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 locationOutcomes 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
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
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 death
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 stent
2011
Impact of Lesion Length and Vessel Size on Clinical Outcomes After Percutaneous Coronary Intervention With Everolimus- Versus Paclitaxel-Eluting Stents Pooled Analysis From the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice) Randomized Trials
Claessen BE, Smits PC, Kereiakes DJ, Parise H, Fahy M, Kedhi E, Serruys PW, Lansky AJ, Cristea E, Sudhir K, Sood P, Simonton CA, Stone GW. Impact of Lesion Length and Vessel Size on Clinical Outcomes After Percutaneous Coronary Intervention With Everolimus- Versus Paclitaxel-Eluting Stents Pooled Analysis From the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice) Randomized Trials. JACC Cardiovascular Interventions 2011, 4: 1209-1215. PMID: 22115661, DOI: 10.1016/j.jcin.2011.07.016.Peer-Reviewed Original ResearchMeSH KeywordsAgedAngioplasty, Balloon, CoronaryCardiovascular AgentsChi-Square DistributionCoronary AngiographyCoronary StenosisDrug-Eluting StentsEverolimusFemaleHumansKaplan-Meier EstimateMaleMiddle AgedMyocardial InfarctionPaclitaxelPredictive Value of TestsProportional Hazards ModelsProsthesis DesignRandomized Controlled Trials as TopicRisk AssessmentRisk FactorsSeverity of Illness IndexSirolimusThrombosisTime FactorsTreatment OutcomeConceptsMajor adverse cardiac eventsPaclitaxel-eluting stentsReference vessel diameterEverolimus-eluting stentsPercutaneous coronary interventionLong lesionsGroup BLesion lengthMACE rateCoronary interventionSmall vesselsGroup AStent typeShort lesionsAdverse cardiac eventsHigh-risk patientsPatient-level dataLarge vesselsLower ratesCOMPARE trialLesion revascularizationEfficacy outcomesAdverse eventsCardiac eventsIndependent predictorsDifferential Clinical Responses to Everolimus-Eluting and Paclitaxel-Eluting Coronary Stents in Patients With and Without Diabetes Mellitus
Stone G, Kedhi E, Kereiakes D, Parise H, Fahy M, Serruys P, Smits P. Differential Clinical Responses to Everolimus-Eluting and Paclitaxel-Eluting Coronary Stents in Patients With and Without Diabetes Mellitus. Circulation 2011, 124: 893-900. PMID: 21824922, DOI: 10.1161/circulationaha.111.031070.Peer-Reviewed Original ResearchConceptsPaclitaxel-eluting stentsPercutaneous coronary interventionEverolimus-eluting stentsDiabetes mellitusLesion revascularizationCoronary interventionStent thrombosisMyocardial infarctionStent typeIschemia-driven target lesion revascularizationEnd pointDifferential clinical responseXIENCE V EverolimusEfficacy end pointTarget lesion revascularizationTreatment of patientsCoronary stent systemSignificant differencesEverolimus-ElutingCoronary revascularizationEfficacy outcomesClinical responseDiabetic statusDiabetic patientsClinical outcomesLong-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
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
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 IIIPatientsStentsEverolimus-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
2008
Comparison of an Everolimus-Eluting Stent and a Paclitaxel-Eluting Stent in Patients With Coronary Artery Disease: A Randomized Trial
Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Mahaffey KW, Cutlip DE, Fitzgerald PJ, Sood P, Su X, Lansky AJ, Investigators F. Comparison of an Everolimus-Eluting Stent and a Paclitaxel-Eluting Stent in Patients With Coronary Artery Disease: A Randomized Trial. JAMA 2008, 299: 1903-1913. PMID: 18430909, DOI: 10.1001/jama.299.16.1903.Peer-Reviewed Original ResearchMeSH KeywordsAgedAngioplasty, Balloon, CoronaryCoronary AngiographyCoronary Artery DiseaseCoronary RestenosisDrug-Eluting StentsEverolimusFemaleHumansImmunosuppressive AgentsLogistic ModelsMaleMiddle AgedMyocardial InfarctionPaclitaxelProspective StudiesSingle-Blind MethodSirolimusUltrasonography, InterventionalConceptsMajor adverse cardiac eventsAdverse cardiac eventsPaclitaxel-eluting stentsSegment late lossSecondary end pointsTarget vessel failureCoronary artery diseaseCardiac eventsLate lossEnd pointArtery diseaseComposite major adverse cardiac eventsAdditional secondary end pointsMajor secondary end pointLesion revascularization proceduresSPIRIT III trialPrimary end pointReference vessel diameterPercutaneous coronary interventionEverolimus-eluting stentsAngiographic late lossCobalt-chromium stentAgents everolimusNoninferior ratesAngiographic outcomes
2006
Effect 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
2004
Six- and Twelve-Month Results From First Human Experience Using Everolimus-Eluting Stents With Bioabsorbable Polymer
Grube E, Sonoda S, Ikeno F, Honda Y, Kar S, Chan C, Gerckens U, Lansky AJ, Fitzgerald PJ. Six- and Twelve-Month Results From First Human Experience Using Everolimus-Eluting Stents With Bioabsorbable Polymer. Circulation 2004, 109: 2168-2171. PMID: 15123533, DOI: 10.1161/01.cir.0000128850.84227.fd.Peer-Reviewed Original ResearchMeSH KeywordsAgedAnticoagulantsCatheterizationCineangiographyCoated Materials, BiocompatibleComorbidityCoronary AngiographyCoronary RestenosisCoronary StenosisDrug ImplantsEverolimusFemaleFollow-Up StudiesGrowth InhibitorsHumansHyperplasiaImmunosuppressive AgentsLactic AcidMaleMiddle AgedMyocardial InfarctionPolyestersPolymersProspective StudiesSingle-Blind MethodSirolimusStainless SteelStentsTreatment OutcomeTunica IntimaUltrasonography, InterventionalConceptsEverolimus-eluting stentsBare metal stentsRestenosis rateMajor adverse cardiac event ratesAdverse cardiac event ratesDe novo coronary lesionsMajor adverse cardiac eventsPercent neointimal volumeSegment restenosis rateAdverse cardiac eventsCardiac event rateNovo coronary lesionsStent restenosis rateTwelve-month resultsFirst human experienceIntravascular ultrasound analysisInitial clinical experienceLate stent malappositionLate stent thrombosisStent neointimal hyperplasiaSignificant reductionRestenosis reductionCardiac eventsI trialCoronary lesions1101-44 Effect of everolimus-eluting stents in preventing neointimal hyperplasia: An intravascular ultrasound analysis from the FUTURE II trial
Sonoda S, Grube E, Shimada Y, Hassan A, Honda Y, Yock P, Chan C, Honda H, Kar S, Hauptmann K, Storger H, Lansky A, Fitzgerald P. 1101-44 Effect of everolimus-eluting stents in preventing neointimal hyperplasia: An intravascular ultrasound analysis from the FUTURE II trial. Journal Of The American College Of Cardiology 2004, 43: a66. DOI: 10.1016/s0735-1097(04)90276-8.Peer-Reviewed Original ResearchEverolimus-eluting stentsIntravascular ultrasound analysisII trialNeointimal hyperplasiaUltrasound analysisHyperplasia
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