2020
Immediate and long-term impact of the COVID-19 pandemic on cardiovascular clinical trials: considerations for study conduct and endpoint determination.
Lansky A, Shah T, Wijns W, Stefanini GG, Farb A, Kaplan A, Xu B, Pietras C, Velazquez E, Serruys PW, Mahfoud F, Baumbach A. Immediate and long-term impact of the COVID-19 pandemic on cardiovascular clinical trials: considerations for study conduct and endpoint determination. EuroIntervention 2020, 16: 787-793. PMID: 33215993, DOI: 10.4244/eijv16i10a147.Peer-Reviewed Original Research
2018
2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials
Hicks KA, Mahaffey KW, Mehran R, Nissen SE, Wiviott SD, Dunn B, Solomon SD, Marler JR, Teerlink JR, Farb A, Morrow DA, Targum SL, Sila CA, Hai M, Jaff MR, Joffe HV, Cutlip DE, Desai AS, Lewis EF, Gibson CM, Landray MJ, Lincoff AM, White CJ, Brooks SS, Rosenfield K, Domanski MJ, Lansky AJ, McMurray JJV, Tcheng JE, Steinhubl SR, Burton P, Mauri L, O’Connor C, Pfeffer MA, Hung HMJ, Stockbridge NL, Chaitman BR, Temple RJ, Initiative S, Fitter H, Illoh K, Cavanaugh K, Scirica B, Irony I, Kichline R, Levine J, Park A, Sacks L, Szarfman A, Unger E, Wachter L, Zuckerman B, Mitchel Y, Peddicord D, Shook T, Kisler B, Jaffe C, Bartley R, DeMets D, Mencini M, Janning C, Bai S, Lawrence J, D’Agostino R, Pocock S. 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials. Journal Of The American College Of Cardiology 2018, 71: 1021-1034. PMID: 29495982, DOI: 10.1016/j.jacc.2017.12.048.Peer-Reviewed Original ResearchConceptsClinical trialsStandardized data collectionTrials InitiativeProspective data collectionEffectiveness of drugsClinical care processesCardiovascular safetyStroke outcomeEndpoint definitionsWriting committeeDrug AdministrationCare processesU.S. FoodTrialsFurther studiesUniform definitionMedical product development programsMultiple trialsFDAData collectionCardiovascularAdministration2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials
Hicks KA, Mahaffey KW, Mehran R, Nissen SE, Wiviott SD, Dunn B, Solomon SD, Marler JR, Teerlink JR, Farb A, Morrow DA, Targum SL, Sila CA, Hai MTT, Jaff MR, Joffe HV, Cutlip DE, Desai AS, Lewis EF, Gibson CM, Landray MJ, Lincoff AM, White CJ, Brooks SS, Rosenfield K, Domanski MJ, Lansky AJ, McMurray JJV, Tcheng JE, Steinhubl SR, Burton P, Mauri L, O'Connor CM, Pfeffer MA, Hung HMJ, Stockbridge NL, Chaitman BR, Temple RJ. 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials. Circulation 2018, 137: 961-972. PMID: 29483172, DOI: 10.1161/circulationaha.117.033502.Peer-Reviewed Original ResearchMeSH KeywordsCardiovascular DiseasesClinical Trials as TopicData CollectionEndpoint DeterminationHumansStrokeUnited StatesUnited States Food and Drug AdministrationConceptsClinical trialsStandardized data collectionTrials InitiativeProspective data collectionEffectiveness of drugsClinical care processesCardiovascular safetyStroke outcomeEndpoint definitionsWriting committeeUS FoodDrug AdministrationCare processesTrialsFurther studiesUniform definitionMedical product development programsMultiple trialsFDAData collectionCardiovascularAdministration
2017
Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials
Lansky AJ, Messé SR, Brickman AM, Dwyer M, van der Worp H, Lazar RM, Pietras CG, Abrams KJ, McFadden E, Petersen NH, Browndyke J, Prendergast B, Ng VG, Cutlip DE, Kapadia S, Krucoff MW, Linke A, Moy C, Schofer J, van Es GA, Virmani R, Popma J, Parides MK, Kodali S, Bilello M, Zivadinov R, Akar J, Furie KL, Gress D, Voros S, Moses J, Greer D, Forrest JK, Holmes D, Kappetein AP, Mack M, Baumbach A. Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials. European Heart Journal 2017, 39: 1687-1697. PMID: 28171522, PMCID: PMC6251670, DOI: 10.1093/eurheartj/ehx037.Peer-Reviewed Original ResearchConceptsCardiovascular proceduresClinical trialsNeurological endpointsAcademic Research ConsortiumBenefit-risk assessmentAdjunctive pharmacologyNeurological complicationsNeurological outcomePreventive therapyClinical effectsNeurovascular injuryNeurological injuryNeurological riskEndpoint definitionsCardiovascular interventionsAscertainment methodsTherapyInjuryResearch ConsortiumRiskTrialsEndpointInherent risksSuch proceduresComplicationsProposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials An Academic Research Consortium Initiative
