RESCUE Trial: Bashir Catheter Thrombolysis for Submassive PE

The Bashir Catheter and Pharmacomechanical Thrombolysis

The Bashir catheter uses six expandable infusion guidewires that fissure thrombus into a basket shape, allowing pulse spray saturation with tissue plasminogen activator followed by continuous infusion, combining mechanical maceration with stimulated endogenous and exogenous lysis.

RESCUE Trial Design and Patient Population

This prospective, single arm, multicenter trial enrolled patients aged 18 to 75 with submassive pulmonary embolism, symptoms of 14 days or less, and an RV to LV diastolic diameter ratio of 0.9 or greater, excluding recent stroke, intracranial disease, or active bleeding.

Primary Efficacy Results: RV/LV Ratio and Thrombus Burden

Among 61 evaluable patients, most with bilateral emboli, the trial met its primary endpoint: a 32 percent reduction in RV to LV ratio at 48 hours, a 36 percent reduction in thrombus burden by the modified Miller index, and a 72 percent reduction in occluded segmental arteries.

Safety Outcomes and the Surrogate Endpoint Question

Patients received just 7 to 14 milligrams of TPA over 5 to 8 hours, with no major bleeding or device related adverse events. Discussion addressed whether RV to LV ratio captures longer term pulmonary vascular impairment and reduced six minute walk results.