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
2013
Response to Letters Regarding Article, “Comparison of Clinical Interpretation With Visual Assessment and Quantitative Coronary Angiography in Patients Undergoing Percutaneous Coronary Intervention in Contemporary Practice
Nallamothu BK, Spertus JA, Lansky AJ, Cohen DJ, Jones PG, Kureshi F, Dehmer GJ, Drozda JP, Walsh MN, Brush JE, Koenig GC, Waites TF, Gantt DS, Kichura G, Chazal RA, O’Brien P, Valentine CM, Rumsfeld JS, Reiber JH, Elmore JG, Krumholz RA, Weaver WD, Krumholz HM. Response to Letters Regarding Article, “Comparison of Clinical Interpretation With Visual Assessment and Quantitative Coronary Angiography in Patients Undergoing Percutaneous Coronary Intervention in Contemporary Practice. Circulation 2013, 128: e463-e464. PMID: 24344070, PMCID: PMC8698215, DOI: 10.1161/circulationaha.113.005507.Peer-Reviewed Original ResearchComparison of Clinical Interpretation With Visual Assessment and Quantitative Coronary Angiography in Patients Undergoing Percutaneous Coronary Intervention in Contemporary Practice
Nallamothu BK, Spertus JA, Lansky AJ, Cohen DJ, Jones PG, Kureshi F, Dehmer GJ, Drozda JP, Walsh MN, Brush JE, Koenig GC, Waites TF, Gantt DS, Kichura G, Chazal RA, O’Brien P, Valentine CM, Rumsfeld JS, Reiber JH, Elmore JG, Krumholz RA, Weaver WD, Krumholz HM. Comparison of Clinical Interpretation With Visual Assessment and Quantitative Coronary Angiography in Patients Undergoing Percutaneous Coronary Intervention in Contemporary Practice. Circulation 2013, 127: 1793-1800. PMID: 23470859, PMCID: PMC3908681, DOI: 10.1161/circulationaha.113.001952.Peer-Reviewed Original ResearchConceptsQuantitative coronary angiographyPercent diameter stenosisPercutaneous coronary interventionDiameter stenosisCoronary interventionCoronary angiographyCoronary lesionsClinical interpretationAngiographic interpretationStenosis severityHigher percent diameter stenosisMedian percent diameter stenosisElective percutaneous coronary interventionMean differenceCoronary stenosis severityIntermediate lesionsUS hospitalsStenosisLesionsAngiographyPatientsInterventionSeverityVisual assessmentSuch findings