Thrombolex Bashir Catheters Studied in Pivotal RESCUE Trial to Treat Acute PE

October 5, 2021—Thrombolex, Inc. announced the results from a prespecified interim analysis of the first 62 evaluable patients in the pivotal RESCUE trial of the company’s Bashir and Bashir S-B endovascular catheters in the treatment of acute pulmonary embolism (PE).

The company noted that the goal of RESCUE is to achieve an additional indication for use of these devices in the treatment of acute PE. Conducted under an FDA investigational device exemption, this RESCUE trial is scheduled to enroll at least 100 evaluable patients with acute intermediate-risk PE.

The findings from this prespecified interim analysis were presented by Akhilesh Sista, MD, during a late-breaking clinical trials session at the VIVA 2021, the annual Vascular InterVentional Advances meeting held October 4-7 in Las Vegas, Nevada.

Dr. Sista, who is Chief of Interventional Radiology at NYU Langone Health in New York, New York, commented in the company’s press release, “These interim results from the RESCUE trial are very exciting. The most notable finding is the Core Lab assessed reduction in pulmonary thrombus burden at 48 hours, which may translate to better short- and long-term outcomes pending further research.

“The reduction in right ventricular to left ventricular (RV/LV) ratio and the absence of device or drug-related adverse events are also salutary outcomes. The expandable infusion basket of the Bashir endovascular catheters, with its pharmacomechanical mode of action, appears to restore blood flow promptly. I look forward to the final results of RESCUE and subsequent investigations that will determine the role of this promising novel technology in the treatment of acute PE.”

According to Thrombolex, the analysis included 44 men and 18 women with an average age of 58.5 years; 90.3% had high intermediate-risk PE with both right ventricular dysfunction and elevated biomarkers.

In the study, each patient was treated with 7 mg of recombinant tissue plasminogen activator (r-tPA) into each pulmonary artery during a period of 5 hours: a total of 14 mg of r-tPA in 58 patients with bilateral PEs; a total of 7 mg of r-tPA in four patients with unilateral PEs. These patients were treated at 18 centers in the United States.

A CT scan performed at 48 hours after infusion showed that the right ventricular to left ventricular (RV/LV) diameter ratio decreased by 32.1% (0.52 ± 0.38; 95% CI, 0.4-0.62; P < .0001), and the pulmonary clot burden by Refined Modified Miller Index had decreased by 36.3% (8.4 ± 4.3; 95% CI, 7.34-9.50; P < .0001). The rate of successful device placement was 100%. There were no device-related complications and the major bleed rate at 72 hours was zero, reported Thrombolex in the press release.