2023
The Supreme Biodegradable Polymer DES in Acute and Chronic Coronary Syndromes: A PIONEER III Substudy
Hussain Y, Saito S, Curtis M, Kereiakes D, Baumbach A, Zidar J, McLaurin B, Dib N, Smits P, Díaz V, Cequier Á, Hofma S, Pietras C, Dressler O, Issever M, Windecker S, Leon M, Lansky A, Investigators I. The Supreme Biodegradable Polymer DES in Acute and Chronic Coronary Syndromes: A PIONEER III Substudy. Journal Of The Society For Cardiovascular Angiography & Interventions 2023, 2: 100629. PMID: 39130696, PMCID: PMC11307614, DOI: 10.1016/j.jscai.2023.100629.Peer-Reviewed Original ResearchTarget lesion failureAcute coronary syndromeChronic coronary syndromePrimary end pointCoronary syndromeDP-EESClinical presentationMajor adverse cardiac eventsEnd pointAdverse cardiac eventsBiodegradable polymer DESPrevious revascularizationLesion failureCardiac eventsCurrent smokersIII trialsLess diabetesCCS groupStent thrombosisPatientsRelative safetyDurable polymerSyndromeMonthsInteraction P
2022
Geographic Variations on the Safety and Efficacy of the Supreme Biodegradable Polymer DES: Results From PIONEER III
Garot P, Leon M, Saito S, Baumbach A, Kereiakes D, Windecker S, Pietras C, Dressler O, Issever M, Curtis M, Bertolet B, Zidar J, Smits P, Diaz V, McLaurin B, Cequier A, Hofma S, Dib N, Namiki A, Takahashi A, Kakuta T, Hirohata A, Lansky A. Geographic Variations on the Safety and Efficacy of the Supreme Biodegradable Polymer DES: Results From PIONEER III. Journal Of The Society For Cardiovascular Angiography & Interventions 2022, 2: 100515. PMID: 39132534, PMCID: PMC11308104, DOI: 10.1016/j.jscai.2022.100515.Peer-Reviewed Original ResearchDrug-eluting stentsDurable polymer everolimus-eluting stentsEverolimus-eluting stentsIII trialsLesion failureClinical outcomesMyocardial infarctionMajor adverse cardiac eventsVessel-related myocardial infarctionBiodegradable polymer drug-eluting stentsAdverse cardiac eventsOutcomes of patientsTarget lesion failureTarget lesion revascularizationLesion revascularizationCardiac eventsPatient characteristicsCardiac deathDES groupProcedural successStent thrombosisSubgroup analysisPatient outcomesNonsignificant trendEnrollment locationSafety and Efficacy of the Supreme Biodegradable Polymer Sirolimus-Eluting Stent in Patients With Diabetes Mellitus
Thomas A, Kereiakes D, Baumbach A, Windecker S, Pietras C, Dressler O, Issever M, Curtis M, Bertolet B, Zidar J, Smits P, Díaz V, McLaurin B, Cequier Á, Takahashi A, Cannon L, Amoroso G, Kakuta T, Saito S, Leon M, Lansky A. Safety and Efficacy of the Supreme Biodegradable Polymer Sirolimus-Eluting Stent in Patients With Diabetes Mellitus. Journal Of The Society For Cardiovascular Angiography & Interventions 2022, 1: 100033. PMID: 39132558, PMCID: PMC11307809, DOI: 10.1016/j.jscai.2022.100033.Peer-Reviewed Original ResearchTarget vessel myocardial infarctionVessel myocardial infarctionDiabetes mellitusDP-EESLesion failureIII trialsCardiac deathMyocardial infarctionBiodegradable Polymer Sirolimus-Eluting StentBiodegradable polymer sirolimus-eluting stentsTarget lesion failureTarget lesion revascularizationPercutaneous coronary interventionSirolimus-Eluting StentsLong-term inflammatory responseDiabetic subgroupsLesion revascularizationNondiabetic patientsSecondary endpointsBackground PatientsCoronary interventionPrespecified analysisComposite endpointPrimary safetyWorse outcomes
2021
SIMILAR OUTCOMES WITH THE SUPREME™BIODEGRADABLE DRUG COATED CORONARY STENT SYSTEM IN ACUTE CORONARY SYNDROME AND CHRONIC CORONARY SYNDROMES: RESULTS OF THE PROSPECTIVE MULTICENTER RANDOMIZED CONTROLLED PIONEER III TRIAL
Lansky A, Saito S, Curtis M, Kereiakes D, Baumbach A, Bertolet B, Zidar J, McLaurin B, Dib N, Smits P, Diaz V, Cequier A, Hofma S, Pietras C, Windecker S, Leon M. SIMILAR OUTCOMES WITH THE SUPREME™BIODEGRADABLE DRUG COATED CORONARY STENT SYSTEM IN ACUTE CORONARY SYNDROME AND CHRONIC CORONARY SYNDROMES: RESULTS OF THE PROSPECTIVE MULTICENTER RANDOMIZED CONTROLLED PIONEER III TRIAL. Journal Of The American College Of Cardiology 2021, 77: 1211. DOI: 10.1016/s0735-1097(21)02570-5.Peer-Reviewed Original Research
