2024
Equity in Modifying Plaque of Women With Undertreated Calcified Coronary Artery Disease: Design and Rationale of EMPOWER CAD study
McEntegart M, Gonzalo N, Fendelander L, West N, Lansky A. Equity in Modifying Plaque of Women With Undertreated Calcified Coronary Artery Disease: Design and Rationale of EMPOWER CAD study. Journal Of The Society For Cardiovascular Angiography & Interventions 2024, 102289. DOI: 10.1016/j.jscai.2024.102289.Peer-Reviewed Original ResearchCoronary artery diseaseCalcified coronary artery diseasePercutaneous coronary interventionTarget lesion failureCoronary intravascular lithotripsyArtery diseaseFemale patientsIntravascular lithotripsySubcohort analysis of patientsPrevalence of coronary artery calcificationEnd pointsOptical coherence tomography imagesComposite of cardiac deathClinical events committeeSafety end pointAnalysis of patientsIndependent core laboratoryIncreased risk of mortalityIschemia-driven target lesion revascularizationTarget vessel myocardial infarctionTarget lesion revascularizationCoronary artery calcificationEffectiveness end pointCAD studiesCardiology clinical trials
2023
Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Lesions: Long-Term Sex-Specific Outcomes
Frampton J, Kearney K, Abbott J, Kereiakes D, Di Mario C, Saito S, Cristea E, Riley R, Fajadet J, Shlofmitz R, Ali Z, Klein A, Price M, Hill J, Stone G, Lansky A. Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Lesions: Long-Term Sex-Specific Outcomes. Journal Of The Society For Cardiovascular Angiography & Interventions 2023, 2: 101069. PMID: 39129889, PMCID: PMC11307843, DOI: 10.1016/j.jscai.2023.101069.Peer-Reviewed Original ResearchIntravascular lithotripsyLesion failureIschemia-driven target lesion revascularizationMajor adverse cardiac event ratesAdverse cardiac event ratesDrug-eluting stent placementMajor adverse cardiac eventsSmaller reference vessel diameterTarget vessel myocardial infarctionCoronary intravascular lithotripsyAdverse cardiac eventsCardiac event ratePrimary end pointTarget lesion failureTarget lesion revascularizationVessel myocardial infarctionReference vessel diameterAdverse clinical eventsHigh procedural successSex-based outcomesSex-specific outcomesLesion revascularizationAngiographic outcomesCardiac eventsCardiac death
2022
Safety 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
Long term outcomes of ultrathin versus standard thickness second‐generation drug eluting stents: Meta‐analysis of randomized trials
Hussain Y, Gaston S, Kluger J, Shah T, Yang Y, Tirziu D, Lansky A. Long term outcomes of ultrathin versus standard thickness second‐generation drug eluting stents: Meta‐analysis of randomized trials. Catheterization And Cardiovascular Interventions 2021, 99: 563-574. PMID: 34236755, DOI: 10.1002/ccd.29866.Peer-Reviewed Original ResearchConceptsSecond generation drug eluting stentsTarget lesion failureDrug eluting stentsLong-term outcomesEluting stentsTerm outcomesRisk ratioIschemia-driven target vessel revascularizationTarget vessel myocardial infarctionLong-term clinical outcomesProbable stent thrombosisTarget vessel revascularizationTerm clinical outcomesVessel myocardial infarctionPercutaneous coronary interventionCoronary artery diseaseConfidence intervalsFirst generation drug eluting stentsRandom-effects modelLesion failureVessel revascularizationCoronary interventionSecondary outcomesArtery diseaseCardiac deathNovel Supreme Drug-Eluting Stents With Early Synchronized Antiproliferative Drug Delivery to Inhibit Smooth Muscle Cell Proliferation After Drug-Eluting Stents Implantation in Coronary Artery Disease
