2001
Fractional Flow Reserve Compared With Intravascular Ultrasound Guidance for Optimizing Stent Deployment
Fearon W, Luna J, Samady H, Powers E, Feldman T, Dib N, Tuzcu E, Cleman M, Chou T, Cohen D, Ragosta M, Takagi A, Jeremias A, Fitzgerald P, Yeung A, Kern M, Yock P. Fractional Flow Reserve Compared With Intravascular Ultrasound Guidance for Optimizing Stent Deployment. Circulation 2001, 104: 1917-1922. PMID: 11602494, DOI: 10.1161/hc4101.097539.Peer-Reviewed Original ResearchAdenosineAngioplasty, Balloon, CoronaryBlood Flow VelocityBlood Vessel Prosthesis ImplantationCoronary AngiographyCoronary Artery DiseaseCoronary CirculationCoronary VesselsFemaleHumansLikelihood FunctionsMaleMiddle AgedPredictive Value of TestsProspective StudiesROC CurveSensitivity and SpecificityStentsTreatment OutcomeUltrasonography, Interventional
2000
Final Results of the Can Routine Ultrasound Influence Stent Expansion (CRUISE) Study
Fitzgerald P, Oshima A, Hayase M, Metz J, Bailey S, Baim D, Cleman M, Deutsch E, Diver D, Leon M, Moses J, Oesterle S, Overlie P, Pepine C, Safian R, Shani J, Simonton C, Smalling R, Teirstein P, Zidar J, Yeung A, Kuntz R, Yock P, Investigators F. Final Results of the Can Routine Ultrasound Influence Stent Expansion (CRUISE) Study. Circulation 2000, 102: 523-530. PMID: 10920064, DOI: 10.1161/01.cir.102.5.523.Peer-Reviewed Original ResearchConceptsIntravascular ultrasoundQuantitative coronary ultrasoundUltrasound guidanceClinical outcomesStent implantationAngiographic guidanceCoronary ultrasoundStent deploymentLarger minimal lumen diameterStent expansionIVUS-guided groupMinimal lumen diameterQuantitative coronary angiographyMinimal stent areaRoutine ultrasound guidanceVessel revascularizationSurgical therapyCoronary angiographyClinical eventsIndex vesselStent areaRegimen studiesLumen diameterPatientsAngiography
1998
Efficacy of Coronary Stenting Versus Balloon Angioplasty in Small Coronary Arteries fn1fn1This study was supported in part by a grant from Johnson & Johnson Interventional Systems, Inc., Warren, New Jersey.
Savage M, Fischman D, Rake R, Leon M, Schatz R, Penn I, Nobuyoshi M, Moses J, Hirshfeld J, Heuser R, Baim D, Cleman M, Brinker J, Gebhardt S, Goldberg S, Investigators F. Efficacy of Coronary Stenting Versus Balloon Angioplasty in Small Coronary Arteries fn1fn1This study was supported in part by a grant from Johnson & Johnson Interventional Systems, Inc., Warren, New Jersey. Journal Of The American College Of Cardiology 1998, 31: 307-311. PMID: 9462572, DOI: 10.1016/s0735-1097(97)00511-1.Peer-Reviewed Original ResearchMeSH KeywordsAngioplasty, Balloon, CoronaryChi-Square DistributionCohort StudiesCoronary AngiographyCoronary DiseaseCoronary VesselsDisease-Free SurvivalElective Surgical ProceduresEquipment DesignFemaleFollow-Up StudiesHumansLinear ModelsMaleMiddle AgedRecurrenceStentsSurvival RateTreatment OutcomeUnited StatesUnited States Food and Drug AdministrationConceptsElective stent placementBalloon angioplastyCoronary arteryStent placementElective stent implantationJohnson Interventional SystemsPostprocedural lumen diameterPrimary end pointEvent-free survivalClinical event ratesSmall coronary arteriesQuantitative coronary angiographyPalmaz-Schatz stentsAngioplasty groupAngiographic characteristicsCoronary angiographyClinical outcomesNew lesionsProcedural successDiameter stenosisStent groupStent implantationAbrupt closurePatientsAngioplasty
