2024
Sex differences in treatment strategies for pulmonary embolism in older adults: The SERIOUS-PE study of RIETE participants and US Medicare beneficiaries.
Bikdeli B, Leyva H, Muriel A, Lin Z, Piazza G, Khairani C, Rosovsky R, Mehdipour G, O'Donoghue M, Madridano O, Lopez-Saez J, Mellado M, Diaz Brasero A, Grandone E, Spagnolo P, Lu Y, Bertoletti L, López-Jiménez L, Jesús Núñez M, Blanco-Molina Á, Gerhard-Herman M, Goldhaber S, Bates S, Jimenez D, Krumholz H, Monreal M. Sex differences in treatment strategies for pulmonary embolism in older adults: The SERIOUS-PE study of RIETE participants and US Medicare beneficiaries. Vascular Medicine 2024, 1358863x241292023. PMID: 39588564, DOI: 10.1177/1358863x241292023.Peer-Reviewed Original ResearchRegistro Informatizado Enfermedad TromboEmbolicaIntermediate-risk PEInferior vena cavaPulmonary embolismFibrinolytic therapyAdvanced therapiesInferior vena cava filter placementUS Medicare beneficiariesSex differencesOlder adultsMedicare beneficiariesAnticoagulation patternsFilter placementVena cavaMale patientsClinical outcomesTreatment strategiesAssess sex differencesPE therapyTherapyRisk factorsStandardized differenceAnticoagulationTherapy utilizationSex disparities
2023
Association of Neighborhood-Level Marginalization With Health Care Use and Clinical Outcomes Following Hospital Discharge in Patients Who Underwent Coronary Catheterization for Acute Myocardial Infarction in a Single-Payer Health Care System
Akioyamen L, Abdel-Qadir H, Han L, Sud M, Mistry N, Alter D, Atzema C, Austin P, Bhatia R, Booth G, Dhalla I, Ha A, Jackevicius C, Kapral M, Krumholz H, Lee D, McNaughton C, Roifman I, Schull M, Sivaswamy A, Tu K, Udell J, Wijeysundera H, Ko D. Association of Neighborhood-Level Marginalization With Health Care Use and Clinical Outcomes Following Hospital Discharge in Patients Who Underwent Coronary Catheterization for Acute Myocardial Infarction in a Single-Payer Health Care System. Circulation Cardiovascular Quality And Outcomes 2023, 16: e010063. PMID: 38050754, DOI: 10.1161/circoutcomes.123.010063.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionMyocardial infarctionHealth care systemHospital dischargeClinical outcomesSocioeconomic statusFirst acute myocardial infarctionProportional hazards regression modelsCare systemSecondary prevention medicationsWorse clinical outcomesHealth service usePopulation-based studyPrimary care physiciansHealth care useHazards regression modelsGreater long-term riskPrescription medication useSingle-payer health care systemUniversal health care systemLong-term riskLow socioeconomic statusCause mortalityDays postdischargePrevention medicationsImpact of Sex‐ and Gender‐Related Factors on Length of Stay Following Non–ST‐Segment–Elevation Myocardial Infarction: A Multicountry Analysis
Bender U, Norris C, Dreyer R, Krumholz H, Raparelli V, Pilote L. Impact of Sex‐ and Gender‐Related Factors on Length of Stay Following Non–ST‐Segment–Elevation Myocardial Infarction: A Multicountry Analysis. Journal Of The American Heart Association 2023, 12: e028553. PMID: 37489737, PMCID: PMC10492965, DOI: 10.1161/jaha.122.028553.Peer-Reviewed Original ResearchConceptsSegment elevation myocardial infarctionMyocardial infarctionGender-related factorsLonger LOSSegment elevation myocardial infarction diagnosisConclusions Older ageObservational cohort studyAdverse clinical outcomesAdjusted multivariable modelAcute myocardial infarctionLength of stayImpact of sexHealth care expendituresGENESIS-PRAXYHospital lengthNon–STCause mortalityCohort studyIndependent predictorsMyocardial infarction diagnosisClinical outcomesShorter LOSMedical historyMultivariable modelUnivariate associations
2022
Clinical decision support in cardiovascular medicine
