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
Randomised 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 coverage
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 AgentsChi-Square DistributionChinaCoronary 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 groupEfficacy and safety of FIREHAWK® abluminal groove filled biodegradable polymer sirolimus-eluting stents for the treatment of long coronary lesions: nine-month angiographic and one-year clinical results from TARGET I trial long cohort.
Xu B, Gao RL, Zhang RY, Wang HC, Li ZQ, Yang YJ, Ma CS, Han YL, Lansky AJ, Huo Y, Li W, Leon MB. Efficacy and safety of FIREHAWK® abluminal groove filled biodegradable polymer sirolimus-eluting stents for the treatment of long coronary lesions: nine-month angiographic and one-year clinical results from TARGET I trial long cohort. Chinese Medical Journal 2013, 126: 1026-32. PMID: 23506573, DOI: 10.3760/cma.j.issn.0366-6999.20123206.Peer-Reviewed Original ResearchConceptsLong coronary lesionsPercutaneous coronary interventionCoronary lesionsMyocardial infarctionLate lossLONG cohortLong lesionsBiodegradable polymer sirolimus-eluting stentsNon-Q-wave myocardial infarctionDrug-eluting stent (DES) failureLong coronary artery diseaseStent late lumen lossOne-year clinical resultsSegment binary restenosisSegment late lossPrimary end pointReference vessel diameterLate lumen lossNative coronary arteriesStent late lossCoronary artery diseaseMajor inclusion criteriaSingle-arm trialSirolimus-eluting stentsAbluminal groove
2012
First report of a novel abluminal groove filled biodegradable polymer rapamycin-eluting stent in de novo coronary artery disease: results of the first in man FIREHAWK trial.
Qian J, Xu B, Lansky AJ, Yang YJ, Qiao SB, Wu YJ, Chen J, Hu FH, Yang WX, Mintz GS, Leon MB, Gao RL. First report of a novel abluminal groove filled biodegradable polymer rapamycin-eluting stent in de novo coronary artery disease: results of the first in man FIREHAWK trial. Chinese Medical Journal 2012, 125: 970-6. PMID: 22613516.Peer-Reviewed Original ResearchConceptsMajor adverse cardiac eventsQuantitative coronary angiographyDrug-eluting stentsAbluminal grooveMyocardial infarctionDe novo coronary artery diseaseDe novo native coronary stenosisIschemia-driven target lesion revascularizationNovo coronary artery diseaseStent late lumen lossFirst-generation drug-eluting stentsComplete strut coverageAdverse cardiac eventsTarget lesion revascularizationTarget vessel revascularizationClinical success rateCoronary artery diseaseLate lumen lossNative coronary stenosisPrior myocardial infarctionStent late lossLate DES thrombosisLong-term restenosisLesion revascularizationPrimary endpoint
2009
The GENESIS (Randomized, Multicenter Study of the Pimecrolimus-Eluting and Pimecrolimus/Paclitaxel-Eluting Coronary Stent System in Patients with De Novo Lesions of the Native Coronary Arteries) Trial
Verheye S, Agostoni P, Dawkins KD, Dens J, Rutsch W, Carrie D, Schofer J, Lotan C, Dubois CL, Cohen SA, Fitzgerald PJ, Lansky AJ. The GENESIS (Randomized, Multicenter Study of the Pimecrolimus-Eluting and Pimecrolimus/Paclitaxel-Eluting Coronary Stent System in Patients with De Novo Lesions of the Native Coronary Arteries) Trial. JACC Cardiovascular Interventions 2009, 2: 205-214. PMID: 19463427, DOI: 10.1016/j.jcin.2008.12.011.Peer-Reviewed Original ResearchConceptsPaclitaxel-eluting stentsMajor adverse cardiac event ratesAdverse cardiac event ratesSingle de novo lesionsMajor adverse clinical eventsStent late lumen lossEnd pointBinary angiographic restenosisCardiac event ratePrimary end pointSecondary end pointsDe novo lesionsRandomized multicenter trialAdverse clinical eventsStent late lossLate lumen lossNative coronary arteriesStent restenosis rateBare metal stentsAngiographic restenosisNovo lesionsCoronary angiographyMulticenter trialRestenosis rateLumen loss
2006
The randomised study of the double dose versus single dose sirolimus-eluting stent for the treatment of diabetic patients with de novo coronary lesions.
