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 outcomes
2021
Abluminal groove-filled biodegradable polymer sirolimus-eluting stent versus durable polymer everolimus-eluting stent: three-year results of the TARGET All Comers trial.
Saito Y, Kelbæk H, Xu B, Hussain Y, Anderson R, Schächinger V, Zheng M, Wijns W, Baumbach A, Lansky AJ. Abluminal groove-filled biodegradable polymer sirolimus-eluting stent versus durable polymer everolimus-eluting stent: three-year results of the TARGET All Comers trial. EuroIntervention 2021, 17: e332-e334. PMID: 32482617, PMCID: PMC9724996, DOI: 10.4244/eij-d-20-00344.Peer-Reviewed Original ResearchDifferential 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
2020
Long‐term serial functional evaluation after implantation of the Fantom sirolimus‐eluting bioresorbable coronary scaffold
Saito Y, Cristea E, Bouras G, Abizaid A, Lutz M, Carrié D, Weber‐Albers J, Dudek D, Anderson J, Lansky A, Investigators T. Long‐term serial functional evaluation after implantation of the Fantom sirolimus‐eluting bioresorbable coronary scaffold. Catheterization And Cardiovascular Interventions 2020, 97: 431-436. PMID: 32077590, DOI: 10.1002/ccd.28804.Peer-Reviewed Original ResearchConceptsPost-percutaneous coronary interventionQuantitative flow ratioBioresorbable coronary scaffoldTarget vessel revascularizationVessel revascularizationFunctional ischemiaStable coronary artery diseaseTime of revascularizationCoronary artery diseaseFractional flow reserveQFR assessmentII trialAngiographic outcomesCoronary interventionUnstable anginaArtery diseaseQFR valueWire-based fractional flow reserveSignificant lesionsFlow reservePatientsTarget vesselRevascularizationQFR analysisFunctional evaluationThe Firehawk Stent: A Review of a Novel Abluminal Groove-Filled Biodegradable Polymer Sirolimus-Eluting Stent.
Saito Y, Grubman D, Cristea E, Lansky A. The Firehawk Stent: A Review of a Novel Abluminal Groove-Filled Biodegradable Polymer Sirolimus-Eluting Stent. Cardiology In Review 2020, 28: 208-212. PMID: 32032131, DOI: 10.1097/crd.0000000000000298.Peer-Reviewed Original ResearchMeSH KeywordsAbsorbable ImplantsDrug-Eluting StentsHumansInflammationPercutaneous Coronary InterventionSirolimusTreatment OutcomeConceptsAbluminal grooveFIREHAWK stentBiodegradable Polymer Sirolimus-Eluting StentLate adverse eventsPercutaneous coronary interventionCurrent clinical evidenceSirolimus-Eluting StentsDrug-eluting stent technologyAdverse eventsCoronary interventionClinical outcomesChronic inflammationClinical evidenceHypersensitivity reactionsRecent trialsDrug concentrationsStent technologyStentsInflammationFIREHAWKReviewSirolimus
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
2015
Comparison of the Absorbable Polymer Sirolimus-Eluting Stent (MiStent) to the Durable Polymer Everolimus-Eluting Stent (Xience) (from the DESSOLVE I/II and ISAR-TEST-4 Studies)
Lansky AJ, Kastrati A, Edelman ER, Parise H, Ng VG, Ormiston J, Wijns W, Byrne RA. Comparison of the Absorbable Polymer Sirolimus-Eluting Stent (MiStent) to the Durable Polymer Everolimus-Eluting Stent (Xience) (from the DESSOLVE I/II and ISAR-TEST-4 Studies). The American Journal Of Cardiology 2015, 117: 532-538. PMID: 26762729, PMCID: PMC5975354, DOI: 10.1016/j.amjcard.2015.11.044.Peer-Reviewed Original ResearchBioabsorbable polymer‐coated sirolimus‐eluting stent implantation preserves coronary vasomotion: A DESSOLVE II trial sub‐study
