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 ResearchMeSH KeywordsCardiovascular DiseasesClinical Trials as TopicCOVID-19Endpoint DeterminationHumansPandemicsSARS-CoV-2
2019
Sex Disparities in Cardiovascular Device Evaluations Strategies for Recruitment and Retention of Female Patients in Clinical Device Trials
Ghare MI, Chandrasekhar J, Mehran R, Ng V, Grines C, Lansky A. Sex Disparities in Cardiovascular Device Evaluations Strategies for Recruitment and Retention of Female Patients in Clinical Device Trials. JACC Cardiovascular Interventions 2019, 12: 301-308. PMID: 30732736, DOI: 10.1016/j.jcin.2018.10.048.Peer-Reviewed Original ResearchConceptsTrial participationClinical trialsClinical trial participationUnderrepresentation of womenMultistakeholder engagementGovernment agenciesFemale patientsFemale enrollmentCardiovascular trialsClinical research personnelNarrative reviewDevice trialsTrialsWomenParticipationPublic awarenessEducation campaigns
2018
Sex disparities in acute myocardial infarction care and outcomes
Gul B, Kozuma K, Haimi I, Zhao W, Simonton C, Ying S, Buda A, Mehta S, Baumbach A, Lansky A. Sex disparities in acute myocardial infarction care and outcomes. Catheterization And Cardiovascular Interventions 2018, 92: e341-e347. PMID: 29745453, DOI: 10.1002/ccd.27622.Peer-Reviewed Original ResearchMeSH KeywordsAgedChinaClinical Trials as TopicFemaleHealthcare DisparitiesHemorrhageHumansJapanMaleMiddle AgedNon-ST Elevated Myocardial InfarctionPercutaneous Coronary InterventionProduct Surveillance, PostmarketingRegistriesRetrospective StudiesRisk AssessmentRisk FactorsSex FactorsST Elevation Myocardial InfarctionStentsTime FactorsTreatment OutcomeUnited StatesConceptsMajor adverse cardiac eventsAcute myocardial infarctionPercutaneous coronary interventionTarget vessel failureCause mortalityXience V stentMajor bleedingUS patientsHigher major adverse cardiac eventsSetting of AMIContemporary percutaneous coronary interventionAcute myocardial infarction careDevice-specific outcomesAdverse cardiac eventsMyocardial infarction carePost-market registryCause deathCardiac eventsCoronary interventionMultivariable analysisFemale sexMyocardial infarctionPatient levelSex disparitiesPatients2017 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
2015
The TriGuard embolic deflection device for prevention of stroke and cerebral embolization during transcatheter aortic valve replacement
Baumbach A, Pietras C, Lansky A. The TriGuard embolic deflection device for prevention of stroke and cerebral embolization during transcatheter aortic valve replacement. Expert Review Of Medical Devices 2015, 12: 649-651. PMID: 26364995, DOI: 10.1586/17434440.2015.1086642.Peer-Reviewed Original ResearchMeSH KeywordsClinical Trials as TopicHeart Valve Prosthesis ImplantationHumansIntracranial EmbolismStrokeTranscatheter Aortic Valve ReplacementConceptsTranscatheter aortic valve implantationAortic valve implantationValve implantationTranscatheter aortic valve replacementIschemic cerebral eventsAortic valve replacementPrevention of strokeCerebral embolizationEmbolic strokeCerebral eventsEmbolic eventsValve replacementEmbolic lesionsClinical studiesNeurocognitive impairmentNeurocognitive functionMemory lossVessel ostiumStrokeBrain circulationImplantationEmbolizationOstiumLesionsIncidenceLocal delivery of paclitaxel in the treatment of peripheral arterial disease
Ng VG, Mena C, Pietras C, Lansky AJ. Local delivery of paclitaxel in the treatment of peripheral arterial disease. European Journal Of Clinical Investigation 2015, 45: 333-345. PMID: 25615282, DOI: 10.1111/eci.12407.Peer-Reviewed Original ResearchConceptsPeripheral artery diseaseEndovascular revascularizationArtery diseaseLocal deliveryClinical studiesLocal drug deliveryPeripheral arterial diseasePeripheral vascular diseasePrimary patency rateSystemic adverse effectsUse of paclitaxelLong-term efficacyDrug-Eluting BalloonDrug-eluting stentsTerms of efficacyBrief exposure periodArterial diseaseBalloon angioplastyPatency ratesVascular diseaseBalloon catheterCoated balloonMEDLINE searchStent failureActive drug
