2013
Impact of advanced age on the safety and effectiveness of paclitaxel‐eluting stent implantation in patients with ST‐segment elevation myocardial infarction undergoing primary angioplasty
Dudek D, Mehran R, Dziewierz A, Witzenbichler B, Brodie BR, Kornowski R, Fahy M, Lansky AJ, Rakowski T, Legutko J, Bryniarski L, Stone GW. Impact of advanced age on the safety and effectiveness of paclitaxel‐eluting stent implantation in patients with ST‐segment elevation myocardial infarction undergoing primary angioplasty. Catheterization And Cardiovascular Interventions 2013, 82: 869-877. PMID: 23359554, DOI: 10.1002/ccd.24813.Peer-Reviewed Original ResearchConceptsPrimary percutaneous coronary interventionST-segment elevation myocardial infarctionPaclitaxel-eluting stent implantationPrimary PCIBare metal stentsElevation myocardial infarctionYears of ageStent implantationOlder patientsMyocardial infarctionLower riskIschemic target vessel revascularizationMajor adverse cardiac eventsHORIZONS-AMI studyHORIZONS-AMI trialReduction of MACEAdverse cardiac eventsTarget vessel revascularizationClinical end pointsPercutaneous coronary interventionLong-term resultsImpact of ageCause deathMajor bleedingPrimary angioplasty
2011
Long-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
Everolimus-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
2008
The Harmonizing Outcomes with RevascularIZatiON and Stents in Acute Myocardial Infarction (HORIZONS-AMI) Trial: Study design and rationale
Mehran R, Brodie B, Cox DA, Grines CL, Rutherford B, Bhatt DL, Dangas G, Feit F, Ohman EM, Parise H, Fahy M, Lansky AJ, Stone GW. The Harmonizing Outcomes with RevascularIZatiON and Stents in Acute Myocardial Infarction (HORIZONS-AMI) Trial: Study design and rationale. American Heart Journal 2008, 156: 44-56. PMID: 18585496, DOI: 10.1016/j.ahj.2008.02.008.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAngioplasty, Balloon, CoronaryAnticoagulantsCombined Modality TherapyCoronary AngiographyDose-Response Relationship, DrugDrug Administration ScheduleDrug-Eluting StentsFollow-Up StudiesHeparin, Low-Molecular-WeightHirudinsHumansMaleMiddle AgedMyocardial InfarctionPeptide FragmentsPlatelet Glycoprotein GPIIb-IIIa ComplexProbabilityProspective StudiesRecombinant ProteinsReference ValuesResearch DesignRisk AssessmentStentsSurvival RateThrombosisTime FactorsConceptsPrimary PCIPrimary percutaneous coronary interventionIIb/IIIa inhibitorsAcute myocardial infarctionBare metal stentsGP IIb/IIIa inhibitorsHORIZONS-AMI trialUnfractionated heparinGlycoprotein IIb/IIIa inhibitorsIdentical bare-metal stentOverall event-free survivalAcute Myocardial Infarction trialEnd pointDirect thrombin inhibitor bivalirudinRoutine useEfficacy end pointMyocardial Infarction trialTarget lesion revascularizationEvent-free survivalClinical end pointsPercutaneous coronary interventionPaclitaxel-eluting stentsNew pharmacologic agentsThrombin inhibitor bivalirudinDrug-eluting stents
2007
Clinical End Points in Coronary Stent Trials
Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Gabriel Steg P, Morel M, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW. Clinical End Points in Coronary Stent Trials. Circulation 2007, 115: 2344-2351. PMID: 17470709, DOI: 10.1161/circulationaha.106.685313.Peer-Reviewed Original ResearchConceptsEnd point definitionsAcademic Research ConsortiumClinical end pointsEnd pointDrug AdministrationConsensus criteriaEffectiveness end pointClinical trial programKey pathophysiological mechanismMost clinical trialsCoronary stent trialsClinical trial purposesEvaluation of safetyTiming of assessmentResearch ConsortiumAssessment of deathStent thrombosisPathophysiological mechanismsAcademic research organizationsStent trialsMyocardial infarctionClinical trialsConsensus recommendationsTrial programPoint definition