Lansky AJ, Messé SR, Brickman AM, Dwyer M, van der Worp HB, Lazar RM, Pietras CG, Abrams KJ, McFadden E, Petersen NH, Browndyke J, Prendergast B, Ng VG, Cutlip DE, Kapadia S, Krucoff MW, Linke A, Moy CS, Schofer J, van Es GA, Virmani R, Popma J, Parides MK, Kodali S, Bilello M, Zivadinov R, Akar J, Furie KL, Gress D, Voros S, Moses J, Greer D, Forrest JK, Holmes D, Kappetein AP, Mack M, Baumbach A. Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials An Academic Research Consortium Initiative. Journal Of The American College Of Cardiology 2017, 69: 679-691. PMID: 28183511, DOI: 10.1016/j.jacc.2016.11.045.Peer-Reviewed Original ResearchMeSH KeywordsCardiovascular DiseasesClinical Trials as TopicEndpoint DeterminationHumansNervous System DiseasesResearch DesignConceptsCardiovascular proceduresClinical trialsNeurological endpointsAcademic Research ConsortiumBenefit-risk assessmentAdjunctive pharmacologyNeurological complicationsNeurological outcomePreventive therapyClinical effectsNeurovascular injuryNeurological injuryNeurological riskEndpoint definitionsCardiovascular interventionsAscertainment methodsTherapyInjuryResearch ConsortiumRiskTrialsEndpointInherent risksSuch proceduresComplications
2011
Rationale and design of the INFUSE-AMI study: A 2 × 2 factorial, randomized, multicenter, single-blind evaluation of intracoronary abciximab infusion and aspiration thrombectomy in patients undergoing percutaneous coronary intervention for anterior ST-segment elevation myocardial infarction
Gibson CM, Maehara A, Lansky AJ, Wohrle J, Stuckey T, Dave R, Cox D, Grines C, Dudek D, Steg G, Parise H, Wolff SD, Cristea E, Stone GW. Rationale and design of the INFUSE-AMI study: A 2 × 2 factorial, randomized, multicenter, single-blind evaluation of intracoronary abciximab infusion and aspiration thrombectomy in patients undergoing percutaneous coronary intervention for anterior ST-segment elevation myocardial infarction. American Heart Journal 2011, 161: 478-486.e7. PMID: 21392601, DOI: 10.1016/j.ahj.2010.10.006.Peer-Reviewed Original ResearchMeSH KeywordsAbciximabAngioplasty, Balloon, CoronaryAntibodies, MonoclonalAntithrombinsCoronary OcclusionCoronary ThrombosisEndpoint DeterminationHirudinsHumansImmunoglobulin Fab FragmentsInfusions, Intra-ArterialMagnetic Resonance Imaging, CineMyocardial InfarctionPatient SelectionPeptide FragmentsPlatelet Aggregation InhibitorsRecombinant ProteinsResearch DesignThrombectomyConceptsPrimary percutaneous coronary interventionST-elevation myocardial infarctionPrimary PCIAnterior ST-elevation myocardial infarctionExport aspiration catheterPercutaneous coronary interventionLocal infusionThrombus aspirationInfarct sizeINFUSE-AMIEnd pointCoronary interventionAspiration catheterMyocardial infarctionInfusion catheterAnterior ST-segment elevation myocardial infarctionST-segment elevation myocardial infarctionSingle-blind randomized studyCardiac magnetic resonance imagingMyocardial infarction 0Mid-left anteriorPrimary end pointSafety end pointSecondary end pointsST-segment resolution
2003
Benefits and Risks of Abciximab Use in Primary Angioplasty for Acute Myocardial Infarction
Tcheng JE, Kandzari DE, Grines CL, Cox DA, Effron MB, Garcia E, Griffin JJ, Guagliumi G, Stuckey T, Turco M, Fahy M, Lansky AJ, Mehran R, Stone GW. Benefits and Risks of Abciximab Use in Primary Angioplasty for Acute Myocardial Infarction. Circulation 2003, 108: 1316-1323. PMID: 12939213, DOI: 10.1161/01.cir.0000087601.45803.86.Peer-Reviewed Original ResearchMeSH KeywordsAbciximabAdultAgedAngioplasty, Balloon, CoronaryAntibodies, MonoclonalCombined Modality TherapyCoronary AngiographyEndpoint DeterminationFemaleHumansImmunoglobulin Fab FragmentsMaleMiddle AgedMyocardial InfarctionPlatelet Aggregation InhibitorsPlatelet Glycoprotein GPIIb-IIIa ComplexStentsTreatment OutcomeConceptsComposite end pointTarget vessel revascularizationIschemia-driven target vessel revascularizationPrimary percutaneous coronary interventionAbciximab treatmentPercutaneous coronary interventionAcute myocardial infarctionMyocardial infarctionCoronary interventionEnd pointPlatelet glycoprotein IIb/IIIa inhibitorsGlycoprotein IIb/IIIa inhibitorsIIb/IIIa inhibitorsInfarct artery reocclusionPrespecified secondary analysisEvent-free survivalFactorial design trialLack of effectAbciximab useAngiographic substudyCADILLAC trialTVR ratesPrimary angioplastyPrimary stentingAngiographic outcomes
2002
Use of localised intracoronary β radiation in treatment of in-stent restenosis: the INHIBIT randomised controlled trial
