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 arteriesHigh-Speed Rotational Atherectomy of Human Coronary Stenoses: Acute and One-Year Outcomes From the New Approaches to Coronary Intervention (NACI) Registry
Brown D, George C, Steenkiste A, Cowley M, Leon M, Cleman M, Moses J, King S, Carrozza J, Holmes D, Burkhard-Meier C, Popma J, Brinker J, Buchbinder M, Investigators F. High-Speed Rotational Atherectomy of Human Coronary Stenoses: Acute and One-Year Outcomes From the New Approaches to Coronary Intervention (NACI) Registry. The American Journal Of Cardiology 1997, 80: 60k-67k. PMID: 9409693, DOI: 10.1016/s0002-9149(97)00765-0.Peer-Reviewed Original ResearchConceptsPercutaneous transluminal coronary angioplastyQ-wave MIRotational atherectomyLesion revascularizationCoronary dissectionCoronary stenosisHigh-speed rotational atherectomyNon-Q-wave MIEmergency CABG surgerySpeed rotational atherectomyAngiographic success rateTarget lesion revascularizationOne-year outcomesProcedural success rateTransluminal coronary angioplastyCoronary Intervention RegistrySide branch occlusionSuccess rateNew percutaneous procedureProgression of diseaseHuman coronary stenosisAngiographic complicationsPreprocedural characteristicsCABG surgeryExtensive diseaseStent 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 perspectiveIntracoronary Doppler assessment of moderate coronary artery disease: comparison with 201Tl imaging and coronary angiography. FACTS Study Group.
Heller L, Cates C, Popma J, Deckelbaum L, Joye J, Dahlberg S, Villegas B, Arnold A, Kipperman R, Grinstead W, Balcom S, Ma Y, Cleman M, Steingart R, Leppo J. Intracoronary Doppler assessment of moderate coronary artery disease: comparison with 201Tl imaging and coronary angiography. FACTS Study Group. Circulation 1997, 96: 484-90. PMID: 9244216, DOI: 10.1161/01.cir.96.2.484.Peer-Reviewed Original ResearchConceptsCoronary flow reserveIntracoronary Doppler ultrasoundExercise-induced ischemiaCoronary angiographyFlow reserveDoppler ultrasoundModerate coronary artery diseaseIndependent core laboratoryCoronary artery diseaseStenotic coronary arteriesIntermediate coronary stenosisMaximum heart rateMean stenosisArtery diseaseDoppler assessmentCoronary arteryCoronary stenosisHeart rateStenosisAngiographyCore laboratoryStenosis severityDiagnostic accuracyPhysiological assessmentIschemia
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 ResearchMeSH KeywordsAgedAngioplasty, Balloon, CoronaryCoronary DiseaseFemaleFollow-Up StudiesHospital CostsHumansLength of StayMaleMiddle AgedStentsConceptsMedical 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 outcomesLength of hospital stay and complications after percutaneous transluminal coronary angioplasty. Clinical and procedural predictors. Heparin Registry Investigators.
Wolfe M, Roubin G, Schweiger M, Isner J, Ferguson J, Cannon A, Cleman M, Cabin H, Leya F, Bonan R, Strony J, Adelman B, Bittl J. Length of hospital stay and complications after percutaneous transluminal coronary angioplasty. Clinical and procedural predictors. Heparin Registry Investigators. Circulation 1995, 92: 311-9. PMID: 7634443, DOI: 10.1161/01.cir.92.3.311.Peer-Reviewed Original ResearchConceptsPercutaneous transluminal coronary angioplastyLength of stayMultivessel coronary artery diseasePTCA complicationsCoronary artery diseaseTransluminal coronary angioplastyHospital stayUnstable anginaBaseline variablesAdvanced ageComplex lesionsArtery diseaseCoronary angioplastyLesion complexityNon-Q-wave myocardial infarctionIndividual baseline variablesBaseline risk factorsClinical risk scoreEmergency bypass surgeryProlonged hospital staySelection of patientsAbrupt vessel closureConventional balloon angioplastyAccess of patientsStrongest predictor
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 placementPhysiologic assessment of ostial left circumflex coronary artery disease using a doppler guidewire before and after rotational atherectomy facilitated angioplasty
Ling F, Brennan J, Cleman M, Cabin H. Physiologic assessment of ostial left circumflex coronary artery disease using a doppler guidewire before and after rotational atherectomy facilitated angioplasty. Catheterization And Cardiovascular Interventions 1994, 32: 53-57. PMID: 8039221, DOI: 10.1002/ccd.1810320113.Peer-Reviewed Case Reports and Technical NotesConceptsRotational atherectomyCircumflex coronary artery diseaseCoronary artery diseaseCoronary flow velocitySuccessful rotational atherectomyCoronary interventionArtery diseaseOstial stenosisDoppler assessmentDoppler evaluationPhysiologic assessmentDoppler guidewireIntermediate stenosisPhysiologic significanceFlow velocity characteristicsAngioplastyAtherectomyStenosisPatientsDiseaseGuidewire
