CytoSorbents’ DrugSorb-ATR Studied in STAR-T Pivotal Trial

August 14, 2023—CytoSorbents Corporation announced that it has completed the pivotal STAR-T randomized controlled trial after the last scheduled patient follow-up.

The trial is evaluating the ability of the company’s DrugSorb-ATR antithrombotic removal system to reduce perioperative bleeding caused by ticagrelor in patients undergoing cardiothoracic surgery. The company anticipates a readout of topline results before the end of the year.

The goal of using DrugSorb-ATR is to allow patients to receive critical surgery without delay, while reducing or preventing the bleeding risk from ticagrelor.

The company noted that ticagrelor confers a risk of major fatal or life-threatening coronary artery bypass graft surgery-related bleeding, particularly if the surgery is performed within the first 5 days of receiving the drug. Waiting in the hospital to wash out the drug is the only acceptable alternative but comes at a high cost and potential clinical risk.

According to the company, DrugSorb-ATR actively removes ticagrelor from blood during the surgery when installed in the heart-lung machine. DrugSorb-ATR has received FDA Breakthrough Device designation for this indication.

The STAR-T pivotal study was conducted by leading cardiothoracic surgery centers in North America and is intended to support FDA and Health Canada marketing approval for DrugSorb-ATR in this application.

The DrugSorb-ATR is based on the company’s polymer adsorption technology for blood purification used in its CytoSorb, which is approved in Europe to reduce “cytokine storm” and other toxins that can cause organ failure.

In addition to the ticagrelor-removal indication, CytoSorbents has received a second FDA Breakthrough Device designation for DrugSorb-ATR to remove the direct oral anticoagulants apixaban and rivaroxaban during cardiothoracic surgery. A pivotal clinical study for this indication is ongoing.