2024
Pragmatic randomized controlled trials: strengthening the concept through a robust international collaborative network: PRIME-9—Pragmatic Research and Innovation through Multinational Experimentation
Omerovic E, Petrie M, Redfors B, Fremes S, Murphy G, Marquis-Gravel G, Lansky A, Velazquez E, Perera D, Reid C, Smith J, van der Meer P, Lipsic E, Juni P, McMurray J, Bauersachs J, Køber L, Rouleau J, Doenst T. Pragmatic randomized controlled trials: strengthening the concept through a robust international collaborative network: PRIME-9—Pragmatic Research and Innovation through Multinational Experimentation. Trials 2024, 25: 80. PMID: 38263138, PMCID: PMC10807265, DOI: 10.1186/s13063-024-07935-y.Peer-Reviewed Original ResearchMeSH KeywordsAdministrative PersonnelEvidence-Based MedicineHumansRandomized Controlled Trials as TopicResearch DesignSample SizeConceptsRandomized controlled trialsValue-based health careHealth policy decision-makingResearch priority settingQuality of healthcareHealthcare delivery systemValue-based healthcareDiverse practice settingsEffectiveness of interventionsPragmatic clinical trialsDiverse patient populationsPublic health impactEvidence-based medicineHealthcare qualityHealth outcomesHealth careHealthcare settingsDecision-making questionsPractice settingsPriority settingDecision-makingAlternative interventionsHealthcareStudy designPRCTs
2019
Validation of the all-comers design: Results of the TARGET-AC substudy
G Toth G, Lansky A, Baumbach A, Kelbæk H, van Royen N, Holmvang L, Janssens L, Brugaletta S, Barbato E, Maillard L, Kiemeneij F, Naber CK, Pucher F, Laursen PN, Ameloot K, Robles C, Milkas A, Sevilla J, Jensen C, Wijns W. Validation of the all-comers design: Results of the TARGET-AC substudy. American Heart Journal 2019, 221: 148-154. PMID: 31924299, DOI: 10.1016/j.ahj.2019.10.019.Peer-Reviewed Original ResearchConceptsComers designRisk factorsNon-ST elevation acute coronary syndromeElevation acute coronary syndromeNER groupReal-world clinical practiceGroup more patientsInternational multicentre registrySignificant valvular diseaseST-elevation infarctionAcute coronary syndromeChronic total occlusionWorld clinical practiceLow inclusion rateMulticentre registryThrombotic stenosisCoronary syndromePrimary PCIStable anginaAngiographic parametersComers populationPatient demographicsStable patientsStudy nursesMore patients
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
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
2008
The Harmonizing Outcomes with RevascularIZatiON and Stents in Acute Myocardial Infarction (HORIZONS-AMI) Trial: Study design and rationale
Mehran R, Brodie B, Cox DA, Grines CL, Rutherford B, Bhatt DL, Dangas G, Feit F, Ohman EM, Parise H, Fahy M, Lansky AJ, Stone GW. The Harmonizing Outcomes with RevascularIZatiON and Stents in Acute Myocardial Infarction (HORIZONS-AMI) Trial: Study design and rationale. American Heart Journal 2008, 156: 44-56. PMID: 18585496, DOI: 10.1016/j.ahj.2008.02.008.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAngioplasty, Balloon, CoronaryAnticoagulantsCombined Modality TherapyCoronary AngiographyDose-Response Relationship, DrugDrug Administration ScheduleDrug-Eluting StentsFollow-Up StudiesHeparin, Low-Molecular-WeightHirudinsHumansMaleMiddle AgedMyocardial InfarctionPeptide FragmentsPlatelet Glycoprotein GPIIb-IIIa ComplexProbabilityProspective StudiesRecombinant ProteinsReference ValuesResearch DesignRisk AssessmentStentsSurvival RateThrombosisTime FactorsConceptsPrimary PCIPrimary percutaneous coronary interventionIIb/IIIa inhibitorsAcute myocardial infarctionBare metal stentsGP IIb/IIIa inhibitorsHORIZONS-AMI trialUnfractionated heparinGlycoprotein IIb/IIIa inhibitorsIdentical bare-metal stentOverall event-free survivalAcute Myocardial Infarction trialEnd pointDirect thrombin inhibitor bivalirudinRoutine useEfficacy end pointMyocardial Infarction trialTarget lesion revascularizationEvent-free survivalClinical end pointsPercutaneous coronary interventionPaclitaxel-eluting stentsNew pharmacologic agentsThrombin inhibitor bivalirudinDrug-eluting stents
2007
