04159nam a22006737a 4500
210719s20212021 xxu||||| |||| 00| 0 eng d
1878-0938
10.1016/j.carrev.2021.04.010 [doi]
S1553-8389(21)00198-6 [pii]
Ovid MEDLINE(R)
34090794
A Patient-Level, Pooled Analysis of Mortality Rates With the Passeo-18 Lux Paclitaxel Drug-Coated Balloon in Peripheral Arterial Disease.
Cardiovascular Revascularization Medicine. 33:49-54, 2021 12.
Cardiovasc Revasc Med. 33:49-54, 2021 12.
Cardiovasc Revasc Med. 2021 Apr 15
Cardiovascular revascularization medicine : including molecular interventions
2021
FY2022
2021 Apr 15
aheadofprint
ppublish
2021-07-19
Cardiovascular Revascularization Medicine. 2021 Apr 15
FY2021
Available in print through MWHC library: 2002 - present
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.
English
*Angioplasty, Balloon
*Peripheral Arterial Disease
*Pharmaceutical Preparations
Angioplasty, Balloon/ae [Adverse Effects]
Coated Materials, Biocompatible
Femoral Artery
Humans
Paclitaxel/ae [Adverse Effects]
Peripheral Arterial Disease/dg [Diagnostic Imaging]
Peripheral Arterial Disease/th [Therapy]
Popliteal Artery
Prospective Studies
Time Factors
Treatment Outcome
MedStar Heart & Vascular Institute
MedStar Washington Hospital Center
Interventional Cardiology Fellowship
Journal Article
Bernardo, Nelson L
Case, Brian
Craig, Paige E
Forrestal, Brian
Waksman, Ron
Yerasi, Charan
Zhang, Cheng
Bernardo NL, Case BC, Craig PE, Forrestal BJ, Torguson R, Waksman R, Yerasi C, Zhang C
https://dx.doi.org/10.1016/j.carrev.2021.04.010
https://dx.doi.org/10.1016/j.carrev.2021.04.010
ART
Article
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Article
authcat
authcat
2021-07-19
0
34090794
34090794
2021-07-19
2021-07-19
ART
6617
6617