Rusinaru D, Vrolix M, Verheye S, Chowdhary S, Schoors D, Di Mario C, Desmet W, Donohoe DJ, Ormiston JA, Knape C, Bezerra H, Lansky A, Wijns W, Investigators O. Bioabsorbable polymer‐coated sirolimus‐eluting stent implantation preserves coronary vasomotion: A DESSOLVE II trial sub‐study. Catheterization And Cardiovascular Interventions 2015, 86: 1141-1150. PMID: 25044635, DOI: 10.1002/ccd.25610.Peer-Reviewed Original ResearchMeSH KeywordsAbsorbable ImplantsAgedCardiac Pacing, ArtificialCardiovascular AgentsCoronary AngiographyCoronary Artery DiseaseCoronary VesselsDrug-Eluting StentsEuropeFemaleHistorically Controlled StudyHumansMaleMiddle AgedNew ZealandPercutaneous Coronary InterventionPolymersProspective StudiesSingle-Blind MethodSirolimusTime FactorsTreatment OutcomeVasoconstrictionVasodilationConceptsZotarolimus-eluting stentsDrug-eluting stentsCoronary vasomotionII trialVasomotor dysfunctionFirst-generation drug-eluting stentsEndeavor zotarolimus-eluting stentsGeneration drug-eluting stentsCoronary vasomotor dysfunctionSirolimus-eluting stentsQuantitative coronary angiographyVessel diameterMaximal pacingCoronary angiographyZES groupCoronary arteryVasomotor responsesHistorical groupStent edgeNormal vasomotionPatientsPercent changeReference segmentsVasomotionSES groupRandomised study of a bioabsorbable polymer-coated sirolimus-eluting stent: results of the DESSOLVE II trial.
Wijns W, Vrolix M, Verheye S, Schoors D, Slagboom T, Gosselink M, Benit E, Donohoe D, Knape C, Attizzani GF, Lansky AJ, Ormiston J. Randomised study of a bioabsorbable polymer-coated sirolimus-eluting stent: results of the DESSOLVE II trial. EuroIntervention 2015, 10: 1383-90. PMID: 24801119, DOI: 10.4244/eijy14m05_03.Peer-Reviewed Original ResearchConceptsZotarolimus-eluting stentsLate lumen lossStent late lumen lossOptical coherence tomographyII trialMajor adverse cardiac eventsMean late lumen lossClinical safety endpointPrimary efficacy hypothesisAdverse cardiac eventsPrimary efficacy endpointStent thrombosis ratesMean neointimal thicknessSirolimus-eluting stentsQuantitative coronary angiographyZES patientsEfficacy endpointPrimary endpointSafety endpointVolume obstructionCardiac eventsCoronary angiographyThrombosis rateZES groupStrut coverageSafety 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
First-in-Human Evaluation of a Bioabsorbable Polymer–Coated Sirolimus-Eluting Stent Imaging and Clinical Results of the DESSOLVE I Trial (DES With Sirolimus and a Bioabsorbable Polymer for the Treatment of Patients With De Novo Lesion in the Native Coronary Arteries)
Ormiston J, Webster M, Stewart J, Vrolix M, Whitbourn R, Donohoe D, Knape C, Lansky A, Attizzani GF, Fitzgerald P, Kandzari DE, Wijns W. First-in-Human Evaluation of a Bioabsorbable Polymer–Coated Sirolimus-Eluting Stent Imaging and Clinical Results of the DESSOLVE I Trial (DES With Sirolimus and a Bioabsorbable Polymer for the Treatment of Patients With De Novo Lesion in the Native Coronary Arteries). JACC Cardiovascular Interventions 2013, 6: 1026-1034. PMID: 24055443, DOI: 10.1016/j.jcin.2013.05.013.Peer-Reviewed Original ResearchMeSH KeywordsAbsorbable ImplantsAdultAgedAged, 80 and overAngina, StableAngina, UnstableAustraliaBelgiumCardiovascular AgentsChromium AlloysCoronary AngiographyCoronary Artery DiseaseCoronary RestenosisCoronary StenosisCoronary