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
2020
Clinical outcome after interventions with paclitaxel-coated balloons: a PCR statement.
Lansky A, Cremonesi A, Scheller B, James S, Grubman D, Fajadet J, Sauguet A, Micari A, Sarno G, Bosiers M, Baumbach A, Wijns W. Clinical outcome after interventions with paclitaxel-coated balloons: a PCR statement. EuroIntervention 2020, 15: 1225-1227. PMID: 32044731, DOI: 10.4244/eijv15i14a220.Peer-Reviewed Original ResearchAngioplasty, BalloonCardiovascular AgentsCoated Materials, BiocompatibleFemoral ArteryPaclitaxelPolymerase Chain ReactionPopliteal ArteryTreatment Outcome
2019
First-in-Human Study of Paclitaxel Drug-Coated Chocolate Coronary Percutaneous Transluminal Coronary Angioplasty Balloon Catheter in De Novo Coronary Artery Lesions
Garcia-Lithgow C, Tirziu D, Zhou S, Bouras G, Shah T, Grubman D, Javier JJ, Mustapha JA, Abizaid A, Lansky AJ. First-in-Human Study of Paclitaxel Drug-Coated Chocolate Coronary Percutaneous Transluminal Coronary Angioplasty Balloon Catheter in De Novo Coronary Artery Lesions. JACC Cardiovascular Interventions 2019, 12: 2568-2570. PMID: 31857033, DOI: 10.1016/j.jcin.2019.08.044.Peer-Reviewed Original Research
2011
5-Year Follow-Up of Polytetrafluoroethylene-Covered Stents Compared With Bare-Metal Stents in Aortocoronary Saphenous Vein Grafts The Randomized BARRICADE (Barrier Approach to Restenosis: Restrict Intima to Curtail Adverse Events) Trial
Stone GW, Goldberg S, O'Shaughnessy C, Midei M, Siegel RM, Cristea E, Dangas G, Lansky AJ, Mehran R. 5-Year Follow-Up of Polytetrafluoroethylene-Covered Stents Compared With Bare-Metal Stents in Aortocoronary Saphenous Vein Grafts The Randomized BARRICADE (Barrier Approach to Restenosis: Restrict Intima to Curtail Adverse Events) Trial. JACC Cardiovascular Interventions 2011, 4: 300-309. PMID: 21435608, DOI: 10.1016/j.jcin.2010.11.013.Peer-Reviewed Original ResearchMeSH KeywordsAgedAngioplasty, Balloon, CoronaryChi-Square DistributionCoated Materials, BiocompatibleCoronary AngiographyCoronary Artery BypassCoronary RestenosisFemaleGraft Occlusion, VascularHumansKaplan-Meier EstimateMaleMetalsMiddle AgedMyocardial InfarctionPlatelet Aggregation InhibitorsPolytetrafluoroethyleneProspective StudiesProsthesis DesignRisk AssessmentRisk FactorsSaphenous VeinStentsThrombosisTime FactorsTreatment OutcomeUnited StatesConceptsSaphenous vein graftsBare metal stentsPercutaneous coronary interventionDiseased saphenous vein graftsHigh-pressure implantationDual antiplatelet therapyTarget vessel failureAntiplatelet therapyMajor secondary end pointEnd pointPrimary end pointSecondary end pointsLong-term prognosisBinary restenosisBMS patientsCoronary interventionVein graftsVessel failureInferior outcomesSaphenous veinDiscrete lesionsPatientsPrior trialsJostentLesions
2008
Effectiveness of Drug-Eluting Stent Implantation for Patients With Unprotected Left Main Coronary Artery Stenosis
