2022
Outcomes of the Novel Supreme Drug-Eluting Stent in Complex Coronary Lesions: A PIONEER III Substudy
Patel K, Lansky A, Kereiakes D, Windecker S, Cristea E, Pietras C, Dressler O, Issever M, Curtis M, Bertolet B, Zidar J, Smits P, Díaz V, McLaurin B, Brogno D, Janssens L, Vrolix M, Gómez-Blázquez I, Sahul Z, Kabour A, Salido L, Cleman M, Saito S, Leon M, Baumbach A, Investigators I. Outcomes of the Novel Supreme Drug-Eluting Stent in Complex Coronary Lesions: A PIONEER III Substudy. Journal Of The Society For Cardiovascular Angiography & Interventions 2022, 1: 100004. PMID: 39130138, PMCID: PMC11308031, DOI: 10.1016/j.jscai.2021.100004.Peer-Reviewed Original ResearchDrug-eluting stentsTarget lesion failureDP-EESComplex lesionsLesion failureAdverse eventsLesion complexityMajor adverse cardiac eventsSingle-blind clinical trialEnd pointAdverse cardiac eventsChronic coronary syndromePrimary end pointSecondary end pointsTarget lesion revascularizationTarget vessel failureComplex coronary lesionsPercutaneous coronary interventionEverolimus-eluting stentsDrug eluting stentsHigh rateLesion revascularizationCoronary syndromeCardiac eventsCoronary intervention
2018
Sex disparities in acute myocardial infarction care and outcomes
Gul B, Kozuma K, Haimi I, Zhao W, Simonton C, Ying S, Buda A, Mehta S, Baumbach A, Lansky A. Sex disparities in acute myocardial infarction care and outcomes. Catheterization And Cardiovascular Interventions 2018, 92: e341-e347. PMID: 29745453, DOI: 10.1002/ccd.27622.Peer-Reviewed Original ResearchMeSH KeywordsAgedChinaClinical Trials as TopicFemaleHealthcare DisparitiesHemorrhageHumansJapanMaleMiddle AgedNon-ST Elevated Myocardial InfarctionPercutaneous Coronary InterventionProduct Surveillance, PostmarketingRegistriesRetrospective StudiesRisk AssessmentRisk FactorsSex FactorsST Elevation Myocardial InfarctionStentsTime FactorsTreatment OutcomeUnited StatesConceptsMajor adverse cardiac eventsAcute myocardial infarctionPercutaneous coronary interventionTarget vessel failureCause mortalityXience V stentMajor bleedingUS patientsHigher major adverse cardiac eventsSetting of AMIContemporary percutaneous coronary interventionAcute myocardial infarction careDevice-specific outcomesAdverse cardiac eventsMyocardial infarction carePost-market registryCause deathCardiac eventsCoronary interventionMultivariable analysisFemale sexMyocardial infarctionPatient levelSex disparitiesPatients
2017
Nine‐month results of the BIOHELIX‐I clinical trial study: Evaluation of the PRO‐Kinetic Energy cobalt chromium bare‐metal stent system
Michael TT, Richardt G, Lansky A, Carney RJ, Khan MA, Shehadeh A, Zeymer U, Gupta S. Nine‐month results of the BIOHELIX‐I clinical trial study: Evaluation of the PRO‐Kinetic Energy cobalt chromium bare‐metal stent system. Catheterization And Cardiovascular Interventions 2017, 92: 1030-1039. PMID: 29271575, DOI: 10.1002/ccd.27434.Peer-Reviewed Original ResearchConceptsTarget vessel revascularizationCoronary artery diseaseIschemia-driven target vessel revascularizationBare metal stentsTarget vessel failureTVF ratePrimary endpointStent systemSymptomatic coronary artery diseaseTarget lesion revascularization rateSingle-arm clinical trialNine‐month resultsDual antiplatelet therapyLesion revascularization rateMean patient agePercutaneous coronary interventionSubset of patientsClinical trial studyPrespecified performance goalArm clinical trialCoronary stent systemDrug-eluting stentsMean lesion lengthMajority of implantsEligible patients
2012
Mid-term results of everolimus-eluting stent in a Japanese population compared with a US randomized cohort: SPIRIT III Japan Registry with harmonization by doing.
