2023
Chocolate Touch Versus Lutonix Drug-Coated Balloon for Femoropopliteal Lesions in Diabetes: The Chocolate Touch Study.
Böhme T, Zeller T, Shishehbor M, Werner M, Brodmann M, Parise H, Holden A, Lichtenberg M, Parikh S, Kashyap V, Pietras C, Tirziu D, Beschorner U, Krishnan P, Niazi K, Wali A, Lansky A. Chocolate Touch Versus Lutonix Drug-Coated Balloon for Femoropopliteal Lesions in Diabetes: The Chocolate Touch Study. Journal Of Endovascular Therapy 2023, 15266028231179589. PMID: 37314243, DOI: 10.1177/15266028231179589.Peer-Reviewed Original ResearchLutonix drug-coated balloonDrug-coated balloonsPrimary safety endpointDM statusFemoropopliteal diseaseDiabetes mellitusSafety endpointFemoropopliteal lesionsSimilar safetyHigh-risk patient populationFemoropopliteal artery lesionsIschemic rest painNon-DM patientsSymptomatic femoropopliteal lesionsPrimary efficacy endpointMajor adverse eventsTherapy of choiceDrug-Coated BalloonMajor amputationRest painEfficacy endpointPrimary patencyAdverse eventsArtery lesionsDiabetes status
2022
Randomized Trial of Chocolate Touch Compared With Lutonix Drug-Coated Balloon in Femoropopliteal Lesions (Chocolate Touch Study)
Shishehbor MH, Zeller T, Werner M, Brodmann M, Parise H, Holden A, Lichtenberg M, Parikh SA, Kashyap VS, Pietras C, Tirziu D, Ardakani S, Beschorner U, Krishnan P, Niazi KA, Wali AU, Lansky AJ. Randomized Trial of Chocolate Touch Compared With Lutonix Drug-Coated Balloon in Femoropopliteal Lesions (Chocolate Touch Study). Circulation 2022, 145: 1645-1654. PMID: 35377157, DOI: 10.1161/circulationaha.122.059646.Peer-Reviewed Original ResearchConceptsLutonix drug-coated balloonDrug-coated balloonsEnd pointPrimary efficacy end pointPrimary safety end pointIndependent clinical events committeeIschemic rest painPrimary efficacy rateEfficacy end pointPrimary end pointSafety end pointClinical events committeeMajor adverse eventsRate of restenosisDrug-Coated BalloonNoninferiority end pointSafety event rateAverage lesion lengthMajor amputationPopliteal diseaseRest painBailout stentingEfficacy ratePrimary patencyAdverse events