Kim YH, Dangas GD, Solinas E, Aoki J, Parise H, Kimura M, Franklin-Bond T, Dasgupta NK, Kirtane AJ, Moussa I, Lansky AJ, Collins M, Stone GW, Leon MB, Moses JW, Mehran R. Effectiveness of Drug-Eluting Stent Implantation for Patients With Unprotected Left Main Coronary Artery Stenosis. The American Journal Of Cardiology 2008, 101: 801-806. PMID: 18328844, DOI: 10.1016/j.amjcard.2007.10.052.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overBlood Vessel Prosthesis ImplantationCoated Materials, BiocompatibleCoronary AngiographyCoronary StenosisElectrocardiographyFemaleFollow-Up StudiesHumansImmunosuppressive AgentsMaleMyocardial RevascularizationPaclitaxelProspective StudiesSirolimusStentsTreatment OutcomeTubulin ModulatorsUltrasonography, InterventionalConceptsHigh surgical riskMain coronary artery stenosisMajor adverse cardiac eventsUnprotected LMCA stenosisAdverse cardiac eventsCoronary artery stenosisSurgical riskLMCA stenosisCardiac eventsArtery stenosisStent thrombosisMyocardial infarctionBifurcation stenosisUnprotected left main coronary artery stenosisLeft main coronary artery stenosisDrug-eluting stent placementUrgent percutaneous coronary interventionQ-wave myocardial infarctionFeasible therapeutic alternativeOutcomes of patientsPercutaneous coronary interventionPaclitaxel-eluting stentsSingle-stent strategyUnfavorable clinical outcomeSirolimus-eluting stents
2006
Drug-Eluting and Bare Nitinol Stents for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery: Long-Term Results from the SIROCCO Trial
Duda SH, Bosiers M, Lammer J, Scheinert D, Zeller T, Oliva V, Tielbeek A, Anderson J, Wiesinger B, Tepe G, Lansky A, Jaff MR, Mudde C, Tielemans H, Beregi JP. Drug-Eluting and Bare Nitinol Stents for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery: Long-Term Results from the SIROCCO Trial. Journal Of Endovascular Therapy 2006, 13: 701-710. PMID: 17154704, DOI: 10.1583/05-1704.1.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAlloysAngioplasty, BalloonAnti-Bacterial AgentsAtherosclerosisBlood Vessel Prosthesis ImplantationCoated Materials, BiocompatibleDouble-Blind MethodDrug CarriersFemaleFemoral ArteryHumansKaplan-Meier EstimateMaleMiddle AgedProspective StudiesProsthesis FailureRecurrenceSafetySirolimusStentsTreatment OutcomeConceptsChronic limb ischemiaAnkle-brachial indexBare stent groupRestenosis rateSirolimus groupLimb ischemiaStent groupSuperficial femoral artery occlusionType C lesionsDouble-blinded studySymptoms of claudicationBare nitinol stentsMajority of patientsSuperficial femoral arteryFemoral artery occlusionStent restenosis rateNitinol self-expanding stentsSelf-expanding stentsTypes of stentsTVR ratesTLR rateArtery occlusionC lesionsClinical outcomesDrug-ElutingAngiographic Results of the First Human Experience With the Biolimus A9 Drug-Eluting Stent for De Novo Coronary Lesions
Costa RA, Lansky AJ, Abizaid A, Müeller R, Tsuchiya Y, Mori K, Cristea E, Leon MB, Sousa JE, Schmidt T, Hauptmann KE, Grube E. Angiographic Results of the First Human Experience With the Biolimus A9 Drug-Eluting Stent for De Novo Coronary Lesions. The American Journal Of Cardiology 2006, 98: 443-446. PMID: 16893694, DOI: 10.1016/j.amjcard.2006.02.051.Peer-Reviewed Original ResearchConceptsNovo coronary lesionsCoronary lesionsDe novo coronary lesionsNoncomplex coronary lesionsLate lumen lossFirst human experienceDrug-eluting stentsAngiographic characteristicsAngiographic findingsAngiographic resultsLumen lossStent groupBaseline lesionsStent restenosisControl groupLesionsStentsUncoated stentsDistal edgeGroupPatientsHyperplasiaRestenosisOutcome After Acute Incomplete Sirolimus-Eluting Stent Apposition as Assessed by Serial Intravascular Ultrasound