2011
Discrepancy in the assessment of jailed side branch lesions by visual estimation and quantitative coronary angiographic analysis
Shin D, Koo B, Waseda K, Park KW, Kim H, Corral M, Lansky A, Honda Y, Fearon WF, Fitzgerald PJ. Discrepancy in the assessment of jailed side branch lesions by visual estimation and quantitative coronary angiographic analysis. Catheterization And Cardiovascular Interventions 2011, 78: 720-726. PMID: 22025472, DOI: 10.1002/ccd.23049.Peer-Reviewed Original ResearchConceptsMean minimum lumen diameterQuantitative coronary angiographyFractional flow reserveSide branch lesionsDiameter stenosisSB lesionsIntraclass correlation coefficientBranch lesionsQuantitative coronary angiographic analysisCoronary angiographic analysisMinimum lumen diameterVisual estimationCoronary angiographyPressure trialAngiographic analysisAngiographic assessmentFlow reserveCore laboratoryStenosisReference diameterLesionsLumen diameterLesion lengthFunctional significance
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 ResearchMeSH KeywordsClinical Trials as TopicCoronary DiseaseCoronary RestenosisDrug Delivery SystemsHumansStentsThrombosisConceptsEnd 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
2001
Normal Flow (TIMI-3) Before Mechanical Reperfusion Therapy Is an Independent Determinant of Survival in Acute Myocardial Infarction
Stone G, Cox D, Garcia E, Brodie B, Morice M, Griffin J, Mattos L, Lansky A, O’Neill W, Grines C. Normal Flow (TIMI-3) Before Mechanical Reperfusion Therapy Is an Independent Determinant of Survival in Acute Myocardial Infarction. Circulation 2001, 104: 636-641. PMID: 11489767, DOI: 10.1161/hc3101.093701.Peer-Reviewed Original ResearchConceptsTIMI 3 flowAcute myocardial infarctionInitial TIMI 3 flowMyocardial infarctionPrimary PTCAEarly reperfusionHeart failureIndependent determinantsNew-onset heart failurePostprocedural TIMI 3 flowTIMI 3 flow ratesMechanical reperfusion therapyTIMI 0/1 flowTIMI 2 flowProspective randomized trialsShorter hospital stayVentricular ejection fractionInitial angiographyAngiographic evidenceHospital stayLytic therapyReperfusion therapyVentricular failureSpontaneous reperfusionEarly administration
2000
Usefulness of stent length in predicting in-stent restenosis (the MULTI-LINK stent trials)
Kereiakes D, Linnemeier T, Baim D, Kuntz R, O’Shaughnessy C, Hermiller J, Fink S, Lansky A, Nishimura N, Broderick T, Popma J. Usefulness of stent length in predicting in-stent restenosis (the MULTI-LINK stent trials). The American Journal Of Cardiology 2000, 86: 336-341. PMID: 10922447, DOI: 10.1016/s0002-9149(00)00928-0.Peer-Reviewed Original Research
1998
Lipid-Lowering Therapy After Coronary Revascularization: The Interventional Cardiologist’s Perspective 11This work was supported by the Cardiology Research Foundation, Washington, DC.
Lansky A, Popma J, Mintz G, Laird J, Saucedo J, Leon M. Lipid-Lowering Therapy After Coronary Revascularization: The Interventional Cardiologist’s Perspective 11This work was supported by the Cardiology Research Foundation, Washington, DC. The American Journal Of Cardiology 1998, 81: 55e-62e. PMID: 9551596, DOI: 10.1016/s0002-9149(98)00199-4.Peer-Reviewed Original ResearchConceptsCoronary eventsCoronary interventionCholesterol levelsAggressive lipid-lowering therapyCardiology Research FoundationLipid-lowering therapyTreatment of stenosisPatients' cholesterol levelsLipid-laden plaqueCoronary revascularizationCoronary atherosclerosisUnderlying diseaseRevascularization proceduresAtherosclerotic progressionCardiologist's practiceAdvanced lesionsCholesterol reductionPlaque accumulationIntravascular ultrasoundOwn carePatientsTherapyInterventionRevascularizationAtherectomy