2020
Defining device success for percutaneous coronary intervention trials: a position statement from the European Association of Percutaneous Cardiovascular Interventions of the European Society of Cardiology.
Chang CC, Kogame N, Onuma Y, Byrne RA, Capodanno D, Windecker S, Morel MA, Cutlip DE, Krucoff MW, Stone GW, Lansky AJ, Mehran R, Spitzer E, Fraser AG, Baumbach A, Serruys PW. Defining device success for percutaneous coronary intervention trials: a position statement from the European Association of Percutaneous Cardiovascular Interventions of the European Society of Cardiology. EuroIntervention 2020, 15: 1190-1198. PMID: 31475907, DOI: 10.4244/eij-d-19-00552.Peer-Reviewed Original ResearchConceptsDevice success rateDrug-eluting stentsPercutaneous coronary intervention trialsCoronary intervention trialsDevice successIntervention trialsClinical trialsSuccess rateSymptomatic coronary artery diseasePercutaneous coronary interventionAdverse clinical eventsCoronary artery diseasePercutaneous Cardiovascular InterventionsDifferent trialsRevascularisation proceduresCoronary interventionAngiographic outcomesArtery diseaseClinical eventsComparative trialsEndpoint definitionsDrug AdministrationCardiovascular interventionsPerformance endpointEuropean Association
2015
Morphological changes and clinical impact of unstable plaques within untreated segments of acute myocardial infarction patients during a 3-year follow-up
Souza CF, Doi H, Mintz GS, Lansky AJ, Witzenbichler B, Guagliumi G, Brodie BR, Kellett MA, Xu K, Mehran R, Stone GW, Maehara A. Morphological changes and clinical impact of unstable plaques within untreated segments of acute myocardial infarction patients during a 3-year follow-up. Coronary Artery Disease 2015, 26: 469-475. PMID: 25919902, DOI: 10.1097/mca.0000000000000251.Peer-Reviewed Original ResearchMeSH KeywordsAgedCoronary Artery DiseaseCoronary VesselsFemaleHumansMaleMiddle AgedMyocardial InfarctionPercutaneous Coronary InterventionPlaque, AtheroscleroticPlatelet Aggregation InhibitorsPredictive Value of TestsProspective StudiesRisk FactorsRupture, SpontaneousStentsTime FactorsTreatment OutcomeUltrasonography, InterventionalWound HealingConceptsST-segment elevation myocardial infarctionPlaque ruptureIntravascular ultrasoundClinical eventsUnstable plaquesLumen compromiseUntreated segmentsAcute Myocardial Infarction trialLong-term clinical outcomesAcute myocardial infarction patientsBaseline intravascular ultrasoundOptimal systemic therapySerial IVUS analysisMyocardial Infarction trialElevation myocardial infarctionInfarct-related arteryMyocardial infarction patientsThree-year followAttenuated plaqueHarmonizing OutcomesNonculprit lesionsSTEMI patientsSystemic therapyClinical outcomesInfarction patients
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 opinionNon-Fibroatheroma Lesion Phenotype and Long-Term Clinical Outcomes A Substudy Analysis From the PROSPECT Study
Dohi T, Mintz GS, McPherson JA, de Bruyne B, Farhat NZ, Lansky AJ, Mehran R, Weisz G, Xu K, Stone GW, Maehara A. Non-Fibroatheroma Lesion Phenotype and Long-Term Clinical Outcomes A Substudy Analysis From the PROSPECT Study. JACC Cardiovascular Imaging 2013, 6: 908-916. PMID: 23850249, DOI: 10.1016/j.jcmg.2013.04.008.Peer-Reviewed Original ResearchMeSH KeywordsAcute Coronary SyndromeAge FactorsAgedAngina, UnstableChi-Square DistributionCoronary VesselsFemaleFibrosisHospitalizationHumansKaplan-Meier EstimateMaleMiddle AgedMultivariate AnalysisMyocardial InfarctionNecrosisPercutaneous Coronary InterventionPhenotypePlaque, AtheroscleroticPredictive Value of TestsProportional Hazards ModelsProspective StudiesRisk FactorsSeverity of Illness IndexSex FactorsTime FactorsTreatment OutcomeUltrasonography, InterventionalVascular CalcificationConceptsMajor adverse cardiac eventsAcute coronary syndromeNonculprit lesionsClinical outcomesLong-term clinical outcomesVirtual histology intravascular ultrasoundPROSPECT studyCox proportional hazards modelAdverse cardiac eventsIntermediate-term prognosisSuccessful percutaneous interventionOverall plaque burdenLesion phenotypeFA lesionsProportional hazards modelSubstudy analysisCoronary syndromeCulprit lesionCardiac eventsPlaque burdenClinical eventsVH-IVUSPercutaneous interventionClinical impactHazards model