2015
A prospective randomized evaluation of the TriGuard™ HDH embolic DEFLECTion device during transcatheter aortic valve implantation: results from the DEFLECT III trial
Lansky AJ, Schofer J, Tchetche D, Stella P, Pietras CG, Parise H, Abrams K, Forrest JK, Cleman M, Reinöhl J, Cuisset T, Blackman D, Bolotin G, Spitzer S, Kappert U, Gilard M, Modine T, Hildick-Smith D, Haude M, Margolis P, Brickman AM, Voros S, Baumbach A. A prospective randomized evaluation of the TriGuard™ HDH embolic DEFLECTion device during transcatheter aortic valve implantation: results from the DEFLECT III trial. European Heart Journal 2015, 36: 2070-2078. PMID: 25990342, DOI: 10.1093/eurheartj/ehv191.Peer-Reviewed Original ResearchTranscatheter aortic valve implantationIschemic brain lesionsAortic valve implantationCerebral protectionNeurologic deficitsValve implantationBrain lesionsNew ischemic brain lesionsCerebral diffusion-weighted magnetic resonance imagingCognitive functionMontreal Cognitive Assessment scoreHealth Stroke ScaleNew neurologic deficitsDiffusion-weighted magnetic resonance imagingProspective Randomized EvaluationNormal cognitive functionCognitive Assessment scoreMagnetic resonance imagingSafety endpointStroke ScaleIII trialsControl subjectsTechnical successResonance imagingTriGuard
2012
Impact of Routine Angiographic Follow-Up After Percutaneous Coronary Intervention With Drug-Eluting Stents in the SPIRIT III Randomized Trial at Three Years
Lansky AJ, Brar SS, Yaqub M, Sood P, Applegate RJ, Lazar D, Jankovic I, Hermiller JB, Koo K, Sudhir K, Stone GW. Impact of Routine Angiographic Follow-Up After Percutaneous Coronary Intervention With Drug-Eluting Stents in the SPIRIT III Randomized Trial at Three Years. The American Journal Of Cardiology 2012, 110: 21-29. PMID: 22464212, DOI: 10.1016/j.amjcard.2012.02.040.Peer-Reviewed Original ResearchMeSH KeywordsAngioplasty, Balloon, CoronaryAntineoplastic Agents, PhytogenicCoronary AngiographyCoronary Artery DiseaseEverolimusFollow-Up StudiesHumansImmunosuppressive AgentsPaclitaxelProspective StudiesProsthesis DesignReproducibility of ResultsSingle-Blind MethodSirolimusTime FactorsTreatment OutcomeConceptsPaclitaxel-eluting stentsID-TLRAngiographic groupClinical followMajor adverse cardiovascular event ratesAdverse cardiovascular event ratesDrug-eluting stent placementMajor adverse cardiovascular eventsBare metal stent implantationSPIRIT IIILandmark survival analysisSPIRIT III trialAdverse cardiovascular eventsSafety end pointCardiovascular event ratesIschemia-driven revascularizationMajor clinical outcomesPercutaneous coronary interventionDrug-eluting stentsRoutine AngiographicCardiovascular eventsCoronary revascularizationRevascularization ratesCoronary interventionIII trials
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 responseThree-Year Results of Safety and Efficacy of the Everolimus-Eluting Coronary Stent in Women (from the SPIRIT III Randomized Clinical Trial)
Ng VG, Lansky AJ, Hermiller JB, Farhat N, Applegate RJ, Yaqub M, Sood P, Su X, Simonton CA, Sudhir K, Stone GW. Three-Year Results of Safety and Efficacy of the Everolimus-Eluting Coronary Stent in Women (from the SPIRIT III Randomized Clinical Trial). The American Journal Of Cardiology 2011, 107: 841-848. PMID: 21255760, DOI: 10.1016/j.amjcard.2010.10.068.Peer-Reviewed Original ResearchConceptsTarget vessel failure rateSPIRIT III trialXIENCE VIII trialsClinical outcomesLow major adverse cardiac event rateMajor adverse cardiac event ratesAdverse cardiac event ratesMajor adverse cardiac eventsTAXUS paclitaxel-eluting stentAdverse cardiac eventsCardiac event rateCoronary artery lesionsLong-term complicationsPaclitaxel-eluting stentsThree-year resultsLesion revascularizationArtery lesionsCardiac eventsComplication rateStent thrombosisTreatment armsClinical benefitTaxus stentSubset analysisLong-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
Side branch occlusion with everolimus-eluting and paclitaxel-eluting stents: three-year results from the SPIRIT III randomised trial.
