2020
Paclitaxel-coated devices in the treatment of femoropopliteal stenosis among patients ≥65 years old: An ACC PVI Registry Analysis
Weissler EH, Annapureddy A, Wang Y, Secemsky EA, Shishehbor MH, Mena-Hurtado C, Jelani QU, Aronow HD, Tsai TT, Patel MR, Curtis JP, Jones WS. Paclitaxel-coated devices in the treatment of femoropopliteal stenosis among patients ≥65 years old: An ACC PVI Registry Analysis. American Heart Journal 2020, 233: 59-67. PMID: 33321119, PMCID: PMC8078180, DOI: 10.1016/j.ahj.2020.12.004.Peer-Reviewed Original ResearchConceptsPeripheral vascular interventionsPCD usePaclitaxel-coated devicesChronic total occlusionSignificant differencesCause mortalityAnalytic cohortFemoropopliteal lesionsOverall cohortPopliteal arteryPrimary outcomeRegistry analysisTotal occlusionUnadjusted ratesFemoropopliteal stenosesInverse probability weightingVascular interventionsAmerican CollegePatientsPractice settingsMortalityReal-world useClaim outcomesDevice useOutcomesOutcomes of treatment with paclitaxel-coated devices for peripheral arterial disease
Kim TI, Kiwan G, Mohamedali A, Zhang Y, Mena-Hurtado C, Mojibian H, Guzman RJ, Ochoa Chaar CI. Outcomes of treatment with paclitaxel-coated devices for peripheral arterial disease. Journal Of Vascular Surgery 2020, 73: 911-917. PMID: 33038480, DOI: 10.1016/j.jvs.2020.08.146.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAmputation, SurgicalCardiovascular AgentsCoated Materials, BiocompatibleDrug-Eluting StentsEndovascular ProceduresFemaleHumansLimb SalvageMaleMiddle AgedPaclitaxelPeripheral Arterial DiseaseProsthesis DesignRetreatmentRetrospective StudiesRisk AssessmentRisk FactorsTime FactorsTreatment OutcomeVascular PatencyConceptsPaclitaxel-coated devicesPeripheral artery diseaseCause of mortalityPCD useRisk of mortalityCumulative doseFemoropopliteal peripheral artery diseaseKaplan-Meier survival curvesLong-term mortalityPeripheral arterial diseaseCox regression analysisDrug-coated balloonsOutcome of treatmentDrug-eluting stentsMajor amputationPrimary patencyReintervention rateArtery diseaseArterial diseaseRandomized trialsOpen surgeryPresent studySingle institutionEndovascular interventionPatientsSafety and efficacy of paclitaxel drug-coated balloon in femoropopliteal in-stent restenosis
Anantha-Narayanan M, Love K, Nagpal S, Sheikh AB, Regan CJ, Mena-Hurtado C. Safety and efficacy of paclitaxel drug-coated balloon in femoropopliteal in-stent restenosis. Expert Review Of Medical Devices 2020, 17: 533-539. PMID: 32525406, DOI: 10.1080/17434440.2020.1770593.Peer-Reviewed Original ResearchConceptsDrug-coated balloonsPlain old balloon angioplastyPeripheral arterial diseaseFP-ISRFP diseaseStent restenosisEfficacy of DCBUse of DCBPaclitaxel drug-coated balloonFirst-line therapyRecurrence of symptomsSelf-expanding nitinol stentsHigher patency rateLong-term safetyLesion revascularizationEndovascular therapyISR rateRandomized studyArterial diseaseBalloon angioplastyFemoropopliteal segmentPatency ratesCommon siteTerm safetyNitinol stents
2017
Stellarex Drug-Coated Balloon for Treatment of Femoropopliteal Disease
