2008
Angiographic Surrogate End Points in Drug-Eluting Stent Trials A Systematic Evaluation Based on Individual Patient Data From 11 Randomized, Controlled Trials
Pocock SJ, Lansky AJ, Mehran R, Popma JJ, Fahy MP, Na Y, Dangas G, Moses JW, Pucelikova T, Kandzari DE, Ellis SG, Leon MB, Stone GW. Angiographic Surrogate End Points in Drug-Eluting Stent Trials A Systematic Evaluation Based on Individual Patient Data From 11 Randomized, Controlled Trials. Journal Of The American College Of Cardiology 2008, 51: 23-32. PMID: 18174032, DOI: 10.1016/j.jacc.2007.07.084.Peer-Reviewed Original ResearchConceptsDrug-eluting stentsBare metal stentsAngiographic measuresTLR riskEnd pointDifferent drug-eluting stentsPrimary end pointRisk of TLRFollow-up angiographyLower revascularization ratesSurrogate end pointsIndividual patient dataSuitable surrogate markerDES trialsRevascularization ratesTLR rateClinical restenosisControlled TrialsFuture trialsStent implantationStent trialsSurrogate marker
2003
Increased CK-MB release is a “trade-off” for optimal stent implantation an intravascular ultrasound study
Iakovou I, Mintz GS, Dangas G, Abizaid A, Mehran R, Kobayashi Y, Lansky AJ, Aymong ED, Nikolsky E, Stone GW, Moses JW, Leon MB. Increased CK-MB release is a “trade-off” for optimal stent implantation an intravascular ultrasound study. Journal Of The American College Of Cardiology 2003, 42: 1900-1905. PMID: 14662249, DOI: 10.1016/j.jacc.2003.06.012.Peer-Reviewed Original ResearchConceptsCK-MB releaseTarget lesion revascularizationOptimal stent implantationStent expansionLesion revascularizationClinical restenosisStent implantationGroup 1Creatine kinase-MB isoenzyme releaseGroup 3Lower mortalityIntravascular ultrasound-guided stentingLower target lesion revascularizationPeak CK-MB valuesMajor adverse cardiac eventsLumen cross-sectional areaAdverse cardiac eventsAggressive stent expansionPercutaneous coronary interventionIntravascular ultrasound studyCK-MB valuesLate mortalityCardiac eventsCoronary interventionConsecutive patientsBeta radiation in lesions > 15 mm: a START subgroup.
Heuser R, Laskey W, Lansky A, Popma J, Bonan R. Beta radiation in lesions > 15 mm: a START subgroup. Journal Of Invasive Cardiology 2003, 15: 641-3. PMID: 14608136.Peer-Reviewed Original ResearchConceptsPlacebo groupLong lesionsStent restenosisSTART trialMajor adverse cardiac eventsAngiographic lesion characteristicsIntracoronary beta radiationAdverse cardiac eventsBinary restenosis rateIncidence of recurrentMean lesion lengthSignificant reductionLesion revascularizationRecurrent restenosisVessel revascularizationAngiographic parametersCardiac eventsClinical restenosisPatient demographicsRestenosis rateCoronary lesionsStent thrombosisLesion characteristicsRadiation groupRadiation therapyOptimal final lumen area and predictors of target lesion revascularization after stent implantation in small coronary arteries
Iakovou I, Mintz GS, Dangas G, Abizaid A, Mehran R, Lansky AJ, Kobayashi Y, Hirose M, Ashby DT, Stone GW, Moses JW, Leon MB. Optimal final lumen area and predictors of target lesion revascularization after stent implantation in small coronary arteries. The American Journal Of Cardiology 2003, 92: 1171-1176. PMID: 14609591, DOI: 10.1016/j.amjcard.2003.07.025.Peer-Reviewed Original ResearchConceptsTarget lesion revascularizationGreater stent expansionSmall coronary arteriesCoronary arteryLesion revascularizationTLR rateStent implantationStent areaSmall vesselsPredictors of TLRAngiographic reference vessel diameterGroup IStent expansionLumen areaHigher TLR rateGroup II patientsBaseline patient characteristicsReference vessel diameterPrior myocardial infarctionEarly clinical eventsReference vessel areaFinal lumen areaHospital outcomesClinical restenosisPatient characteristics
2002
Balloon‐based radiation therapy for treatment of in‐stent restenosis in human coronary arteries: Results from the BRITE I study
