2024
Artificial Intelligence in Cardiovascular Clinical Trials
Cunningham J, Abraham W, Bhatt A, Dunn J, Felker G, Jain S, Lindsell C, Mace M, Martyn T, Shah R, Tison G, Fakhouri T, Psotka M, Krumholz H, Fiuzat M, O’Connor C, Solomon S, Collaboratory H. Artificial Intelligence in Cardiovascular Clinical Trials. Journal Of The American College Of Cardiology 2024, 84: 2051-2062. PMID: 39505413, DOI: 10.1016/j.jacc.2024.08.069.Peer-Reviewed Original ResearchConceptsArtificial intelligenceIntegrate AIPatient privacyClinical trialsRandomized clinical trialsClinical event outcomesCardiovascular clinical trialsIntelligenceInaccurate resultsRandomized trialsInterpreting imagesCardiovascular therapyMedical decision makingDecision makingGold standardValidity of trial resultsClinical trial operationsPrivacy
2022
Direct Oral Anticoagulants vs Vitamin K Antagonists in Patients With Antiphospholipid Syndromes Meta-Analysis of Randomized Trials
Khairani C, Bejjani A, Piazza G, Jimenez D, Monreal M, Chatterjee S, Pengo V, Woller S, Cortes-Hernandez J, Connors J, Kanthi Y, Krumholz H, Middeldorp S, Falanga A, Cushman M, Goldhaber S, Garcia D, Bikdeli B. Direct Oral Anticoagulants vs Vitamin K Antagonists in Patients With Antiphospholipid Syndromes Meta-Analysis of Randomized Trials. Journal Of The American College Of Cardiology 2022, 81: 16-30. PMID: 36328154, PMCID: PMC9812926, DOI: 10.1016/j.jacc.2022.10.008.Peer-Reviewed Original ResearchConceptsDirect oral anticoagulantsVitamin K antagonistsVenous thromboembolic eventsArterial thrombotic eventsSubsequent venous thromboembolic eventsThrombotic antiphospholipid syndromeMajor bleedingThrombotic eventsK antagonistsOral anticoagulantsAntiphospholipid syndromeUse of DOACsMain efficacy outcomeMain safety outcomeCochrane Central RegisterAdequate allocation concealmentRandom-effects modelRandom sequence generationThromboembolic eventsCentral RegisterEfficacy outcomesArterial thrombosisControlled TrialsRandomized trialsAllocation concealment
2021
Recent Randomized Trials of Antithrombotic Therapy for Patients With COVID-19 JACC State-of-the-Art Review
Talasaz AH, Sadeghipour P, Kakavand H, Aghakouchakzadeh M, Kordzadeh-Kermani E, Van Tassell BW, Gheymati A, Ariannejad H, Hosseini SH, Jamalkhani S, Sholzberg M, Monreal M, Jimenez D, Piazza G, Parikh SA, Kirtane AJ, Eikelboom JW, Connors JM, Hunt BJ, Konstantinides SV, Cushman M, Weitz JI, Stone GW, Krumholz HM, Lip GYH, Goldhaber SZ, Bikdeli B. Recent Randomized Trials of Antithrombotic Therapy for Patients With COVID-19 JACC State-of-the-Art Review. Journal Of The American College Of Cardiology 2021, 77: 1903-1921. PMID: 33741176, PMCID: PMC7963001, DOI: 10.1016/j.jacc.2021.02.035.Peer-Reviewed Original ResearchConceptsCOVID-19Recent randomized trialsCommon pathophysiological featuresDuration of therapyClinical trial enterpriseMacrovascular thrombosisThromboprophylactic regimensAntithrombotic therapyAntithrombotic strategiesEndothelial injuryFuture RCTsMedical wardsIllness severityRandomized trialsPathophysiological featuresJACC StateAntithrombotic agentsCoronavirus diseasePatientsRCTsTherapyTrialsRegimensThrombosisOutpatients
2020
Sulodexide versus Control and the Risk of Thrombotic and Hemorrhagic Events: Meta-Analysis of Randomized Trials