2012
Characteristics and Clinical Significance of Angiographically Mild Lesions in Acute Coronary Syndromes
Brener SJ, Mintz GS, Cristea E, Weisz G, Maehara A, McPherson JA, Marso SP, Farhat N, Botker HE, Dressler O, Xu K, Templin B, Zhang Z, Lansky AJ, de Bruyne B, Serruys PW, Stone GW. Characteristics and Clinical Significance of Angiographically Mild Lesions in Acute Coronary Syndromes. JACC Cardiovascular Imaging 2012, 5: s86-s94. PMID: 22421235, DOI: 10.1016/j.jcmg.2011.12.007.Peer-Reviewed Original ResearchMeSH KeywordsAcute Coronary SyndromeAgedAngioplasty, Balloon, CoronaryChi-Square DistributionCoronary AngiographyCoronary Artery DiseaseCoronary StenosisEuropeFemaleFibrosisHumansKaplan-Meier EstimateMaleMiddle AgedNecrosisPlaque, AtheroscleroticPredictive Value of TestsProportional Hazards ModelsProspective StudiesRecurrenceRisk AssessmentRisk FactorsSeverity of Illness IndexTime FactorsTreatment OutcomeUltrasonography, InterventionalUnited StatesVascular CalcificationConceptsAcute coronary syndromePercutaneous coronary interventionMajor adverse cardiac eventsAdverse cardiac eventsCoronary syndromeNC lesionsCoronary interventionCardiac eventsDiameter stenosisSuccessful percutaneous coronary interventionMedian diameter stenosisRecurrent ischemic eventsThin-cap fibroatheromaNonculprit lesionsIschemic eventsUntreated lesionsClinical eventsClinical significanceMild lesionsPatientsLesionsNormal segmentsOne-halfSyndromeRecurrent events
2009
Bivalirudin in patients undergoing primary angioplasty for acute myocardial infarction (HORIZONS-AMI): 1-year results of a randomised controlled trial
Mehran R, Lansky AJ, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Gersh BJ, Pocock SJ, Wong SC, Nikolsky E, Gambone L, Vandertie L, Parise H, Dangas GD, Stone GW, Investigators F. Bivalirudin in patients undergoing primary angioplasty for acute myocardial infarction (HORIZONS-AMI): 1-year results of a randomised controlled trial. The Lancet 2009, 374: 1149-1159. PMID: 19717185, DOI: 10.1016/s0140-6736(09)61484-7.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAngioplasty, Balloon, CoronaryAnticoagulantsFemaleFollow-Up StudiesHemorrhageHeparinHirudinsHumansKaplan-Meier EstimateMaleMiddle AgedMyocardial InfarctionPeptide FragmentsPlatelet Aggregation InhibitorsPlatelet Glycoprotein GPIIb-IIIa ComplexProportional Hazards ModelsRecombinant ProteinsStentsSurvival RateThrombosisTreatment OutcomeConceptsGlycoprotein IIb/IIIa inhibitorsST-segment elevation myocardial infarctionNet adverse clinical eventsPercutaneous coronary interventionAdverse clinical eventsBivalirudin groupMajor bleedingClinical eventsControl groupMyocardial infarctionAcute ST-segment elevation myocardial infarctionIIb/IIIa inhibitorsPrimary percutaneous coronary interventionHORIZONS-AMI trialMajor haemorrhagic complicationsPrimary trial endpointRate of MACERate of NACEElevation myocardial infarctionOnset of symptomsAcute myocardial infarctionOptimum treatment strategyWithdrawal of consentThrombin inhibitor bivalirudinImportant clinical implicationsClassification and Potential Mechanisms of Intravascular Ultrasound Patterns of Stent Fracture
Doi H, Maehara A, Mintz GS, Tsujita K, Kubo T, Castellanos C, Liu J, Yang J, Oviedo C, Aoki J, Franklin-Bond T, Dasgupta N, Lansky AJ, Dangas GD, Stone GW, Moses JW, Mehran R, Leon MB. Classification and Potential Mechanisms of Intravascular Ultrasound Patterns of Stent Fracture. The American Journal Of Cardiology 2009, 103: 818-823. PMID: 19268738, DOI: 10.1016/j.amjcard.2008.11.051.Peer-Reviewed Original ResearchConceptsStent fractureStent failureIndex stentingDrug-eluting stent (DES) failurePaclitaxel-eluting Taxus stentSirolimus-eluting Cypher stentsIntravascular ultrasound findingsBare metal stentsComplete stent fractureCoronary aneurysmsClinical eventsFracture groupTaxus stentUltrasound findingsUltrasound patternAneurysm formationIVUS analysisMetal stentsSimilar clinical eventsCypher stentsAneurysmsStent segmentIVUSPotential mechanismsStents
2008
Contemporary outcomes of rescue percutaneous coronary intervention for acute myocardial infarction: Comparison with primary angioplasty and the role of distal protection devices (EMERALD trial)