Waksman R, Buchbinder M, Reisman M, Lansky AJ, Trauthen B, Whiting J, Li A. Balloon‐based radiation therapy for treatment of in‐stent restenosis in human coronary arteries: Results from the BRITE I study. Catheterization And Cardiovascular Interventions 2002, 57: 286-294. PMID: 12410499, DOI: 10.1002/ccd.10359.Peer-Reviewed Original ResearchMeSH KeywordsAgedArteriesBlood Vessel ProsthesisCatheterizationCoronary AngiographyCoronary RestenosisDose-Response Relationship, RadiationFemaleFollow-Up StudiesHumansIncidenceMaleMiddle AgedPilot ProjectsProspective StudiesRadiotherapy, Computer-AssistedReoperationRisk FactorsStentsTime FactorsTreatment OutcomeConceptsStent restenosisRadiation therapyMajor adverse cardiac eventsAdverse cardiac eventsIntracoronary radiation therapyStudy eligibility criteriaStent restenosis resultsInstances of deathHuman coronary arteriesBinary restenosisRepeat PTCAPrimary endpointCardiac eventsClinical restenosisEmergency surgeryLate complicationsAngioplasty siteRestenosis rateRecurrence rateTotal occlusionConventional therapyCoronary arteryEligibility criteriaLate thrombosisTarget vesselRandomized Trial of 90Sr/90Y β-Radiation Versus Placebo Control for Treatment of In-Stent Restenosis
Popma JJ, Suntharalingam M, Lansky AJ, Heuser RR, Speiser B, Teirstein PS, Massullo V, Bass T, Henderson R, Silber S, von Rottkay P, Bonan R, Ho KK, Osattin, MPH A, Kuntz RE. Randomized Trial of 90Sr/90Y β-Radiation Versus Placebo Control for Treatment of In-Stent Restenosis. Circulation 2002, 106: 1090-1096. PMID: 12196334, DOI: 10.1161/01.cir.0000027814.96651.72.Peer-Reviewed Original ResearchConceptsTarget vessel revascularizationStent restenosisPlacebo-treated patientsPrimary end pointCatheter-based treatmentIn-Stent RestenosisPlacebo sourcesStent thrombosesAngiographic restenosisClinical restenosisFirst multicenterIntracoronary radiationMyocardial infarctionPlacebo controlPatientsPrescribed doseRestenosisConventional treatmentIntracoronary catheterEnd pointDay 244PlaceboRevascularizationTreatmentIncidenceComparison of clinical outcomes using stents versus no stents after percutaneous coronary intervention for proximal left anterior descending versus proximal right and left circumflex coronary arteries
Ashby DT, Dangas G, Mehran R, Lansky AJ, Narasimaiah R, Iakovou I, Polena S, Satler LF, Pichard AD, Kent KM, Stone GW, Leon MB. Comparison of clinical outcomes using stents versus no stents after percutaneous coronary intervention for proximal left anterior descending versus proximal right and left circumflex coronary arteries. The American Journal Of Cardiology 2002, 89: 1162-1166. PMID: 12008168, DOI: 10.1016/s0002-9149(02)02297-x.Peer-Reviewed Original ResearchMeSH KeywordsAgedArteriesBlood Vessel Prosthesis ImplantationCohort StudiesCoronary Artery DiseaseCoronary RestenosisCoronary VesselsDistrict of ColumbiaFemaleFollow-Up StudiesHumansMaleMiddle AgedPostoperative ComplicationsRadiographyStentsStroke VolumeSurvival AnalysisTime FactorsTreatment OutcomeConceptsPercutaneous coronary interventionTarget lesion revascularizationProximal LAD arteryProximal rightClinical restenosisCoronary interventionCircumflex arteryProcedural successLAD arteryProximal coronary artery stenosisSingle-vessel coronary diseaseAnterior descending (LAD) stenosisHigh rateCircumflex coronary arteryLower procedural successCoronary artery stenosisSignificant differencesDifferent lesion locationsCoronary artery stentsLesion revascularizationProximal LADCoronary diseaseArtery stenosisClinical outcomesHospital eventsQuantitative angiographic methods for appropriate end-point analysis, edge-effect evaluation, and prediction of recurrent restenosis after coronary brachytherapy with gamma irradiation
Lansky AJ, Dangas G, Mehran R, Desai KJ, Stone G, Leon M, Mintz G, Waksman R, Wu H, Fahy M. Quantitative angiographic methods for appropriate end-point analysis, edge-effect evaluation, and prediction of recurrent restenosis after coronary brachytherapy with gamma irradiation. Journal Of The American College Of Cardiology 2002, 39: 274-280. PMID: 11788219, DOI: 10.1016/s0735-1097(01)01745-4.Peer-Reviewed Original ResearchConceptsTarget vessel revascularizationRecurrent restenosisDiameter stenosisReceiver operator curveStent restenosisIn-Stent Restenosis TrialIntracoronary radiation therapyPercent diameter stenosisQuantitative coronary angiographyQuantitative angiographic methodsAngiographic locationBlinded therapyRestenosis TrialVessel revascularizationClinical restenosisCoronary angiographyRestenosis rateRestenotic lesionsTreatment failureWashington RadiationBrachytherapy trialsInterventional treatmentVascular brachytherapyEnd-point analysisRadiation therapy
2000