Bikdeli B, Chatterjee S, Kirtane AJ, Parikh SA, Andreozzi GM, Desai NR, Francese DP, Gibson CM, Piazza G, Goldhaber SZ, Eikelboom JW, Krumholz HM, Stone GW. Sulodexide versus Control and the Risk of Thrombotic and Hemorrhagic Events: Meta-Analysis of Randomized Trials. Seminars In Thrombosis And Hemostasis 2020, 46: 908-918. PMID: 33086402, DOI: 10.1055/s-0040-1716874.Peer-Reviewed Original ResearchConceptsDeep vein thrombosisUse of sulodexideCause mortalityCardiovascular mortalityReduced oddsPulmonary embolismOdds ratioOdds of VTESafety of sulodexideCardiovascular risk factorsCochrane Central RegisterPeripheral arterial diseaseHistory of MIThrombotic cardiovascular diseasesRandom-effects modelCardiovascular efficacyOral glycosaminoglycansCardiovascular outcomesHemorrhagic eventsCentral RegisterVein thrombosisControlled TrialsArterial diseaseRandomized trialsRisk factorsPharmacological Agents Targeting Thromboinflammation in COVID-19: Review and Implications for Future Research
Bikdeli B, Madhavan MV, Gupta A, Jimenez D, Burton JR, Der Nigoghossian C, Chuich T, Nouri SN, Dreyfus I, Driggin E, Sethi S, Sehgal K, Chatterjee S, Ageno W, Madjid M, Guo Y, Tang LV, Hu Y, Bertoletti L, Giri J, Cushman M, Quéré I, Dimakakos EP, Gibson CM, Lippi G, Favaloro EJ, Fareed J, Tafur AJ, Francese DP, Batra J, Falanga A, Clerkin KJ, Uriel N, Kirtane A, McLintock C, Hunt BJ, Spyropoulos AC, Barnes GD, Eikelboom JW, Weinberg I, Schulman S, Carrier M, Piazza G, Beckman JA, Leon MB, Stone GW, Rosenkranz S, Goldhaber SZ, Parikh SA, Monreal M, Krumholz HM, Konstantinides SV, Weitz JI, Lip GYH, Group T. Pharmacological Agents Targeting Thromboinflammation in COVID-19: Review and Implications for Future Research. Thrombosis And Haemostasis 2020, 120: 1004-1024. PMID: 32473596, PMCID: PMC7516364, DOI: 10.1055/s-0040-1713152.Peer-Reviewed Original ResearchConceptsSevere acute respiratory syndrome coronavirus 2Acute respiratory syndrome coronavirus 2COVID-19Respiratory syndrome coronavirus 2Subgroup of patientsCOVID-19 patientsFuture prospective studiesManagement of thrombosisSyndrome coronavirus 2Coronavirus disease 2019Mechanism of actionViral illnessThrombotic eventsRandomized trialsProspective studyAntithrombotic effectCoronavirus 2Antithrombotic agentsAntithrombotic drugsAntiviral effectDisease 2019Thrombotic diseaseAntithrombotic propertiesDosing approachWorldwide pandemic
2017
Heterogeneity in Early Responses in ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial)
Dhruva SS, Huang C, Spatz ES, Coppi AC, Warner F, Li SX, Lin H, Xu X, Furberg CD, Davis BR, Pressel SL, Coifman RR, Krumholz HM. Heterogeneity in Early Responses in ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial). Hypertension 2017, 70: 94-102. PMID: 28559399, DOI: 10.1161/hypertensionaha.117.09221.Peer-Reviewed Original ResearchConceptsAntihypertensive therapySystolic blood pressure responseAdverse cardiovascular eventsFavorable initial responseBlood pressure responseHigher hazard ratioCardiovascular eventsCardiovascular outcomesHazard ratioMultivariable adjustmentHeart failureAverage SBPRandomized trialsOdds ratioCardiovascular diseaseSBPStudy participantsRespondersMonthsPressure responseImmediate respondersALLHATEarly responseInitial responseSuperior discrimination
2012
Hospital-Level Outcomes Associated with Laparoscopic Colectomy for Cancer in the Minimally Invasive Era