Lu Y, Melnick ER, Krumholz HM. Clinical decision support in cardiovascular medicine. The BMJ 2022, 377: e059818. PMID: 35613721, DOI: 10.1136/bmj-2020-059818.Peer-Reviewed Original ResearchConceptsCardiovascular diseaseCardiovascular careEffectiveness of CDSRisk factor modificationClinical decision support toolQuality of careClinical decision supportClinical outcomesFactor modificationHealth information technologyClinical practicePatient careDiseaseCardiovascular medicineCDS effectivenessCareEffectiveness of deliveryMissed opportunityTreatmentFailureProper evidenceHealthcare processesMedicineEvidencePreventionStudy protocol for the Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): A longitudinal study of the medium and long-term sequelae of SARS-CoV-2 infection
O’Laughlin K, Thompson M, Hota B, Gottlieb M, Plumb ID, Chang AM, Wisk LE, Hall AJ, Wang RC, Spatz ES, Stephens KA, Huebinger RM, McDonald SA, Venkatesh A, Gentile N, Slovis BH, Hill M, Saydah S, Idris AH, Rodriguez R, Krumholz HM, Elmore JG, Weinstein RA, Nichol G, . Study protocol for the Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): A longitudinal study of the medium and long-term sequelae of SARS-CoV-2 infection. PLOS ONE 2022, 17: e0264260. PMID: 35239680, PMCID: PMC8893622, DOI: 10.1371/journal.pone.0264260.Peer-Reviewed Original ResearchConceptsSARS-CoV-2 infectionLong-term sequelaePatient-reported outcomesRelative riskAcute SARS-CoV-2 infectionSARS-CoV-2 negative participantsHealth system encountersPredictors of sequelaeHealth recordsInstitutional review board approvalLongitudinal studyDigital health recordsReview board approvalSARS-CoV-2Secure online platformClinical outcomesStudy protocolNegative participantsViral testsSimilar symptomatologyNew diagnosisBoard approvalSequelaeSelf-administered surveyInfection
2021
Prior Authorization, Copayments, and Utilization of Sacubitril/Valsartan in Medicare and Commercial Plans in Patients With Heart Failure With Reduced Ejection Fraction
Ozaki AF, Krumholz HM, Mody FV, Tran TT, Le QT, Yokota M, Jackevicius CA. Prior Authorization, Copayments, and Utilization of Sacubitril/Valsartan in Medicare and Commercial Plans in Patients With Heart Failure With Reduced Ejection Fraction. Circulation Cardiovascular Quality And Outcomes 2021, 14: e007665. PMID: 34465124, DOI: 10.1161/circoutcomes.120.007665.Peer-Reviewed Original ResearchConceptsSacubitril/valsartanSacubitril/valsartan useInsurance plan typeReduced ejection fractionHeart failureEjection fractionValsartan useCommercial plansNew York Heart Association classPA criteriaReduced ejection fraction patientsReduced ejection fraction populationPlan typeEjection fraction patientsMedicare plansEjection fraction populationCross-sectional studyProportion of plansPrescription copaymentsAssociation classCopayment amountPrimary outcomeClinical outcomesPlan populationMore prescriptions
2020
Newly diagnosed diabetes and outcomes after acute myocardial infarction in young adults
Ding Q, Spatz ES, Lipska KJ, Lin H, Spertus JA, Dreyer RP, Whittemore R, Funk M, Bueno H, Krumholz HM. Newly diagnosed diabetes and outcomes after acute myocardial infarction in young adults. Heart 2020, 107: 657-666. PMID: 33082173, PMCID: PMC8005796, DOI: 10.1136/heartjnl-2020-317101.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionHealth statusDischarge diagnosisPharmacological treatmentMyocardial infarctionShort-term health statusYoung AMI Patients (VIRGO) studyDisease-specific health statusYoung adultsQuality of lifeHospital complicationsHospital mortalityMedication initiationBaseline characteristicsClinical outcomesDiabetesPatientsDiagnosisPatient studiesMonthsComplicationsInfarctionSignificant differencesOutcomesMortalityNon-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 interpretationOutcomesMarkersInterventionClinical Outcomes With Beta-Blocker Use in Patients With Recent History of Myocardial Infarction