Saito S, Nakamura S, Fujii K, Nakamura M, Isshiki T, Hirayama H, Kikuchi T, Fujita H, Nonogi H, Mitsudo K, Kimura T, Igarashi K, Saito K, Lansky AJ, Stone GW, Honda Y, Waseda K, Fitzgerald PJ, Sudhir K. Mid-term results of everolimus-eluting stent in a Japanese population compared with a US randomized cohort: SPIRIT III Japan Registry with harmonization by doing. Journal Of Invasive Cardiology 2012, 24: 444-50. PMID: 22954564.Peer-Reviewed Original ResearchConceptsMajor adverse cardiac eventsPaclitaxel-eluting stentsDrug-eluting stentsSegment late lossJapan RegistryLate lossUS patientsEES groupPrimary endpointSingle-arm multicenter studySecond-generation drug-eluting stentsFirst-generation drug-eluting stentsLower late lossTarget vessel failureAdverse cardiac eventsMid-term resultsCardiac eventsPES groupMulticenter studyJapanese patientsNeointimal volumeApposition ratePatientsStudy aimClinical programs
2011
Clinical and angiographic outcomes of elderly patients treated with everolimus-eluting versus paclitaxel-eluting stents: three-year results from the SPIRIT III randomised trial.
Hermiller JB, Nikolsky E, Lansky AJ, Applegate RJ, Sanz M, Yaqub M, Sood P, Cao S, Sudhir K, Stone GW. Clinical and angiographic outcomes of elderly patients treated with everolimus-eluting versus paclitaxel-eluting stents: three-year results from the SPIRIT III randomised trial. EuroIntervention 2011, 7: 307-13. PMID: 21729832, DOI: 10.4244/eijv7i3a54.Peer-Reviewed Original ResearchConceptsPaclitaxel-eluting stentsPercutaneous coronary interventionSegment restenosisYounger patientsElderly patientsLower incidenceSegment late lumen lossSegment late lossSPIRIT III trialTarget vessel failureLate lumen lossDrug-eluting stentsYears of ageThree-year resultsLower ratesAge-specific mechanismsStent assignmentAngiographic outcomesCoronary interventionIII trialsInducible ischaemiaEE patientsPE patientsLumen lossNeointimal response5-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 trialsJostentLesionsLong-Term (Three-Year) Safety and Efficacy of Everolimus-Eluting Stents Compared to Paclitaxel-Eluting Stents (from the SPIRIT III Trial)
Applegate RJ, Yaqub M, Hermiller JB, Sood P, Yu S, Doostzadeh J, Williams JE, Farhat N, Caputo R, Lansky AJ, Cutlip DE, Sudhir K, Stone GW. Long-Term (Three-Year) Safety and Efficacy of Everolimus-Eluting Stents Compared to Paclitaxel-Eluting Stents (from the SPIRIT III Trial). The American Journal Of Cardiology 2011, 107: 833-840. PMID: 21247538, DOI: 10.1016/j.amjcard.2010.10.069.Peer-Reviewed Original ResearchMeSH KeywordsCoronary AngiographyCoronary Artery DiseaseCoronary RestenosisCoronary ThrombosisDrug-Eluting StentsEverolimusFemaleFollow-Up StudiesHumansImmunosuppressive AgentsLogistic ModelsMaleMiddle AgedPaclitaxelProspective StudiesSingle-Blind MethodSirolimusSurvival RateTreatment OutcomeTubulin ModulatorsUnited StatesConceptsPaclitaxel-eluting stentsMajor adverse cardiovascular eventsSPIRIT III trialAdverse cardiovascular eventsCardiovascular eventsIII trialsPrimary clinical end pointLimited long-term dataTarget lesion revascularizationTarget vessel failureEvent-free survivalClinical end pointsEverolimus-Eluting StentsLong-term safetyLesion revascularizationCardiac deathCoronary arteryMyocardial infarctionSPIRIT IIClinical trialsEfficacy profileUnited States sitesLandmark analysisTerm safetyXIENCE V
2010
Clinical Follow-Up 3 Years After Everolimus- and Paclitaxel-Eluting Stents A Pooled Analysis From the SPIRIT II (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) and SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) Randomized Trials
