3:00 PM Abstract No. 351 ■ DISTINGUISHED ABSTRACT ACCESS PTS Study: ACCElerated thrombolySiS for post-thrombotic syndrome using the acoustic pulse thrombolysis EkoSonic® endovascular system: midterm results of a multicenter study

Abstract

Post thrombotic syndrome (PTS), a potentially devastating long-term outcome of deep vein thrombosis (DVT), develops in >50% of patients following proximal DVT. Unfortunately, treatment options are limited. A multi-center, prospective, single-arm study evaluated the efficacy and safety of endovascular recanalization of venography proven chronic venous-occlusive disease, utilizing venoplasty with ultrasound-accelerated, catheter-directed thrombolysis (USCDT). Inclusion criteria were persistent femoral DVT diagnosed ≥6 months, Villalta Score (VS) ≥8 and failure of 3 months of anticoagulation and compression therapy. Exclusion criteria were isolated iliofemoral DVT, high bleeding risk as assessed by the treating clinician & filling defect ≥3 cm into the IVC. Following standard techniques to cross the venous occlusion, patients underwent venoplasty followed by minimum of 12h USCDT with further venoplasty and venous stenting as needed. Patients will be followed out to 12 months. The primary efficacy endpoint was a reduction in VS ≥ 4 at 30 days post-USCDT in ≥50% of patients. The primary safety endpoints were major bleeding within 72 hours of procedure start and pulmonary embolism (PE) within 30 days post-USCDT. Other measures tracked included the Venous Severity Score (VCSS) and quality of life as assessed by the VEINES-QOL questionnaire. Of 81 patients enrolled, 78 patients (mean age 55, male 68%) received treatment and 77 limbs were evaluable for endpoint assessment. Mean USCDT duration was 22.8 ± 5.4 hours and tPA dose was 18.5 ± 7.6 mg. The Villalta score improved from 15.8 (baseline) to 9.8 and 8.2 at 30 and 180 days, respectively (p<0.0001). The actual primary endpoint was met in 67% (p = 0.003). VCSS improved from 12.3 (baseline) to 8.4 and 7.0 at 30 and 180 days, respectively (p<0.0001). VEINES-QOL improved from 60.6 (baseline) to 70.7 and 80.2 (30 and 180 days, respectively) (p<0.0001). One major bleed occurred within 72 hours post-USCDT. One PE occurred within 30 days of USCDT. In chronic DVT patients with PTS, ACCESS PTS demonstrates intervention utilizing USCDT with venoplasty is safe and effective in achieving clinically relevant improvement in PTS and quality of life.