Fox JP, Desai MM, Krumholz HM, Gross CP. Hospital-Level Outcomes Associated with Laparoscopic Colectomy for Cancer in the Minimally Invasive Era. Journal Of Gastrointestinal Surgery 2012, 16: 2112-2119. PMID: 22948842, PMCID: PMC3670114, DOI: 10.1007/s11605-012-2018-z.Peer-Reviewed Original ResearchConceptsLaparoscopy rateLaparoscopic colectomyShorter hospitalizationColon resectionHospital mortalityPostoperative morbidityLow postoperative morbidity rateHigher laparoscopy ratePostoperative morbidity rateRisk-standardized outcomesLow postoperative morbidityShorter hospital stayNationwide Inpatient SampleShort-term outcomesHigher procedure volumeHospital stayComparable morbidityRandomized trialsMorbidity rateInvasive eraInpatient SampleOutcomes AssociatedColectomyMortality rateProcedure volumeRole of Intensive Glucose Control in Development of Renal End Points in Type 2 Diabetes Mellitus: Systematic Review and Meta-analysis
Coca SG, Ismail-Beigi F, Haq N, Krumholz HM, Parikh CR. Role of Intensive Glucose Control in Development of Renal End Points in Type 2 Diabetes Mellitus: Systematic Review and Meta-analysis. JAMA Internal Medicine 2012, 172: 761-769. PMID: 22636820, PMCID: PMC3688081, DOI: 10.1001/archinternmed.2011.2230.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedBlood GlucoseDiabetes Mellitus, Type 2Diabetic NephropathiesDisease ProgressionFemaleGlycated HemoglobinHumansHypoglycemic AgentsKidney Failure, ChronicKidney Function TestsMaleMiddle AgedMonitoring, PhysiologicPrognosisRandomized Controlled Trials as TopicRenal DialysisRisk AssessmentSeverity of Illness IndexConceptsIntensive glucose controlRenal end pointsSerum creatinine levelsConventional glucose controlGlucose controlType 2 diabetesRenal diseaseCreatinine levelsEnd pointGlycemic controlSystematic reviewType 2 diabetes mellitusAggressive glycemic controlClinical renal outcomesKidney-related outcomesIntensive glycemic controlRenal outcomesCumulative incidenceDiabetes mellitusRandomized trialsConventional therapyLanguage restrictionsMacroalbuminuriaMicroalbuminuriaType 2
2008
An early invasive strategy versus ischemia-guided management after fibrinolytic therapy for ST-segment elevation myocardial infarction: A meta-analysis of contemporary randomized controlled trials
Wijeysundera HC, You JJ, Nallamothu BK, Krumholz HM, Cantor WJ, Ko DT. An early invasive strategy versus ischemia-guided management after fibrinolytic therapy for ST-segment elevation myocardial infarction: A meta-analysis of contemporary randomized controlled trials. American Heart Journal 2008, 156: 564-572.e2. PMID: 18760142, DOI: 10.1016/j.ahj.2008.04.024.Peer-Reviewed Original ResearchMeSH KeywordsAngioplasty, Balloon, CoronaryCardiac CatheterizationElectrocardiographyFemaleFibrinolytic AgentsHemorrhageHumansInjections, IntravenousInpatientsMaleMiddle AgedMyocardial InfarctionMyocardial IschemiaMyocardial ReperfusionRandomized Controlled Trials as TopicRecurrenceStentsStrokeThrombolytic TherapyConceptsST-segment elevation myocardial infarctionEarly invasive strategyPercutaneous coronary interventionElevation myocardial infarctionFibrinolytic therapyInvasive strategyMajor bleedingSTEMI patientsMyocardial infarctionHospital major bleedingIntravenous fibrinolytic therapyLarge randomized trialsRisk of strokeSignificant reductionCause mortalityEligible trialsCoronary interventionRandomized trialsContemporary trialsStent useInclusion criteriaPatientsReinfarctionTherapyTrials
2007
Randomized Trial of Telemonitoring to Improve Heart Failure Outcomes (Tele-HF): Study Design
