2024
Results of SurVeil Versus IN.PACT Admiral Paclitaxel Coated Balloons in Femoropopliteal Arteries: Outcomes of the Randomised TRANSCEND Study Through 24 Months
Brodmann M, Gray W, Schneider P, Kurzmann-Guetl K, Schweiger L, Zeller T, Thieme M, Kilaru S, Bachinsky W, Feldman R, Holden A, Varcoe R, Lansky A, Rosenfield K, Investigators T. Results of SurVeil Versus IN.PACT Admiral Paclitaxel Coated Balloons in Femoropopliteal Arteries: Outcomes of the Randomised TRANSCEND Study Through 24 Months. European Journal Of Vascular And Endovascular Surgery 2024 PMID: 39615582, DOI: 10.1016/j.ejvs.2024.11.351.Peer-Reviewed Original ResearchFemoropopliteal artery diseasePrimary safetyPrimary patencyTRANSCEND studiesNon-inferiorityArtery diseaseRutherford stage 2Procedure related deathNon-inferiority clinical studyTarget lesion revascularisationTarget vessel revascularisationPaclitaxel coated balloonTarget limb amputationPrimary efficacyEfficacy endpointBinary restenosisClinical studiesFemoropopliteal arteriesSecondary outcomesRelated deathsCoated balloonsPatientsMonthsEfficacyPatency
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
2021
A randomized evaluation of the TriGuard™ HDH cerebral embolic protection device to Reduce the Impact of Cerebral Embolic LEsions after TransCatheter Aortic Valve ImplanTation: the REFLECT I trial
Lansky AJ, Makkar R, Nazif T, Messé S, Forrest J, Sharma R, Schofer J, Linke A, Brown D, Dhoble A, Horwitz P, Zang M, DeMarco F, Rajagopal V, Dwyer MG, Zivadinov R, Stella P, Rovin J, Parise H, Kodali S, Baumbach A, Moses J. A randomized evaluation of the TriGuard™ HDH cerebral embolic protection device to Reduce the Impact of Cerebral Embolic LEsions after TransCatheter Aortic Valve ImplanTation: the REFLECT I trial. European Heart Journal 2021, 42: 2670-2679. PMID: 34000004, DOI: 10.1093/eurheartj/ehab213.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve replacementEfficacy endpointCerebral embolic protection devicesTranscatheter aortic valve implantationCentral nervous system injuryCerebral embolic lesionsCerebral ischemic lesionsHealth Stroke ScalePrimary efficacy endpointPrimary safety outcomeAortic valve replacementAortic valve implantationEmbolic protection devicesNervous system injuryDiffusion-weighted magnetic resonanceMontreal Cognitive AssessmentEffectiveness endpointCause mortalityCerebral protectionSafety endpointStroke ScaleValve implantationValve replacementI trialIschemic lesionsRandomized Evaluation of TriGuard 3 Cerebral Embolic Protection After Transcatheter Aortic Valve Replacement REFLECT II
Nazif TM, Moses J, Sharma R, Dhoble A, Rovin J, Brown D, Horwitz P, Makkar R, Stoler R, Forrest J, Messé S, Dickerman S, Brennan J, Zivadinov R, Dwyer MG, Lansky AJ, Investigators R. Randomized Evaluation of TriGuard 3 Cerebral Embolic Protection After Transcatheter Aortic Valve Replacement REFLECT II. JACC Cardiovascular Interventions 2021, 14: 515-527. PMID: 33663779, DOI: 10.1016/j.jcin.2020.11.011.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve replacementAortic valve replacementSafety endpointValve replacementProcedure-related ischemic strokeCerebral embolic protectionComposite efficacy endpointPrimary safety endpointCerebral embolizationCerebral protectionEfficacy endpointII trialCerebral injuryIschemic strokeEmbolic protectionPatientsDrug AdministrationUS sitesU.S. FoodEndpointData reviewTrialsMulticenterEmbolizationInjury
2019
Treating Post-Angioplasty Dissection in the Femoropopliteal Arteries Using the Tack Endovascular System 12-Month Results From the TOBA II Study
Gray WA, Cardenas JA, Brodmann M, Werner M, Bernardo NI, George JC, Lansky A. Treating Post-Angioplasty Dissection in the Femoropopliteal Arteries Using the Tack Endovascular System 12-Month Results From the TOBA II Study. JACC Cardiovascular Interventions 2019, 12: 2375-2384. PMID: 31806218, DOI: 10.1016/j.jcin.2019.08.005.Peer-Reviewed Original ResearchMeSH KeywordsAgedAngioplasty, BalloonBlood Vessel ProsthesisBlood Vessel Prosthesis ImplantationEuropeFemaleFemoral ArteryHumansMaleMiddle AgedPeripheral Arterial DiseasePopliteal ArteryProspective StudiesProsthesis DesignRisk FactorsStentsTime FactorsTreatment OutcomeUnited StatesVascular Access DevicesVascular PatencyVascular System InjuriesConceptsProximal popliteal arteryDrug-coated balloonsSuperficial femoral arteryPlain balloonPopliteal arteryFemoral arteryTack Endovascular SystemLong-term outcomesDCB angioplastyEfficacy endpointPrimary patencyResidual stenosisRestenotic lesionsMulticenter studyFemoropopliteal arteriesEndovascular SystemAngioplastyArteryClassification 2DissectionLesionsBalloonStenosisPatencyPatients
