@article{8e7749c851cd4a6d866d217a1f18eb61,
title = "No Mortality Signal With Stellarex Low-Dose Paclitaxel DCB: ILLUMENATE Pivotal 4-Year Outcomes",
abstract = "Background: Paclitaxel-coated balloons have shown safety and efficacy in the short- to intermediate-term; however, long-term data remain limited. Objectives: To report late safety and efficacy outcomes for a low-dose paclitaxel drug-coated balloon (DCB) compared with percutaneous transluminal angioplasty (PTA) in femoropopliteal lesions from a large randomized controlled trial (RCT). Methods: ILLUMENATE Pivotal is a multicenter, single-blind RCT conducted across 43 US and EU centers to examine the safety and efficacy of the Stellarex DCB for the treatment of femoropopliteal disease. Assessments were recorded for all active patients at 36 and 48 months. Vital status of patients formally exited from the study was also collected. Results: Primary patency through 36 months for patients treated with DCB was significantly higher compared with PTA (p=0.016). The primary safety endpoint through 36 months was 77.4% and 72.4%, respectively (p=0.377). Kaplan-Meier analysis indicated that a higher proportion of DCB subjects were event-free compared with PTA at all study visits. The rate of major adverse event (MAE) through 48 months was 32.9% in the DCB group and 37.9% in the PTA group (p=0.428). No differences in the rate of mortality were evident through 48 months of follow-up with 15.6% in the DCB group and 15.2% in the PTA group (p=0.929). Conclusions: Stellarex DCB was associated with significantly higher patency compared with PTA through 3 years with no mortality difference detected through 4 years. The data from the ILLUMENATE Pivotal RCT support the long-term safety and efficacy of the low-dose Stellarex DCB.",
keywords = "CD-TLR, ILLUMENATE Pivotal, Stellarex, drug-coated balloon, femoropopliteal artery, mortality, paclitaxel, peripheral artery disease",
author = "Lyden, {Sean P.} and Faries, {Peter L.} and Niazi, {Khusrow A.K.} and Ravish Sachar and Ash Jain and Marianne Brodmann and Martin Werner and Ami Sood and Prakash Krishnan",
note = "Funding Information: The authors thank Teresa Yurik, MS, for statistical support and Kristina Davis, PhD, and Trisha Tarra, PhD, for assistance with medical writing. The author(s) disclosed receipt of the following financial support for the research, authorship and/or publication of this article: This trial was originally funded by Covidien who divested of the product to Spectranetics when acquired by Medtronic. Spectranetics was then acquired by Covidien, then Philips. The company and the National Co-PIs were responsible for design and conduct of the study, in the collection, analysis, interpretation of the data, and in the preparation, review and approval of the manuscript. Funding Information: Dr Niazi has received research grants from Medtronic, Philips, Boston Scientific, and TriReme. Dr Brodmann has received speaking honoraria and consulting for Medtronic, BD Bard, Boston Scientific, Biotronik, Intact Vascular, Cagent, Phillips Spectranetics, and Bayer Healthcare. Dr Sood is an employee of Philips. Dr Krishnan is a National Co-PI and is a consultant for Philips, Medtronic, and Abbott. Dr Jain, Faries, and Werner have no disclosures. Funding Information: The author(s) disclosed receipt of the following financial support for the research, authorship and/or publication of this article: This trial was originally funded by Covidien who divested of the product to Spectranetics when acquired by Medtronic. Spectranetics was then acquired by Covidien, then Philips. The company and the National Co-PIs were responsible for design and conduct of the study, in the collection, analysis, interpretation of the data, and in the preparation, review and approval of the manuscript. Publisher Copyright: {\textcopyright} The Author(s) 2022.",
year = "2022",
month = dec,
doi = "10.1177/15266028211068769",
language = "English",
volume = "29",
pages = "929--936",
journal = "Journal of Endovascular Therapy",
issn = "1526-6028",
publisher = "SAGE Publications Inc.",
number = "6",
}