Lansky AJ, Kereiakes DJ, Baumbach A, Windecker S, Hussain Y, Pietras C, Dressler O, Issever O, Curtis M, Bertolet B, Zidar JP, Smits PC, Díaz V, McLaurin B, Hofma S, Cequier Á, Dib N, Benit E, Mathur A, Brogno D, Berland J, Wykrzykowska J, Piegari G, Brugaletta S, Saito S, Leon MB, Investigators O. Novel Supreme Drug-Eluting Stents With Early Synchronized Antiproliferative Drug Delivery to Inhibit Smooth Muscle Cell Proliferation After Drug-Eluting Stents Implantation in Coronary Artery Disease. Circulation 2021, 143: 2143-2154. PMID: 33820424, DOI: 10.1161/circulationaha.120.052482.Peer-Reviewed Original ResearchConceptsDurable polymer everolimus-eluting stentsDrug-eluting stentsTarget lesion revascularizationAntiproliferative drug deliveryChronic coronary syndromeVessel myocardial infarctionLesion revascularizationCoronary syndromeLesion failureMyocardial infarctionDrug-Eluting Stent ImplantationTarget vessel myocardial infarctionLong-term clinical outcomesDP-EES groupPrimary end pointTarget lesion failureSmooth muscle cell proliferationPercutaneous coronary interventionSingle-blind trialCoronary artery diseaseEverolimus-eluting stentsMuscle cell proliferationLong-term inflammatory responseDrug eluting stentsCardiovascular deathDifferential impact of abluminal groove‐filled biodegradable‐polymer sirolimus‐eluting stent versus durable‐polymer everolimus‐eluting stent on and off dual antiplatelet therapy
Saito Y, Wijns W, Baumbach A, Xu B, Kelbæk H, Zheng M, Morel M, Anderson R, Schächinger V, Lansky A, Investigators T. Differential impact of abluminal groove‐filled biodegradable‐polymer sirolimus‐eluting stent versus durable‐polymer everolimus‐eluting stent on and off dual antiplatelet therapy. Catheterization And Cardiovascular Interventions 2021, 99: 357-365. PMID: 33502809, DOI: 10.1002/ccd.29468.Peer-Reviewed Original ResearchConceptsDual antiplatelet therapyTarget lesion failureDrug-eluting stentsTarget vessel myocardial infarctionBiodegradable polymer drug-eluting stentsChronic coronary syndromeAcute coronary syndromeDAPT discontinuationVessel myocardial infarctionAntiplatelet therapyCoronary syndromeMyocardial infarctionDurable polymer drug-eluting stentsIschemia-driven target lesion revascularizationIschemic coronary artery diseaseTarget lesion revascularizationIschemia-driven revascularizationPercutaneous coronary interventionCoronary artery diseaseIschemic coronary diseaseComer studyLesion revascularizationDAPT durationLesion failurePrimary endpoint
2019
Clinical outcomes of complex lesions treated with an abluminal groove‐filled biodegradable polymer sirolimus‐eluting stent and durable polymer everolimus‐eluting stent
Saito Y, Baumbach A, Wijns W, Xu B, Kelbæk H, Zheng M, Morel M, Anderson R, Schächinger V, Lansky A, Investigators T. Clinical outcomes of complex lesions treated with an abluminal groove‐filled biodegradable polymer sirolimus‐eluting stent and durable polymer everolimus‐eluting stent. Catheterization And Cardiovascular Interventions 2019, 96: 1023-1028. PMID: 31769161, DOI: 10.1002/ccd.28609.Peer-Reviewed Original ResearchConceptsHigh-risk patientsClinical outcomesComer studyI trialDurable polymer everolimus-eluting stentsTarget vessel myocardial infarctionSirolimus-eluting coronary stentYear clinical outcomesTarget lesion failureVessel myocardial infarctionLow-risk patientsWorse clinical outcomesEverolimus-eluting stentsHigh-risk groupLow-risk groupStrict eligibility criteriaFIREHAWK stentLesion failurePrimary endpointRandomized trialsMyocardial infarctionRisk groupsInclusion criteriaComplex lesionsXIENCE stent2-Year Clinical Outcomes of an Abluminal Groove–Filled Biodegradable-Polymer Sirolimus-Eluting Stent Compared With a Durable-Polymer Everolimus-Eluting Stent
Xu B, Saito Y, Baumbach A, Kelbæk H, van Royen N, Zheng M, Morel MA, Knaapen P, Slagboom T, Johnson TW, Vlachojannis G, Arkenbout KE, Holmvang L, Janssens L, Ochala A, Brugaletta S, Naber CK, Anderson R, Rittger H, Berti S, Barbato E, Toth GG, Maillard L, Valina C, Buszman P, Thiele H, Schächinger V, Lansky A, Wijns W, Investigators T. 2-Year Clinical Outcomes of an Abluminal Groove–Filled Biodegradable-Polymer Sirolimus-Eluting Stent Compared With a Durable-Polymer Everolimus-Eluting Stent. JACC Cardiovascular Interventions 2019, 12: 1679-1687. PMID: 31129092, DOI: 10.1016/j.jcin.2019.05.001.Peer-Reviewed Original ResearchMeSH KeywordsAbsorbable ImplantsAgedCardiovascular AgentsCoronary Artery DiseaseCoronary