000			04159nam a22006737a 4500
008			210719s20212021 xxu||||| |||| 00| 0 eng d
022			_a1878-0938
024			_a10.1016/j.carrev.2021.04.010 [doi]
024			_aS1553-8389(21)00198-6 [pii]
040			_aOvid MEDLINE(R)
099			_a34090794
245			_aA Patient-Level, Pooled Analysis of Mortality Rates With the Passeo-18 Lux Paclitaxel Drug-Coated Balloon in Peripheral Arterial Disease.
251			_aCardiovascular Revascularization Medicine. 33:49-54, 2021 12.
252			_aCardiovasc Revasc Med. 33:49-54, 2021 12.
252			_zCardiovasc Revasc Med. 2021 Apr 15
253			_aCardiovascular revascularization medicine : including molecular interventions
260			_c2021
260			_fFY2022
260			_p2021 Apr 15
265			_saheadofprint
265			_sppublish
266			_d2021-07-19
268			_aCardiovascular Revascularization Medicine. 2021 Apr 15
269			_fFY2021
501			_aAvailable in print through MWHC library: 2002 - present
520			_aBACKGROUND: 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.
520			_aCONCLUSIONS: 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.
520			_aMATERIALS 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.
520			_aRESULTS: 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.
546			_aEnglish
650			_a*Angioplasty, Balloon
650			_a*Peripheral Arterial Disease
650			_a*Pharmaceutical Preparations
650			_aAngioplasty, Balloon/ae [Adverse Effects]
650			_aCoated Materials, Biocompatible
650			_aFemoral Artery
650			_aHumans
650			_aPaclitaxel/ae [Adverse Effects]
650			_aPeripheral Arterial Disease/dg [Diagnostic Imaging]
650			_aPeripheral Arterial Disease/th [Therapy]
650			_aPopliteal Artery
650			_aProspective Studies
650			_aTime Factors
650			_aTreatment Outcome
651			_aMedStar Heart & Vascular Institute
651			_aMedStar Washington Hospital Center
656			_aInterventional Cardiology Fellowship
657			_aJournal Article
700			_aBernardo, Nelson L
700			_aCase, Brian
700			_aCraig, Paige E
700			_aForrestal, Brian
700			_aWaksman, Ron
700			_aYerasi, Charan
700			_aZhang, Cheng
790			_aBernardo NL, Case BC, Craig PE, Forrestal BJ, Torguson R, Waksman R, Yerasi C, Zhang C
856			_uhttps://dx.doi.org/10.1016/j.carrev.2021.04.010 _zhttps://dx.doi.org/10.1016/j.carrev.2021.04.010
942			_cART _dArticle
999			_c6617 _d6617