Caixeta A, Lansky AJ, Serruys PW, Hermiller JB, Ruygrok P, Onuma Y, Gordon P, Yaqub M, Miquel-Hebert K, Veldhof S, Sood P, Su X, Jonnavithula L, Sudhir K, Stone GW, Investigators S. Clinical Follow-Up 3 Years After Everolimus- and Paclitaxel-Eluting Stents A Pooled Analysis From the SPIRIT II (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) and SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) Randomized Trials. JACC Cardiovascular Interventions 2010, 3: 1220-1228. PMID: 21232715, DOI: 10.1016/j.jcin.2010.07.017.Peer-Reviewed Original ResearchMeSH KeywordsAngioplasty, Balloon, CoronaryAntineoplastic Agents, PhytogenicAspirinClopidogrelConfidence IntervalsCoronary Artery DiseaseDrug-Eluting StentsEverolimusFemaleFollow-Up StudiesHumansImmunosuppressive AgentsKaplan-Meier EstimateLogistic ModelsMaleMiddle AgedPaclitaxelPlatelet Aggregation InhibitorsProportional Hazards ModelsRandomized Controlled Trials as TopicRiskRisk Reduction BehaviorSirolimusTiclopidineTime FactorsConceptsMajor adverse cardiac eventsPaclitaxel-eluting stentsAdverse cardiac eventsTarget vessel failureCardiac eventsMyocardial infarctionSPIRIT IIProbable stent thrombosisAcademic Research ConsortiumEverolimus-eluting stentsVessel failureSignificant reductionLesion revascularizationPES patientsRevascularization eventsIII trialsClinical outcomesEE patientsStent thrombosisPooled analysisCumulative ratePersistent reductionSPIRIT IIIPatientsStentsA pooled gender based analysis comparing the XIENCE V(R) everolimus-eluting stent and the TAXUS paclitaxel-eluting stent in male and female patients with coronary artery disease, results of the SPIRIT II and SPIRIT III studies: two-year analysis.
Seth A, Serruys PW, Lansky A, Hermiller J, Onuma Y, Miquel-Hebert K, Yu S, Veldhof S, Sood P, Sudhir K, Stone GW. A pooled gender based analysis comparing the XIENCE V(R) everolimus-eluting stent and the TAXUS paclitaxel-eluting stent in male and female patients with coronary artery disease, results of the SPIRIT II and SPIRIT III studies: two-year analysis. EuroIntervention 2010, 5: 788-94. PMID: 20142192, DOI: 10.4244/eijv5i7a132.Peer-Reviewed Original ResearchMeSH KeywordsAgedAngioplasty, Balloon, CoronaryCardiovascular AgentsCoronary AngiographyCoronary RestenosisCoronary StenosisDrug-Eluting StentsEverolimusFemaleHumansKaplan-Meier EstimateMaleMiddle AgedMulticenter Studies as TopicMyocardial InfarctionPaclitaxelProsthesis DesignRandomized Controlled Trials as TopicRetrospective StudiesRisk AssessmentRisk FactorsSex FactorsSingle-Blind MethodSirolimusThrombosisTime FactorsTreatment OutcomeConceptsMajor adverse cardiac eventsPaclitaxel-eluting stentsTAXUS paclitaxel-eluting stentTarget vessel failureAngiographic late lossLate lossDiameter stenosisIII studyPooled analysisSPIRIT IIAdverse cardiac eventsSegment late lossStent late lossCoronary artery diseaseEES groupCardiac eventsArtery diseaseFemale patientsPES groupPatient levelClinical dataXIENCE VStent typeTwo-year analysisWomen
2009
Clinical and angiographic outcomes with an everolimus‐eluting stent in large coronary arteries: The SPIRIT III 4.0 mm registry
Gordon PC, Applegate RJ, Hermiller JB, Weinsier SB, Doostzadeh J, Cao S, Sudhir K, Lansky AJ, Stone GW. Clinical and angiographic outcomes with an everolimus‐eluting stent in large coronary arteries: The SPIRIT III 4.0 mm registry. Catheterization And Cardiovascular Interventions 2009, 75: 179-186. PMID: 19877267, DOI: 10.1002/ccd.22259.Peer-Reviewed Original ResearchMeSH KeywordsAgedAngioplasty, Balloon, CoronaryCardiovascular AgentsCoronary AngiographyCoronary StenosisDrug-Eluting StentsEverolimusFemaleHumansKaplan-Meier EstimateMaleMiddle AgedMyocardial InfarctionPaclitaxelPredictive Value