1997
Acute and Long-Term Outcome After Palmaz-Schatz Stenting: Analysis From the New Approaches To Coronary Intervention (NACI) Registry
Carrozza J, Schatz R, George C, Leon M, King S, Hirshfeld J, Curry R, Ivanhoe R, Buchbinder M, Cleman M, Goldberg S, Ricci D, Popma J, Safian R, Baim D, Investigators F. Acute and Long-Term Outcome After Palmaz-Schatz Stenting: Analysis From the New Approaches To Coronary Intervention (NACI) Registry. The American Journal Of Cardiology 1997, 80: 78k-88k. PMID: 9409695, DOI: 10.1016/s0002-9149(97)00767-4.Peer-Reviewed Original ResearchConceptsPalmaz-Schatz stentsStent Restenosis StudyTarget lesion revascularizationCoronary Intervention RegistryRecent myocardial infarctionMinimum lumen diameterMyocardial infarctionLesion revascularizationIntervention RegistryProcedural successCoronary arteryHigh riskHigh incidenceLumen diameterSignificant left main stenosisLeft main coronary arteryQ-wave myocardial infarctionPalmaz-Schatz stentingDe novo lesionsLeft main stenosisSaphenous vein graftsCohort of patientsCongestive heart failureMain coronary arteryNative coronary arteriesStent Placement Compared with Balloon Angioplasty for Obstructed Coronary Bypass Grafts
Savage M, Douglas J, Fischman D, Pepine C, King S, Werner J, Bailey S, Overlie P, Fenton S, Brinker J, Leon M, Goldberg S, Heuser R, Smalling R, Safian R, Cleman M, Buchbinder M, Snead D, Rake R, Gebhardt S. Stent Placement Compared with Balloon Angioplasty for Obstructed Coronary Bypass Grafts. New England Journal Of Medicine 1997, 337: 740-747. PMID: 9287229, DOI: 10.1056/nejm199709113371103.Peer-Reviewed Original ResearchConceptsSaphenous vein graftsBalloon angioplastyStent groupLuminal diameterBypass surgeryBypass graftStent placementAortocoronary venous bypass graftsCoronary artery bypass surgeryBypass graft lesionsMajor cardiac complicationsStandard balloon angioplastyPrimary end pointMajor cardiac eventsCoronary bypass graftsTreatment of stenosisPalmaz-Schatz stentsLargest mean increaseAngioplasty groupAngiographic restenosisCardiac complicationsHemorrhagic complicationsAngiographic outcomesCardiac eventsCoronary angiographyHealth after coronary stenting or balloon angioplasty: Results from the Stent Restenosis Study
Krumholz H, Cohen D, Williams C, Baim D, Brinker J, Cabin H, Heuser R, Hirshfeld J, Leon M, Moses J, Savage M, Cleman M. Health after coronary stenting or balloon angioplasty: Results from the Stent Restenosis Study. American Heart Journal 1997, 134: 337-344. PMID: 9327686, DOI: 10.1016/s0002-8703(97)70065-6.Peer-Reviewed Original ResearchConceptsStent Restenosis StudyCoronary stentingBalloon angioplastyRestenosis StudyDuke Activity Status IndexPalmaz-Schatz coronary stentingCanadian Cardiovascular Society classificationPalmaz-Schatz coronary stent implantationPercutaneous transluminal coronary angioplastyU.S. clinical sitesLong-term HRQoLForm Health SurveyHealth-related qualityMedical Outcomes StudyTransluminal coronary angioplastyCoronary stent implantationConventional balloon angioplastyDisease-specific measuresAngiographic restenosisConventional angioplastyIschemic eventsBodily painConsecutive patientsCoronary angioplastyCardiovascular perspective
1996
Economic assessment of platelet glycoprotein IIb/IIIa inhibition for prevention of ischemic complications of high-risk coronary angioplasty. EPIC Investigators.
