Thrombolex today presented the final results of its National Institutes of Health (NIH)-sponsored RESCUE trial at TCT 2022 (16–19 September, Boston, USA).
This investigational device exemption (IDE) trial demonstrated that pharmacomechanical catheter-directed thrombolysis (PMCDT) therapy using the Bashir endovascular catheter (Thrombolex) led to a significant improvement in right ventricular function with an excellent safety profile. The magnitude of reduction in pulmonary artery obstruction in the RESCUE trial was markedly greater than what has been reported in other contemporary pulmonary embolism (PE) trials, a press release reports.
The RESCUE trial is a prospective, multicentre trial evaluating the Bashir catheter in 109 patients with intermediate risk acute PE at 18 sites in the USA. The Bashir catheter was used to deliver 7mg of recombinant tissue plasminogen activator (r-tPA) into each pulmonary artery over a five-hour infusion period. The primary efficacy endpoint was the core lab-assessed change in the computed tomography angiography (CTA)-derived mean right ventricular to left ventricular (RV/LV) diameter ratio at 48 hours, and 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. At 48 hours after delivering r-tPA, the RV/LV ratio decreased from baseline by 0.56, a reduction of 33.3% (p<0.0001). A key secondary efficacy endpoint was the core lab assessed reduction in pulmonary artery obstruction as measured by the refined Modified Miller Index (MMI), which demonstrated a reduction of 35.9% (p<0.0001). Compared to other contemporary core lab-assessed CDT trials, this reduction in pulmonary artery obstruction was more than two-fold greater with the Bashir catheter, per mg of r-tPA administered.
“The RESCUE trial demonstrated extremely rapid resolution of thrombus and a remarkable reduction in PA obstruction, with a less than a 1% rate of major bleeding. This represents a major advance in the treatment of acute PE,” said Kenneth Rosenfield (Massachusetts General Hospital, Boston, USA), co-principal investigator of the RESCUE study.
“We are absolutely delighted with the results of the RESCUE trial and thank all those who made this possible, especially our physician investigators and their patients. We would also like to thank the NIH and the Commonwealth of Pennsylvania Department of Health for their support,” said Marvin Woodall, executive chairman of Thrombolex.