BTG releases results of ACCESS PTS trial

Global specialist healthcare company BTG highlighted the results of its ACCESS PTS trial, presented at the Society for Vascular Medicine 28th Annual Scientific Sessions in New Orleans, on Friday.

The FTSE 250 company said the study found chronic deep vein thrombosis (DVT) patients with post-thrombotic syndrome (PTS) could be treated safely and effectively with its ‘EKOS’ therapy.

It said the ACCESS PTS protocol using EKOS therapy was now the only treatment regimen proven to “significantly reduce” the signs and symptoms of PTS and show a significant improvement in quality of life.

The ACCESS PTS study is a multicentre prospective single-arm study of 73 patients with iliofemoral DVT, meeting eligibility including a Villalta Score of 8 or greater, and who had failed three months of conservative therapy, the BTG board explained.

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 patient quality of life, the board added, with one bleeding incident and one 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 of Vascular & Interventional Associates.

“EKOS therapy is a useful and important option for physicians treating debilitating chronic DVT and PTS.”

In addition to Dr Garcia, the study's authors included Dr Keith Sterling of Inova Alexandria Hospital, Dr Michael Jaff of Newton-Wellesley Hospital, Dr Kenneth Ouriel of Syntactx, Dr Susan Kahn of Jewish General Hospital, and Dr Anthony Comerota of Jobst Vascular Institute.

“With the ACCESS PTS study, BTG is once again demonstrating our commitment to advancing the treatment of VTE patients,” said EKOS vice president and general manager Matt Stupfel.

“Chronic DVT can be both debilitating and life threatening.

“Until now, most chronic DVT and PTS sufferers had no other treatment options.”

Stupfel said the ACCESS PTS data proved that EKOS therapy was a safe and effective option for treating chronic DVT.

“EKOS is setting the standard for interventional chronic-DVT treatment, getting patients back on their feet and on with their lives.”