Pharmacomechanical Catheter-Directed Thrombolysis With the Bashir Endovascular Catheter for Acute Pulmonary Embolism: The RESCUE Study.

Background: Catheter-directed thrombolysis (CDT) has been associated with rapid recovery of right ventricular (RV) function. The Bashir catheter was developed for enhanced thrombolysis in large vessels such as the pulmonary arteries (PAs) with lower doses of tissue plasminogen activator (tPA).
Objectives: The aim of this study was to evaluate the efficacy and safety of tPA infused using a pharmacomechanical (PM) CDT device called the Bashir endovascular catheter in patients with intermediate-risk acute pulmonary embolism (PE).
Methods: Patients with symptoms of acute PE with computed tomographic evidence of RV dilatation were enrolled. The Bashir catheter was used to deliver 7 mg tPA into each PA over 5 hours. The primary efficacy endpoint was the core laboratory-assessed change in computed tomographic angiography-derived RV/left ventricular (LV) diameter ratio at 48 hours, and the primary safety endpoint was serious adverse events (SAEs) including major bleeding at 72 hours.
Results: At 18 U.S. sites, 109 patients were enrolled. The median device placement time was 15 minutes. At 48 hours after PM-CDT, the RV/LV diameter ratio decreased by 0.56 (33.3%; P < 0.0001). PA obstruction as measured by the refined modified Miller index was reduced by 35.9% (P < 0.0001). One patient (0.92%) had 2 SAEs: a retroperitoneal bleed (procedure related) and iliac vein thrombosis (device related). Two other procedure-related SAEs were epistaxis and non-access site hematoma with anemia.
Conclusions: PM-CDT with the Bashir endovascular catheter is associated with a significant reduction in RV/LV diameter ratio and a very low rate of adverse events or major bleeding in patients with intermediate-risk acute PE. The notable finding was a significant reduction in PA obstruction with low-dose tPA. (Recombinant tPA by Endovascular Administration for the Treatment of Submassive PE Using CDT for the Reduction of Thrombus Burden [RESCUE]; NCT04248868).
Competing Interests: Funding Support and Author Disclosures The study was sponsored by the National Heart, Lung, and Blood Institute (NHLBI) under a Small Business Innovation Research grant to Thrombolex (Grant # R44HL151032-03, Principal investigator, Brian G. Firth, MD, PhD), the Commonwealth of Pennsylvania Department of Health, and Thrombolex. Dr Bashir is the coinventor of the Bashir endovascular catheter; has equity interest in Thrombolex; and is supported by an NHLBI grant under the Small Business Innovation Research grant mechanism. Dr Sista has received research grant support from the NHLBI; and is an unpaid member of the scientific advisory board of Thrombolex. Dr Piazza has received research grant support from EKOS, a BTG International Group company, Bayer, the Bristol Myers Squibb/Pfizer Alliance, Daiichi-Sankyo, Portola, and Janssen; and has received consulting fees from Amgen, Pfizer, Boston Scientific, and Thrombolex. Dr Firth is chief scientific officer for Thrombolex. Dr Comerota is a member of the scientific advisory board of Thrombolex. Dr Rosenfield is a member of the scientific advisory board or a consultant for Abbott Vascular, Access Vascular, Boston Scientific–BTG, Volcano-Philips, Surmodics, Cruzar Systems, Magneto, Summa Therapeutics, and the University of Maryland; is an unpaid member of the scientific advisory board of Thrombolex; has received grants from the National Institutes of Health and Boston Scientific; has equity in Access Vascular, Accolade, Contego, Endospan, Embolitech, Eximo, JanaCare, PQ Bypass, Primacea, MD Insider, Shockwave, Silk Road, Summa Therapeutics, Cruzar Systems, Capture Vascular, Magneto, Micell, and Valcare; and is a board member of VIVA Physicians, a not-for-profit 501(c)(3) organization, and the National PERT Consortium, a not-for-profit 501(c)(3) organization. Dr Darki has received research grant support from EKOS, a BTG International Group company. Dr Jaber has received consultation fees and institutional educational and research grants from Inari Medical and Medtronic. Dr Gandhi is a consultant to Boston Scientific, Medtronic, Penumbra, and Inari. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
(Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)