of TestsProspective StudiesRegistriesRisk AssessmentSingle-Blind MethodSirolimusThrombosisTime FactorsTreatment OutcomeUnited StatesConceptsMajor adverse cardiac eventsTarget vessel failureSegment late lossSPIRIT III trialLarge coronary arteriesPaclitaxel-eluting stentsLate lossCoronary arteryIII trialsXIENCE VDe novo native coronary artery lesionsNovo native coronary artery lesionsNative coronary artery lesionsPE armSPIRIT IIIAdverse cardiac eventsCoronary artery lesionsAdverse clinical eventsAngiographic late lossEES patientsNoninferior ratesPrimary endpointAngiographic outcomesArtery lesionsCardiac eventsSPIRIT IV trial design: A large-scale randomized comparison of everolimus-eluting stents and paclitaxel-eluting stents in patients with coronary artery disease
Nikolsky E, Lansky AJ, Sudhir K, Doostzadeh J, Cutlip DE, Piana R, Su X, White R, Simonton CA, Stone GW. SPIRIT IV trial design: A large-scale randomized comparison of everolimus-eluting stents and paclitaxel-eluting stents in patients with coronary artery disease. American Heart Journal 2009, 158: 520-526.e2. PMID: 19781409, DOI: 10.1016/j.ahj.2009.07.025.Peer-Reviewed Original ResearchConceptsPaclitaxel-eluting stentsTarget lesion revascularizationCoronary artery diseaseSPIRIT IVLesion revascularizationArtery diseaseDiabetes mellitusIschemia-driven target lesion revascularizationNovo native coronary artery lesionsMajor adverse cardiac eventsNative coronary artery diseaseNative coronary artery lesionsTarget vessel myocardial infarctionEnd pointUS clinical sitesAdverse cardiac eventsPrimary end pointTarget lesion failureTarget vessel failureVessel myocardial infarctionCoronary artery lesionsReference vessel diameterClinical end pointsMulticenter clinical trialAngiographic late loss
2008
Comparison of an Everolimus-Eluting Stent and a Paclitaxel-Eluting Stent in Patients With Coronary Artery Disease: A Randomized Trial
Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Mahaffey KW, Cutlip DE, Fitzgerald PJ, Sood P, Su X, Lansky AJ, Investigators F. Comparison of an Everolimus-Eluting Stent and a Paclitaxel-Eluting Stent in Patients With Coronary Artery Disease: A Randomized Trial. JAMA 2008, 299: 1903-1913. PMID: 18430909, DOI: 10.1001/jama.299.16.1903.Peer-Reviewed Original ResearchMeSH KeywordsAgedAngioplasty, Balloon, CoronaryCoronary AngiographyCoronary Artery DiseaseCoronary RestenosisDrug-Eluting StentsEverolimusFemaleHumansImmunosuppressive AgentsLogistic ModelsMaleMiddle AgedMyocardial InfarctionPaclitaxelProspective StudiesSingle-Blind MethodSirolimusUltrasonography, InterventionalConceptsMajor adverse cardiac eventsAdverse cardiac eventsPaclitaxel-eluting stentsSegment late lossSecondary end pointsTarget vessel failureCoronary artery diseaseCardiac eventsLate lossEnd pointArtery diseaseComposite major adverse cardiac eventsAdditional secondary end pointsMajor secondary end pointLesion revascularization proceduresSPIRIT III trialPrimary end pointReference vessel diameterPercutaneous coronary interventionEverolimus-Eluting StentsAngiographic late lossCobalt-chromium stentAgents everolimusNoninferior ratesAngiographic outcomes
2005
Intravascular ultrasound assessment of lesions with target vessel failure after sirolimus-eluting stent implantation
Takebayashi H, Kobayashi Y, Mintz GS, Carlier SG, Fujii K, Yasuda T, Moussa I, Mehran R, Dangas GD, Collins MB, Kreps E, Lansky AJ, Stone GW, Leon MB, Moses JW. Intravascular ultrasound assessment of lesions with target vessel failure after sirolimus-eluting stent implantation. The American Journal Of Cardiology 2005, 95: 498-502. PMID: 15695138, DOI: 10.1016/j.amjcard.2004.10.020.Peer-Reviewed Original ResearchConceptsSirolimus-eluting stent implantationTarget vessel failureIntravascular ultrasound evaluationMinimum stent areaIntravascular ultrasound assessmentStent restenosesNew stenosisNew lesionsUltrasound evaluationNegative remodelingStent implantationUltrasound assessmentPlaque areaStent areaStent failureLesionsRestenosesVessel failureFailureThrombosesStenosisPatients