Mark D, Talley J, Topol E, Bowman L, Lam L, Anderson K, Jollis J, Cleman M, Lee K, Aversano T, Untereker W, Davidson-Ray L, Califf R. Economic assessment of platelet glycoprotein IIb/IIIa inhibition for prevention of ischemic complications of high-risk coronary angioplasty. EPIC Investigators. Circulation 1996, 94: 629-35. PMID: 8772681, DOI: 10.1161/01.cir.94.4.629.Peer-Reviewed Original ResearchMeSH KeywordsAbciximabAgedAngioplastyAntibodies, MonoclonalAnticoagulantsAspirinBlood TransfusionCosts and Cost AnalysisDouble-Blind MethodFemaleHeparinHumansImmunoglobulin Fab FragmentsInfusions, IntravenousInjections, IntravenousMaleMiddle AgedMyocardial IschemiaPlatelet Aggregation InhibitorsPlatelet Glycoprotein GPIIb-IIIa ComplexRecurrenceStentsTreatment OutcomeUnited StatesConceptsHigh-risk coronary angioplastyC7E3 FabIschemic eventsCoronary angioplastyInitial hospitalizationPlatelet glycoprotein IIb/IIIa inhibitionGlycoprotein IIb/IIIa inhibitionIIb/IIIa inhibitionAggressive platelet inhibitionBaseline medical costsIschemic end pointsReduced ischemic eventsAcute ischemic eventsCost of therapyEPIC trialMajor bleedingBleeding episodesIschemic complicationsStandard carePlatelet inhibitionHospitalization ratesReceptor antibodiesHospital costsMedical costsMedicare fee
1995
In-hospital and one-year economic outcomes after coronary stenting or balloon angioplasty. Results from a randomized clinical trial. Stent Restenosis Study Investigators.
Cohen D, Krumholz H, Sukin C, Ho K, Siegrist R, Cleman M, Heuser R, Brinker J, Moses J, Savage M, Detre K, Leon M, Baim D. In-hospital and one-year economic outcomes after coronary stenting or balloon angioplasty. Results from a randomized clinical trial. Stent Restenosis Study Investigators. Circulation 1995, 92: 2480-7. PMID: 7586348, DOI: 10.1161/01.cir.92.9.2480.Peer-Reviewed Original ResearchConceptsMedical care costsInitial hospital costsCoronary stentingVascular complicationsConventional angioplastyBalloon angioplastyCare costsInitial hospitalizationInitial stentingHospital costsPalmaz-Schatz coronary stent implantationCatheterization laboratory costsElective coronary stentingPatient's initial hospitalizationSingle coronary lesionsSubsequent hospital visitsSubsequent revascularization proceduresSymptomatic coronary diseaseCoronary stent implantationConventional balloon angioplastyRandomized clinical trialsLength of stayDetailed resource utilizationAngiographic restenosisRepeat revascularizationImmediate results and late outcomes after stent implantation in saphenous vein graft lesions: The multicenter U.S. Palmaz-Schatz stent experience
Wong S, Baim D, Schatz R, Teirstein P, King S, Curry R, Heuser R, Ellis S, Cleman M, Overlie P, Hirshfeld J, Walker C, Litvack F, Fish D, Brinker J, Buchbinder M, Goldberg S, Chuang Y, Leon M, Group P. Immediate results and late outcomes after stent implantation in saphenous vein graft lesions: The multicenter U.S. Palmaz-Schatz stent experience. Journal Of The American College Of Cardiology 1995, 26: 704-712. PMID: 7642863, DOI: 10.1016/0735-1097(95)00217-r.Peer-Reviewed Original ResearchConceptsSaphenous vein graft lesionsVein graft lesionsGraft lesionsStent implantationDiameter stenosisStent placementActuarial event-free survivalFavorable late clinical outcomeNative coronary artery diseaseSaphenous vein graft angioplastySaphenous vein graft diseaseImproved long-term outcomesMultivariate logistic regression analysisFrequent periprocedural complicationsLate clinical outcomesStandard balloon angioplastyStent placement resultsVein graft angioplastyEvent-free survivalProcedural success rateOverall restenosis rateVein graft diseaseCoronary artery diseaseReference vessel sizeLong-term outcomes