2017
Novel Nitinol Stent for Lesions up to 24 cm in the Superficial Femoral and Proximal Popliteal Arteries: 24-Month Results From the TIGRIS Randomized Trial
Laird JR, Zeller T, Loewe C, Chamberlin J, Begg R, Schneider PA, Nanjundappa A, Bunch F, Schultz S, Harlin S, Lansky A, Jaff MR. Novel Nitinol Stent for Lesions up to 24 cm in the Superficial Femoral and Proximal Popliteal Arteries: 24-Month Results From the TIGRIS Randomized Trial. Journal Of Endovascular Therapy 2017, 25: 68-78. PMID: 29285955, DOI: 10.1177/1526602817749242.Peer-Reviewed Original ResearchConceptsTarget lesion revascularizationMajor adverse eventsProximal popliteal arteryPrimary patencyPopliteal arteryStent fractureAnkle/brachial indexPrimary safety endpointPrimary efficacy endpointTreatment of lesionsQuality of lifeSame time pointsLesion revascularizationRutherford categoryEfficacy endpointSafety endpointSecondary endpointsAdverse eventsBrachial indexSuperficial femoralProcedure successFracture ratesClinical successControl groupArtery
2015
Randomised study of a bioabsorbable polymer-coated sirolimus-eluting stent: results of the DESSOLVE II trial.
Wijns W, Vrolix M, Verheye S, Schoors D, Slagboom T, Gosselink M, Benit E, Donohoe D, Knape C, Attizzani GF, Lansky AJ, Ormiston J. Randomised study of a bioabsorbable polymer-coated sirolimus-eluting stent: results of the DESSOLVE II trial. EuroIntervention 2015, 10: 1383-90. PMID: 24801119, DOI: 10.4244/eijy14m05_03.Peer-Reviewed Original ResearchConceptsZotarolimus-eluting stentsLate lumen lossStent late lumen lossOptical coherence tomographyII trialMajor adverse cardiac eventsMean late lumen lossClinical safety endpointPrimary efficacy hypothesisAdverse cardiac eventsPrimary efficacy endpointStent thrombosis ratesMean neointimal thicknessSirolimus-eluting stentsQuantitative coronary angiographyZES patientsEfficacy endpointPrimary endpointSafety endpointVolume obstructionCardiac eventsCoronary angiographyThrombosis rateZES groupStrut coverage
2014
Short and long-term safety and efficacy of polymer-free vs. durable polymer drug-eluting stents. A comprehensive meta-analysis of randomized trials including 6178 patients
Navarese EP, Kowalewski M, Cortese B, Kandzari D, Dias S, Wojakowski W, Buffon A, Lansky A, Angelini P, Torguson R, Kubica J, Kelm M, de Boer MJ, Waksman R, Suryapranata H. Short and long-term safety and efficacy of polymer-free vs. durable polymer drug-eluting stents. A comprehensive meta-analysis of randomized trials including 6178 patients. Atherosclerosis 2014, 233: 224-231. PMID: 24529148, DOI: 10.1016/j.atherosclerosis.2013.12.024.Peer-Reviewed Original ResearchConceptsDurable polymer drug-eluting stentsDrug-eluting stentsStent thrombosisPolymer-free drug-eluting stentsRandomized trialsMyocardial infarctionMain efficacy endpointLong-term safetyLesion revascularizationEfficacy endpointSafety endpointVessel revascularizationMI ratesLong followCochrane DatabaseSafety profileClinical practiceRCTsGoogle ScholarConflicting resultsRevascularizationSignificant differencesEfficacyPatientsEndpoint
2013
Challenges in cardiac device innovation: is neuroimaging an appropriate endpoint? Consensus from the 2013 Yale-UCL Cardiac Device Innovation Summit
Meller SM, Baumbach A, Voros S, Mullen M, Lansky AJ. Challenges in cardiac device innovation: is neuroimaging an appropriate endpoint? Consensus from the 2013 Yale-UCL Cardiac Device Innovation Summit. BMC Medicine 2013, 11: 257. PMID: 24330754, PMCID: PMC4029193, DOI: 10.1186/1741-7015-11-257.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve implantationAortic valve implantationLesion volumeCerebral eventsValve implantationNew lesionsClinical studiesSurrogate endpointsAppropriate endpointsPrimary efficacy endpointDiffusion-weighted magnetic resonance imagingCerebral protection devicesUseful surrogate endpointTotal lesion volumeMagnetic resonance imagingSample size limitationsEfficacy endpointClinical outcomesDevice successOngoing trialsNeurological protectionClinical eventsResonance imagingMRI valuesConsensus opinionLow-dose of oral factor Xa inhibitors in patients with a recent acute coronary syndrome: A systematic review and meta-analysis of randomized trials