ThrombosisDrug-Eluting StentsDual Anti-Platelet TherapyEuropeEverolimusFemaleHumansMaleMiddle AgedPercutaneous Coronary InterventionPolymersProspective StudiesProsthesis DesignRisk FactorsSirolimusTime FactorsTreatment OutcomeConceptsTarget lesion failureXIENCE stentXience groupLesion failurePrimary endpointClinical outcomesIschemia-driven target lesion revascularizationTarget vessel myocardial infarctionProbable stent thrombosisTarget lesion revascularizationVessel myocardial infarctionLong-term outcomesDurable polymer everolimusBiodegradable Polymer SirolimusAbluminal grooveFIREHAWK stentLesion revascularizationCardiac deathComparable safetyStent thrombosisMyocardial infarctionClinical trialsEfficacy profileNoninferiority trialLandmark analysis
2018
Targeted therapy with a localised abluminal groove, low-dose sirolimus-eluting, biodegradable polymer coronary stent (TARGET All Comers): a multicentre, open-label, randomised non-inferiority trial
Lansky A, Wijns W, Xu B, Kelbæk H, van Royen N, Zheng M, Morel MA, Knaapen P, Slagboom T, Johnson TW, Vlachojannis G, Arkenbout KE, Holmvang L, Janssens L, Ochala A, Brugaletta S, Naber CK, Anderson R, Rittger H, Berti S, Barbato E, Toth GG, Maillard L, Valina C, Buszman P, Thiele H, Schächinger V, Baumbach A, Investigators T. Targeted therapy with a localised abluminal groove, low-dose sirolimus-eluting, biodegradable polymer coronary stent (TARGET All Comers): a multicentre, open-label, randomised non-inferiority trial. The Lancet 2018, 392: 1117-1126. PMID: 30190206, DOI: 10.1016/s0140-6736(18)31649-0.Peer-Reviewed Original ResearchConceptsLate lumen lossStent late lumen lossTarget lesion failureCoronary artery diseaseNon-inferiority trialXience groupPrimary endpointLesion failureLumen lossAbluminal grooveAngiographic substudyComers populationArtery diseaseMyocardial ischaemiaMyocardial infarctionIschaemia-driven target lesion revascularisationAsymptomatic coronary artery diseaseTarget vessel myocardial infarctionIschemic coronary artery diseaseST-elevation myocardial infarctionRandom block allocationTarget lesion revascularisationStent thrombosis ratesVessel myocardial infarctionElevation myocardial infarction
2015
Safety and efficacy of a novel abluminal groove‐filled biodegradable polymer sirolimus‐eluting stent for the treatment of de novo coronary lesions: Two‐year results from a prospective patient‐level pooled analysis of TARGET trials
Gao Z, Zhang R, Xu B, Yang Y, Ma C, Li H, Chen S, Han Y, Yuan Z, Lansky AJ, Guan C, Leon MB, Gao R, Investigators F. Safety and efficacy of a novel abluminal groove‐filled biodegradable polymer sirolimus‐eluting stent for the treatment of de novo coronary lesions: Two‐year results from a prospective patient‐level pooled analysis of TARGET trials. Catheterization And Cardiovascular Interventions 2015, 85: 734-743. PMID: 25678281, DOI: 10.1002/ccd.25861.Peer-Reviewed Original ResearchMeSH KeywordsAbsorbable ImplantsAgedCardiovascular AgentsChinaCoronary Artery DiseaseDrug-Eluting StentsFemaleHumansKaplan-Meier EstimateMaleMiddle AgedMyocardial InfarctionPercutaneous Coronary InterventionPolymersProspective StudiesProsthesis DesignRandomized Controlled Trials as TopicRegistriesRisk FactorsSirolimusTime FactorsTreatment OutcomeConceptsTarget lesion failureFIREHAWK stentStent thrombosisCoronary lesionsMyocardial infarctionNovel abluminal groove-filled biodegradable polymer sirolimus-eluting stentDe novo native coronary lesionsBiodegradable polymer sirolimus-eluting stentsDe novo coronary lesionsPatient-level pooled analysisTarget vessel myocardial infarctionNew drug-eluting stentsNative coronary lesionsNovo coronary lesionsProbable stent thrombosisTarget lesion revascularizationVessel myocardial infarctionSirolimus-eluting stentsPatient-level analysisPatient-level dataLong-term safetyDrug-eluting stentsTwo-year resultsObjective performance criteriaLesion revascularization
2013
A randomised comparison of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: clinical and angiographic follow-up of the TARGET I trial.