1994
Long-term angiographic and clinical outcome after implantation of a ballon-expandable stent in the native coronary circulation
Savage M, Fischman D, Schatz R, Teirstein P, Leon M, Baim D, Ellis S, Topol E, Hirshfeld J, Cleman M, Buchbinder M, Bailey S, Heuser R, Walker C, Curry R, Gebhardt S, Rake R, Goldberg S, group F. Long-term angiographic and clinical outcome after implantation of a ballon-expandable stent in the native coronary circulation. Journal Of The American College Of Cardiology 1994, 24: 1207-1212. PMID: 7930240, DOI: 10.1016/0735-1097(94)90099-x.Peer-Reviewed Original ResearchConceptsNative coronary circulationAdverse clinical eventsMinimal lumen diameterClinical eventsUntreated lesionsStent implantationLumen diameterRepeat angioplastyClinical outcomesCoronary arteryCoronary circulationMyocardial infarctionEvent-free survival rateFinal minimal lumen diameterSingle Palmaz-Schatz stentsSubsequent adverse clinical eventsInitial angiographic resultsCoronary bypass surgeryNative coronary arteriesCoronary stent implantationFavorable clinical outcomeFollow-up angiographyLower restenosis rateEdge detection programPalmaz-Schatz stentsA Randomized Comparison of Coronary-Stent Placement and Balloon Angioplasty in the Treatment of Coronary Artery Disease
Fischman D, Leon M, Baim D, Schatz R, Savage M, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M, Cleman M, Heuser R, Almond D, Teirstein P, Fish R, Colombo A, Brinker J, Moses J, Shaknovich A, Hirshfeld J, Bailey S, Ellis S, Rake R, Goldberg S. A Randomized Comparison of Coronary-Stent Placement and Balloon Angioplasty in the Treatment of Coronary Artery Disease. New England Journal Of Medicine 1994, 331: 496-501. PMID: 8041414, DOI: 10.1056/nejm199408253310802.Peer-Reviewed Original ResearchConceptsStandard balloon angioplastyCoronary stent placementBalloon angioplastyLarger luminal diameterAngioplasty groupProcedural successStent groupLuminal diameterOriginal target lesionRecurrent myocardial ischemiaSymptomatic coronary diseaseCoronary artery diseaseLower ratesLarge immediate increasesCoronary eventsArtery diseaseCoronary angiographyCoronary diseaseStented lesionsClinical outcomesCoronary lesionsRandomized comparisonClinical eventsCoronary stenosisStent placement
1993
Fate of lesion-related side branches after coronary artery stenting
Fischman D, Savage M, Leon M, Schatz R, Ellis S, Cleman M, Hirshfeld J, Teirstein P, Bailey S, Walker C, Goldberg S. Fate of lesion-related side branches after coronary artery stenting. Journal Of The American College Of Cardiology 1993, 22: 1641-1646. PMID: 8227832, DOI: 10.1016/0735-1097(93)90589-s.Peer-Reviewed Original ResearchConceptsSide branch occlusionStandard balloon angioplastyBalloon angioplastyBranch occlusionOstial stenosisCoronary arteryStent placementAcute side branch occlusionPalmaz-Schatz stent placementSide branchesImportant potential complicationConventional balloon angioplastySerial coronary angiographyLong-term patencySide branch ostiumPossible adverse effectsConventional angioplastyCoronary angiographyCoronary stentingMechanical obstructionPotential complicationsOstial diseaseAngioplastyPatencyCoronary stents
1992
Restenosis after placement of Palmaz-Schatz stents in native coronary arteries. Initial results of a multicenter experience.