Dangas G, Stone GW, Weinberg MD, Webb J, Cox DA, Brodie BR, Krucoff MW, Gibbons RJ, Lansky AJ, Mehran R, Investigators F. Contemporary outcomes of rescue percutaneous coronary intervention for acute myocardial infarction: Comparison with primary angioplasty and the role of distal protection devices (EMERALD trial). American Heart Journal 2008, 155: 1090-1096. PMID: 18513524, DOI: 10.1016/j.ahj.2007.12.003.Peer-Reviewed Original ResearchConceptsST-segment resolutionTIMI 3 flowDistal protection devicesPrimary PCIDistal protectionInfarct sizeRescue PCIPost-procedural TIMI 3 flowRescue percutaneous coronary interventionComplete ST-segment resolutionSimilar myocardial perfusionPercutaneous coronary interventionST-elevation MIAcute myocardial infarctionHigher baseline ratesPrespecified comparisonPCI patientsPrimary angioplastyMonth mortalityPrimary endpointCoronary interventionClinical outcomesMulticenter trialClinical eventsPatient population
2006
A multicenter, randomized, dose-finding study of gamma intracoronary radiation therapy to inhibit recurrent restenosis after stenting.
Price MJ, Moses JW, Leon MB, Mehran R, Negoita M, Lansky A, Collins M, Giap H, Lin R, Jani S, Steuterman S, Balter S, Dalton J, Lipsztein R, Tripuraneni P, Teirstein PS. A multicenter, randomized, dose-finding study of gamma intracoronary radiation therapy to inhibit recurrent restenosis after stenting. Journal Of Invasive Cardiology 2006, 18: 169-73. PMID: 16732060.Peer-Reviewed Original ResearchConceptsIntracoronary radiation therapyStent restenosisRadiation therapyLesion late lossTarget lesion revascularizationHigh-dose groupDose-finding studySignificant clinical problemBare metal stentsRadiation dose prescriptionHigh radiation doseBinary restenosisLesion revascularizationRecurrent restenosisVessel revascularizationAdverse eventsCoronary interventionRecurrent stenosisComposite endpointRandomized studyDose groupClinical eventsMyocardial infarctionRadiation failureGy group
2005
Creatine kinase-MB enzyme elevation and long-term clinical events after successful coronary stenting in lesions with ruptured plaque
Fujii K, Carlier SG, Mintz GS, Kobayashi Y, Jacoboff D, Nierenberg H, Takebayashi H, Yasuda T, Moussa I, Dangas G, Mehran R, Lansky AJ, Kreps EM, Collins M, Stone GW, Leon MB, Moses JW. Creatine kinase-MB enzyme elevation and long-term clinical events after successful coronary stenting in lesions with ruptured plaque. The American Journal Of Cardiology 2005, 95: 355-359. PMID: 15670544, DOI: 10.1016/j.amjcard.2004.09.033.Peer-Reviewed Original ResearchMeSH KeywordsAnalysis of VarianceCase-Control StudiesChi-Square DistributionCineangiographyCoronary AngiographyCoronary Artery DiseaseCreatine KinaseCreatine Kinase, MB FormFemaleHumansImage Processing, Computer-AssistedIsoenzymesMaleMiddle AgedRuptureStatistics, NonparametricStentsUltrasonography, InterventionalConceptsAcute coronary syndromeCoronary syndromeCoronary stentingClinical outcomesStent implantationRuptured plaquesCreatine kinase-MB isoenzyme releaseCreatine kinase‐MB enzyme elevationLong-term clinical eventsCK-MB elevationCK-MB releaseSuccessful coronary stentingControl patientsUnstable anginaEnzyme elevationIndependent predictorsProcedural complicationsClinical eventsPlaque ruptureIntravascular ultrasoundPatientsLong-term eventsPlaquesComposite rateSyndrome
2004
Gamma radiation for in‐stent restenosis: effect of lesion length on angiographic and clinical outcomes
Mehran R, Iakovou I, Dangas G, Lansky AJ, Stone GW, Mintz GS, Kent KM, Pichard AD, Satler LF, Fahy M, Leon MB, Waksman R. Gamma radiation for in‐stent restenosis: effect of lesion length on angiographic and clinical outcomes. Catheterization And Cardiovascular Interventions 2004, 61: 354-359. PMID: 14988895, DOI: 10.1002/ccd.10786.Peer-Reviewed Original ResearchConceptsISR groupLesion lengthClinical eventsIn-Stent Restenosis TrialBaseline lesion lengthLower late lossShort lesion groupTreatment of ISRStent restenosis lesionsLong-term outcomesRecurrent ISRRestenosis lesionsRestenosis TrialAngiographic outcomesISR lesionsRestenosis rateClinical outcomesWashington RadiationLate lossStent restenosisLumen dimensionsLong ISRRadiation treatmentPowerful predictorPatients
2003
Impact of gender on the incidence and outcome of contrast-induced nephropathy after percutaneous coronary intervention.
