2025
Ticagrelor Versus Prasugrel in Acute Coronary Syndrome: Real-World Treatment and Safety
Bahouth F, Chutko B, Sholy H, Hassanain S, Zaid G, Radzishevsky E, Fahmwai I, Hamoud M, Samnia N, Khoury J, Dobrecky-Mery I. Ticagrelor Versus Prasugrel in Acute Coronary Syndrome: Real-World Treatment and Safety. Medicines 2025, 12: 13. PMID: 40407605, PMCID: PMC12194868, DOI: 10.3390/medicines12020013.Peer-Reviewed Original ResearchAcute coronary syndromeCoronary syndromeAntiplatelet drugsCardiovascular deathComposite endpoint of cardiovascular deathAdmitted with acute coronary syndromeEndpoint of cardiovascular deathTreated with ticagrelorTreated with prasugrelSingle-center studyRetrospective observational studyRecurrent cardiac eventsDual antiplatelet drugsReal-world treatmentPercutaneous coronary interventionBARC classificationSignificant bleedingPrasugrel groupPrimary endpointP2Y12 inhibitorsNo significant differenceACS patientsCardiac eventsComposite endpointPrasugrelEfficacy of cannabinoids for the prophylaxis of chemotherapy-induced nausea and vomiting—a systematic review and meta-analysis
Chow R, Basu A, Kaur J, Hui D, Im J, Prsic E, Boldt G, Lock M, Eng L, Ng T, Zimmermann C, Scotte F. Efficacy of cannabinoids for the prophylaxis of chemotherapy-induced nausea and vomiting—a systematic review and meta-analysis. Supportive Care In Cancer 2025, 33: 193. PMID: 39953210, PMCID: PMC11828838, DOI: 10.1007/s00520-025-09251-w.Peer-Reviewed Original ResearchConceptsChemotherapy-induced nausea and vomitingEfficacy of cannabinoidsTHC:CBDMeta-analysisPrevention of chemotherapy-induced nausea and vomitingProphylaxis of chemotherapy-induced nausea and vomitingChemotherapy-induced nausea and vomiting controlControlled TrialsCochrane Central Register of Controlled TrialsCentral Register of Controlled TrialsRegister of Controlled TrialsNausea and vomitingChemotherapy-induced nauseaMethodsA literature searchCochrane Central RegisterComplete responseRandomized Controlled TrialsNo vomitingAdjunctive therapyRescue medicationAntiemetic regimensComposite endpointSubgroup analysisCannabinoidSecondary prevention
2024
OP-1 LONG-TERM EFFICACY AND SAFETY OF OPEN-LABEL SELADELPAR TREATMENT IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS: INTERIM 2-YEAR RESULTS FROM THE ASSURE STUDY
Trivedi P, Levy C, Kowdley K, Gordon S, Bowlus C, Hurtado M, Hirschfield G, Gulamhusien A, Lawitz E, Villamil A, de Guevara Cetina A, Mayo M, Younes Z, Shibolet O, Yimam K, Pratt D, Heo J, Morgera U, Andreone P, Kremer A, Corpechot C, Goel A, Peyton A, Elbeshbeshy H, Crittenden D, Heusner C, Proehl S, Zhou S, McWherter C. OP-1 LONG-TERM EFFICACY AND SAFETY OF OPEN-LABEL SELADELPAR TREATMENT IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS: INTERIM 2-YEAR RESULTS FROM THE ASSURE STUDY. Annals Of Hepatology 2024, 29: 101599. DOI: 10.1016/j.aohep.2024.101599.Peer-Reviewed Original ResearchPrimary biliary cholangitisCrossover patientsBiliary cholangitisBiochemical markers of cholestasisBiochemical markersMarkers of cholestasisPhase 3 trialLong-term efficacyNumerical rating scaleLong-term usePlacebo patientsOpen-labelMethods PatientsAdverse eventsComposite endpointSafety resultsSeladelparUrsodeoxycholic acidPlaceboPhase 3 responsePruritusPatientsEndpointAssurance studyCholangitisCOBALT: A Confirmatory Trial of Obeticholic Acid in Primary Biliary Cholangitis With Placebo and External Controls
