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 ResearchConceptsCardiovascular proceduresClinical trialsNeurological endpointsAcademic Research ConsortiumBenefit-risk assessmentAdjunctive pharmacologyNeurological complicationsNeurological outcomePreventive therapyClinical effectsNeurovascular injuryNeurological injuryNeurological riskEndpoint definitionsCardiovascular interventionsAscertainment methodsTherapyInjuryResearch ConsortiumRiskTrialsEndpointInherent risksSuch proceduresComplications
2016
Clinical outcomes after PCI treatment of very long lesions with the XIENCE V everolimus eluting stent; Pooled analysis from the SPIRIT and XIENCE V USA prospective multicenter trials
Bouras G, Jhamnani S, Ng VG, Haimi I, Mao V, Deible R, Cao S, Sudhir K, Lansky AJ. Clinical outcomes after PCI treatment of very long lesions with the XIENCE V everolimus eluting stent; Pooled analysis from the SPIRIT and XIENCE V USA prospective multicenter trials. Catheterization And Cardiovascular Interventions 2016, 89: 984-991. PMID: 27545721, DOI: 10.1002/ccd.26711.Peer-Reviewed Original ResearchConceptsMajor adverse cardiac eventsLong coronary lesionsTarget lesion failurePercutaneous coronary interventionAcademic Research ConsortiumMean lesion lengthCoronary lesionsXIENCE VCoronary interventionStent thrombosisLesion lengthRate of TLFControl groupSecond generation drug eluting stentsLong lesion groupAdverse cardiac eventsProbable stent thrombosisPrimary outcome measureCoronary stent systemDrug eluting stentsLesion failureCardiac eventsPooled analysisWorse outcomesLesion group
2012
Clinical Outcomes Following Stent Thrombosis Occurring In-Hospital Versus Out-of-Hospital Results From the HORIZONS-AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) Trial
Dangas GD, Claessen BE, Mehran R, Brener S, Brodie BR, Dudek D, Witzenbichler B, Peruga JZ, Guagliumi G, Moses JW, Lansky AJ, Xu K, Stone GW. Clinical Outcomes Following Stent Thrombosis Occurring In-Hospital Versus Out-of-Hospital Results From the HORIZONS-AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) Trial. Journal Of The American College Of Cardiology 2012, 59: 1752-1759. PMID: 22575312, DOI: 10.1016/j.jacc.2011.12.042.Peer-Reviewed Original ResearchConceptsST-segment elevation myocardial infarctionHospital stent thrombosisPrimary percutaneous coronary interventionGlycoprotein IIb/IIIa inhibitorsHORIZONS-AMI trialStent thrombosisMajor bleedingClinical outcomesUnfractionated heparinMyocardial infarctionST eventsPrimary PCIIIb/IIIa inhibitorsProbable stent thrombosisAcademic Research ConsortiumElevation myocardial infarctionPercutaneous coronary interventionSTEMI patientsCoronary interventionHospital phaseBetter prognosisMultivariable analysisReperfusion resultsSubgroup analysisMost deaths
2011
Low Stent Thrombosis Risk with the XIENCE V® Everolimus‐Eluting Coronary Stent: Evidence from Randomized and Single‐Arm Clinical Trials
BEZENEK S, HERMILLER J, LANSKY A, YAQUB M, HATTORI K, CAO S, SOOD P, SUDHIR K. Low Stent Thrombosis Risk with the XIENCE V® Everolimus‐Eluting Coronary Stent: Evidence from Randomized and Single‐Arm Clinical Trials. Journal Of Interventional Cardiology 2011, 24: 326-341. PMID: 21443551, DOI: 10.1111/j.1540-8183.2011.00628.x.Peer-Reviewed Original ResearchConceptsEverolimus-Eluting Coronary Stent SystemDual antiplatelet therapyXIENCE VST ratesRisk factorsLow stent thrombosis ratesSingle-arm clinical trialOccurrence of STStent thrombosis riskAcademic Research ConsortiumStent thrombosis ratesPotential risk factorsCoronary stent systemLow ST ratesHigh compliance rateSPIRIT FIRSTAntiplatelet therapyThrombosis rateSPIRIT trialComplex patientsThrombosis riskClinical trialsStent systemThin strut designDrug usage
2010
Clinical Follow-Up 3 Years After Everolimus- and Paclitaxel-Eluting Stents A Pooled Analysis From the SPIRIT II (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) and SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) Randomized Trials
Caixeta A, Lansky AJ, Serruys PW, Hermiller JB, Ruygrok P, Onuma Y, Gordon P, Yaqub M, Miquel-Hebert K, Veldhof S, Sood P, Su X, Jonnavithula L, Sudhir K, Stone GW, Investigators S. Clinical Follow-Up 3 Years After Everolimus- and Paclitaxel-Eluting Stents A Pooled Analysis From the SPIRIT II (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) and SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) Randomized Trials. JACC Cardiovascular Interventions 2010, 3: 1220-1228. PMID: 21232715, DOI: 10.1016/j.jcin.2010.07.017.Peer-Reviewed Original ResearchMeSH KeywordsAngioplasty, Balloon, CoronaryAntineoplastic Agents, PhytogenicAspirinClopidogrelConfidence IntervalsCoronary Artery DiseaseDrug-Eluting StentsEverolimusFemaleFollow-Up StudiesHumansImmunosuppressive AgentsKaplan-Meier EstimateLogistic ModelsMaleMiddle AgedPaclitaxelPlatelet Aggregation InhibitorsProportional Hazards ModelsRandomized Controlled Trials as TopicRiskRisk Reduction BehaviorSirolimusTiclopidineTime FactorsConceptsMajor adverse cardiac eventsPaclitaxel-eluting stentsAdverse cardiac eventsTarget vessel failureCardiac eventsMyocardial infarctionSPIRIT IIProbable stent thrombosisAcademic Research ConsortiumEverolimus-eluting stentsVessel failureSignificant reductionLesion revascularizationPES patientsRevascularization eventsIII trialsClinical outcomesEE patientsStent thrombosisPooled analysisCumulative ratePersistent reductionSPIRIT IIIPatientsStents
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