Krishnan P, Faries P, Niazi K, Jain A, Sachar R, Bachinsky WB, Cardenas J, Werner M, Brodmann M, Mustapha JA, Mena-Hurtado C, Jaff MR, Holden AH, Lyden SP, Mewissen M, Katzen B, Nanjundappa A, Khuddus M, Ricci J, Fry D, Shishehbor M, Bosarge C, Kovach R, Goodwin M, Raja M, Mayeda G, Sandhu J, Rosales O, Crowder W, Paolini D, Henretta J, Desai P, Farhat N, Kang E, Ansel G, Ghani M, Miller W, Pollock C, Korngold E, Angle J, Schultz G, Gensler T, Lopez L, Park J, Al-Khoury G, Joels C, Metzger C. Stellarex Drug-Coated Balloon for Treatment of Femoropopliteal Disease. Circulation 2017, 136: 1102-1113. PMID: 28729250, PMCID: PMC5598919, DOI: 10.1161/circulationaha.117.028893.Peer-Reviewed Original ResearchMeSH KeywordsAgedAngioplasty, BalloonCardiovascular AgentsCoated Materials, BiocompatibleFemaleFemoral ArteryHalf-LifeHumansKaplan-Meier EstimateMaleMiddle AgedPaclitaxelPeripheral Arterial DiseaseProspective StudiesSeverity of Illness IndexSingle-Blind MethodTime FactorsTreatment OutcomeVascular PatencyConceptsDrug-coated balloonsPrimary safety end pointSafety end pointTarget lesion revascularizationLesion revascularizationPrimary patencyEnd pointFemoropopliteal diseaseClinical outcomesPivotal studiesDifferent drug-coated balloonsPrimary effectiveness end pointStellarex drug-coated balloonTarget limb major amputationEffectiveness end pointAnkle-brachial indexProcedure-related deathsFemoropopliteal artery diseasePrimary patency rateDrug-Coated BalloonKaplan-Meier estimatesPaclitaxel plasma concentrationsQuality of lifeDCB cohortMajor amputation
2015
Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease
Rosenfield K, Jaff MR, White CJ, Rocha-Singh K, Mena-Hurtado C, Metzger DC, Brodmann M, Pilger E, Zeller T, Krishnan P, Gammon R, Müller-Hülsbeck S, Nehler MR, Benenati JF, Scheinert D. Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease. New England Journal Of Medicine 2015, 373: 145-153. PMID: 26106946, DOI: 10.1056/nejmoa1406235.Peer-Reviewed Original ResearchConceptsDrug-coated balloonsPaclitaxel-coated balloonPeripheral artery diseasePercutaneous transluminal angioplastyPrimary patencyArtery diseaseTransluminal angioplastyStandard angioplastyStandard balloonSymptomatic femoropopliteal peripheral artery diseaseFemoropopliteal peripheral artery diseasePrimary efficacy end pointPrimary safety end pointEnd pointSignificant between-group differencesComposite of freedomPrimary safety eventsSymptomatic intermittent claudicationEfficacy end pointSafety end pointFemoropopliteal artery diseaseProportion of patientsSignificant atherosclerotic lesionsBetween-group differencesRate of deathLocal delivery of paclitaxel in the treatment of peripheral arterial disease
Ng VG, Mena C, Pietras C, Lansky AJ. Local delivery of paclitaxel in the treatment of peripheral arterial disease. European Journal Of Clinical Investigation 2015, 45: 333-345. PMID: 25615282, DOI: 10.1111/eci.12407.Peer-Reviewed Original ResearchConceptsPeripheral artery diseaseEndovascular revascularizationArtery diseaseLocal deliveryClinical studiesLocal drug deliveryPeripheral arterial diseasePeripheral vascular diseasePrimary patency rateSystemic adverse effectsUse of paclitaxelLong-term efficacyDrug-Eluting BalloonDrug-eluting stentsTerms of efficacyBrief exposure periodArterial diseaseBalloon angioplastyPatency ratesVascular diseaseBalloon catheterCoated balloonMEDLINE searchStent failureActive drug