Obonska K, Navarese EP, Lansky A, Tarantini G, Rossini R, Kozinski M, Musumeci G, Di Pasquale G, Górny B, Szczesniak A, Kowalewski M, Gurbel PA, Kubica J. Low-dose of oral factor Xa inhibitors in patients with a recent acute coronary syndrome: A systematic review and meta-analysis of randomized trials. Atherosclerosis 2013, 229: 482-488. PMID: 23672879, DOI: 10.1016/j.atherosclerosis.2013.04.022.Peer-Reviewed Original ResearchConceptsAcute coronary syndromeRecent acute coronary syndromeOral factor Xa inhibitorsMajor bleeding complicationsNew oral anticoagulantsFactor Xa inhibitorsBleeding complicationsMajor bleedingCoronary syndromeOral anticoagulantsStandard therapyMyocardial infarctionOdds ratioXa inhibitorsSetting of ACSSystematic reviewAnti-Xa groupIntracranial bleeding ratesRecurrent MI ratesSecondary efficacy endpointsNew myocardial infarctionFactor X inhibitorsDose-related increaseEfficacy endpointPrimary endpoint
2012
Use of a Novel Crossing and Re-Entry System in Coronary Chronic Total Occlusions That Have Failed Standard Crossing Techniques Results of the FAST-CTOs (Facilitated Antegrade Steering Technique in Chronic Total Occlusions) Trial
Whitlow PL, Burke MN, Lombardi WL, Wyman RM, Moses JW, Brilakis ES, Heuser RR, Rihal CS, Lansky AJ, Thompson CA, Investigators F. Use of a Novel Crossing and Re-Entry System in Coronary Chronic Total Occlusions That Have Failed Standard Crossing Techniques Results of the FAST-CTOs (Facilitated Antegrade Steering Technique in Chronic Total Occlusions) Trial. JACC Cardiovascular Interventions 2012, 5: 393-401. PMID: 22516395, DOI: 10.1016/j.jcin.2012.01.014.Peer-Reviewed Original ResearchMeSH KeywordsAgedAngioplasty, Balloon, CoronaryCathetersChronic DiseaseCoronary AngiographyCoronary OcclusionDrug-Eluting StentsEquipment DesignFemaleHumansMaleMiddle AgedMyocardial InfarctionPredictive Value of TestsProspective StudiesProsthesis DesignRetreatmentTime FactorsTreatment FailureUnited StatesConceptsCoronary chronic total occlusionsElevation myocardial infarctionPercutaneous coronary interventionChronic total occlusionCrossing catheterTotal occlusionMyocardial infarctionMajor adverse cardiac event ratesST-segment elevation myocardial infarctionAdverse cardiac event ratesSuccessful percutaneous coronary interventionSegment elevation myocardial infarctionCardiac event ratePrimary efficacy endpointRe-entry catheterSingle-arm trialCTO-PCI successMean lesion lengthDistal true lumenCardiac reinterventionEfficacy endpointCoronary interventionEmergency surgeryHemodynamic instabilityPCI success
2002
Localized intracoronary beta radiation therapy to inhibit recurrence of in-stent restenosis
Waksman R, Raizner A, Yeung A, Lansky A, Vandertie L, on behalf of the INHIBIT Investigators. Localized intracoronary beta radiation therapy to inhibit recurrence of in-stent restenosis. Clinical Research In Cardiology 2002, 91: 40-41. DOI: 10.1007/s00392-002-1307-z.Peer-Reviewed Original ResearchTarget lesion revascularizationMajor adverse cardiac eventsPrimary safety endpointTarget vessel revascularizationLesion revascularizationStent restenosisMyocardial infarctionSafety endpointRestenosis rateRadiated groupLong lesionsRadiation therapyBinary angiographic restenosis rateIntracoronary beta-radiation therapyBeta-radiation therapyIntracoronary beta radiationSuccessful coronary interventionAdverse cardiac eventsAngiographic restenosis ratePrimary efficacy endpointIntracoronary radiation therapyRecurrence of restenosisCentering catheterOverall revascularizationEfficacy endpointUse of localised intracoronary β radiation in treatment of in-stent restenosis: the INHIBIT randomised controlled trial
Waksman R, Raizner AE, Yeung AC, Lansky AJ, Vandertie L, investigators I. Use of localised intracoronary β radiation in treatment of in-stent restenosis: the INHIBIT randomised controlled trial. The Lancet 2002, 359: 551-557. PMID: 11867107, DOI: 10.1016/s0140-6736(02)07741-3.Peer-Reviewed Original ResearchConceptsBinary angiographic restenosis ratePrimary safety endpointAngiographic restenosis rateTarget lesion revascularisationStent restenosisPlacebo groupSafety endpointRestenosis rateRadiated groupMyocardial infarctionMajor adverse cardiac eventsIntracoronary beta radiationIntracoronary β-radiationSuccessful coronary interventionAdverse cardiac eventsPrimary efficacy endpointRecurrence of restenosisBeta-radiation treatmentEfficacy endpointAngiographic outcomesCardiac eventsCoronary interventionIntracoronary stentingProcedural successVascular brachytherapy