Jackevicius CA, Krumholz HM, Ross JS, Koh M, Chong A, Austin PC, Stukel TA, Azizi P, Ko DT. Clinical Outcomes With Beta-Blocker Use in Patients With Recent History of Myocardial Infarction. Canadian Journal Of Cardiology 2020, 36: 1633-1640. PMID: 32416066, DOI: 10.1016/j.cjca.2020.01.024.Peer-Reviewed Original ResearchConceptsPrior myocardial infarctionMyocardial infarctionStable patientsPopulation-based observational studyAngina 1 yearDeath/hospitalizationHistory of revascularisationBeta-blocker useMajor cardiovascular eventsHospital discharge diagnosisUse of BBsIndividual end pointsContemporary clinical trialsYears of ageCardiovascular eventsIndex dateCohort studyComposite outcomeBB useHeart failureMedian agePrimary outcomeClinical outcomesAtrial fibrillationDischarge diagnosis
2019
Population Impact of Generic Valsartan Recall
Jackevicius CA, Krumholz HM, Chong A, Koh M, Ozaki AF, Austin PC, Udell JA, Ko DT. Population Impact of Generic Valsartan Recall. Circulation 2019, 141: 411-413. PMID: 31707798, DOI: 10.1161/circulationaha.119.044494.Peer-Reviewed Original ResearchConceptsNational Ambulatory Care Reporting System databaseEmergency department visitsRegistered Persons DatabaseOntario Registered Persons DatabaseReporting System databaseHealth care systemDrug recallsSegmented regression analysisBaseline comorbiditiesOral medicationsDepartment visitsHospital admissionMedication useClinical outcomesDischarge diagnosisVital statusChronic conditionsHealthcare databasesHealth CanadaCare systemCanadian InstituteHealth informationPopulation impactPatientsRegression analysisPatient-Reported Quality of Hospital Discharge Transitions: Results from the SILVER-AMI Study
Richards BG, Hajduk AM, Perry J, Krumholz HM, Khan AM, Chaudhry SI. Patient-Reported Quality of Hospital Discharge Transitions: Results from the SILVER-AMI Study. Journal Of General Internal Medicine 2019, 35: 808-814. PMID: 31654359, PMCID: PMC7080904, DOI: 10.1007/s11606-019-05414-8.Peer-Reviewed Original ResearchConceptsDays of dischargeEmergency department utilizationAcute myocardial infarctionPatient-reported qualityHospital discharge processOlder patientsAcute Myocardial Infarction StudyMyocardial Infarction StudyProspective cohort studyMedical record reviewEmergency room utilizationAdults age 75Key ResultsA totalHospital Consumer AssessmentSILVER-AMI StudyHospital discharge transitionsHigh-risk periodDesignMulti-centerCohort studyHospital dischargeMedian ageClinical outcomesRecord reviewAdverse outcomesResultsA totalDisparities in Socioeconomic Context and Association With Blood Pressure Control and Cardiovascular Outcomes in ALLHAT
Shahu A, Herrin J, Dhruva SS, Desai NR, Davis BR, Krumholz HM, Spatz ES. Disparities in Socioeconomic Context and Association With Blood Pressure Control and Cardiovascular Outcomes in ALLHAT. Journal Of The American Heart Association 2019, 8: e012277. PMID: 31362591, PMCID: PMC6761647, DOI: 10.1161/jaha.119.012277.Peer-Reviewed Original ResearchConceptsBlood pressure controlLow-income sitesCardiovascular outcomesPressure controlALLHAT participantsPoor blood pressure controlEnd-stage renal diseaseHospitalization/mortalityAdverse cardiovascular eventsCardiovascular risk factorsWorse cardiovascular outcomesHigh blood pressureStandardized treatment protocolRandomized clinical trialsBackground Observational studiesLow socioeconomic statusHighest income quintileAngina hospitalizationCardiovascular eventsCause mortalityCoronary revascularizationClinical characteristicsBlood pressureRenal diseaseClinical outcomes
2018
Presentation, Clinical Profile, and Prognosis of Young Patients With Myocardial Infarction With Nonobstructive Coronary Arteries (MINOCA): Results From the VIRGO Study
