BTG has highlighted the results of the ACCESS PTS trial, presented at the Society for Vascular Medicine 28th annual scientific sessions (14–17 June, New Orleans USA). The study found chronic deep vein thrombosis patients with post-thrombotic syndrome can be treated safely and effectively with Ekos therapy.
The ACCESS PTS study is a multicentre prospective single-arm study of 73 patients with iliofemoral deep vein thrombosis, meeting eligibility criteria including a Villalta Score of eight or greater, and who had failed three 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 with a p-value of <0.0001. On average, patients treated in the study experienced a symptom reduction from severe down to borderline mild. The study also showed a 21% improvement in patients’ quality of life. There was one bleeding incident and one pulmonary embolism, meeting the study’s safety endpoint.
The ACCESS PTS protocol using Ekos therapy is now the only treatment regimen proven to significantly reduce the signs and symptoms of post-thombotic syndrome and show a significant improvement in quality of life, a press release from BTG says.
“ACCESS PTS demonstrates that Ekos therapy with balloon dilatation is effective and safe in reducing the signs and symptoms of post-thrombotic syndrome for patients suffering from chronic deep vein thrombosis, while improving their quality of life,” said lead investigator Mark Garcia of Vascular & Interventional Associates of Delaware in Wilmington, USA. “Ekos therapy is a useful and important option for physicians treating debilitating chronic deep vein thrombosis and post-thrombotic syndrome.”