2004
High-dose 7-hexanoyltaxol-eluting stent with polymer sleeves for coronary revascularizationOne-year results from the SCORE randomized trial
GRUBE E, LANSKY A, HAUPTMANN K, DIMARIO C, DISCIASCIO G, COLOMBO A, SILBER S, STUMPF J, REIFART N, FAJADET J. High-dose 7-hexanoyltaxol-eluting stent with polymer sleeves for coronary revascularizationOne-year results from the SCORE randomized trial. Journal Of The American College Of Cardiology 2004, 44: 1368-1372. DOI: 10.1016/s0735-1097(04)01351-8.Peer-Reviewed Original ResearchConceptsRestenosis rateStent thrombosisMajor adverse cardiac event ratesAdverse cardiac event ratesDe novo coronary lesionsTarget vessel revascularization rateEnd pointNon-Q-wave MIAngiographic restenosis rateCardiac event rateNovo coronary lesionsPrimary end pointUnacceptable safety profileVessel revascularization rateMyocardial infarction rateOpen-label trialStent thrombosis ratesClinical end pointsOne-year resultsQuantitative coronary angiographyCoronary revascularizationRevascularization ratesInfarction rateCardiac deathCoronary angiographyHigh-dose 7-hexanoyltaxol-eluting stent with polymer sleeves for coronary revascularization One-year results from the SCORE randomized trial
Grube E, Lansky A, Hauptmann K, Di Mario C, Di Sciascio G, Colombo A, Silber S, Stumpf J, Reifart N, Fajadet J, Marzocchi A, Schofer J, Dumas P, Hoffmann R, Guagliumi G, Pitney M, Russell M. High-dose 7-hexanoyltaxol-eluting stent with polymer sleeves for coronary revascularization One-year results from the SCORE randomized trial. Journal Of The American College Of Cardiology 2004, 44: 1368-1372. PMID: 15464315, DOI: 10.1016/j.jacc.2004.06.054.Peer-Reviewed Original ResearchConceptsRestenosis rateStent thrombosisMajor adverse cardiac event ratesAdverse cardiac event ratesDe novo coronary lesionsTarget vessel revascularization rateEnd pointNon-Q-wave MIAngiographic restenosis rateCardiac event rateNovo coronary lesionsPrimary end pointUnacceptable safety profileVessel revascularization rateMyocardial infarction rateOpen-label trialStent thrombosis ratesClinical end pointsOne-year resultsQuantitative coronary angiographyCoronary revascularizationRevascularization ratesInfarction rateCardiac deathCoronary angiography
2000
Long-term clinical events following creatine kinase–myocardial band isoenzyme elevation after successful coronary stenting
Saucedo J, Mehran R, Dangas G, Hong M, Lansky A, Kent K, Satler L, Pichard A, Stone G, Leon M. Long-term clinical events following creatine kinase–myocardial band isoenzyme elevation after successful coronary stenting. Journal Of The American College Of Cardiology 2000, 35: 1134-1141. PMID: 10758952, DOI: 10.1016/s0735-1097(00)00513-1.Peer-Reviewed Original ResearchMeSH KeywordsAgedAnalysis of VarianceAngioplasty, Balloon, CoronaryBiomarkersCoronary DiseaseCreatine KinaseDisease-Free SurvivalFemaleHumansIncidenceLogistic ModelsMaleMiddle AgedPredictive Value of TestsPrognosisProspective StudiesPulmonary EdemaRadiographyRecurrenceRisk FactorsSeverity of Illness IndexStentsTreatment OutcomeConceptsCK-MB elevationCreatine kinase-myocardial band isoenzyme (CK-MB) elevationMajor adverse clinical eventsCK-MB riseAdverse clinical eventsCoronary stentingLate mortalityClinical eventsGroup 1Group 3Group 2Long-term clinical importanceLong-term clinical eventsHospital recurrent ischemiaLate clinical outcomesCardiac enzyme elevationEvent-free survivalClinical end pointsHigher late mortalityPercutaneous coronary interventionPercutaneous coronary revascularizationCK-MB levelsNative coronary arteriesSuccessful coronary stentingSuccessful stent implantation