant Bleeding* 0.89 ( ) 0.89 ( ) 0.87 ( ) 0.30 ( ) 0.89 ( ) * two studies included Vedovati MC et al, Int J Cardiol 2014
22 Treatment for pulmonary embolism Eur Heart J 2014
23 The CHEST guidelines DVT of the leg or PE Concomitant cancer Yes No LMWH LMWH followed by VKAs NOACs Grade IIB *Same grade of recommendation for different NOACs Clive Kearon,et al. Chest 2016
24 Acute and long-term treatment of VTE The goals The acute PE phase revascularization for intermediate risk filters home-treatment After the acute phase
25 VTE in Italy: in vs out hospital management Dentali, Annals Med 2015
26 PE: duration of hospitalization over time Data from 23,858 patients included in the RIETE Registry Jimenez D, JAMA 2016
27 PE: 3-month outcome of home treatment 13 studies (1657 patients) with outpatients (<24 h), 3 studies (256 patients) with early discharge (<72 h) 5 studies (383 patients) with inpatients Zondag W et al., Eur Resp J 2013
28 Design Aujesky et al Zondag et al Agterof et al Otero et al Open-label, RCT Prospective cohort Prospective cohort Open-label, RCT HoT PE ongoing Prospective cohort, phase IV Eligibility criteria Systolic BP 100 mmhg 100 mmhg 90 mmhg 90 mmhg 100 mmhg Clinical prediction rule PESI class I or II Hestia - Uresandi 0-2 Modified Hestia Biomarkers No No NT-proBNP Troponin T No (analysis planned) Absence of RVD No No No TTE CT or TTE Renal function CrCl 30 CrCl 30 Creatinine <150 umol/l Platelet count /mm Body weight 150 kg - - BMI <30 kg/m 2 Respiratory function Others Time of discharge SaO 2 90%, or PaO 2 60 mmhg No history of HIT <24 h vs inpatient management PE: home treatment SaO 2 >90% in air No history of HIT; no hepatic impairment <24 h <24 h SaO 2 >90% in air - No SaO 2 93%; NYHA I or II; severe COPD No surgery <15 days 3- to 5-day vs inpatient CrCl 15 SaO 2 >90% in air No history of HIT; no severe hepatic impairment 48 h of admission
29 Clinical prognostic rules and in-hospital mortality IMPACT PESI spesi Hestia Mortality in low risk (%) Sensitivity (95% CI) 95.2 ( ) 90.5 ( ) 100 ( ) 100 ( ) Specificity (95% CI) 29.1 ( ) 39.1 ( ) 31.8 ( ) 26.8 ( ) PPV (95% CI) 3.5 ( ) 3.8 ( ) 3.8 ( ) 3.5 ( ) NPV (95% CI) 99.6 ( ) 99.4 ( ) 100 ( ) 100 ( ) IMPACT= In-hospital Mortality for Pulmonary embolism using Claims data Weeda ER et al., Thrombosis Journal 2016
30 Acute and long-term treatment of VTE The goals The acute PE phase After the acute phase optimal agent CTPH
31 Treatment for PE & DVT Current standard of care LMWH or Fonda VKAs RECOVER I & II DABIGATRAN HOKUSAI VTE EDOXABAN LMWH DABI 150 mg bid EDO 60 mg od EDO 30mg od EINSTEIN DVT+PE RIVAROXABAN Riva 15mg bid 3 wks RIVA 20 mg od AMPLIFY APIXABAN Api 10 mg bid 1 wk API 5 mg bid Day 1 Day 5-11
32 European Society for Vascular Medicine Long term course of PE 2nd Annual Congress May 8-10, 2016, Rome - Italy Study on the COurse of Pulmonary Embolism Acute PE 805 patients 647 patients included 158 patients excluded CTEPH Suspected CTEPH recurrent VTE Suspected recurrent VTE 11 patients 1.7% 95% CI 0.9 to patients 6.2% 95% CI 4.5 to 8.3 Pesavento R et al., Submitted
33 European Society for Vascular Medicine Long term course of PE 2nd Annual Congress May 8-10, 2016, Rome - Italy Study on the COurse of Pulmonary Embolism RPO at 6m: 50.1% ( ) HR 2.42*; 95% CI, *adjusted for age,unprovoked PE, RPO, time of OAT withdrawal Pesavento R et al. ISTH 2016 Pesavento R et al. ISTH 2016
34 Thrombolysis & CTEPH 667 PEITHO patients 41.6±15.7 months at F-U after randomization Persistent dyspnea (mostly mild) 22.8% functional limitation 19.7% NYHA III-IV 7.4% No differences between the two treatment arms. Echocardiography did not reveal significant differences in residual pulmonary hypertension or RV dysfunction. PEITHO Investigators, submitted
35 Thrombolysis & CTPH CTEPH confirmed in 4 TNK (1.4%) and 6 placebo (2.2%) patients (P=0.740). PEITHO Investigators, submitted
36 Acute and long-term treatment of VTE Evidence not enough for treatment upgrading in HD stable NOACs effective and safe for treatment of VTE No clinical benefit by time-definite treatment extension
37 Management of pulmonary embolism Cecilia Becattini University of Perugia, Italy
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