Lansky AJ, Yaqub M, Hermiller JB, Smith RS, Farhat N, Caputo R, Williams JE, Sanz M, Koo K, Sood P, Sudhir K, Stone GW. Side branch occlusion with everolimus-eluting and paclitaxel-eluting stents: three-year results from the SPIRIT III randomised trial. EuroIntervention 2010, 6 Suppl J: j44-52. PMID: 21930490, DOI: 10.4244/eijv6supja8.Peer-Reviewed Original ResearchMeSH KeywordsAgedAngioplasty, Balloon, CoronaryCardiovascular AgentsCoronary AngiographyCoronary Artery DiseaseCoronary RestenosisDrug-Eluting StentsEverolimusFemaleHumansKaplan-Meier EstimateMaleMiddle AgedMyocardial InfarctionPaclitaxelProspective StudiesProsthesis DesignRisk AssessmentRisk FactorsSingle-Blind MethodSirolimusTime FactorsTreatment OutcomeUnited StatesConceptsPeriprocedural myocardial infarctionSide branch occlusionBranch occlusionMyocardial infarctionStent placementDrug-eluting stent placementIndependent angiographic core laboratoryPaclitaxel-eluting stent placementLong-term adverse outcomesSPIRIT III trialPaclitaxel-eluting stentsAngiographic core laboratoryThree-year resultsLower ratesSide branchesEES armIII trialsMI ratesIndependent predictorsClinical outcomesAdverse outcomesProcedural angiogramsGrade 0Stent typeCore laboratoryClinical 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 IIIPatientsStentsComparison of everolimus-eluting and paclitaxel-eluting coronary stents in patients with two treated vessels: 2-year results from the SPIRIT III randomised trial.
Applegate RJ, Hermiller JJ, Sanz M, Doostzadeh J, Pierson W, Su X, Lansky AJ, Sudhir K, Stone GW. Comparison of everolimus-eluting and paclitaxel-eluting coronary stents in patients with two treated vessels: 2-year results from the SPIRIT III randomised trial. EuroIntervention 2010, 6: 437-46. PMID: 20884430, DOI: 10.4244/eij30v6i4a75.Peer-Reviewed Original ResearchConceptsPaclitaxel-eluting stentsClinical outcomesStent typeMajor adverse cardiac eventsTwo-year event ratesSPIRIT IIIPaclitaxel-eluting coronary stentsSPIRIT III trialYear clinical outcomesAdverse cardiac eventsCardiac eventsIII trialsPE groupTwo-vesselPatientsEvent ratesCoronary stentsTrialsVessel treatmentStentsOutcomesVesselsSignificant interactionStentingLesionsEvaluation of the effects of everolimus‐eluting and paclitaxel‐eluting stents on target lesions with jailed side branches: 2‐year results from the SPIRIT III randomized trial
Applegate R, Hermiller J, Williams J, Gordon P, Doostzadeh J, Cao S, Su X, Sudhir K, Lansky A, Simonton C, Stone G. Evaluation of the effects of everolimus‐eluting and paclitaxel‐eluting stents on target lesions with jailed side branches: 2‐year results from the SPIRIT III randomized trial. Catheterization And Cardiovascular Interventions 2010, 76: 644-651. PMID: 20506356, DOI: 10.1002/ccd.22606.Peer-Reviewed Original ResearchMeSH KeywordsAgedAngioplasty, Balloon, CoronaryBiomarkersCardiovascular AgentsCoronary AngiographyCoronary Artery DiseaseCreatine Kinase, MB FormDrug-Eluting StentsEverolimusFemaleHumansKaplan-Meier EstimateMaleMiddle AgedMyocardial InfarctionMyocardiumNecrosisPaclitaxelProspective StudiesProsthesis DesignRisk AssessmentRisk FactorsSeverity of Illness IndexSingle-Blind MethodSirolimusTime FactorsTreatment OutcomeUnited StatesConceptsPaclitaxel-eluting stentsMajor adverse cardiac eventsTwo-year clinical outcomesTAXUS paclitaxel-eluting stentSPIRIT III trialXience V EESAdverse cardiac eventsMyocardial infarction rateUpper normal levelCreatine kinase-MBSide branchesLower ratesThinner stent strutsPeriprocedural increasePeriprocedural myonecrosisPES patientsEES groupIII trialsInfarction rateCardiac eventsSide branch compromiseCardiac deathPES groupClinical outcomesAdverse outcomesANGIOGRAPHIC FEATURES RELATED TO INCOMPLETE STENT APPOSITION IN SPIRIT III TRIAL. A QUANTITATIVE ANALYSIS OF VESSEL CURVATURE
