2022
Catheter-Directed Thrombolysis vs Anticoagulation in Patients With Acute Intermediate-High–risk Pulmonary Embolism
Sadeghipour P, Jenab Y, Moosavi J, Hosseini K, Mohebbi B, Hosseinsabet A, Chatterjee S, Pouraliakbar H, Shirani S, Shishehbor MH, Alizadehasl A, Farrashi M, Rezvani MA, Rafiee F, Jalali A, Rashedi S, Shafe O, Giri J, Monreal M, Jimenez D, Lang I, Maleki M, Goldhaber SZ, Krumholz HM, Piazza G, Bikdeli B. Catheter-Directed Thrombolysis vs Anticoagulation in Patients With Acute Intermediate-High–risk Pulmonary Embolism. JAMA Cardiology 2022, 7: 1189-1197. PMID: 36260302, PMCID: PMC9582964, DOI: 10.1001/jamacardio.2022.3591.Peer-Reviewed Original ResearchConceptsConventional catheter-directed thrombolysisRV/LV ratioRisk pulmonary embolismCatheter-directed thrombolysisProportion of patientsPulmonary embolismLV ratioMajor bleedingPrimary outcomeRight ventricleClinical trialsIntermediate-high risk pulmonary embolismDefinitive clinical outcome trialsMain safety outcomeMajor gastrointestinal bleedingRV/LVClinical events committeeClinical outcome trialsLarge cardiovascular centresCause mortalityEfficacy outcomesGastrointestinal bleedingMonotherapy groupOutcome trialsSecondary outcomes
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