TY  - BOOK
AU  - Bernardo, Nelson L
AU  - Case, Brian
AU  - Craig, Paige E
AU  - Forrestal, Brian
AU  - Waksman, Ron
AU  - Yerasi, Charan
AU  - Zhang, Cheng
TI  - A Patient-Level, Pooled Analysis of Mortality Rates With the Passeo-18 Lux Paclitaxel Drug-Coated Balloon in Peripheral Arterial Disease
SN  - 1878-0938
PY  - 2021///
KW  - *Angioplasty, Balloon
KW  - *Peripheral Arterial Disease
KW  - *Pharmaceutical Preparations
KW  - Angioplasty, Balloon/ae [Adverse Effects]
KW  - Coated Materials, Biocompatible
KW  - Femoral Artery
KW  - Humans
KW  - Paclitaxel/ae [Adverse Effects]
KW  - Peripheral Arterial Disease/dg [Diagnostic Imaging]
KW  - Peripheral Arterial Disease/th [Therapy]
KW  - Popliteal Artery
KW  - Prospective Studies
KW  - Time Factors
KW  - Treatment Outcome
KW  - MedStar Heart & Vascular Institute
KW  - MedStar Washington Hospital Center
KW  - Interventional Cardiology Fellowship
KW  - Journal Article
N1  - Available in print through MWHC library: 2002 - present
N2  - BACKGROUND: Recent meta-analyses have raised concerns about mortality with paclitaxel drug-coated balloons (DCB). This pooled, patient-level analysis of the BIOLUX P-I, P-II, and P-III studies was performed to evaluate the safety and efficacy of Passeo-18 Lux DCB; CONCLUSIONS: Our patient-level analysis shows that overall the use of the Passeo-18 Lux paclitaxel DCB in infrainguinal arteries was not associated with increased mortality at 1 year and reinforces the efficacy of DCB angioplasty in preventing amputation or the need for reintervention. Copyright (c) 2021. Published by Elsevier Inc; MATERIALS AND METHODS: Individual patient-level demographic, clinical, diagnostic, and procedural data from the BIOLUX P-I, BIOLUX P-II, and BIOLUX P-III studies were pooled in a common database. Clinical safety (all-cause mortality and cardiovascular mortality) and efficacy (any amputation, target lesion/vessel revascularization) were extracted. Cox proportional modeling was used to assess the effect of critical limb ischemia at the time of enrollment and the occurrence of new amputation as a time-dependent variable on mortality; RESULTS: A total of 1009 patients were included in the analysis. Sixty-six patients were treated with percutaneous transluminal angioplasty (PTA) and 943 underwent DCB angioplasty. The cumulative incidence of all-cause mortality did not differ between the groups (PTA 6.7%, DCB 6.7%, p = 0.65). The composite efficacy endpoint of freedom from any amputation and target lesion/vessel revascularization was superior in the DCB arm compared to PTA [PTA 28.8%, DCB 16.7%, p = 0.02]. Both in unadjusted and adjusted Cox proportional models (adjusted for critical limb ischemia and amputation), the use of DCB was not associated with any mortality at 1 year
UR  - https://dx.doi.org/10.1016/j.carrev.2021.04.010
ER  -