2021
Randomized Evaluation of TriGuard 3 Cerebral Embolic Protection After Transcatheter Aortic Valve Replacement REFLECT II
Nazif TM, Moses J, Sharma R, Dhoble A, Rovin J, Brown D, Horwitz P, Makkar R, Stoler R, Forrest J, Messé S, Dickerman S, Brennan J, Zivadinov R, Dwyer MG, Lansky AJ, Investigators R. Randomized Evaluation of TriGuard 3 Cerebral Embolic Protection After Transcatheter Aortic Valve Replacement REFLECT II. JACC Cardiovascular Interventions 2021, 14: 515-527. PMID: 33663779, DOI: 10.1016/j.jcin.2020.11.011.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve replacementAortic valve replacementSafety endpointValve replacementProcedure-related ischemic strokeCerebral embolic protectionComposite efficacy endpointPrimary safety endpointCerebral embolizationCerebral protectionEfficacy endpointII trialCerebral injuryIschemic strokeEmbolic protectionPatientsDrug AdministrationUS sitesU.S. FoodEndpointData reviewTrialsMulticenterEmbolizationInjury
2020
Defining device success for percutaneous coronary intervention trials: a position statement from the European Association of Percutaneous Cardiovascular Interventions of the European Society of Cardiology.
Chang CC, Kogame N, Onuma Y, Byrne RA, Capodanno D, Windecker S, Morel MA, Cutlip DE, Krucoff MW, Stone GW, Lansky AJ, Mehran R, Spitzer E, Fraser AG, Baumbach A, Serruys PW. Defining device success for percutaneous coronary intervention trials: a position statement from the European Association of Percutaneous Cardiovascular Interventions of the European Society of Cardiology. EuroIntervention 2020, 15: 1190-1198. PMID: 31475907, DOI: 10.4244/eij-d-19-00552.Peer-Reviewed Original ResearchConceptsDevice success rateDrug-eluting stentsPercutaneous coronary intervention trialsCoronary intervention trialsDevice successIntervention trialsClinical trialsSuccess rateSymptomatic coronary artery diseasePercutaneous coronary interventionAdverse clinical eventsCoronary artery diseasePercutaneous Cardiovascular InterventionsDifferent trialsRevascularisation proceduresCoronary interventionAngiographic outcomesArtery diseaseClinical eventsComparative trialsEndpoint definitionsDrug AdministrationCardiovascular interventionsPerformance endpointEuropean Association
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 ResearchConceptsClinical trialsStandardized data collectionTrials InitiativeProspective data collectionEffectiveness of drugsClinical care processesCardiovascular safetyStroke outcomeEndpoint definitionsWriting committeeUS FoodDrug AdministrationCare processesTrialsFurther studiesUniform definitionMedical product development programsMultiple trialsFDAData collectionCardiovascularAdministration
2009
Gastrointestinal Bleeding in Patients With Acute Coronary Syndromes: Incidence, Predictors, and Clinical Implications Analysis From the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) Trial
Nikolsky E, Stone GW, Kirtane AJ, Dangas GD, Lansky AJ, McLaurin B, Lincoff AM, Feit F, Moses JW, Fahy M, Manoukian SV, White HD, Ohman EM, Bertrand ME, Cox DA, Mehran R. Gastrointestinal Bleeding in Patients With Acute Coronary Syndromes: Incidence, Predictors, and Clinical Implications Analysis From the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) Trial. Journal Of The American College Of Cardiology 2009, 54: 1293-1302. PMID: 19778672, DOI: 10.1016/j.jacc.2009.07.019.Peer-Reviewed Original ResearchMeSH KeywordsAcute Coronary SyndromeAge FactorsAgedAngioplasty, Balloon, CoronaryAnticoagulantsClopidogrelCoronary Artery BypassFemaleGastrointestinal HemorrhageHeparinHirudinsHumansIncidenceIschemiaLength of StayMaleMiddle AgedMultivariate AnalysisMyocardial InfarctionPeptide FragmentsPlatelet Aggregation InhibitorsPlatelet Glycoprotein GPIIb-IIIa ComplexRecombinant ProteinsRisk AssessmentSex FactorsStentsThrombosisTiclopidineConceptsAcute coronary syndromeGastrointestinal bleedingACUITY trialComposite ischemiaCardiac mortalityCause mortalityCoronary syndromeHigh-risk acute coronary syndromesStudy drug administrationOpen-label usePotential hemorrhagic complicationsST-segment deviationAntiplatelet medicationsBaseline anemiaHemorrhagic complicationsIschemic complicationsIndependent predictorsClinical outcomesMultivariable analysisStent thrombosisMyocardial infarctionSerious conditionPatientsDrug AdministrationOlder ageSafety and Efficacy of Drug-Eluting and Bare Metal Stents
Kirtane AJ, Gupta A, Iyengar S, Moses JW, Leon MB, Applegate R, Brodie B, Hannan E, Harjai K, Jensen LO, Park SJ, Perry R, Racz M, Saia F, Tu JV, Waksman R, Lansky AJ, Mehran R, Stone GW. Safety and Efficacy of Drug-Eluting and Bare Metal Stents. Circulation 2009, 119: 3198-3206. PMID: 19528338, DOI: 10.1161/circulationaha.108.826479.Peer-Reviewed Original ResearchConceptsBare metal stentsDrug-eluting stentsTarget vessel revascularizationMyocardial infarctionVessel revascularizationObservational studyMetal stentsEfficacy end pointTotal patientsOverall mortalityDrug-ElutingDES useLabel indicationsLabel useResidual confoundingBMS useRCTsPatientsDrug AdministrationInfarctionRevascularizationEnd pointMortality dataComparable reductionStents
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
2005
Stent underexpansion and residual reference segment stenosis are related to stent thrombosis after sirolimus-eluting stent implantation An intravascular ultrasound study
Fujii K, Carlier SG, Mintz GS, Yang YM, Moussa I, Weisz G, Dangas G, Mehran R, Lansky AJ, Kreps EM, Collins M, Stone GW, Moses JW, Leon MB. Stent underexpansion and residual reference segment stenosis are related to stent thrombosis after sirolimus-eluting stent implantation An intravascular ultrasound study. Journal Of The American College Of Cardiology 2005, 45: 995-998. PMID: 15808753, DOI: 10.1016/j.jacc.2004.12.066.Peer-Reviewed Original ResearchConceptsSirolimus-eluting stent implantationMinimum stent cross-sectional areaSuccessful SES implantationStent thrombosisSegment stenosisStent thrombosis groupStent underexpansionSES implantationThrombosis groupControl patientsStent implantationStent cross-sectional areaIntravascular ultrasound studyIndependent predictorsUltrasound studyThrombosisDrug AdministrationControl groupNumber of casesStenosisStent expansionPatientsU.S. FoodUnderexpansionCross-sectional area