Kimura M, Mintz GS, Carlier S, Takebayashi H, Fujii K, Sano K, Yasuda T, Costa RA, Costa JR, Quen J, Tanaka K, Lui J, Weisz G, Moussa I, Dangas G, Mehran R, Lansky AJ, Kreps EM, Collins M, Stone GW, Moses JW, Leon MB. Outcome After Acute Incomplete Sirolimus-Eluting Stent Apposition as Assessed by Serial Intravascular Ultrasound. The American Journal Of Cardiology 2006, 98: 436-442. PMID: 16893693, DOI: 10.1016/j.amjcard.2006.02.050.Peer-Reviewed Original ResearchConceptsIncomplete stent appositionSES implantationStent appositionSirolimus-eluting stent implantationComplete resolution groupIntravascular ultrasound findingsIncidence of restenosisSerial intravascular ultrasoundConsecutive patientsStent thrombosisStent implantationUltrasound findingsPlaque areaAneurysm formationStent restenosisIntravascular ultrasoundPatientsLumen areaStent strutsGreater decreaseVessel wallThrombosisRestenosisLesionsGreater increaseEffect of Everolimus-Eluting Stents in Different Vessel Sizes (from the Pooled FUTURE I and II Trials)
Tsuchiya Y, Lansky AJ, Costa RA, Mehran R, Pietras C, Shimada Y, Sonoda S, Cristea E, Negoita M, Dangas GD, Moses JW, Leon MB, Fitzgerald PJ, Müller R, Störger H, Hauptmann KE, Grube E. Effect of Everolimus-Eluting Stents in Different Vessel Sizes (from the Pooled FUTURE I and II Trials). The American Journal Of Cardiology 2006, 98: 464-469. PMID: 16893698, DOI: 10.1016/j.amjcard.2006.02.054.Peer-Reviewed Original ResearchMeSH KeywordsAgedBlood Vessel Prosthesis ImplantationCoated Materials, BiocompatibleCoronary AngiographyCoronary RestenosisCoronary VesselsEverolimusFemaleFollow-Up StudiesHumansImmunosuppressive AgentsMaleMiddle AgedProspective StudiesProsthesis DesignSirolimusStentsTreatment OutcomeUltrasonography, InterventionalConceptsBare metal stentsDe novo coronary lesionsNovo coronary lesionsCoronary lesionsNeointimal proliferationStent late lumen lossMid-term outcomesLate lumen lossEverolimus-Eluting StentsQuantitative coronary angiographyMinimum lumen areaVessel sizeII trialCoronary angiographyI trialIncomplete appositionLumen lossStent thrombosisAneurysm formationStent restenosisIntravascular ultrasoundMetal stentsReference diameterLumen areaPatientsTreatment of Coronary Artery Perforations Complicating Percutaneous Coronary Intervention With a Polytetrafluoroethylene-Covered Stent Graft
Lansky AJ, Yang YM, Khan Y, Costa RA, Pietras C, Tsuchiya Y, Cristea E, Collins M, Mehran R, Dangas GD, Moses JW, Leon MB, Stone GW. Treatment of Coronary Artery Perforations Complicating Percutaneous Coronary Intervention With a Polytetrafluoroethylene-Covered Stent Graft. The American Journal Of Cardiology 2006, 98: 370-374. PMID: 16860026, DOI: 10.1016/j.amjcard.2006.02.041.Peer-Reviewed Original ResearchConceptsPercutaneous coronary interventionCoronary stent graftEmergency coronary bypass surgeryQ-wave myocardial infarctionCoronary bypass surgeryCoronary interventionCoronary perforationStent graftBypass surgeryMyocardial infarctionOverall procedure success rateReversal of anticoagulationLife-threatening complicationsCoronary artery perforationProcedure success rateStent-graft implantationAbrupt vessel closureEffective treatment optionProlonged balloon inflationMulticenter seriesCardiogenic shockArtery perforationPericardial tamponadeCardiac arrestTreatment optionsComparative Early and Late Outcomes After Primary Percutaneous Coronary Intervention in ST-Segment Elevation and Non–ST-Segment Elevation Acute Myocardial Infarction (from the CADILLAC Trial)