Costa RA, Sousa JE, Abizaid A, Chaves A, Feres F, Sousa AG, Musumeci G, Mehran R, Fitzgerald PJ, Lansky AJ, Leon MB, Shiran A, Halon DA, Lewis BS, Guagliumi G. The randomised study of the double dose versus single dose sirolimus-eluting stent for the treatment of diabetic patients with de novo coronary lesions. EuroIntervention 2006, 2: 295-301. PMID: 19755304.Peer-Reviewed Original ResearchDe novo coronary lesionsSirolimus-eluting stentsNovo coronary lesionsDiabetic patientsCoronary lesionsDouble doseRevascularisation ratesStent late lumen lossLesion revascularisation rateDouble-blind fashionLate lumen lossBare metal stentsIncomplete stent appositionBinary restenosisPrimary endpointStent thrombosisLumen lossLate thrombosesNeointimal proliferationProcedure successNeointimal volumeNeointimal hyperplasiaPatientsMetal stentsBlind fashionEffect of Everolimus-Eluting Stents in Different Vessel Sizes (from the Pooled FUTURE I and II Trials)
Tsuchiya Y, Lansky AJ, Costa RA, Mehran R, Pietras C, Shimada Y, Sonoda S, Cristea E, Negoita M, Dangas GD, Moses JW, Leon MB, Fitzgerald PJ, Müller R, Störger H, Hauptmann KE, Grube E. Effect of Everolimus-Eluting Stents in Different Vessel Sizes (from the Pooled FUTURE I and II Trials). The American Journal Of Cardiology 2006, 98: 464-469. PMID: 16893698, DOI: 10.1016/j.amjcard.2006.02.054.Peer-Reviewed Original ResearchMeSH KeywordsAgedBlood Vessel Prosthesis ImplantationCoated Materials, BiocompatibleCoronary AngiographyCoronary RestenosisCoronary VesselsEverolimusFemaleFollow-Up StudiesHumansImmunosuppressive AgentsMaleMiddle AgedProspective StudiesProsthesis DesignSirolimusStentsTreatment OutcomeUltrasonography, InterventionalConceptsBare metal stentsDe novo coronary lesionsNovo coronary lesionsCoronary lesionsNeointimal proliferationStent late lumen lossMid-term outcomesLate lumen lossEverolimus-Eluting StentsQuantitative coronary angiographyMinimum lumen areaVessel sizeII trialCoronary angiographyI trialIncomplete appositionLumen lossStent thrombosisAneurysm formationStent restenosisIntravascular ultrasoundMetal stentsReference diameterLumen areaPatients
2005
Angiographic results of the first human experience with everolimus-eluting stents for the treatment of coronary lesions (the FUTURE I trial)
Costa RA, Lansky AJ, Mintz GS, Mehran R, Tsuchiya Y, Negoita M, Gilutz Y, Nikolsky E, Fahy M, Pop R, Cristea E, Carlier S, Dangas G, Stone GW, Leon MB, Müller R, Techen G, Grube E. Angiographic results of the first human experience with everolimus-eluting stents for the treatment of coronary lesions (the FUTURE I trial). The American Journal Of Cardiology 2005, 95: 113-116. PMID: 15619406, DOI: 10.1016/j.amjcard.2004.08.074.Peer-Reviewed Original ResearchConceptsCoronary lesionsDe novo coronary lesionsStent late lumen lossNoncomplex coronary lesionsSegment diameter stenosisNovo coronary lesionsLate lumen lossEverolimus-eluting stentsFirst human experienceMetallic stent groupEdge restenosisAngiographic characteristicsSegment restenosisAngiographic findingsAngiographic resultsStent thrombosisDiameter stenosisLumen lossStent groupAneurysm formationStent restenosisMetallic stentsRestenosisLesionsStents