July 7, 2017 — BTG plc recently highlighted the results of the ACCESS PTS trial, presented at the Society for Vascular Medicine 28th Annual Scientific Sessions, June 14-17 in New Orleans. The study found chronic deep vein thrombosis (DVT) patients with post-thrombotic syndrome (PTS) can be treated safely and effectively with Ekos therapy. The ACCESS PTS protocol using Ekos therapy is now the only treatment regimen proven to significantly reduce the signs and symptoms of PTS and show a significant improvement in quality of life, according to the company.
The ACCESS PTS study is a multicenter prospective single-arm study of 73 patients with iliofemoral DVT, meeting eligibility including a Villalta Score of 8 or greater (Villalta Score measures the signs and symptoms of PTS), 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 percent 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 percent improvement in patients’ quality of life. There was one bleeding incident and one pulmonary embolism (PE), meeting the study’s safety endpoint.
“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, M.D., of Vascular & Interventional Associates of Delaware in Wilmington, Del. “EKOS therapy is a useful and important option for physicians treating debilitating chronic DVT and PTS.”
In addition to Garcia, the study’s authors include Keith Sterling, M.D., of Inova Alexandria Hospital, Alexandria, Va.; Michael Jaff, DO, of Newton-Wellesley Hospital, Boston; Kenneth Ouriel, M.D., of Syntactx; Susan Kahn, M.D., of Jewish General Hospital, Pelham, N.Y.; and Anthony Comerota, M.D., of Jobst Vascular Institute, Toledo, Ohio.
For more information: www.btg-im.com