Cox DA, Stone GW, Grines CL, Stuckey T, Zimetbaum PJ, Tcheng JE, Turco M, Garcia E, Guagliumi G, Iwaoka RS, Mehran R, O’Neill W, Lansky AJ, Griffin JJ, Investigators C. Comparative Early and Late Outcomes After Primary Percutaneous Coronary Intervention in ST-Segment Elevation and Non–ST-Segment Elevation Acute Myocardial Infarction (from the CADILLAC Trial). The American Journal Of Cardiology 2006, 98: 331-337. PMID: 16860018, DOI: 10.1016/j.amjcard.2006.01.102.Peer-Reviewed Original ResearchMeSH KeywordsAbciximabAgedAngioplasty, Balloon, CoronaryAntibodies, MonoclonalAnticoagulantsBlood Vessel Prosthesis ImplantationCoated Materials, BiocompatibleElectrocardiographyFemaleFollow-Up StudiesHumansImmunoglobulin Fab FragmentsMaleMiddle AgedMyocardial InfarctionPlatelet Glycoprotein GPIIb-IIIa ComplexStentsStroke VolumeSurvival RateTime FactorsTreatment OutcomeConceptsST-segment elevation myocardial infarctionPrimary percutaneous coronary interventionPrimary PCIMyocardial Infarction (TIMI) grade 3 flowIschemic target vessel revascularizationGrade 3 flowOutcomes of patientsTarget vessel revascularizationPercutaneous coronary interventionVessel revascularizationAcute MICoronary interventionMyocardial infarctionAcute ST-segment elevation myocardial infarctionSegment elevation acute myocardial infarctionMajor adverse cardiac eventsElevation acute myocardial infarctionOngoing chest painSimilar late mortalityAdverse cardiac eventsElevation myocardial infarctionST-segment elevationAcute myocardial infarctionHigher ejection fractionPostprocedural Thrombolysis
2005
Randomized comparison of carbon ion–implanted stent versus bare metal stent in coronary artery disease: The Asian Pacific Multicenter Arthos Stent Study (PASS) trial
Kim YH, Lee CW, Hong MK, Park SW, Tahk SJ, Yang JY, Saito S, Santoso T, Quan L, Ge J, Weissman NJ, Lansky AJ, Mintz GS, Park SJ. Randomized comparison of carbon ion–implanted stent versus bare metal stent in coronary artery disease: The Asian Pacific Multicenter Arthos Stent Study (PASS) trial. American Heart Journal 2005, 149: 336-341. PMID: 15846274, DOI: 10.1016/j.ahj.2004.02.018.Peer-Reviewed Original ResearchMeSH KeywordsAngioplasty, Balloon, CoronaryCarbonCoated Materials, BiocompatibleCoronary AngiographyCoronary RestenosisCoronary StenosisFemaleHumansMaleMiddle AgedProsthesis DesignStentsConceptsMajor adverse cardiac eventsAngiographic restenosis rateLong-term outcomesLate lossRestenosis rateGroup 2Group 1Adverse cardiac eventsNative coronary lesionsNonfatal myocardial infarctionCoronary artery diseaseMulticenter clinical studyLesion revascularizationPrimary endpointSecondary endpointsBaseline characteristicsCardiac eventsArtery diseaseCoronary lesionsHospital eventsRandomized comparisonBare metalMyocardial infarctionClinical studiesInflammatory reaction
2004
High-dose 7-hexanoyltaxol-eluting stent with polymer sleeves for coronary revascularizationOne-year results from the SCORE randomized trial