Iakovou I, Dangas G, Mehran R, Lansky AJ, Ashby DT, Fahy M, Mintz GS, Kent KM, Pichard AD, Satler LF, Stone GW, Leon MB. Impact of gender on the incidence and outcome of contrast-induced nephropathy after percutaneous coronary intervention. Journal Of Invasive Cardiology 2003, 15: 18-22. PMID: 12499523.Peer-Reviewed Original ResearchConceptsContrast-induced nephropathyChronic renal failureOne-year mortalityIndependent predictorsPercutaneous interventionDiabetes mellitusClinical outcomesFemale genderMultivariate analysisOne-year clinical eventsNYHA IV classSevere heart failurePercutaneous coronary interventionImpact of genderCoronary interventionRenal failureHeart failureMale patientsCIN developmentClinical eventsPatientsMortalityMellitusNephropathySignificant gender differences
2000
Importance of lesion length on new device angioplasty of native coronary arteries
Saucedo J, Kennard E, Popma J, Talley D, Lansky A, Leon M, Baim D. Importance of lesion length on new device angioplasty of native coronary arteries. Catheterization And Cardiovascular Interventions 2000, 50: 19-25. PMID: 10816274, DOI: 10.1002/(sici)1522-726x(200005)50:1<19::aid-ccd4>3.0.co;2-h.Peer-Reviewed Original ResearchConceptsTarget lesion revascularizationNew device angioplastyMore target lesion revascularizationLesion revascularizationLong lesionsLesion lengthRight coronary artery diseaseSmaller minimal lumen diameterLong lesion groupMore multivessel diseaseNative coronary arteriesCoronary artery diseaseCoronary Intervention RegistryEarly clinical eventsMinimal lumen diameterLonger lesion lengthMultivessel diseaseAngiographic outcomesIntervention RegistryArtery diseaseClinical outcomesHospital eventsTotal occlusionClinical eventsCoronary arteryRandomized Trial of Contrast Media Utilization in High-Risk PTCA
Davidson C, Laskey W, Hermiller J, Harrison J, Matthai W, Vlietstra R, Brinker J, Kereiakes D, Muhlestein J, Lansky A, Popma J, Buchbinder M, Hirshfeld J. Randomized Trial of Contrast Media Utilization in High-Risk PTCA. Circulation 2000, 101: 2172-2177. PMID: 10801758, DOI: 10.1161/01.cir.101.18.2172.Peer-Reviewed Original ResearchConceptsMajor adverse clinical eventsHospital major adverse clinical eventsPrimary end pointClinical eventsNonionic dimer iodixanolDimer iodixanolEnd pointLow-osmolar contrast agentsHigh-risk PTCAHospital clinical eventsThrombus-related eventsTotal clinical eventsDouble-blind trialAcute coronary syndromeHigh-risk patientsProspective multicenter trialAdverse clinical eventsCoronary artery interventionPTCA outcomeAngiographic successCoronary syndromeNovo lesionsArtery interventionMulticenter trialRandomized trialsLong-term clinical events following creatine kinase–myocardial band isoenzyme elevation after successful coronary stenting
Saucedo J, Mehran R, Dangas G, Hong M, Lansky A, Kent K, Satler L, Pichard A, Stone G, Leon M. Long-term clinical events following creatine kinase–myocardial band isoenzyme elevation after successful coronary stenting. Journal Of The American College Of Cardiology 2000, 35: 1134-1141. PMID: 10758952, DOI: 10.1016/s0735-1097(00)00513-1.Peer-Reviewed Original ResearchMeSH KeywordsAgedAnalysis of VarianceAngioplasty, Balloon, CoronaryBiomarkersCoronary DiseaseCreatine KinaseDisease-Free SurvivalFemaleHumansIncidenceLogistic ModelsMaleMiddle AgedPredictive Value of TestsPrognosisProspective StudiesPulmonary EdemaRadiographyRecurrenceRisk FactorsSeverity of Illness IndexStentsTreatment OutcomeConceptsCK-MB elevationCreatine kinase-myocardial