Gao RL, Xu B, Lansky AJ, Yang YJ, Ma CS, Han YL, Chen SL, Li H, Zhang RY, Fu GS, Yuan ZY, Jiang H, Huo Y, Li W, Zhang YJ, Leon MB. A randomised comparison of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: clinical and angiographic follow-up of the TARGET I trial. EuroIntervention 2013, 9: 75-83. PMID: 23685298, DOI: 10.4244/eijv9i1a12.Peer-Reviewed Original ResearchMeSH KeywordsAbsorbable ImplantsAgedAnalysis of VarianceAntineoplastic AgentsChinaChi-Square DistributionCoronary AngiographyCoronary Artery DiseaseCoronary RestenosisCoronary StenosisCoronary ThrombosisDrug-Eluting StentsEverolimusFemaleHumansLeast-Squares AnalysisMaleMiddle AgedMyocardial InfarctionPercutaneous Coronary InterventionPolymersPredictive Value of TestsProspective StudiesProsthesis DesignSirolimusTime FactorsTreatment OutcomeConceptsIschaemia-driven target lesion revascularisationStent late lumen lossTarget vessel myocardial infarctionLate lumen lossTarget lesion failureSingle de novo coronary lesionsDe novo coronary lesionsNovo coronary lesionsCoronary lesionsPrimary endpointCardiac deathI trialNovel abluminal groove-filled biodegradable polymer sirolimus-eluting stentSingle de novo native coronary lesionsDe novo native coronary lesionsBiodegradable polymer sirolimus-eluting stentsNine monthsNative coronary lesionsProbable stent thrombosisTarget lesion revascularisationVessel myocardial infarctionSirolimus-eluting stentsNon-inferiority trialLesion revascularisationEES group
2010
Comparison of Everolimus-Eluting and Paclitaxel-Eluting Coronary Stents in Patients Undergoing Multilesion and Multivessel Intervention The 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) and SPIRIT IV (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) Randomized Trials
Kereiakes DJ, Sudhir K, Hermiller JB, Gordon PC, Ferguson J, Yaqub M, Sood P, Su X, Yakubov S, Lansky AJ, Stone GW. Comparison of Everolimus-Eluting and Paclitaxel-Eluting Coronary Stents in Patients Undergoing Multilesion and Multivessel Intervention The 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) and SPIRIT IV (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) Randomized Trials. JACC Cardiovascular Interventions 2010, 3: 1229-1239. PMID: 21232716, DOI: 10.1016/j.jcin.2010.09.014.Peer-Reviewed Original ResearchMeSH KeywordsAngioplasty, Balloon, CoronaryAntineoplastic Agents, PhytogenicCoronary Artery BypassCoronary Artery DiseaseDrug-Eluting StentsEverolimusFemaleHumansImmunosuppressive AgentsKaplan-Meier EstimateMaleMiddle AgedPaclitaxelRandomized Controlled Trials as TopicSirolimusTime FactorsUnited StatesConceptsPaclitaxel-eluting stentsIschemia-driven target lesion revascularizationTarget vessel myocardial infarctionSPIRIT IV trialTarget lesion revascularizationVessel myocardial infarctionLesion revascularizationMultivessel diseaseMultivessel interventionAbsolute benefitMyocardial infarctionOptimal revascularization strategySingle-vessel interventionDe novo lesionsReference vessel diameterEverolimus-ElutingMultilesion interventionEfficacy outcomesNovo lesionsRevascularization strategyCoronary diseaseClinical outcomesCoronary arteryClinical safetySingle lesionEverolimus-Eluting versus Paclitaxel-Eluting Stents in Coronary Artery Disease
Stone GW, Rizvi A, Newman W, Mastali K, Wang JC, Caputo R, Doostzadeh J, Cao S, Simonton CA, Sudhir K, Lansky AJ, Cutlip DE, Kereiakes DJ. Everolimus-Eluting versus Paclitaxel-Eluting Stents in Coronary Artery Disease. New England Journal Of Medicine 2010, 362: 1663-1674. PMID: 20445180, DOI: 10.1056/nejmoa0910496.Peer-Reviewed Original ResearchConceptsPaclitaxel-eluting stentsTarget lesion failureEverolimus-eluting stentsMajor secondary end pointPrimary end pointSecondary end pointsEnd pointMyocardial infarctionIschemia-driven target lesion revascularizationRoutine follow-up angiographyTarget vessel myocardial infarctionComposite rateTarget lesion revascularizationClinical end pointsCoronary artery diseaseSubgroup of patientsFollow-up angiographyEverolimus-ElutingAngiographic findingsPrespecified subgroupsArtery diseaseCardiac deathStent thrombosisPatientsStents
2009
SPIRIT 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