Kowdley K, Hirschfield G, Coombs C, Malecha E, Bessonova L, Li J, Rathnayaka N, Mells G, Jones D, Trivedi P, Hansen B, Smith R, Wason J, Hiu S, Kareithi D, Mason A, Bowlus C, Muller K, Carbone M, Berenguer M, Milkiewicz P, Adekunle F, Villamil A. COBALT: A Confirmatory Trial of Obeticholic Acid in Primary Biliary Cholangitis With Placebo and External Controls. The American Journal Of Gastroenterology 2024, 120: 390-400. PMID: 39140490, PMCID: PMC11774195, DOI: 10.14309/ajg.0000000000003029.Peer-Reviewed Original ResearchPrimary biliary cholangitisObeticholic acidClinical outcomesFunctional unblindingPlacebo armBiliary cholangitisConfirmatory trialsUS healthcare claims databasePrimary biliary cholangitis patientsOCA therapyObeticholic acid treatmentPrimary composite endpointAs-treated analysisHealthcare claims databaseNegative clinical outcomesUncontrolled ascitesPlacebo patientsHepatic decompensationPrimary endpointLiver transplantationComposite endpointCommercial therapySafety signalsPlaceboTreatment crossoverFeasibility of Amulet occluder implantation after failed left atrial appendage occlusion attempt: Insights from the EMERGE LAA postapproval study
Makkar A, Alkhouli M, Ellis C, Shah A, Coylewright M, Freeman J, Anderson J, Gage R, Lakkireddy D. Feasibility of Amulet occluder implantation after failed left atrial appendage occlusion attempt: Insights from the EMERGE LAA postapproval study. Heart Rhythm 2024, 21: 2126-2135. PMID: 38768843, DOI: 10.1016/j.hrthm.2024.05.004.Peer-Reviewed Original ResearchLeft atrial appendage occlusionAmulet occluderPost-approval studiesAdverse eventsImplant successOccluder implantationLow rate of adverse eventsRate of adverse eventsOutcomes of patientsSafety composite endpointImplantation attemptLAAO proceduresAppendage occlusionSafety endpointsPatient cohortComposite endpointFDA approvalPatientsHospital dischargeIntricate anatomyAnatomical scenariosOccluderImplantationEndpointLow rateSodium Zirconium Cyclosilicate in HFrEF and Hyperkalemia REALIZE-K Design and Baseline Characteristics
Kosiborod M, Cherney D, Connelly K, Desai A, Guimarães P, Kuthi L, Lala A, Madrini V, Merkely B, Villota J, Squire I, Testani J, Vaclavik J, Verma S, Wranicz J, Dahl M, Eudicone J, Friberg L, Petrie M. Sodium Zirconium Cyclosilicate in HFrEF and Hyperkalemia REALIZE-K Design and Baseline Characteristics. JACC Heart Failure 2024, 12: 1707-1716. PMID: 38878009, DOI: 10.1016/j.jchf.2024.05.003.Peer-Reviewed Original ResearchMineralocorticoid receptor antagonistsSodium zirconium cyclosilicateZirconium cyclosilicateBaseline characteristicsOpen-label run-inN-terminal pro B-type natriuretic peptideMineralocorticoid receptor antagonist useRun-inPro B-type natriuretic peptideB-type natriuretic peptidePlacebo-controlled trialRisk of hyperkalemiaReduced ejection fractionPrimary composite endpointDouble-blindEjection fractionReceptor antagonistLowered potassiumOptimal therapyNatriuretic peptideIncident hyperkalemiaProportion of participantsTherapy useHFrEFComposite endpointSurrogate endpoints in clinical trials of p16-positive squamous cell carcinoma of the oropharynx: an individual patient data meta-analysis
Gharzai L, Morris E, Suresh K, Nguyen-Tân P, Rosenthal D, Gillison M, Harari P, Garden A, Koyfman S, Caudell J, Jones C, Mitchell D, Krempl G, Ridge J, Gensheimer M, Bonner J, Filion E, Dunlap N, Stokes W, Le Q, Torres-Saavedra P, Mierzwa M, Schipper M. Surrogate endpoints in clinical trials of p16-positive squamous cell carcinoma of the oropharynx: an individual patient data meta-analysis. The Lancet Oncology 2024, 25: 366-375. PMID: 38423050, PMCID: PMC10962533, DOI: 10.1016/s1470-2045(24)00016-0.Peer-Reviewed Original ResearchConceptsLocoregional progression-free survivalProgression-free survivalIntermediate clinical endpointsMetastasis-free survivalOverall survivalClinical endpointsOropharyngeal cancerComposite endpointIncidence of human papillomavirus (HPV)-related cancersP16-positive squamous cell carcinomaHuman papillomavirus (HPV)-related cancersP16-positive oropharyngeal cancerCancer treated with chemotherapyIndividual Patient Data Meta-AnalysisMedian Follow-UpPatient data meta-analysisSquamous-cell carcinomaSquamous cell carcinomaPatient levelClinical trial endpointsTreatment effectsData Meta-AnalysisLocoregional progressionNational Cancer InstituteDistant metastasisDistinct characteristics and prognosis of IgA nephropathy patients with nephrotic syndrome: a propensity score-matched cohort study
