2023
Targeted therapy with a localised abluminal groove, low-dose sirolimus-eluting, biodegradable-polymer coronary stent - five-year results of the TARGET All Comers randomised clinical trial.
Lansky A, Xu B, Baumbach A, Kelbæk H, van Royen N, Zheng M, Knaapen P, Slagboom T, Johnson T, Vlachojannis G, Arkenbout K, Holmvang L, Janssens L, Brugaletta S, Naber C, Schmitz T, Anderson R, Rittger H, Berti S, Barbato E, Toth G, Maillard L, Valina C, Buszman P, Thiele H, Schächinger V, Wijns W. Targeted therapy with a localised abluminal groove, low-dose sirolimus-eluting, biodegradable-polymer coronary stent - five-year results of the TARGET All Comers randomised clinical trial. EuroIntervention 2023, 19: e844-e855. PMID: 37860860, PMCID: PMC10687649, DOI: 10.4244/eij-d-23-00409.Peer-Reviewed Original ResearchConceptsTarget lesion failureDP-EES groupPercutaneous coronary interventionBP-SES groupBP-SESPrimary endpointDP-EESRate of TLFBiodegradable polymer sirolimus-eluting stentsST-elevation myocardial infarction (STEMI) presentationMyocardial infarction presentationSirolimus-eluting stentsFive-year resultsLong-term safetyAbluminal grooveLesion failureSecondary endpointsComers populationCoronary interventionMyocardial ischaemiaStent implantationClinical trialsTargeted therapyLandmark analysisStudy outcomesLong-term PCI outcomes in chronic versus acute coronary syndromes: 5-year results of the TARGET All Comers trial
Patel K, Lansky A, Kelbaek H, Xu B, Van Royen N, Johnson T, Anderson R, Wijns W, Baumbach A. Long-term PCI outcomes in chronic versus acute coronary syndromes: 5-year results of the TARGET All Comers trial. European Heart Journal 2023, 44: ehad655.1494. DOI: 10.1093/eurheartj/ehad655.1494.Peer-Reviewed Original ResearchAcute coronary syndromeChronic coronary syndromeProbable stent thrombosisCoronary syndromeStent thrombosisFIREHAWK stentLesion failureClinical presentationLong-term PCI outcomesPatient-oriented composite endpointTarget lesion revascularisationMajor adverse eventsLong-term outcomesLong-term safetyCCS cohortComer patientsID-TLRLesion revascularisationCCS patientsOpen labelAdverse eventsBaseline characteristicsACS cohortComposite endpointComers trialCoronary 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 deathThe 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 outcomesOutcomes 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
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 infarctionAcute and one-year clinical outcomes following implantation of bioresorbable vascular scaffolds: the ABSORB UK Registry.
Baumbach A, Zaman A, West NEJ, O'Kane P, Egred M, Johnson T, Wheatcroft S, Bowles R, de Belder A, Bouras G, Lansky A, Hill J, Mathur A, de Belder MA, Banning AP. Acute and one-year clinical outcomes following implantation of bioresorbable vascular scaffolds: the ABSORB UK Registry. EuroIntervention 2018, 13: 1554-1560. PMID: 29131802, DOI: 10.4244/eij-d-17-00886.Peer-Reviewed Original ResearchMeSH KeywordsAbsorbable ImplantsAcute Coronary SyndromeAdultClinical Decision-MakingCoronary Artery DiseaseCoronary ThrombosisFemaleHumansMaleMiddle AgedPatient SelectionPercutaneous Coronary InterventionPractice Patterns, Physicians'Product Surveillance, PostmarketingProspective StudiesProsthesis DesignRegistriesRisk FactorsTime FactorsTreatment OutcomeUnited KingdomConceptsBioresorbable vascular scaffoldDe novo coronary lesionsOne-year clinical outcomesIndependent clinical events committeeMajor adverse cardiac eventsAbsorb bioresorbable vascular scaffoldCareful implantation techniqueAdverse cardiac eventsNovo coronary lesionsTarget lesion failureAcute coronary syndromeClinical events committeeB2/CCareful patient selectionContemporary drug-eluting stentsDrug-eluting stentsVascular scaffoldsSmall vessel sizeDefinite STCoronary syndromeLesion failureCardiac eventsPatient ageReal-world practiceBVS implantation
2016
Clinical outcomes after PCI treatment of very long lesions with the XIENCE V everolimus eluting stent; Pooled analysis from the SPIRIT and XIENCE V USA prospective multicenter trials
Bouras G, Jhamnani S, Ng VG, Haimi I, Mao V, Deible R, Cao S, Sudhir K, Lansky AJ. Clinical outcomes after PCI treatment of very long lesions with the XIENCE V everolimus eluting stent; Pooled analysis from the SPIRIT and XIENCE V USA prospective multicenter trials. Catheterization And Cardiovascular Interventions 2016, 89: 984-991. PMID: 27545721, DOI: 10.1002/ccd.26711.Peer-Reviewed Original ResearchConceptsMajor adverse cardiac eventsLong coronary lesionsTarget lesion failurePercutaneous coronary interventionAcademic Research ConsortiumMean lesion lengthCoronary lesionsXIENCE VCoronary interventionStent thrombosisLesion lengthRate of TLFControl groupSecond generation drug eluting stentsLong lesion groupAdverse cardiac eventsProbable stent thrombosisPrimary outcome measureCoronary stent systemDrug eluting stentsLesion failureCardiac eventsPooled analysisWorse outcomesLesion group
2013
Meta-Analysis of Everolimus-Eluting Versus Paclitaxel-Eluting Stents in Coronary Artery Disease Final 3-Year Results of the SPIRIT Clinical Trials Program (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions)
Dangas GD, Serruys PW, Kereiakes DJ, Hermiller J, Rizvi A, Newman W, Sudhir K, Smith RS, Cao S, Theodoropoulos K, Cutlip DE, Lansky AJ, Stone GW. Meta-Analysis of Everolimus-Eluting Versus Paclitaxel-Eluting Stents in Coronary Artery Disease Final 3-Year Results of the SPIRIT Clinical Trials Program (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions). JACC Cardiovascular Interventions 2013, 6: 914-922. PMID: 24050859, DOI: 10.1016/j.jcin.2013.05.005.Peer-Reviewed Original ResearchMeSH KeywordsAgedCardiovascular AgentsCoronary Artery DiseaseCoronary RestenosisCoronary ThrombosisDrug-Eluting StentsEverolimusFemaleHumansKaplan-Meier EstimateMaleMiddle AgedMulticenter Studies as TopicMultivariate AnalysisMyocardial InfarctionPaclitaxelPercutaneous Coronary InterventionProportional Hazards ModelsProsthesis DesignRandomized Controlled Trials as TopicRisk FactorsSirolimusTime FactorsTreatment OutcomeConceptsPaclitaxel-eluting stentsIschemia-driven target lesion revascularizationMajor adverse cardiac eventsAdverse cardiac eventsTarget lesion revascularizationLesion failureMyocardial infarctionLesion revascularizationCause mortalityCardiac eventsStent thrombosisStent typeEvent ratesTarget lesion failureClinical trial programException of diabetesIndividual patient dataIndividual clinical outcomesCardiac deathComposite endpointClinical outcomesSPIRIT IIClinical trialsCoronary implantationTrial program