Ekos Therapy for Postthrombotic Syndrome Evaluated in ACCESS PTS Study
June 16, 2017—BTG International announced that results of the ACCESS PTS trial were presented at the Society for Vascular Medicine's 28th annual scientific sessions, held June 14–17 in New Orleans, Louisiana. ACCESS PTS found that chronic DVT patients with postthrombotic syndrome (PTS) can be treated safely and effectively with Ekos therapy, which uses ultrasonic waves in combination with clot-dissolving thrombolytic drugs. Mark Garcia, MD, of Vascular & Interventional Associates of Delaware in Wilmington, Delaware, served as the study's Lead Investigator and presented the data.
The ACCESS PTS study is a multicenter, prospective, single-arm study of 73 patients with iliofemoral deep vein thrombosis (DVT) who met eligibility criteria, including a Villalta Score of ≥ 8, and who had failed 3 months of conservative therapy. Patients were treated with anticoagulation drugs followed by Ekos therapy with balloon dilatation.
The study met its primary efficacy endpoint and showed a significant improvement of Villalta Scores of 34% at 30 days across 77 limbs treated among the 73 patients (P < .0001). On average, patients treated in the study experienced a symptom reduction from severe to borderline mild. The study also showed a 21% improvement in patients’ quality of life, as measured by VEINES-QOL. The safety endpoint was met, with one bleeding incident and one pulmonary embolism.
In BTG's press release, Dr. Garcia commented, “ACCESS PTS demonstrates that Ekos therapy with balloon dilatation is effective and safe in reducing the signs and symptoms of postthrombotic syndrome for patients suffering from chronic DVT, while improving their quality of life." He added, "Ekos therapy is a useful and important option for physicians treating debilitating chronic DVT and PTS.”