No Mortality Signal With Stellarex Low-Dose Paclitaxel DCB: ILLUMENATE Pivotal 4-Year Outcomes

Autor:	Sean P. Lyden, Peter L. Faries, Khusrow A. K. Niazi, Ravish Sachar, Ash Jain, Marianne Brodmann, Martin Werner, Ami Sood, Prakash Krishnan
Rok vydání:	2022
Předmět:	Time Factors Paclitaxel Cardiovascular Agents Femoral Artery Peripheral Arterial Disease Treatment Outcome Coated Materials Biocompatible Humans Popliteal Artery Radiology Nuclear Medicine and imaging Surgery Cardiology and Cardiovascular Medicine Angioplasty Balloon Vascular Patency
Zdroj:	Journal of Endovascular Therapy. 29:929-936
ISSN:	1545-1550 1526-6028
Popis:	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.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::be987061a32a3ca9d1e464db5eb64eed https://doi.org/10.1177/15266028211068769 Zobrazit plný text záznamu