2020
Non-inferiority trials using a surrogate marker as the primary endpoint: An increasing phenotype in cardiovascular trials
Bikdeli B, Caraballo C, Welsh J, Ross JS, Kaul S, Stone GW, Krumholz HM. Non-inferiority trials using a surrogate marker as the primary endpoint: An increasing phenotype in cardiovascular trials. Clinical Trials 2020, 17: 723-728. PMID: 32838556, PMCID: PMC8088773, DOI: 10.1177/1740774520949157.Peer-Reviewed Original ResearchConceptsNon-inferiority trialPrimary endpointClinical outcome trialsNon-inferiority marginSurrogate markerNon-inferiority designCardiovascular trialsOutcome trialsClinical outcomesDefinitive clinical outcome trialsNon-inferiority criteriaStudy protocolSurrogate outcomesBACKGROUND/Median numberSurrogate endpointsPrimary analysisCardiovascular interventionsCardiovascular medicineTrialsEndpointClinical interpretationOutcomesMarkersIntervention
2017
Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review
Pease AM, Krumholz HM, Downing NS, Aminawung JA, Shah ND, Ross JS. Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review. The BMJ 2017, 357: j1680. PMID: 28468750, PMCID: PMC5421452, DOI: 10.1136/bmj.j1680.Peer-Reviewed Original ResearchConceptsSingle pivotal trialPivotal trialsPostapproval studiesSurrogate markerPrimary endpointNovel drugsClinical outcomesClinical studiesLimited evidenceSystematic reviewDouble-blind studyMedian total numberClinical evidenceSuperior efficacyBlind studyDrug AdministrationOriginal FDATrial approvalDiseaseTrialsDrugsFDAEndpointEfficacyMarkers
2005
Prior Aspirin Use and Outcomes in Elderly Patients Hospitalized With Acute Myocardial Infarction
Portnay EL, Foody JM, Rathore SS, Wang Y, Masoudi FA, Curtis JP, Krumholz HM. Prior Aspirin Use and Outcomes in Elderly Patients Hospitalized With Acute Myocardial Infarction. Journal Of The American College Of Cardiology 2005, 46: 967-974. PMID: 16168277, PMCID: PMC2790536, DOI: 10.1016/j.jacc.2005.06.049.Peer-Reviewed Original ResearchConceptsPrior aspirin useCondition-specific readmissionAspirin useMyocardial infarctionCause readmissionMedicare beneficiariesSix-month mortalityAcute myocardial infarctionElderly patientsMultivariable adjustmentPrognostic significanceHigh riskReadmissionLower riskLower mortalityPatientsOne monthMortalityMonthsInfarctionOne-thirdNational sampleRiskMarkersAssociation
1991
Reperfusion arrhythmias after thrombolysis. Electrophysiologic tempest, or much ado about nothing.
Krumholz HM, Goldberger AL. Reperfusion arrhythmias after thrombolysis. Electrophysiologic tempest, or much ado about nothing. CHEST Journal 1991, 99: 135s-140s. PMID: 2009810, DOI: 10.1378/chest.99.4.135s.Peer-Reviewed Original ResearchConceptsThrombolytic therapyMyocardial infarctionAcute myocardial infarctionSignificant clinical interestReperfusion arrhythmiasSuccessful reperfusionMyocardial reperfusionIdioventricular rhythmClinical eventsVentricular tachyarrhythmiasNoninvasive markerAnimal studiesArrhythmiasConsistent markerReperfusionClinical interestInfarctionTherapyCurrent dataMarkersThrombolysisTachyarrhythmias