Chaudhry SI, Barton B, Mattera J, Spertus J, Krumholz HM. Randomized Trial of Telemonitoring to Improve Heart Failure Outcomes (Tele-HF): Study Design. Journal Of Cardiac Failure 2007, 13: 709-714. PMID: 17996818, PMCID: PMC2702538, DOI: 10.1016/j.cardfail.2007.06.720.Peer-Reviewed Case Reports and Technical NotesConceptsHeart failure outcomesHeart failureClinical statusFailure outcomesDecompensated heart failureHeart failure decompensationCare of patientsPrimary care practicesSelf-reported weightUsual careHospital readmissionDaily symptomsRandomized trialsGeneral cardiologyPatient participationHealth behaviorsCare practicesPatientsFrequent monitoringFavorable effectInterventionOutcomesSymptomsTrialsCareSummary of Evidence Regarding Hospital Strategies to Reduce Door-to-Balloon Times for Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Bradley EH, Nallamothu BK, Curtis JP, Webster TR, Magid DJ, Granger CB, Moscucci M, Krumholz HM. Summary of Evidence Regarding Hospital Strategies to Reduce Door-to-Balloon Times for Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention. Critical Pathways In Cardiology A Journal Of Evidence-Based Medicine 2007, 6: 91-97. PMID: 17804968, DOI: 10.1097/hpc.0b013e31812da7bc.Peer-Reviewed Original ResearchConceptsST-segment elevation myocardial infarctionElevation myocardial infarctionPercutaneous coronary interventionBalloon timeCoronary interventionCross-sectional designMyocardial infarctionCatheterization laboratoryPrompt percutaneous coronary interventionPrimary percutaneous coronary interventionHospital-based strategiesEmergency medicine physiciansHospital strategiesSummary of evidenceRandomized trialsPrehospital electrocardiogramCatheterization teamObservational studyMedicine physiciansClinical importanceComputerized searchPatientsEffective interventionsHospitalHospital effortsRescue Angioplasty or Repeat Fibrinolysis After Failed Fibrinolytic Therapy for ST-Segment Myocardial Infarction A Meta-Analysis of Randomized Trials
Wijeysundera HC, Vijayaraghavan R, Nallamothu BK, Foody JM, Krumholz HM, Phillips CO, Kashani A, You JJ, Tu JV, Ko DT. Rescue Angioplasty or Repeat Fibrinolysis After Failed Fibrinolytic Therapy for ST-Segment Myocardial Infarction A Meta-Analysis of Randomized Trials. Journal Of The American College Of Cardiology 2007, 49: 422-430. PMID: 17258087, DOI: 10.1016/j.jacc.2006.09.033.Peer-Reviewed Original ResearchConceptsRescue percutaneous coronary interventionPercutaneous coronary interventionST-segment myocardial infarctionFibrinolytic therapyCause mortalityMinor bleedingRandomized trialsRisk of strokeSignificant clinical improvementImproved clinical outcomesSignificant risk reductionFixed-effects modelRescue angioplastySTEMI patientsClinical improvementConservative managementConservative treatmentCoronary interventionHospital dischargeHeart failureClinical outcomesMyocardial infarctionBest therapyCommon treatmentPatients
2006
Regional Differences in Process of Care and Outcomes for Older Acute Myocardial Infarction Patients in the United States and Ontario, Canada
