Thrombolex Shares Promising Results from RAPID-PE Interim Analysis
THROMBOLEX™, Inc. has recently announced the results from the prespecified interim analysis of the first 50 patients enrolled in its RAPID-PE study. This key information was shared during an Innovation Session at TCT. The study is a prospective, multicenter evaluation focusing on the effectiveness of On-The-Table (OTT) pharmaco-mechanical lysis (PML) treatment without a post-procedure infusion, using the innovative BASHIR™ Endovascular Catheter (BEC) aimed at treating patients with intermediate-risk acute pulmonary embolism (PE).
Understanding the RAPID-PE Trial
The RAPID-PE trial has been carefully designed as a single-arm, prospective study that aims to assess both the safety and efficacy of OTT PML. The process comprises a unique protocol where 4 mg of r-tPA is administered into each pulmonary artery, totaling 8 mg for cases involving bilateral PE. This is achieved through multiple hand-injected pulse sprays utilizing the specialized 8 Fr BEC device. The dual mechanism enabled by the BEC device facilitates immediate mechanical fissures to restore blood flow, allowing the low-dose lytic agent to act effectively on and beyond the clot.
Key Findings from the Interim Analysis
The interim analysis has significant implications, as it reported outcomes from 50 patients, with a total of 62 out of the anticipated 500 patients having been enrolled to date. Impressively, none of the high intermediate-risk PE patients experienced death or hemodynamic decompensation within 7 days, which is a critical endpoint of this study. Additionally, major bleeding incidents, classified by the ISTH criteria, were reported at a mere 2% (with one case documented as an access-site bleed after a loading dose of an oral anticoagulant).
Procedure Overview and Efficiency
The procedures were conducted with a median total time of 43.5 minutes, and the catheter dwelled for a median of 17.5 minutes. Notably, only 8% of patients required intensive care unit (ICU) admission following these procedures, which has further positive implications for patient recovery outcomes. Moreover, the median length of hospital stay was recorded as 2.9 days, pointing to a streamlined and efficient treatment process.
Experts Weigh In on the Results
Dr. Wissam Jaber, from Emory University and the presenting author of the study, emphasized the importance of these results: “This interim cohort demonstrates that On-The-Table, low-dose PML with the BEC device can democratize the catheter-based treatment of intermediate-risk PE patients with excellent safety and remarkably efficient lab times, often without the need for an ICU stay.”
Marvin Woodall, Executive Chairman of Thrombolex Inc, expressed optimism regarding the trial’s ongoing validation of their novel Pharmaco-Mechanical approach. He stated, “The combination of mechanical blood flow restoration with targeted low-dose lysis may reduce ICU utilization and overall resource burden while ensuring strong clinical outcomes. We eagerly anticipate the completion of enrollment and the sharing of full results.”
About THROMBOLEX
Founded in 2016, THROMBOLEX is committed to designing, developing, and distributing innovative endovascular catheters that are predominantly used in interventional procedures. Their focus is particularly on pharmaco-mechanical lysis (PML) treatments for patients with venous and arterial thromboembolic (VTE) conditions. The company currently markets eight distinct FDA-cleared devices, all based on the innovative BASHIR™ Endovascular Catheter technology platform.
Contact Details
For general inquiries about Thrombolex, you can reach out via email at info@thrombolex.com for more detailed information regarding their solutions and innovations.
Frequently Asked Questions
What is the RAPID-PE study?
The RAPID-PE study is a prospective, multicenter trial evaluating the use of On-The-Table pharmaco-mechanical lysis for treating intermediate-risk acute pulmonary embolism.
What are the main findings from the interim analysis?
The interim analysis indicated no deaths or hemodynamic decompensation within seven days for the first 50 patients, showcasing impressive safety results.
How long did the procedures take on average?
The median total procedure time was about 43.5 minutes, demonstrating efficiency in the treatment process.
What are the implications of the study for ICU stays?
Only 8% of patients required ICU admission after the procedure, suggesting the treatment can be effectively managed outside of intensive care.
What is the future outlook for Thrombolex?
Thrombolex aims to complete patient enrollment in the RAPID-PE study and is eager to share comprehensive results when available.