Percutaneous Coronary Revascularization Using a Trilayer Metal Phosphorylcholine-Coated Zotarolimus-Eluting Stent
Abizaid A, Lansky AJ, Fitzgerald PJ, Tanajura LF, Feres F, Staico R, Mattos L, Abizaid A, Chaves A, Centemero M, Sousa AG, Sousa JE, Zaugg MJ, Schwartz LB. Percutaneous Coronary Revascularization Using a Trilayer Metal Phosphorylcholine-Coated Zotarolimus-Eluting Stent. The American Journal Of Cardiology 2007, 99: 1403-1408. PMID: 17493469, DOI: 10.1016/j.amjcard.2006.12.064.Peer-Reviewed Original ResearchMeSH KeywordsAgedAngioplasty, Balloon, CoronaryBlood Vessel Prosthesis ImplantationCardiovascular AgentsCoronary AngiographyCoronary CirculationCoronary RestenosisCoronary StenosisFemaleFollow-Up StudiesHumansMaleMiddle AgedPhosphorylcholineProspective StudiesProsthesis DesignResearch DesignSirolimusStentsTreatment OutcomeTunica IntimaUltrasonography, InterventionalConceptsCoronary artery stenosisQuantitative coronary angiographyZoMaxx stentCoronary angiographyArtery stenosisDe novo coronary artery stenosisSingle-arm prospective clinical trialDevice-deployment success ratesMajor adverse cardiac eventsSegment late lumen lossCoronary occlusive diseaseIntravascular ultrasound resultsNeointimal volume obstructionAdverse cardiac eventsIndependent core laboratoryLate lumen lossNative coronary arteriesPercutaneous coronary revascularizationProspective clinical trialsCoronary stent systemReduction of restenosisCoronary revascularizationVolume obstructionCardiac eventsObstructive lesions
2004
Acute Catheterization and Urgent Intervention Triage strategY (ACUITY) trial: Study design and rationale
Stone GW, Bertrand M, Colombo A, Dangas G, Farkouh ME, Feit F, Lansky AJ, Lincoff AM, Mehran R, Moses JW, Ohman M, White HD. Acute Catheterization and Urgent Intervention Triage strategY (ACUITY) trial: Study design and rationale. American Heart Journal 2004, 148: 764-775. PMID: 15523305, DOI: 10.1016/j.ahj.2004.04.036.Peer-Reviewed Original ResearchMeSH KeywordsAngina, UnstableAngioplasty, Balloon, CoronaryAnticoagulantsAntithrombinsCardiac CatheterizationCombined Modality TherapyCoronary Artery BypassEnoxaparinHeparinHirudinsHumansMulticenter Studies as TopicMyocardial InfarctionPeptide FragmentsPlatelet Glycoprotein GPIIb-IIIa ComplexProspective StudiesRandomized Controlled Trials as TopicRecombinant ProteinsResearch DesignConceptsIIb/IIIa inhibitionUrgent Intervention Triage Strategy (ACUITY) trialIIb/IIIa inhibitorsAcute CatheterizationInhibitor administrationStrategy trialMyocardial infarctionGlycoprotein IIb/IIIa inhibitorsPrimary study end pointAdverse ischemic eventsHigh-risk ACSComposite of deathStudy end pointAcute coronary syndromeHigh-risk patientsSurgical revascularization proceduresTreatment of choiceSecond random assignmentACUITY trialMajor bleedingSurgical revascularizationUnplanned revascularizationCoronary syndromeEarly angiographyIschemic eventsCoordinated series of studies to evaluate characteristics and mechanisms of acute coronary syndromes in high-risk patients randomly assigned to enoxaparin or unfractionated heparin: Design and rationale of the SYNERGY Library
Petersen JL, Mahaffey KW, Becker RC, Goodman SG, Kleiman NS, Marian AJ, Stone GW, Lansky AJ, Lincoff AM, Hazen SL, Nessel CC, Toro-Figueroa L, Tate L, Reist CJ, Cohen M, Califf RM, Ferguson JJ. Coordinated series of studies to evaluate characteristics and mechanisms of acute coronary syndromes in high-risk patients randomly assigned to enoxaparin or unfractionated heparin: Design and rationale of the SYNERGY Library. American Heart Journal 2004, 148: 269-276. PMID: 15308996, DOI: 10.1016/j.ahj.2004.03.022.Peer-Reviewed Original ResearchConceptsAcute coronary syndromeHigh-risk patientsCoronary syndromeClinical trialsGlycoprotein IIb/IIIa Inhibitors (SYNERGY) trialSegment elevation acute coronary syndromesElevation acute coronary syndromeCore laboratory facilityEffect of enoxaparinCardiovascular clinical trialsNovel pharmacologic targetsHigh-risk conditionsFurther drug developmentSYNERGY patientsInflammatory markersInhibitor trialsMulticenter trialCoronary arteriogramsUnfractionated heparinPatient populationMyocardial infarctionCoagulation studiesPharmacologic targetPatientsEnoxaparin