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February 27, 2020

ACCESS PTS Study Supports Boston Scientific’s EkoSonic System to Treat Postthrombotic Syndrome

February 27, 2020—Results from the ACCESS PTS study of ultrasound-accelerated thrombolysis and venoplasty for the treatment of the postthrombotic syndrome (PTS) were recently published by Mark J. Garcia, MD, et al online in Journal of the American Heart Association (JAHA). The study evaluated acoustic pulse thrombolysis using the EkoSonic endovascular system (Boston Scientific Corporation) to treat PTS, which is a common complication of deep vein thrombosis (DVT) with limited treatment options.

The study showed that percutaneous transluminal venoplasty and ultrasound-accelerated thrombolysis resulted in successful recanalization of chronic venous obstruction with improved PTS severity and quality of life with results sustained at 1-year after the procedure, concluded the investigators in JAHA.

ACCESS PTS is a multicenter, single-arm, prospective study evaluating patients with chronic deep vein thrombosis and PTS (Villalta score ≥ 8) who received a minimum of 3 months of the standard of care treatment including anticoagulation and medical-grade compression.

Patients in the ACCESS PTS study underwent percutaneous transluminal venoplasty and ultrasound-accelerated thrombolysis, with data collected on clinical characteristics, PTS, imaging, and quality of life to 1 year.

As summarized in JAHA, the primary efficacy outcome was a reduction of ≥ 4 points in the Villalta score 30 days after the procedure. The primary safety outcomes were major bleeding episodes within 72 hours and symptomatic pulmonary embolism during the index hospitalization.

A total of 82 limbs (78 patients) were treated (age, 54.6 ± 12.7 years; 32.1% women; baseline mean Villalta score, 15.5 ± 5.2).

In JAHA, the ACCESS PTS investigators reported the following results at 1 year:

  • The primary endpoint was met in 64.6% (51/79) of limbs treated
  • 77.3% (51/66) of limbs continued with a Villalta score reduction ≥ 4
  • Mean Villalta score decreased by 8.2 ± 6.4 from baseline (P < .0001)
  • Mean Venous Clinical Severity Score decreased by 5.7 ± 4.4 from baseline (P < .001)
  • > 90% of all treated segments had patency with ultrasound flow present
  • Physical Component Summary mean score of the 36-Item Short Form Health Survey improved from 38.9 ± 9.5 at baseline to 45.2 ± 9.8 (P ≤ .0001)
  • Mean Venous Insufficiency Epidemiological and Economic Study–Quality of Life increased from 61.9 ± 19.7 at baseline to 82.6 ± 20.8 (P < .0001).

Additionally, the investigators stated that iliofemoral venous stenting was performed in 40 patients with iliofemoral disease, with similar improvements seen in all outcomes regardless of stenting status. One patient developed severe bleeding within 72 hours of the intervention and died at 32 days after the procedure (1.3% mortality rate).

In discussing the findings with Endovascular Today, Dr. Garcia commented, “The ACCESS PTS study is the first trial looking at endovascular treatment for a minimum of femoropopliteal chronic DVT in patients suffering from PTS. Most importantly, it demonstrated that something can safely and successfully be done for this patient population. Too many times these patients are told: there is nothing, you have to live with it.”

Dr. Garcia continued, “The results demonstrated that in all outcomes measured, a statistically significant improvement was seen to 1 year. Although we recognize that iliofemoral venous obstruction can be more devastating, the study also showed that for some, isolated femoropopliteal obstruction can lead to significant postthrombotic sequelae and quality of life limitations as seen in our baseline data. The new message to the medical community and patients should be: there is hope—something can be done.”

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