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ACCESS PTS study

ACCESS PTS study shows efficacy of EKOS Therapy

DVT patients with PTS can be treated safely and effectively with EKOS therapy
Second OPTALYSE PE Study demonstrates safety and efficacy of shorter, lower dose EKOS therapy for pulmonary embolism

The results of the ACCESS PTS (Accelerated Thrombolysis for Post-Thrombotic Syndrome Using the Ekos System) trial has reported chronic deep vein thrombosis (DVT) patients with post-thrombotic syndrome (PTS) can be treated safely and effectively with EKOS therapy. According to BTG, 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. The outcomes were presented at the Society for Vascular Medicine 28th Annual Scientific Sessions in New Orleans.

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 (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% at 30 days across 77 limbs treated among the 73 patients (p <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 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, Dr Mark Garcia from theVascular & Interventional Associates of Delaware in Wilmington, DE. “EKOS therapy is a useful and important option for physicians treating debilitating chronic DVT and PTS.”

 “With the ACCESS PTS study, BTG is once again demonstrating our commitment to advancing the treatment of VTE patients. Chronic DVT can be both debilitating and life threatening. Until now, most chronic DVT and PTS sufferers had no other treatment options,” said EKOS® Vice President and General Manager Matt Stupfel. “The ACCESS PTS data proves that EKOS® therapy is 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.”

In addition to Dr Garcia, the study’s authors include 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.

The EKOS system uses ultrasonic waves in combination with clot-dissolving thrombolytic drugs to effectively dissolve clots and restore healthy blood flow.

OPTALYSE PE Study

In addition, the company also announced that the results of the OPTALYSE PE trial, presented at the American Thoracic Society International Conference in Washington, DC, show that pulmonary embolism (PE) can be treated effectively with EKOS over a much shorter period and at safer thrombolytic doses far below the current standard, which will allow for scheduling flexibility and efficiencies in clinician time and drug costs.

OPTALYSE PE included 101 patients with acute proximal PE at 17 centres randomised to one of four cohorts. All patients received therapeutic anticoagulation along with EKOS Acoustic Pulse Thrombolysis Therapy. The first cohort received 4mg per catheter of a standard clot dissolving medication called tissue plasminogen activator (tPA) over 2 hours. The second cohort received 4mg per catheter tPA over 4 hours. The third cohort received 6mg per catheter tPA over 6 hours. The fourth cohort received 12mg per catheter tPA over 6 hours.

All cohorts saw a significant reduction in the main indicator of right heart strain from PE (measured as right ventricular to left ventricular diameter ratio (RV/LV)) by approximately 23 to 26 percent. This is consistent with results achieved in previous EKOS® studies when treatment was applied for 12 to 24 hours. The OPTALYSE PE results also showed a very low bleeding rate of 3% compared to 10% in the previous SEATTLE II study where patients were treated with 24mg for 12 or 24 hours.

“OPTALYSE PE sets a new standard for PE treatment,” said study author, Dr Victor Tapson of the Pulmonary and Critical Care Division at Cedars-Sinai Medical Center in Los Angeles. “This trial builds on a growing body of clinical evidence, including the ULTIMA and SEATTLE II studies, showing a significant reduction in right-heart strain with shorter treatment durations and lower tPA doses. In addition to moving patients out of danger more quickly, hospitals can potentially save significant intensive care, drug and clinician time and cost due to increased safety and shorter treatment durations.”

The study’s authors include Dr Tapson; Dr Gregory Piazza and Dr Samuel Goldhaber of Brigham and Women’s Hospital, in Boston; Keith Sterling of Inova Alexandria Hospital, Alexandria, Virginia, Dr Kenneth Ouriel of Syntactx, New York; and Ping-Yu Liu of the Fred Hutchinson Cancer Center, Seattle.