Lima-Filho M, Lansky A, Yamasaki M, Ako J, Wahle A, Yu P, Shimohama T, Waseda K, Koo B, Nakatami D, Otake H, Honda Y, Sudhir K, Stone G, Fitzgerald P. ANGIOGRAPHIC FEATURES RELATED TO INCOMPLETE STENT APPOSITION IN SPIRIT III TRIAL. A QUANTITATIVE ANALYSIS OF VESSEL CURVATURE. Journal Of The American College Of Cardiology 2010, 55: a190.e1783. DOI: 10.1016/s0735-1097(10)61784-6.Peer-Reviewed Original Research
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 eventsGender‐based evaluation of the XIENCE V™ everolimus‐eluting coronary stent system:
Lansky AJ, Ng VG, Mutlu H, Cristea E, Guiran JB, Midei M, Newman W, Sanz M, Sood P, Doostzadeh J, Su X, White R, Cao S, Sudhir K, Stone GW. Gender‐based evaluation of the XIENCE V™ everolimus‐eluting coronary stent system:. Catheterization And Cardiovascular Interventions 2009, 74: 719-727. PMID: 19530147, DOI: 10.1002/ccd.22067.Peer-Reviewed Original ResearchMeSH KeywordsAgedAngioplasty, Balloon, CoronaryCardiovascular AgentsCardiovascular DiseasesCoronary AngiographyCoronary Artery DiseaseCoronary RestenosisDrug-Eluting StentsEverolimusFemaleHumansKaplan-Meier EstimateLinear ModelsLogistic ModelsMaleMiddle AgedMyocardial InfarctionPaclitaxelProspective StudiesProsthesis DesignRisk AssessmentRisk FactorsSex FactorsSingle-Blind MethodSirolimusThrombosisTime FactorsTreatment OutcomeWomen's HealthConceptsSPIRIT III trialIII trialsXIENCE VTaxus stentXience V stentTVF rateTAXUS paclitaxel-eluting stentRate of MACECoronary artery lesionsStent thrombosis ratesPercutaneous coronary interventionStent late lossPaclitaxel-eluting stentsCoronary stent systemHigher MACEMore hypertensionAngiographic characteristicsArtery lesionsCoronary interventionThrombosis rateAngiographic resultsClinical outcomesClinical benefitStent placementSubset analysis
2002
Prolonged antiplatelet therapy and reduced stenting eliminates late thrombosis after radiation: the SCRIPPS III trial
Teirstein P, Moses J, Leon M, Casterella P, Reilly J, Glap H, Jani S, Balter S, Tripuraneni P, Lansky A, Negoita M, Mehran R. Prolonged antiplatelet therapy and reduced stenting eliminates late thrombosis after radiation: the SCRIPPS III trial. Journal Of The American College Of Cardiology 2002, 39: 65. DOI: 10.1016/s0735-1097(02)80281-9.Peer-Reviewed Original ResearchGamma vascular brachytherapy neutralizes the negative impact of diabetes mellitus on clinical outcomes after PCI for in-stent restenosis: pooled data from Gamma I, Gamma II, and SCRIPPS III trials
Adamian M, Moussa I, Mehran R, Dangas G, Lansky A, Mintz G, Moussavian M, Abizaid A, Adamyan Y, Mohamed M, Kuntz R, Stone G, Moses J, Leon M, Tierstein P. Gamma vascular brachytherapy neutralizes the negative impact of diabetes mellitus on clinical outcomes after PCI for in-stent restenosis: pooled data from Gamma I, Gamma II, and SCRIPPS III trials. Journal Of The American College Of Cardiology 2002, 39: 64. DOI: 10.1016/s0735-1097(02)80276-5.Peer-Reviewed Original Research