band isoenzyme (CK-MB) elevationMajor adverse clinical eventsCK-MB riseAdverse clinical eventsCoronary stentingLate mortalityClinical eventsGroup 1Group 3Group 2Long-term clinical importanceLong-term clinical eventsHospital recurrent ischemiaLate clinical outcomesCardiac enzyme elevationEvent-free survivalClinical end pointsHigher late mortalityPercutaneous coronary interventionPercutaneous coronary revascularizationCK-MB levelsNative coronary arteriesSuccessful coronary stentingSuccessful stent implantationRelation of coronary artery size to one-year clinical events after new device angioplasty of native coronary arteries (a New Approach to Coronary Intervention [NACI] Registry report)
Saucedo J, Popma J, Kennard E, Talley J, Lansky A, Leon M, Baim D, Investigators F. Relation of coronary artery size to one-year clinical events after new device angioplasty of native coronary arteries (a New Approach to Coronary Intervention [NACI] Registry report). The American Journal Of Cardiology 2000, 85: 166-171. PMID: 10955371, DOI: 10.1016/s0002-9149(99)00649-9.Peer-Reviewed Original ResearchConceptsReference vessel diameterNew device angioplastyNative coronary arteriesMinimal lumen diameterClinical eventsAngiographic outcomesCoronary arteryFinal minimal lumen diameterFinal percent diameter stenosisMajor adverse clinical eventsOne-year clinical eventsSmaller reference vessel diameterBaseline lesion characteristicsRisk of TLRCombined end pointAdverse clinical eventsCoronary artery diseaseCoronary Intervention RegistryEarly clinical eventsIncidence of deathSmall vesselsCoronary artery sizePercent diameter stenosisLesion revascularizationMultivessel disease
1999
Creatine Kinase-MB Enzyme Elevation Following Successful Saphenous Vein Graft Intervention Is Associated With Late Mortality
Hong M, Mehran R, Dangas G, Mintz G, Lansky A, Pichard A, Kent K, Satler L, Stone G, Leon M. Creatine Kinase-MB Enzyme Elevation Following Successful Saphenous Vein Graft Intervention Is Associated With Late Mortality. Circulation 1999, 100: 2400-2405. PMID: 10595951, DOI: 10.1161/01.cir.100.24.2400.Peer-Reviewed Original ResearchConceptsCK-MB elevationSaphenous vein graft interventionCK-MB riseVein graft interventionLate mortalityGraft interventionClinical eventsCreatine kinase‐MB enzyme elevationPeriprocedural CK-MB elevationNormal CK-MBMajor clinical eventsLate clinical eventsCreatine kinase elevationStrong independent predictorHospital complicationsSVG angioplastySVG interventionSVG lesionsConsecutive patientsDiabetes mellitusEnzyme elevationIndependent predictorsPrognostic significanceCK-MBMultivariate analysis
1998
Final Results of the Balloon vs Optimal Atherectomy Trial (BOAT)
Baim D, Cutlip D, Sharma S, Ho K, Fortuna R, Schreiber T, Feldman R, Shani J, Senerchia C, Zhang Y, Lansky A, Popma J, Kuntz R. Final Results of the Balloon vs Optimal Atherectomy Trial (BOAT). Circulation 1998, 97: 322-331. PMID: 9468205, DOI: 10.1161/01.cir.97.4.322.Peer-Reviewed Original ResearchConceptsAngiographic restenosisBalloon angioplastyHigh short-term successPrespecified primary end pointLower angiographic restenosisNative vessel lesionsSingle de novoPrimary end pointTarget vessel failureTarget vessel revascularizationResidual diameter stenosisLate clinical eventsConventional balloon angioplastyCreatine kinase-MBLow residual stenosisSignificant reductionHospital complicationsResidual stenosisLesion successMajor complicationsAngiographic restudyDiameter stenosisVessel lesionsClinical eventsLong-term benefits