Safdar B, Spatz ES, Dreyer RP, Beltrame JF, Lichtman JH, Spertus JA, Reynolds HR, Geda M, Bueno H, Dziura JD, Krumholz HM, D'Onofrio G. Presentation, Clinical Profile, and Prognosis of Young Patients With Myocardial Infarction With Nonobstructive Coronary Arteries (MINOCA): Results From the VIRGO Study. Journal Of The American Heart Association 2018, 7: e009174. PMID: 29954744, PMCID: PMC6064896, DOI: 10.1161/jaha.118.009174.Peer-Reviewed Original ResearchConceptsMI-CAD patientsNonobstructive coronary arteriesMI-CADYounger patientsClinical profileCoronary arteryMyocardial infarctionTraditional cardiac risk factorsAcute myocardial infarction patientsCardiac risk factorsGestational diabetes mellitusMyocardial infarction patientsTimes higher oddsMINOCA patientsSAQ qualityVIRGO StudyClinical characteristicsHypercoaguable stateDiabetes mellitusObstructive diseaseClinical outcomesInfarction patientsRisk factorsMINOCAPsychosocial statusClinical Outcomes of Plavix and Generic Clopidogrel for Patients Hospitalized With an Acute Coronary Syndrome
Ko DT, Krumholz HM, Tu JV, Austin PC, Stukel TA, Koh M, Chong A, de Melo JF, Jackevicius CA. Clinical Outcomes of Plavix and Generic Clopidogrel for Patients Hospitalized With an Acute Coronary Syndrome. Circulation Cardiovascular Quality And Outcomes 2018, 11: e004194. PMID: 29535091, DOI: 10.1161/circoutcomes.117.004194.Peer-Reviewed Original ResearchMeSH KeywordsAcute Coronary SyndromeAgedAged, 80 and overClopidogrelCost SavingsCost-Benefit AnalysisDatabases, FactualDrug CostsDrug SubstitutionDrugs, GenericFemaleHemorrhageHumansMaleOntarioPatient AdmissionPatient ReadmissionPlatelet Aggregation InhibitorsPurinergic P2Y Receptor AntagonistsRecurrenceRisk AssessmentRisk FactorsTime FactorsTreatment OutcomeConceptsAcute coronary syndromeGeneric clopidogrelClinical outcomesCoronary syndromePrimary outcomeRecurrent acute coronary syndromeSubstantial healthcare cost savingsPopulation-based observational studyPropensity-weighted cohortsComposite of deathTransient ischemic attackComposite end pointEffect of clopidogrelElevation myocardial infarctionHealthcare cost savingsCox proportional hazardsRate of deathIschemic attackACS hospitalizationCause readmissionBaseline characteristicsHospital dischargeRecurrent hospitalizationsMean ageMyocardial infarction
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 approvalDiseaseTrialsDrugsFDAEndpointEfficacyMarkersTwo Decades of Cardiovascular Trials With Primary Surrogate Endpoints: 1990–2011
Bikdeli B, Punnanithinont N, Akram Y, Lee I, Desai NR, Ross JS, Krumholz HM. Two Decades of Cardiovascular Trials With Primary Surrogate Endpoints: 1990–2011. Journal Of The American Heart Association 2017, 6: e005285. PMID: 28325713, PMCID: PMC5524035, DOI: 10.1161/jaha.116.005285.Peer-Reviewed Original ResearchConceptsClinical outcome trialsOutcome trialsEndpoint trialsPrimary endpointCardiovascular trialsClinical outcome studiesClinical outcomesSurrogate markerPatient's perspectiveSurrogate endpointsOutcome studiesNew England JournalSample cohortTrial resultsTrialsSurrogate trialsEndpointPositive resultsAmerican MedicalInterventionHigh-impact journalsCohortComparison of two independent systematic reviews of trials of recombinant human bone morphogenetic protein-2 (rhBMP-2): the Yale Open Data Access Medtronic Project
Low J, Ross JS, Ritchie JD, Gross CP, Lehman R, Lin H, Fu R, Stewart LA, Krumholz HM. Comparison of two independent systematic reviews of trials of recombinant human bone morphogenetic protein-2 (rhBMP-2): the Yale Open Data Access Medtronic Project. Systematic Reviews 2017, 6: 28. PMID: 28196521, PMCID: PMC5310069, DOI: 10.1186/s13643-017-0422-x.Peer-Reviewed Original ResearchConceptsParticipant-level dataSystematic reviewSummary estimatesRecombinant human bone morphogenetic protein-2Inclusion criteriaCenter BIndividual participant-level dataMeta-analysis inclusion criteriaHuman bone morphogenetic protein-2Trial inclusion criteriaMulti-site clinical trialMain outcome measuresMost clinical outcomesStatistical methodsConcurrent systematic reviewIndependent systematic reviewsProtein 2Bone morphogenetic protein-2Summary efficacyMorphogenetic protein-2Adverse eventsClinical outcomesSurgical approachTrial inclusionClinical trialsACC/AHA Special Report: Clinical Practice Guideline Implementation Strategies: A Summary of Systematic Reviews by the NHLBI Implementation Science Work Group A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines
