Thrombolex’s Bashir Catheter for Acute PE Evaluated in Subanalysis of RESCUE Trial

March 6, 2023—Thrombolex, Inc. announced findings from a subanalysis of the RESCUE trial of pharmacomechanical catheter-directed thrombolysis (PMCDT) therapy using the company’s Bashir endovascular catheter in patients with acute pulmonary embolism (PE).

Robert A. Lookstein, MD, presented the data during a Late-Breaking Trial session at SIR 2023, the Society for Interventional Radiology’s annual scientific meeting held March 4-9, 2023, in Phoenix, Arizona. Dr. Lookstein is Executive Vice Chair, Diagnostic, Molecular, and Interventional Radiology at the Icahn School of Medicine at Mount Sinai Hospital in New York, New York.

RESCUE is an FDA-approved investigational device exemption trial sponsored by the National Heart, Lung, and Blood Institute.

The company reported that the core laboratory analysis of the trial demonstrated that PMCDT therapy using the Bashir device led to a significant reduction in segmental arterial occlusions (71%; P < .0001), which correlated with the reduction in right ventricular to left ventricular (RV/LV) ratio (P = .0026).

There was also a significant reduction in main pulmonary artery (PA) occlusions (61%; P < .0001) but this did not correlate significantly with the reduction in RV/LV ratio.

This reduction in occlusions of both the main PAs and the segmental arteries explains why the overall reduction in PA obstruction as assessed by the refined Modified Miller Index is greater with the Bashir endovascular catheter than results that have been reported in other contemporary thrombectomy or thrombolysis trials for the treatment of acute PE. The magnitude of effect of these other treatments on segmental arterial occlusions has not previously been reported, noted the company.

According to Thrombolex, the prospective, multicenter RESCUE trial evaluated the Bashir catheter in 109 patients with intermediate risk acute PE at 18 sites in the United States. The Bashir device was used to deliver 7 mg of recombinant tissue plasminogen activator (tPA) into each PA during a 5-hour infusion period.

The primary efficacy endpoint was the core lab-assessed change in the CT angiography-derived mean RV/LV diameter ratio at 48 hours. The primary safety endpoint was serious adverse events, including major bleeding at 72 hours. The median device placement time was 15 minutes and length of hospital stay was 2.8 days.

The final results from the RESCUE trial were presented 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 company’s press release, Dr. Lookstein commented, “The RESCUE trial demonstrated rapid resolution of obstruction in the main and especially segmental arteries, with less than a 1% major bleeding rate. It is imperative that future PE trials assess the reduction in obstruction in more distal PAs since it has been shown that both the degree of residual PA obstruction and reduction in pulmonary vascular volumes, presumably due to reduced PA inflow, are significant predictors of late PE-related mortality. This novel approach with the Bashir catheter and low-dose tPA represents a major advance in the treatment of acute PE.”

Thrombolex advised that the Bashir endovascular catheter has not been cleared by the FDA for the treatment of acute PE. However, the company is currently marketing seven different FDA-cleared devices that are based on the Bashir platform technology.