Ko DT, Krumholz HM, Wang Y, Foody JM, Masoudi FA, Havranek EP, You JJ, Alter DA, Stukel TA, Newman AM, Tu JV. Regional Differences in Process of Care and Outcomes for Older Acute Myocardial Infarction Patients in the United States and Ontario, Canada. Circulation 2006, 115: 196-203. PMID: 17190861, DOI: 10.1161/circulationaha.106.657601.Peer-Reviewed Original ResearchConceptsRisk-standardized mortality ratesTreatment patternsAMI patientsMortality rateOlder acute myocardial infarction patientsInvasive cardiac procedure useAcute myocardial infarction treatmentAcute myocardial infarction patientsBeta-blocker useCardiac catheterization useCardiac procedure useEnzyme inhibitor useMyocardial infarction patientsProcess of careService Medicare beneficiariesHealth care delivery systemSimilar treatment patternsMyocardial infarction treatmentCare delivery systemInvasive cardiac therapyBaseline characteristicsInhibitor useMedication useIllness severityRandomized trials
2005
Thiazolidinediones, Metformin, and Outcomes in Older Patients With Diabetes and Heart Failure
Masoudi FA, Inzucchi SE, Wang Y, Havranek EP, Foody JM, Krumholz HM. Thiazolidinediones, Metformin, and Outcomes in Older Patients With Diabetes and Heart Failure. Circulation 2005, 111: 583-590. PMID: 15699279, DOI: 10.1161/01.cir.0000154542.13412.b1.Peer-Reviewed Original ResearchConceptsHeart failureInsulin-sensitizing drugsOlder patientsLower riskCox proportional hazards modelAntidiabetic drug prescriptionRetrospective cohort studyPrincipal discharge diagnosisClustering of patientsProportional hazards modelCohort studySecondary outcomesPrimary outcomeMetformin treatmentRandomized trialsThiazolidinedione treatmentDischarge diagnosisInsulin sensitizersAdverse outcomesDrug prescriptionsMultivariable modelObservational studyHospital variablesThiazolidinedione classHigh risk
2004
Adverse Effects of β-Blocker Therapy for Patients With Heart Failure: A Quantitative Overview of Randomized Trials
Ko DT, Hebert PR, Coffey CS, Curtis JP, Foody JM, Sedrakyan A, Krumholz HM. Adverse Effects of β-Blocker Therapy for Patients With Heart Failure: A Quantitative Overview of Randomized Trials. JAMA Internal Medicine 2004, 164: 1389-1394. PMID: 15249347, DOI: 10.1001/archinte.164.13.1389.Peer-Reviewed Original ResearchMeSH KeywordsAdrenergic beta-AntagonistsAgedBisoprololBradycardiaCarbazolesCarvedilolDizzinessFatigueFemaleFollow-Up StudiesHeart Conduction SystemHeart FailureHumansHypotensionMaleMetoprololMiddle AgedPropanolaminesRisk FactorsRisk Reduction BehaviorSeverity of Illness IndexStatistics as TopicTreatment FailureVentricular Dysfunction, LeftWithholding TreatmentConceptsBeta-blocker therapyHeart failureAdverse effectsLeft ventricular systolic dysfunctionBeta-blocker trialsCardiovascular adverse effectsChronic heart failureHeart Failure TrialVentricular systolic dysfunctionΒ-blocker therapyRisk of hypotensionLife-saving therapyRandom-effects modelHF hospitalizationCause mortalitySystolic dysfunctionCause withdrawalsFailure TrialRandomized trialsAbsolute riskElectronic searchPatientsMEDLINE databaseTherapyAbsolute increase
2003
Is there evidence of implicit exclusion criteria for elderly subjects in randomized trials? Evidence from the GUSTO-1 study
Krumholz HM, Gross CP, Peterson ED, Barron HV, Radford MJ, Parsons LS, Every NR. Is there evidence of implicit exclusion criteria for elderly subjects in randomized trials? Evidence from the GUSTO-1 study. American Heart Journal 2003, 146: 839-847. PMID: 14597933, DOI: 10.1016/s0002-8703(03)00408-3.Peer-Reviewed Original ResearchConceptsCooperative Cardiovascular ProjectRandomized trialsExclusion criteriaEligibility criteriaMortality rateClinical practiceKillip class III/IVClass III/IVOccluded Coronary Arteries (GUSTO-I) trialCoronary Arteries trialHospital mortality rateMyocardial infarction careTrial eligibility criteriaHigh mortality rateRetrospective registryBaseline characteristicsClinical characteristicsElderly patientsOlder patientsCCP patientsClinical presentationClinical eventsMyocardial infarctionHealthy cohortHospital characteristics
