Thrombolex Presents Final Results From RESCUE Trial of Bashir Catheter

September 17, 2022—Thrombolex, Inc. announced that the final results of its RESCUE trial demonstrated that pharmacomechanical catheter-directed thrombolysis (CDT) therapy using the company's Bashir endovascular catheter led to a significant improvement in right ventricular function with an excellent safety profile.

According to the company, RESCUE is a prospective, multicenter trial evaluating the Bashir catheter in 109 patients with intermediate-risk acute pulmonary embolism at 18 sites in the United States. Sponsored by the National Institutes of Health, the trial was conducted under an investigational device exemption approved by the FDA.

The results were presented during the Late Breaking Innovation Session at TCT 2022, the 34th annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held September 16-19 in Boston, Massachusetts.

In the RESCUE trial, the Bashir catheter was used to deliver 7 mg of recombinant tissue plasminogen activator (r-tPA) into each pulmonary artery over a 5-hour infusion period, stated the company.

The primary efficacy endpoint was the core lab-assessed change in the CT angiography-derived mean right ventricular to left ventricular (RV/LV) diameter ratio at 48 hours. The primary safety endpoint was serious adverse events, including major bleeding at 72 hours.

As summarized in the Thrombolex press release, the median device placement time was 15 minutes and length of hospital stay was 2.8 days.

At 48 hours after delivering r-tPA, the RV/LV ratio decreased from baseline by 0.56, a reduction of 33.3% (P < .0001). A key secondary efficacy endpoint was the core lab-assessed reduction in pulmonary artery obstruction as measured by the refined Modified Miller Index, which demonstrated a reduction of 35.9% (P < .0001).

Compared to other contemporary core lab-assessed CDT trials, this reduction in pulmonary artery obstruction was more than two-fold greater with the Bashir catheter, per mg of r-tPA administered, stated the company.

"The RESCUE trial demonstrated extremely rapid resolution of thrombus and a remarkable reduction in pulmonary artery obstruction, with a < 1% rate of major bleeding," commented Kenneth Rosenfield, MD, in the Thrombolex press release. "This represents a major advance in the treatment of acute pulmonary embolism."

Dr. Rosenfield, who serves as coprincipal investigator of the RESCUE trial, is Section Head, Vascular Medicine & Intervention at the Massachusetts General Hospital in Boston, Massachusetts.

In January 2022, Thrombolex announced positive results from the prespecified interim analysis of the RESCUE trial. Ripal Gandhi, MD, of the Miami Cardiac and Vascular Institute in Miami, Florida, presented the data at ISET 2022, the International Symposium on Endovascular Therapy held January 16-19 in Hollywood, Florida.