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 stentsMyocardial risk area defined by technetium-99m sestamibi imaging during percutaneous transluminal coronary angioplasty: Comparison with coronary angiography
Haronian H, Remetz M, Sinusas A, Baron J, Miller H, Cleman M, Zaret B, Wackers F. Myocardial risk area defined by technetium-99m sestamibi imaging during percutaneous transluminal coronary angioplasty: Comparison with coronary angiography. Journal Of The American College Of Cardiology 1993, 22: 1033-1043. PMID: 8409038, DOI: 10.1016/0735-1097(93)90413-u.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAngioplasty, Balloon, CoronaryClinical ProtocolsCollateral CirculationCoronary AngiographyCoronary DiseaseEvaluation Studies as TopicFemaleHumansMaleMiddle AgedMyocardial InfarctionObserver VariationPredictive Value of TestsPrognosisReproducibility of ResultsRisk FactorsSeverity of Illness IndexTechnetium Tc 99m SestamibiTomography, Emission-Computed, Single-PhotonConceptsMyocardial risk areaCoronary angiographyCoronary angioplastyQuantitative myocardial perfusionMyocardial perfusionMyocardial areaPercutaneous transluminal coronary angioplastyAngiographic risk scoresSmall risk areasTransluminal coronary angioplastyCoronary artery diseaseCoronary artery stenosisInitial myocardial uptakeAngioplasty balloon inflationArtery diseaseLeft anteriorNonperfused areaArtery stenosisCoronary anatomyCoronary arteryBalloon inflationPatient managementMyocardial uptakeRisk scoreAngioplastyCoronary angioplasty with gradual versus rapid balloon inflation: Initial results and complications
Ilia R, Cabin H, McConnell S, Cleman M, Remetz M. Coronary angioplasty with gradual versus rapid balloon inflation: Initial results and complications. Catheterization And Cardiovascular Interventions 1993, 29: 199-202. PMID: 8402842, DOI: 10.1002/ccd.1810290305.Peer-Reviewed Original ResearchMeSH KeywordsAngioplasty, Balloon, CoronaryCoronary AngiographyCoronary DiseaseCoronary VesselsFemaleHumansMaleMiddle AgedConceptsInflation protocolFrequency of dissectionLesion morphological characteristicsRapid balloon inflationProcedure-related complicationsComplete success rateSuccess rateGradual inflationUnstable anginaComplication rateCoronary angioplastySignificant group differencesArterial damageBalloon inflationDissection rateHigh success rateDiseased vesselsMore lesionsPatientsLesionsInflation groupGroup differencesAngioplastyComplicationsVessel diameter ratio
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 ResearchMeSH KeywordsCoronary AngiographyCoronary DiseaseCoronary VesselsFollow-Up StudiesHumansMaleMiddle AgedRecurrenceStentsTreatment OutcomeConceptsNative 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 1StenosisDissectionValidation of continuous radionuclide left ventricular functioning monitoring in detecting silent myocardial ischemia during balloon angioplasty of the left anterior descending coronary artery
Kayden D, Remetz M, Cabin H, Deckelbaum L, Cleman M, Wackers F, Zaret B. Validation of continuous radionuclide left ventricular functioning monitoring in detecting silent myocardial ischemia during balloon angioplasty of the left anterior descending coronary artery. The American Journal Of Cardiology 1991, 67: 1339-1343. PMID: 2042565, DOI: 10.1016/0002-9149(91)90462-t.Peer-Reviewed Original ResearchConceptsSilent myocardial ischemiaLV ejection fractionLV dysfunctionMyocardial ischemiaEjection fractionLV functionBalloon inflationRelative end-systolic volumeTransient ST-segment depressionPercutaneous transluminal coronary angioplastyMean LV ejection fractionST-segment depressionContinuous electrocardiographic monitoringTransluminal coronary angioplastyLeft ventricular functionST-segment changesEnd-diastolic volumeEnd-systolic volumeIschemic decreaseCoronary angioplastyVentricular functionElectrocardiographic changesElectrocardiographic monitoringBalloon angioplastyCoronary arteryClinical 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 incidence