2002
β-Blocker Therapy and Symptoms of Depression, Fatigue, and Sexual Dysfunction
Ko DT, Hebert PR, Coffey CS, Sedrakyan A, Curtis JP, Krumholz HM. β-Blocker Therapy and Symptoms of Depression, Fatigue, and Sexual Dysfunction. JAMA 2002, 288: 351-357. PMID: 12117400, DOI: 10.1001/jama.288.3.351.Peer-Reviewed Original ResearchConceptsBeta-blocker therapySexual dysfunctionDepressive symptomsSymptoms of depressionAdverse eventsHeart failureMyocardial infarctionSignificant annual increaseAdditional reportsLipid solubilityAdverse effectsWithdrawal of therapyΒ-blocker therapyPatient-reported symptomsNumber of patientsEnglish-language articlesInclusion of trialsPlacebo groupMortality benefitRandomized trialsStudy treatmentCardiac patientsPlacebo controlRisk of fatigueClinical trials
2001
Aspirin and Angiotensin-Converting Enzyme Inhibitors Among Elderly Survivors of Hospitalization for an Acute Myocardial Infarction
Krumholz HM, Chen YT, Wang Y, Radford MJ. Aspirin and Angiotensin-Converting Enzyme Inhibitors Among Elderly Survivors of Hospitalization for an Acute Myocardial Infarction. JAMA Internal Medicine 2001, 161: 538-544. PMID: 11252112, DOI: 10.1001/archinte.161.4.538.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionACE inhibitorsMyocardial infarctionInteraction of aspirinEnzyme inhibitorsAngiotensin-converting enzyme inhibitorAngiotensin converting enzyme (ACE) inhibitorsElderly patientsSecondary preventionRandomized trialsElderly survivorsLower riskAspirinPatientsMultivariate analysisHospitalizationMortalityMedicationsInfarctionInhibitorsTherapySurvivorsTrialsPreventionAspirin and the Treatment of Heart Failure in the Elderly
Krumholz HM, Chen YT, Radford MJ. Aspirin and the Treatment of Heart Failure in the Elderly. JAMA Internal Medicine 2001, 161: 577-582. PMID: 11252118, DOI: 10.1001/archinte.161.4.577.Peer-Reviewed Original ResearchConceptsCoronary artery diseaseHeart failureArtery diseaseBenefits of aspirinPatients 65 yearsRetrospective cohort studyUse of aspirinGroup of patientsAspirin prescriptionAspirin therapyCohort studyDischarge medicationsOlder patientsPatient characteristicsRandomized trialsVascular diseaseTreatment characteristicsConnecticut hospitalsBaseline differencesAspirinPatientsLower mortalityStrong associationDiseaseStudy sample
1999
Beta-blocker therapy for secondary prevention of myocardial infarction in elderly diabetic patients
Chen J, Marciniak T, Radford M, Wang Y, Krumholz H. Beta-blocker therapy for secondary prevention of myocardial infarction in elderly diabetic patients. Journal Of The American College Of Cardiology 1999, 34: 1388-1394. PMID: 10551683, DOI: 10.1016/s0735-1097(99)00383-6.Peer-Reviewed Original ResearchConceptsBeta-blocker therapyElderly diabetic patientsAcute myocardial infarctionInsulin-treated diabeticsOne-year mortalityDiabetic patientsDiabetic complicationsMyocardial infarctionNational Cooperative Cardiovascular ProjectSix-month readmission ratesOne-year mortality rateRetrospective cohort studyRisk of readmissionHospital medical recordsCooperative Cardiovascular ProjectCommunity practice settingsElderly diabeticsCohort studyComplication rateReadmission ratesSecondary preventionClinical factorsHospital readmissionRandomized trialsPotential confounders