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 death