RESCUE-II of Thrombolex Bashir Device Evaluates On-The-Table Pharmacomechanical Lysis to Treat Acute PE

October 28, 2024—Thrombolex announced findings from the RESCUE-II trial, which is evaluating the company’s Bashir endovascular catheter to treat acute intermediate high-risk pulmonary embolism (PE) in nine patients. The Bashir device was used to deliver 4 mg of recombinant tissue plasminogen activator (r-tPA) into each pulmonary artery (PA).

Christian Bichard, MD, presented the RESCUE-II results during the Innovations in Endovascular Therapies session at TCT 2024, the 36th annual Transcatheter Cardiovascular Therapeutics annual scientific symposium of the Cardiovascular Research Foundation held October 27-30 in Washington, DC.

According to Thrombolex, the study showed the following:

• The independent core laboratory-assessed primary endpoint of the right ventricular to left ventricular diameter ratio at 48 hours was reduced by 22.3% (P = .0001).
• The reduction in the secondary endpoint of PA obstruction, as measured by the Refined Modified Miller Index, was reduced by 29.2% (P = .0001).
• The reduction in segmental PA occlusion was 55% (P < .0001).

The company noted the total procedure time was 39 minutes, while the device placement and treatment time was 17 minutes. All catheters and sheaths were removed on the table (OTT). There were no device-related adverse events or major bleeds by International Society on Thrombosis and Hemostasis criteria at 72 hours.

These core laboratory-assessed outcomes parallel those seen with other contemporary catheter-based PE therapies, without requiring infusion in the intensive care unit (ICU).

Thrombolex advised that the RESCUE-II trial was conducted at Temple University Hospital in Philadelphia, Pennsylvania, and funded by the Commonwealth of Pennsylvania, Department of Health.

The principal investigator of RESCUE-II is Parth Rali, MD, Associate Professor of Thoracic Medicine and Surgery at Lewis Katz School of Medicine at Temple University. Dr. Rali and Vladimir Lakhter, DO, Associate Professor of Medicine at Temple, commented on the findings in the company’s press release.

“The trial represents a potentially major advance in treating acute PE,” stated Dr. Rali. “This unique OTT treatment protocol is safe and effective, maximizing clot lysis with small doses of a thrombolytic while helping healthcare systems manage their limited resources.”

Dr. Lakhter added, “This OTT treatment protocol without post-procedural thrombolytic infusion may obviate the need for an ICU stay and dramatically increase access to this life-saving treatment around the globe.”

The company noted that RESCUE-II is a successor study to the pivotal RESCUE trial that used the Bashir endovascular catheter to deliver 2 mg of tPA into each pulmonary artery followed by a 5-mg infusion over 5 hours into each pulmonary artery, for a total of 14 mg for a bilateral PE.

On October 23, Thrombolex announced the start of enrollment in the RAPID-PE trial that plans to enroll up to 500 patients at up to 50 centers in the United States, using this single session protocol without postprocedure infusion.