VesselsDrug Therapy, CombinationDrug-Eluting StentsFemaleHumansMaleMiddle AgedMyocardial InfarctionNeointimaNew ZealandPercutaneous Coronary InterventionPlatelet Aggregation InhibitorsPolymersProspective StudiesProsthesis DesignSeverity of Illness IndexSirolimusTime FactorsTomography, Optical CoherenceTreatment OutcomeUltrasonography, InterventionalConceptsStent late lumen lossLate lumen lossSirolimus-eluting stentsOptical coherence tomographyIntravascular ultrasoundMajor adverse cardiac eventsSymptomatic coronary artery diseaseCoherence tomographyComplete strut coverageNeointimal volume obstructionUnderwent repeat angiographyAdverse cardiac eventsDual antiplatelet therapyCoronary artery diseaseUnstable angina pectorisDrug-eluting stentsLong-term riskAntiplatelet therapyVolume obstructionCardiac eventsRepeat angiographyAdverse eventsAngina pectorisArtery diseaseI trialA 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
2008
A Novel Bioresorbable Polymer Paclitaxel-Eluting Stent for the Treatment of Single and Multivessel Coronary Disease Primary Results of the COSTAR (Cobalt Chromium Stent With Antiproliferative for Restenosis) II Study
Krucoff MW, Kereiakes DJ, Petersen JL, Mehran R, Hasselblad V, Lansky AJ, Fitzgerald PJ, Garg J, Turco MA, Simonton CA, Verheye S, Dubois CL, Gammon R, Batchelor WB, O'Shaughnessy CD, Hermiller JB, Schofer J, Buchbinder M, Wijns W, Group C. A Novel Bioresorbable Polymer Paclitaxel-Eluting Stent for the Treatment of Single and Multivessel Coronary Disease Primary Results of the COSTAR (Cobalt Chromium Stent With Antiproliferative for Restenosis) II Study. Journal Of The American College Of Cardiology 2008, 51: 1543-1552. PMID: 18420096, DOI: 10.1016/j.jacc.2008.01.020.Peer-Reviewed Original ResearchMeSH KeywordsAbsorbable ImplantsAngioplasty, Balloon, CoronaryAntineoplastic Agents, PhytogenicChromium AlloysClopidogrelCoronary AngiographyCoronary Artery DiseaseCoronary RestenosisDiabetes MellitusFemaleHumansMaleMiddle AgedPaclitaxelPlatelet Aggregation InhibitorsPolymersRiskThromboembolismTiclopidineTime FactorsConceptsPercutaneous coronary interventionTarget vessel revascularizationDrug-eluting stentsMajor adverse cardiac eventsMultivessel percutaneous coronary interventionTaxus drug-eluting stentsMyocardial infarctionAdjudicated deathAdverse cardiac eventsPrimary end pointSegment late lossSingle target lesionPre-specified subgroupsStent thrombosis ratesTreatment of SingleVessel revascularizationCardiac eventsCoronary interventionII studyThrombosis rateAngiographic analysisEpicardial vesselsTarget lesionsLate lossPatients
2007
Cobalt chromium stent with antiproliferative for restenosis trial in India (COSTAR I).
Kaul U, Gupta RK, Mathur A, Dani S, Sapra R, Nayak PR, Lansky A, Cristea E, Carlier S, Gambone L, Litvack F. Cobalt chromium stent with antiproliferative for restenosis trial in India (COSTAR I). Indian Heart Journal 2007, 59: 165-72. PMID: 19122251.Peer-Reviewed Original ResearchConceptsStent late lossGroup 2Group 1Late lossI trialCoronary lesionsGroup 3De novo coronary lesionsSegment late lossBinary restenosis rateNative coronary lesionsNovo coronary lesionsMulti-center registryCoronary stent systemRelease formulationExtended-release formulationSmall-caliber vesselsCobalt-chromium stentNovo lesionsPrimary endpointRestenosis TrialRestenosis rateClinical outcomesFeasibility trialClinical results