2004
Non–Polymer-Based Paclitaxel-Coated Coronary Stents for the Treatment of Patients With De Novo Coronary Lesions
Lansky AJ, Costa RA, Mintz GS, Tsuchiya Y, Midei M, Cox DA, O’Shaughnessy C, Applegate RA, Cannon LA, Mooney M, Farah A, Tannenbaum MA, Yakubov S, Kereiakes DJ, Wong SC, Kaplan B, Cristea E, Stone GW, Leon MB, Knopf WD, O’Neill W. Non–Polymer-Based Paclitaxel-Coated Coronary Stents for the Treatment of Patients With De Novo Coronary Lesions. Circulation 2004, 109: 1948-1954. PMID: 15078794, DOI: 10.1161/01.cir.0000127129.94129.6f.Peer-Reviewed Original ResearchConceptsTarget vessel failureDe novo coronary lesionsNovo coronary lesionsBinary restenosisEnd pointCoronary lesionsMore type C lesionsPrespecified primary end pointPrespecified end pointStent binary restenosisBaseline clinical characteristicsPrimary end pointSecondary end pointsType C lesionsSmooth muscle cell proliferationMulticenter Clinical EvaluationStent late lossTreatment of patientsLarger reference diameterMuscle cell proliferationMicrotubule-stabilizing compoundClinical characteristicsPotent antitumor activityC lesionsClinical evaluation
2001
Final results of a randomized trial comparing the MULTI-LINK stent with the Palmaz-Schatz stent for narrowings in native coronary arteries
Baim D, Cutlip D, Midei M, Linnemeier T, Schreiber T, Cox D, Kereiakes D, Popma J, Robertson L, Prince R, Lansky A, Ho K, Kuntz R, Investigators A. Final results of a randomized trial comparing the MULTI-LINK stent with the Palmaz-Schatz stent for narrowings in native coronary arteries. The American Journal Of Cardiology 2001, 87: 157-162. PMID: 11152831, DOI: 10.1016/s0002-9149(00)01308-4.Peer-Reviewed Original ResearchConceptsTarget vessel failurePS stentPalmaz-SchatzMajor adverse cardiac eventsNative vessel lesionsAdverse cardiac eventsPrimary end pointNative coronary arteriesSuccessful stent deliveryPalmaz-Schatz stentsAngiographic outcomesCardiac eventsAngiographic restudyAcute resultsDiameter stenosisVessel lesionsCoronary arteryVessel failureClinical equivalenceStent deliveryNonsignificant trendPatientsExcellent deliverabilityEnd pointStentsFinal results of a randomized trial comparing the NIR stent to the Palmaz-Schatz stent for narrowings in native coronary arteries
Baim D, Cutlip D, O’Shaughnessy C, Hermiller J, Kereiakes D, Giambartolomei A, Katz S, Lansky A, Fitzpatrick M, Popma J, Ho K, Leon M, Kuntz R, Investigators N. Final results of a randomized trial comparing the NIR stent to the Palmaz-Schatz stent for narrowings in native coronary arteries. The American Journal Of Cardiology 2001, 87: 152-156. PMID: 11152830, DOI: 10.1016/s0002-9149(00)01307-2.Peer-Reviewed Original ResearchConceptsPrimary end pointTarget vessel failureNIR stentPS stentBetter acute angiographic resultsTarget vessel failure rateMajor adverse cardiac eventsEnd pointSingle coronary lesionsAdverse cardiac eventsNative coronary arteriesNorth American trialsSuccessful stent deliveryAcute angiographic resultsPalmaz-Schatz stentsPrespecified cohortCardiac eventsAngiographic restudyAngiographic resultsCoronary lesionsPS patientsDiameter stenosisCoronary arteryVessel failureStent placement
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 restenosis
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