Chan WV, Pearson TA, Bennett GC, Cushman WC, Gaziano TA, Gorman PN, Handler J, Krumholz HM, Kushner RF, MacKenzie TD, Sacco RL, Smith SC, Stevens VJ, Wells BL. ACC/AHA Special Report: Clinical Practice Guideline Implementation Strategies: A Summary of Systematic Reviews by the NHLBI Implementation Science Work Group A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Journal Of The American College Of Cardiology 2017, 69: 1076-1092. PMID: 28132746, DOI: 10.1016/j.jacc.2016.11.004.Peer-Reviewed Original ResearchConceptsEducational outreach visitsClinical practice guidelinesProcess of careClinical outcomesOutreach visitsPractice guidelinesSystematic reviewImplementation interventionsCardiology/American Heart Association Task ForceAmerican Heart Association Task ForceLow baseline adherenceOverweight/obesityGuideline implementation strategiesMixed effectivenessGuideline implementation interventionsCost-effectiveness outcomesProvider incentivesEvidence-based strategiesBlood pressureBlood InstituteImplementation science literatureNational HeartClinicians' knowledgeAmerican CollegeExclusion criteriaACC/AHA Special Report
Chan WV, Pearson TA, Bennett GC, Cushman WC, Gaziano TA, Gorman PN, Handler J, Krumholz HM, Kushner RF, MacKenzie TD, Sacco RL, Smith SC, Stevens VJ, Wells BL, Castillo G, Heil SK, Stephens J, Jacobson Vann J. ACC/AHA Special Report. Circulation 2017, 135: e122-e137. PMID: 28126839, DOI: 10.1161/cir.0000000000000481.Peer-Reviewed Original ResearchConceptsEducational outreach visitsClinical practice guidelinesProcess of careClinical outcomesOutreach visitsPractice guidelinesImplementation interventionsSystematic reviewLow baseline adherenceOverweight/obesityMixed effectivenessGuideline implementation interventionsCost-effectiveness outcomesProvider incentivesEvidence-based strategiesBlood pressureBlood InstituteImplementation science literatureNational HeartClinicians' knowledgeExclusion criteriaIndependent reviewersCare outcomesClinician skepticismHigher age
2016
The china patient‐centered evaluative assessment of cardiac events (PEACE) prospective study of percutaneous coronary intervention: Study design
Du X, Pi Y, Dreyer RP, Li J, Li X, Downing NS, Li L, Feng F, Zhan L, Zhang H, Guan W, Xu X, Li S, Lin Z, Masoudi FA, Spertus JA, Krumholz HM, Jiang L, Group F. The china patient‐centered evaluative assessment of cardiac events (PEACE) prospective study of percutaneous coronary intervention: Study design. Catheterization And Cardiovascular Interventions 2016, 88: e212-e221. PMID: 26945565, PMCID: PMC5215582, DOI: 10.1002/ccd.26461.Peer-Reviewed Original ResearchMeSH KeywordsChinaClinical ProtocolsCoronary AngiographyHealth StatusHealthcare DisparitiesHumansMedication AdherenceMyocardial InfarctionPatient Reported Outcome MeasuresPatient-Centered CarePercutaneous Coronary InterventionPredictive Value of TestsProspective StudiesResearch DesignRisk AssessmentRisk FactorsSecondary PreventionTime FactorsTreatment OutcomeConceptsPercutaneous coronary interventionPatient-reported outcomesCardiovascular risk factor controlRisk factor controlProspective studyHealth statusMedical historyLong-term clinical outcomesLong-term patient outcomesHospital-level factorsIndependent core laboratoryNationwide prospective studyLong-term outcomesPatient's medical historyHospital outcomesCoronary interventionPatient demographicsSecondary preventionConsecutive patientsMedical chartsPCI indicationPrimary outcomeClinical outcomesClinical presentationHealthcare utilization