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
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 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
2013
Pre-hypertension: another 'pseudodisease’?
Meier P, Messerli FH, Baumbach A, Lansky AJ. Pre-hypertension: another 'pseudodisease’? BMC Medicine 2013, 11: 211. PMID: 24229371, PMCID: PMC3848832, DOI: 10.1186/1741-7015-11-211.Peer-Reviewed Original ResearchConceptsBlood pressureCardiovascular riskRisk factorsCommon cardiovascular risk factorsCardiovascular risk factorsEnd-organ damageIndependent risk factorRisk markersHealthy peopleHypertensionBMC MedicineMmHgPseudodiseaseExpert CommitteeSignificant proportionSignificant markersRiskMarkersSystolicPatientsDisease
2012
Strategies for Multivessel Revascularization in Patients with Diabetes
Farkouh ME, Domanski M, Sleeper LA, Siami FS, Dangas G, Mack M, Yang M, Cohen DJ, Rosenberg Y, Solomon SD, Desai AS, Gersh BJ, Magnuson EA, Lansky A, Boineau R, Weinberger J, Ramanathan K, Sousa JE, Rankin J, Bhargava B, Buse J, Hueb W, Smith CR, Muratov V, Bansilal S, King S, Bertrand M, Fuster V. Strategies for Multivessel Revascularization in Patients with Diabetes. New England Journal Of Medicine 2012, 367: 2375-2384. PMID: 23121323, DOI: 10.1056/nejmoa1211585.Peer-Reviewed Original ResearchConceptsPercutaneous coronary interventionCoronary artery diseaseMultivessel coronary artery diseaseDrug-eluting stentsCABG groupPCI groupArtery diseaseMyocardial infarctionMedical therapyMean ageAdvanced coronary artery diseaseLow-density lipoprotein cholesterolAggressive medical therapyBenefit of CABGComposite of deathCoronary artery bypassNonfatal myocardial infarctionPatients' mean ageThree-vessel diseaseSystolic blood pressurePrimary outcome measureRate of deathMultivessel revascularizationNonfatal strokeCoronary intervention
2009
Gender‐based evaluation of the XIENCE V™ everolimus‐eluting coronary stent system:
Lansky AJ, Ng VG, Mutlu H, Cristea E, Guiran JB, Midei M, Newman W, Sanz M, Sood P, Doostzadeh J, Su X, White R, Cao S, Sudhir K, Stone GW. Gender‐based evaluation of the XIENCE V™ everolimus‐eluting coronary stent system:. Catheterization And Cardiovascular Interventions 2009, 74: 719-727. PMID: 19530147, DOI: 10.1002/ccd.22067.Peer-Reviewed Original ResearchMeSH KeywordsAgedAngioplasty, Balloon, CoronaryCardiovascular AgentsCardiovascular DiseasesCoronary AngiographyCoronary Artery DiseaseCoronary RestenosisDrug-Eluting StentsEverolimusFemaleHumansKaplan-Meier EstimateLinear ModelsLogistic ModelsMaleMiddle AgedMyocardial InfarctionPaclitaxelProspective StudiesProsthesis DesignRisk AssessmentRisk FactorsSex FactorsSingle-Blind MethodSirolimusThrombosisTime FactorsTreatment OutcomeWomen's HealthConceptsSPIRIT III trialIII trialsXIENCE VTaxus stentXience V stentTVF rateTAXUS paclitaxel-eluting stentRate of MACECoronary artery lesionsStent thrombosis ratesPercutaneous coronary interventionStent late lossPaclitaxel-eluting stentsCoronary stent systemHigher MACEMore hypertensionAngiographic characteristicsArtery lesionsCoronary interventionThrombosis rateAngiographic resultsClinical outcomesClinical benefitStent placementSubset analysis
2006
Serial Angiographic Follow-Up of Sirolimus-Eluting Stents for Unprotected Left Main Coronary Artery Revascularization
Price MJ, Cristea E, Sawhney N, Kao JA, Moses JW, Leon MB, Costa RA, Lansky AJ, Teirstein PS. Serial Angiographic Follow-Up of Sirolimus-Eluting Stents for Unprotected Left Main Coronary Artery Revascularization. Journal Of The American College Of Cardiology 2006, 47: 871-877. PMID: 16487858, DOI: 10.1016/j.jacc.2005.12.015.Peer-Reviewed Original ResearchMeSH KeywordsAgedAngioplasty, Balloon, CoronaryCardiovascular DiseasesCoronary AngiographyCoronary RestenosisCoronary StenosisFemaleHumansMaleSirolimusStentsConceptsLate lossParent vesselUnprotected left main coronary artery stenosisLeft main coronary artery stenosisFinal minimal luminal diameterMain coronary artery revascularizationMain coronary artery stenosisSirolimus-eluting stent implantationEfficacy of SESCoronary artery revascularizationAngiographic Follow-upSirolimus-Eluting StentsCoronary artery stenosisMinimal luminal diameterArtery revascularizationCircumflex ostiumLesion restenosisLesion revascularizationLMCA diseaseLMCA interventionLMCA lesionsSES implantationAngiographic outcomesIndependent predictorsArtery stenosis