The PARAGON stent study: a randomized trial of a new martensitic nitinol stent versus the Palmaz-Schatz stent for treatment of complex native coronary arterial lesions
Holmes D, Lansky A, Kuntz R, Bell M, Buchbinder M, Fortuna R, O’Shaughnessy C, Popma J, Investigators F. The PARAGON stent study: a randomized trial of a new martensitic nitinol stent versus the Palmaz-Schatz stent for treatment of complex native coronary arterial lesions. The American Journal Of Cardiology 2000, 86: 1073-1079. PMID: 11074202, DOI: 10.1016/s0002-9149(00)01162-0.Peer-Reviewed Original ResearchConceptsStent minimal lumen diameterTarget vessel failureMinimal lumen diameterAngiographic restenosisPalmaz-SchatzLumen diameterPS stentEnd pointSignificant differencesAverage stent lengthBinary angiographic restenosisInfrequent adverse eventsPrimary end pointSecondary end pointsSmaller reference vesselsCoronary arterial lesionsNative coronary lesionsPrior bypass surgeryLong-term outcomesPalmaz-Schatz stentsPrior restenosisLesion revascularizationPercutaneous revascularizationBypass surgeryClinical restenosisIntracoronary γ-Radiation Therapy After Angioplasty Inhibits Recurrence in Patients With In-Stent Restenosis
Waksman R, White R, Chan R, Bass B, Geirlach L, Mintz G, Satler L, Mehran R, Serruys P, Lansky A, Fitzgerald P, Bhargava B, Kent K, Pichard A, Leon M. Intracoronary γ-Radiation Therapy After Angioplasty Inhibits Recurrence in Patients With In-Stent Restenosis. Circulation 2000, 101: 2165-2171. PMID: 10801757, DOI: 10.1161/01.cir.101.18.2165.Peer-Reviewed Original ResearchConceptsStent restenosisIntracoronary gamma radiation therapyLess target lesion revascularizationBinary angiographic restenosisSuccessful coronary interventionTarget lesion revascularizationMajor cardiac eventsIndependent core laboratoryIntracoronary stent implantationInitial clinical trialsGamma radiation therapyLesion revascularizationAngiographic restenosisVessel revascularizationAngiographic outcomesCardiac eventsClinical restenosisCoronary interventionAdjunct therapyProcedural successStent implantationClinical trialsTreatment protocolNeointimal formationRadiation groupIntracoronary β-Radiation Therapy Inhibits Recurrence of In-Stent Restenosis
Waksman R, Bhargava B, White L, Chan R, Mehran R, Lansky A, Mintz G, Satler L, Pichard A, Leon M, Kent K. Intracoronary β-Radiation Therapy Inhibits Recurrence of In-Stent Restenosis. Circulation 2000, 101: 1895-1898. PMID: 10779453, DOI: 10.1161/01.cir.101.16.1895.Peer-Reviewed Original ResearchConceptsRevascularization ratesBinary angiographic restenosis rateIntracoronary gamma radiation therapyTarget vessel revascularization rateTarget lesion revascularization ratePercutaneous transluminal coronary angioplastyVessel revascularization rateAngiographic restenosis rateLesion revascularization rateTransluminal coronary angioplastyIn-Stent RestenosisGamma radiation therapyRecurrent ISRPlacebo groupClinical restenosisAdjunct therapyConsecutive patientsCoronary angioplastyRestenosis rateRotational atherectomyStent implantationBalloon catheterNative coronariesStent restenosisPatientsVascular remodeling and the local delivery of cytochalasin B after coronary angioplasty in humans
Lehmann K, Popma J, Werner J, Lansky A, Wilensky R. Vascular remodeling and the local delivery of cytochalasin B after coronary angioplasty in humans. Journal Of The American College Of Cardiology 2000, 35: 583-591. PMID: 10716458, DOI: 10.1016/s0735-1097(99)00603-8.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAngioplasty, Balloon, CoronaryCatheterization, PeripheralCoronary AngiographyCoronary DiseaseCoronary VesselsCytochalasin BDrug Delivery SystemsElectrocardiographyFeasibility StudiesFemaleHumansInfusions, Intra-ArterialMaleMiddle AgedMyocardial RevascularizationSafetyTreatment OutcomeConceptsCoronary angioplastyLocal deliveryVascular remodelingMinimal stenosis diameterSuccessful balloon angioplastyCombined end pointActive drug groupSuccessful coronary angioplastyLate lumen lossCytochalasin BSystemic drug administrationWarrants further studyInadequate dosingPlacebo groupClinical restenosisPharmacologic preventionAngioplasty siteClinical outcomesBalloon angioplastyLumen lossDrug groupsArterial constrictionElectrocardiographic variablesStenosis diameterAtherosclerotic plaques