Ellis S, Savage M, Fischman D, Baim D, Leon M, Goldberg S, Hirshfeld J, Cleman M, Teirstein P, Walker C. Restenosis after placement of Palmaz-Schatz stents in native coronary arteries. Initial results of a multicenter experience. Circulation 1992, 86: 1836-1844. PMID: 1451256, DOI: 10.1161/01.cir.86.6.1836.Peer-Reviewed Original ResearchConceptsNative coronary arteriesIncidence of restenosisPalmaz-Schatz stentsHistory of restenosisCoronary arteryStent placementMultiple stentsSingle stentPoor long-term resultsQuantitative angiographic dataStandard coronary angioplastyExcellent angiographic resultsLong-term resultsSuccessful stent placementMultiple overlapping stentsPrior restenosisStent closureBaseline characteristicsMulticenter experienceConsecutive patientsCoronary angioplastySuch patientsAngiographic resultsOverall incidenceRandomized trials
1991
Effect of intracoronary stenting on intimal dissection after balloon angioplasty: Results of quantitative and qualitative coronary analysis
Fischman D, Savage M, Leon M, Schatz R, Ellis S, Cleman M, Teirstein P, Walker C, Bailey S, Hirshfeld J, Goldberg S. Effect of intracoronary stenting on intimal dissection after balloon angioplasty: Results of quantitative and qualitative coronary analysis. Journal Of The American College Of Cardiology 1991, 18: 1445-1451. PMID: 1939944, DOI: 10.1016/0735-1097(91)90673-w.Peer-Reviewed Original ResearchConceptsResidual luminal stenosisIntimal dissectionBalloon angioplastyIntracoronary stentingAngiographic appearanceStent implantationLuminal stenosisGrade 0Simple dissectionMean diameter stenosisComplex dissectionConventional balloon angioplastyPalmaz-Schatz stentsQuantitative coronary analysisConventional angioplastyConsecutive patientsCoronary angiographyIntimal disruptionDiameter stenosisDissection gradeAngioplastyGrade 2Grade 1StenosisDissectionClinical experience with the Palmaz-Schatz coronary stent
Schatz R, Goldberg S, Leon M, Baim D, Hirshfeld J, Cleman M, Ellis S, Topol E. Clinical experience with the Palmaz-Schatz coronary stent. Journal Of The American College Of Cardiology 1991, 17: 155-159. PMID: 2016473, DOI: 10.1016/0735-1097(91)90952-6.Peer-Reviewed Original ResearchConceptsSingle stentPrior angioplastyAngiographic restenosisPalmaz-Schatz coronary stentHigher thrombosis rateUrgent bypass surgeryMajor bleeding eventsNative coronary arteriesBalloon-expandable stentsSuccessful elective stentingBleeding eventsBypass surgeryComplication rateDeath 3Elective stentingCoronary angioplastyCoronary stentingRoutine angioplastyThrombosis rateSubacute thrombosisAngioplasty resultsCoronary arteryMyocardial infarctionSubgroup analysisHigh incidenceClinical experience with the Palmaz-Schatz coronary stent. Initial results of a multicenter study.
Schatz R, Baim D, Leon M, Ellis S, Goldberg S, Hirshfeld J, Cleman M, Cabin H, Walker C, Stagg J. Clinical experience with the Palmaz-Schatz coronary stent. Initial results of a multicenter study. Circulation 1991, 83: 148-161. PMID: 1984878, DOI: 10.1161/01.cir.83.1.148.Peer-Reviewed Original ResearchConceptsUrgent bypass surgeryBypass surgeryPerioperative complicationsMyocardial infarctionGroup 2Group 1Palmaz-Schatz coronary stentSuccessful elective coronary angioplastyUnderwent cardiac catheterizationElective coronary angioplastyNative coronary arteriesAbsence of symptomsBalloon-expandable stentsClinical thrombosisPerioperative deathsElective angioplastyCardiac catheterizationCoronary angioplastyMajor complicationsMulticenter studyCoronary arteryPatient populationLower incidencePatientsAbrupt closure