Waksman R, Raizner AE, Yeung AC, Lansky AJ, Vandertie L, investigators I. Use of localised intracoronary β radiation in treatment of in-stent restenosis: the INHIBIT randomised controlled trial. The Lancet 2002, 359: 551-557. PMID: 11867107, DOI: 10.1016/s0140-6736(02)07741-3.Peer-Reviewed Original ResearchMeSH KeywordsBrachytherapyCoronary RestenosisElectrocardiographyEndpoint DeterminationFemaleHumansMaleMiddle AgedPhosphorus RadioisotopesStentsTreatment OutcomeConceptsBinary angiographic restenosis ratePrimary safety endpointAngiographic restenosis rateTarget lesion revascularisationStent restenosisPlacebo groupSafety endpointRestenosis rateRadiated groupMyocardial infarctionMajor adverse cardiac eventsIntracoronary beta radiationIntracoronary β-radiationSuccessful coronary interventionAdverse cardiac eventsPrimary efficacy endpointRecurrence of restenosisBeta-radiation treatmentEfficacy endpointAngiographic outcomesCardiac eventsCoronary interventionIntracoronary stentingProcedural successVascular brachytherapyQuantitative coronary angiography in regression trials: a review of methodologic considerations, endpoint selection, and limitations
Lansky AJ, Desai K, Leon MB. Quantitative coronary angiography in regression trials: a review of methodologic considerations, endpoint selection, and limitations. The American Journal Of Cardiology 2002, 89: 4-9. PMID: 11879660, DOI: 10.1016/s0002-9149(01)02326-8.Peer-Reviewed Original ResearchMeSH KeywordsCoronary AngiographyCoronary Artery DiseaseDisease ProgressionEndpoint DeterminationHumansRemission InductionResearchConceptsDisease progressionAngiographic methodsCoronary atherosclerosis regressionQuantitative coronary angiographyLesion-based analysisQuantitative angiographic methodsCoronary angiographyAtherosclerosis regressionClinical trialsRegression trialsMethodologic considerationsEndpoint selectionProgressionTrialsCategorical assessmentContinuous measureRegressionAngiography
2001
Acute and 6‐month clinical and angiographic outcome after implantation of the ACS Duet stent for single‐vessel coronary artery disease: Final results of the European and U.S. ACS Multi‐link Duet Registry
Foley D, Kererakes D, Riele J, Nishimura N, Veldhof S, Fink S, Yeung A, van Hoogenhuyze D, Lansky A, van Es G, Kutryk M, Serruys P. Acute and 6‐month clinical and angiographic outcome after implantation of the ACS Duet stent for single‐vessel coronary artery disease: Final results of the European and U.S. ACS Multi‐link Duet Registry. Catheterization And Cardiovascular Interventions 2001, 54: 25-33. PMID: 11553944, DOI: 10.1002/ccd.1233.Peer-Reviewed Original ResearchConceptsCoronary artery diseaseArtery diseaseSingle-vessel coronary artery diseaseMajor adverse cardiac eventsNative coronary artery lesionsObstructive coronary artery diseaseEffective percutaneous treatmentAdverse cardiac eventsCoronary artery lesionsProspective observational studyMinimum luminal diameterQuantitative coronary angiographyCoronary stent systemAdequate predilatationAngiographic outcomesArtery lesionsCardiac eventsCoronary angiographyPercutaneous treatmentRestenosis rateTarget lesionsLate outcomesLuminal diameterObservational studyStent systemStent Thrombosis in the Modern Era
Cutlip D, Baim D, Ho K, Popma J, Lansky A, Cohen D, Carrozza J, Chauhan M, Rodriguez O, Kuntz R. Stent Thrombosis in the Modern Era. Circulation 2001, 103: 1967-1971. PMID: 11306525, DOI: 10.1161/01.cir.103.15.1967.Peer-Reviewed Original ResearchMeSH KeywordsAspirinBlood Vessel Prosthesis ImplantationCausalityCoronary DiseaseCoronary ThrombosisEndpoint DeterminationFemaleGraft Occlusion, VascularHumansIncidenceLogistic ModelsMaleMiddle AgedMulticenter Studies as TopicMyocardial RevascularizationOdds RatioPlatelet Aggregation InhibitorsRandomized Controlled Trials as TopicSurvival RateTiclopidineTreatment OutcomeConceptsTotal stent lengthStent thrombosisAntiplatelet therapyStent lengthClinical consequencesFinal minimal lumen diameterLumen diameterNative coronary artery lesionsAngiographic stent thrombosisClinical stent thrombosisHigh-pressure deploymentRoutine antiplatelet therapyCoronary artery lesionsIncidence of deathMinimal lumen diameterProcedure-related variablesSecond-generation stentsCoronary stent trialsSerious clinical consequencesFinal lumen diameterNonrandomized registryAntithrombotic regimensArtery lesionsPersistent dissectionMyocardial infarction