2022
Patient-Level Analysis of Watchman Left Atrial Appendage Occlusion in Practice Versus Clinical Trials
Friedman DJ, Du C, Wang Y, Agarwal V, Varosy PD, Masoudi FA, Holmes DR, Reddy VY, Price MJ, Curtis JP, Freeman JV. Patient-Level Analysis of Watchman Left Atrial Appendage Occlusion in Practice Versus Clinical Trials. JACC Cardiovascular Interventions 2022, 15: 950-961. PMID: 35512918, PMCID: PMC9370831, DOI: 10.1016/j.jcin.2022.02.029.Peer-Reviewed Original ResearchConceptsRegistry patientsHemorrhagic stroke riskIschemic strokeWarfarin patientsTrial patientsStroke riskLAAO patientsClinical practiceMore pericardial effusionsPeriprocedural ischemic strokePropensity-matched analysisAtrial appendage occlusionCox proportional hazardsPatient-level dataFine-Gray modelMore comorbiditiesPROTECT AFNoncardiovascular deathPericardial effusionHemorrhagic strokeAppendage occlusionDevice implantationTrial criteriaClinical trialsSimilar risk
2019
Validating the use of registries and claims data to support randomized trials: Rationale and design of the Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study
Strom JB, Tamez H, Zhao Y, Valsdottir LR, Curtis J, Brennan JM, Shen C, Popma JJ, Mauri L, Yeh RW. Validating the use of registries and claims data to support randomized trials: Rationale and design of the Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study. American Heart Journal 2019, 212: 64-71. PMID: 30953936, PMCID: PMC6535119, DOI: 10.1016/j.ahj.2019.02.007.Peer-Reviewed Original ResearchConceptsMedical therapyDual Antiplatelet Therapy StudyEnd pointEnd-point eventsClinical trial programEfficacy of therapyPatient-level dataClinical trial dataHealth system dataUse of registriesNew medical treatmentsProcedural registryRandomized trialsClaims databasePatient populationNational registryAdministrative claimsOutcome dataMedical treatmentTrial programTrial dataRegistryTrial informationTherapy studiesTrial results