GRUBE E, LANSKY A, HAUPTMANN K, DIMARIO C, DISCIASCIO G, COLOMBO A, SILBER S, STUMPF J, REIFART N, FAJADET J. High-dose 7-hexanoyltaxol-eluting stent with polymer sleeves for coronary revascularizationOne-year results from the SCORE randomized trial. Journal Of The American College Of Cardiology 2004, 44: 1368-1372. DOI: 10.1016/s0735-1097(04)01351-8.Peer-Reviewed Original ResearchConceptsRestenosis rateStent thrombosisMajor adverse cardiac event ratesAdverse cardiac event ratesDe novo coronary lesionsTarget vessel revascularization rateEnd pointNon-Q-wave MIAngiographic restenosis rateCardiac event rateNovo coronary lesionsPrimary end pointUnacceptable safety profileVessel revascularization rateMyocardial infarction rateOpen-label trialStent thrombosis ratesClinical end pointsOne-year resultsQuantitative coronary angiographyCoronary revascularizationRevascularization ratesInfarction rateCardiac deathCoronary angiographyHigh-dose 7-hexanoyltaxol-eluting stent with polymer sleeves for coronary revascularization One-year results from the SCORE randomized trial
Grube E, Lansky A, Hauptmann K, Di Mario C, Di Sciascio G, Colombo A, Silber S, Stumpf J, Reifart N, Fajadet J, Marzocchi A, Schofer J, Dumas P, Hoffmann R, Guagliumi G, Pitney M, Russell M. High-dose 7-hexanoyltaxol-eluting stent with polymer sleeves for coronary revascularization One-year results from the SCORE randomized trial. Journal Of The American College Of Cardiology 2004, 44: 1368-1372. PMID: 15464315, DOI: 10.1016/j.jacc.2004.06.054.Peer-Reviewed Original ResearchConceptsRestenosis rateStent thrombosisMajor adverse cardiac event ratesAdverse cardiac event ratesDe novo coronary lesionsTarget vessel revascularization rateEnd pointNon-Q-wave MIAngiographic restenosis rateCardiac event rateNovo coronary lesionsPrimary end pointUnacceptable safety profileVessel revascularization rateMyocardial infarction rateOpen-label trialStent thrombosis ratesClinical end pointsOne-year resultsQuantitative coronary angiographyCoronary revascularizationRevascularization ratesInfarction rateCardiac deathCoronary angiographySix- and Twelve-Month Results From First Human Experience Using Everolimus-Eluting Stents With Bioabsorbable Polymer
Grube E, Sonoda S, Ikeno F, Honda Y, Kar S, Chan C, Gerckens U, Lansky AJ, Fitzgerald PJ. Six- and Twelve-Month Results From First Human Experience Using Everolimus-Eluting Stents With Bioabsorbable Polymer. Circulation 2004, 109: 2168-2171. PMID: 15123533, DOI: 10.1161/01.cir.0000128850.84227.fd.Peer-Reviewed Original ResearchMeSH KeywordsAgedAnticoagulantsCatheterizationCineangiographyCoated Materials, BiocompatibleComorbidityCoronary AngiographyCoronary RestenosisCoronary StenosisDrug ImplantsEverolimusFemaleFollow-Up StudiesGrowth InhibitorsHumansHyperplasiaImmunosuppressive AgentsLactic AcidMaleMiddle AgedMyocardial InfarctionPolyestersPolymersProspective StudiesSingle-Blind MethodSirolimusStainless SteelStentsTreatment OutcomeTunica IntimaUltrasonography, InterventionalConceptsEverolimus-eluting stentsBare metal stentsRestenosis rateMajor adverse cardiac event ratesAdverse cardiac event ratesDe novo coronary lesionsMajor adverse cardiac eventsPercent neointimal volumeSegment restenosis rateAdverse cardiac eventsCardiac event rateNovo coronary lesionsStent restenosis rateTwelve-month resultsFirst human experienceIntravascular ultrasound analysisInitial clinical experienceLate stent malappositionLate stent thrombosisStent neointimal hyperplasiaSignificant reductionRestenosis reductionCardiac eventsI trialCoronary lesions