Ultrasound-assisted catheter-directed thrombolysis: Does it really work? The BERNUTIFUL trial
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1 Ultrasound-assisted catheter-directed thrombolysis: Does it really work? The BERNUTIFUL trial Rolf P. Engelberger Division of Angiology CHUV, Lausanne & Inselspital, Bern Switzerland
2 Disclosure Speaker name: Rolf P. ENGELBERGER. I have the following potential conflicts of interest to report: Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) I do not have any potential conflict of interest
3 Ilio-femoral DVT: Current guidelines
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6 Pharmacomechanical thrombolysis PMT AngioJet Power Pulse thombolysis + thrombectomy (Venturi effect) Trellis Fragmentation + local thrombolysis + aspiration with embolic protection EKOS Ultrasound-assisted thrombolysis
7 Ultrasound-assisted thrombolysis Ultrasound pulses Mechanism of Action Fibrin separation Active drug delivery by acoustic streaming Ultrasound delivered in: High frequency (2.2 Mhz) Low power (0.5 W per element) Pulses of varying waveforms Fibrin without Ultrasound Fibrin With Ultrasound Braaten et al. Thromb Haemost 1997; 78:
8 Ultrasound-assisted thrombolysis EkoSonic MACH4 Endovascular System catheters (EKOS Corporation)
9 Ultrasound-assisted thrombolysis Individual Ultrasound elements Engelberger & Kucher, EHJ 2014
10 BERNUTIFUL the BERN Ultrasound-assisted Thrombolysis for Ilio-Femoral deep vein thrombosis versus standard catheter directed thrombolysis trial Aim: to investigate if the addition of intravascular high-frequency, low-power ultrasound energy facilitates the resolution of thrombosis during catheter-directed thrombolysis (CDT) Engelberger, Kucher et al. Circulation Cardiovasc Interv, in press supported by the Swiss National Science Foundation: 32003B_140804
11 BERNUTIFUL Methods Single center randomized controlled trial Inclusion criteria: symptomatic proximal DVT involving the iliac and/or common femoral veins with symptom duration of <2 weeks Exclusion criteria: age <18 y or >75 y; established PTS or previous symptomatic DVT <2 years in the in- dex leg; limb-threatening circulatory compromise; massive PE; active bleeding or increased bleeding risk, intolerance/allergy to study drugs/contrast medium, egfr <30 ml/min; pregnancy, lactation, or parturition within the previous 30 days; life expectancy <24 months or chronic nonambulatory status
12 Primary endpoint Percentage of thrombus load reduction from baseline to 15 hours of CDT according to the length-adjusted thrombus (LAT) score - Engelberger, Kucher et al. Circulation Cardiovasc Interv, in press
13 Lengths-adjusted thrombus (LAT) score Known distance between 2 radioopaque ultrasound elements (= 1 ultrasound-segment) Scoring for each ultrasoundelement 0 point if (near) completely free of filling defects 1 point if partially thrombosed 2 points if (near) completely thrombosed Total LAT score = sum of ultrasound-element scores * ultrasound-element lengths in cm Engelberger, Kucher et al. Circulation Cardiovasc Interv, in press
14 BERNUTIFUL Study flow chart Patients with objectively confirmed symptomatic acute ilio-femoral DVT (n=92) Patients excluded: DVT symptom duration >14 days: 20 Age <18 (2) or >75 years (5) Significant bleeding risk, or known coagulation disorder : 3 Established PTS or previous symptomatic DVT within the last 2 years in the index leg: 3 Limb-threatening circulatory compromise: 2 History intracranial bleed: 2 Pregnancy: 2 Life expectancy < 24 months or chronic non-ambulatory status: 2 Inability to tolerate catheter procedure due to severe dyspnea or acute systemic illness: 2 Major surgery <10 days: 1 Patients included and Randomized (N=48, mean age 50±20y, 52% women) USAT(n = 24): 20 mg r-tpa in 15 hours CDT(n = 24): 20 mg r-tpa in 15 hours Primary endpoint (assessed by blinded core laboratory): Percentage of thrombus load reduction from baseline to 15 hours of catheter thrombolysis 2nd endpoints (non-blinded): Adjunctive thrombus removal, stenting rate, bleedings (n=48) Follow-up at 3, 6, 12 m (non-blinded) : Duplex for patency, Villalta score for PTS severity, CEAP
15 BERNUTIFUL Results Primary Endpoint: Percentage of Thrombus Load Reduction p= ±27% 54±27% USAT CDT N=24 N=24
16 BERNUTIFUL Results Secondary outcomes: Adjunctive therapy Adjunctive catheter thrombus removal therapy Adjunctive stenting Number of implanted stents USAT N = 24 CDT N = 24 7 (29%) 11 (46%) (80%) 1.3± (83%) 1.4±1.1 p
17 BERNUTIFUL Results Safety outcomes Major bleeding Minor bleeding USAT N = 24 CDT N = 24 1 (4.2%) (4.2%) 2 (8.3%) 0.99 p
18 BERNUTIFUL Results Secondary outcomes at 3 months USAT N = 24 CDT N = 24 Primary patency 3 months 100% 96% 0.33 Secondary patency 3 months 100% 100% 1.00 Mean Villalta score 3 months (post-thrombotic syndrome) 3.0±3.9 [range 0-15] 1.9±1.9 [range 0-7] p 0.21
19 BERNUTIFUL Conclusions A standardized thrombolysis regimen with 20 mg r- tpa over 15 hours for the treatment of patients with acute ilio-femoral DVT is safe and associated with a high degree of thrombus load reduction. The addition of high-frequency (2.2 MHz), low-power (0.5 W) intravascular ultrasound did not facilitate thrombus resolution
20 Ultrasound-assisted catheter-directed thrombolysis: Does it really work? BERNUTIFUL Trial with negative results for patients with acute ilio-femoral DVT Potential advantage in non-acute DVT? Better results with increased ultrasound energy? Better in other vascular beds? RCT in patients with thrombosed infrainguinal native arteries or bypass grafts (ISRCTN ) ongoing ULTIMA trial in pulmonary embolism Dumantepe et al, EJVES 2013; Schrijver et al, Trials 2011; Kucher et al, Circulation 2014
21 Thank you for your attention
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