Jiang Y, Chen P, Zhao W, Liu L, Shi S, Lv J, Zhang H. Distinct characteristics and prognosis of IgA nephropathy patients with nephrotic syndrome: a propensity score-matched cohort study. Frontiers In Medicine 2024, 11: 1344219. PMID: 38439903, PMCID: PMC10910015, DOI: 10.3389/fmed.2024.1344219.Peer-Reviewed Original ResearchNephrotic syndromeEnd-stage kidney diseaseNS patientsIgAN patientsComposite endpointRisk of composite endpointElevated serum uric acid levelsSerum uric acid levelsNon-NS groupLow C3 levelsScore-matched cohort studyIgA nephropathy patientsUric acid levelsIncreased complement activationSevere foot process effacementMESTC scoreFoot process effacementPropensity score matchingRemission rateSevere hematuriaRenal biopsyActive diseaseClinical characteristicsNephropathy patientsPoor prognosisFirst Experience With Amulet in the United States Early Insights From EMERGE LAA Postapproval Study
Alkhouli M, Freeman J, Ellis C, Shah A, Gada H, Coylewright M, Lo M, Makkar A, Agarwal H, Lakkireddy D. First Experience With Amulet in the United States Early Insights From EMERGE LAA Postapproval Study. JACC Cardiovascular Interventions 2024, 17: 422-434. PMID: 38310499, DOI: 10.1016/j.jcin.2023.11.027.Peer-Reviewed Original ResearchPericardial effusionAmulet occluderImplant successAdverse eventsIn-HospitalFood and Drug Administration approvalOpen cardiac surgeryMajor adverse eventsDrug Administration approvalComposite endpoint eventsFood and Drug AdministrationSafety composite endpointPatients in-hospitalImplantation attemptSystemic embolismCardiac surgeryAppendage occlusionOccluder implantationAdministration approvalComposite endpointDevice implantationEndpoint eventsPostapproval studiesEndovascular interventionLearning curve effect
2023
Long-term PCI outcomes in chronic versus acute coronary syndromes: 5-year results of the TARGET All Comers trial
Patel K, Lansky A, Kelbaek H, Xu B, Van Royen N, Johnson T, Anderson R, Wijns W, Baumbach A. Long-term PCI outcomes in chronic versus acute coronary syndromes: 5-year results of the TARGET All Comers trial. European Heart Journal 2023, 44: ehad655.1494. DOI: 10.1093/eurheartj/ehad655.1494.Peer-Reviewed Original ResearchAcute coronary syndromeChronic coronary syndromeProbable stent thrombosisCoronary syndromeStent thrombosisFIREHAWK stentLesion failureClinical presentationLong-term PCI outcomesPatient-oriented composite endpointTarget lesion revascularisationMajor adverse eventsLong-term outcomesLong-term safetyCCS cohortComer patientsID-TLRLesion revascularisationCCS patientsOpen labelAdverse eventsBaseline characteristicsACS cohortComposite endpointComers trialEffect of dapagliflozin on outpatient worsening heart failure in patients with mildly reduced or preserved ejection fraction: the DELIVER trial
