RESCUE Study: PM-CDT With Bashir Catheter Holds Promise For Treating Acute PE
Pharmacomechanical catheter-directed thrombolysis (PM-CDT) with the Bashir catheter was associated with a significant reduction in the right ventricular/left ventricular (RV/LV) diameter ratio and relief of pulmonary artery (PA) obstruction in patients with intermediate risk of acute pulmonary embolism (PE), according to results of the RESCUE study presented Sept. 17 during TCT 2022 in Boston and simultaneously published in JACC: Cardiovascular Interventions.
The prospective multicenter trial enrolled 109 patients with symptoms of acute PE and CT evidence of RV dilatation. The Bashir catheter was used to deliver 7 mgs of tissue-plasminogen activator (t-PA) into each PA over five hours. The primary efficacy endpoint was the core laboratory assessed change in CTA-derived RV/LV diameter ratio at 48 hours. The primary safety endpoint was serious adverse events including major bleeding at 72 hours.
Overall findings showed a significant reduction in the RV/LV ratio at 48 hours with minimal bleeding complications or device related adverse events. Additionally, researchers said PA obstruction was reduced by 35.9% at 48 hours. "The magnitude of this reduction is threefold higher than with other [percutaneous mechanical thrombectomy] devices and two-fold higher than with other thrombolysis catheters at a similar dose of t-PA," according to Riyaz Bashir, MD, FACC, and colleagues. Improvement in hemodynamics like cardiac output and PA pressures was also observed within five hours of initiating PM-CDT.
"The safety profile of the Bashir catheter and the ease of use should facilitate the adoption of this therapy across a wide spectrum of health care institutions globally, particularly if RCTs confirm the benefit of PM-CDT in patients with intermediate-risk acute PE," said Bashir, et al. "Future studies are also needed to assess the direct effect of acute reduction in PA obstruction on long-term clinical outcomes, including chronic thromboembolic pulmonary disease/hypertension, post PE syndrome and long-term mortality."
Keywords: Transcatheter Cardiovascular Therapeutics, TCT22, Pulmonary Artery, Dilatation, Thrombolytic Therapy, Pulmonary Embolism, Catheters, Tomography, X-Ray Computed, Cardiac Output, Hemodynamics, Lung Diseases, Hemorrhage, Hypertension
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