Chatur S, Vaduganathan M, Claggett B, Desai A, Docherty K, Jhund P, De Boer R, Hernandez A, Inzucchi S, Kosiborod M, Lam C, Martinez F, Shah S, Mcmurray J, Solomon S. Effect of dapagliflozin on outpatient worsening heart failure in patients with mildly reduced or preserved ejection fraction: the DELIVER trial. European Heart Journal 2023, 44: ehad655.751. DOI: 10.1093/eurheartj/ehad655.751.Peer-Reviewed Original ResearchUrgent HF visitsHeart failureHF eventsHF hospitalizationHF visitsEjection fractionFirst presentationSubsequent mortalityComposite endpointSubsequent deathEffect of dapagliflozinTreatment effectsBackground HospitalizationCV causesCV deathDose uptitrationPrimary endpointPrognostic importanceClinical trialsFirst manifestationLandmark analysisAmbulatory careHospitalizationClinical relevancePatientsDAPT Is Comparable to OAC Following LAAC With WATCHMAN FLX A National Registry Analysis
Coylewright M, Holmes D, Kapadia S, Hsu J, Gibson D, Freeman J, Yeh R, Piccini J, Price M, Allocco D, Nair D. DAPT Is Comparable to OAC Following LAAC With WATCHMAN FLX A National Registry Analysis. JACC Cardiovascular Interventions 2023, 16: 2708-2718. PMID: 37943200, DOI: 10.1016/j.jcin.2023.08.013.Peer-Reviewed Original ResearchConceptsDual antiplatelet therapyDevice-related thrombusOral anticoagulationWatchman FLXStroke preventionLong-term oral anticoagulationComposite endpoint rateMedical therapy optionsNational registry analysisSimilar safety profilePropensity-matched analysisAtrial appendage occlusionAspirin patientsDAPT patientsMajor bleedingAntiplatelet therapyComposite endpointDrug regimensMedication regimensAppendage occlusionComorbid conditionsAtrial fibrillationRegistry analysisSafety profileMean ageOpen‐label, clinical trial extension: Two‐year safety and efficacy results of seladelpar in patients with primary biliary cholangitis
Mayo M, Vierling J, Bowlus C, Levy C, Hirschfield G, Neff G, Galambos M, Gordon S, Borg B, Harrison S, Thuluvath P, Goel A, Shiffman M, Swain M, Jones D, Trivedi P, Kremer A, Aspinall R, Sheridan D, Dörffel Y, Yang K, Choi Y, McWherter C. Open‐label, clinical trial extension: Two‐year safety and efficacy results of seladelpar in patients with primary biliary cholangitis. Alimentary Pharmacology & Therapeutics 2023, 59: 186-200. PMID: 37904314, DOI: 10.1111/apt.17755.Peer-Reviewed Original ResearchConceptsPrimary biliary cholangitisBiliary cholangitisLiver injurySerious treatment-related adverse eventsBiochemical markersLong-term extension studyTreatment-related adverse eventsAnti-pruritic effectsClinical trial extensionsSecondary efficacy analysesTwo-Year SafetyUnexpected histological findingsNon-alcoholic steatohepatitisLong-term safetyAdverse eventsElevated bilirubinComposite endpointDose adjustmentEfficacy analysisHistological findingsTrial extensionEfficacy dataEfficacy resultsSelective peroxisomePatientsSacubitril/valsartan in heart failure with mildly reduced or preserved ejection fraction: a pre-specified participant-level pooled analysis of PARAGLIDE-HF and PARAGON-HF
Vaduganathan M, Mentz R, Claggett B, Miao Z, Kulac I, Ward J, Hernandez A, Morrow D, Starling R, Velazquez E, Williamson K, Desai A, Zieroth S, Lefkowitz M, McMurray J, Braunwald E, Solomon S. Sacubitril/valsartan in heart failure with mildly reduced or preserved ejection fraction: a pre-specified participant-level pooled analysis of PARAGLIDE-HF and PARAGON-HF. European Heart Journal 2023, 44: 2982-2993. PMID: 37210743, PMCID: PMC10424880, DOI: 10.1093/eurheartj/ehad344.Peer-Reviewed Original ResearchConceptsSacubitril/valsartanRenal composite endpointPARAGON-HFHeart failureEjection fractionPooled analysisHF eventsRenal eventsCardiovascular deathComposite endpointLeft ventricular ejection fractionVentricular ejection fractionActive-controlled trialParticipant-level dataPrimary endpointSecondary endpointsClinical outcomesNatriuretic peptideLike patientsTreatment benefitCare settingsPatientsPrimary analysisLVEFValsartan
2022
Clinical Characteristics and Prognosis of MINOCA Caused by Atherosclerotic and Nonatherosclerotic Mechanisms Assessed by OCT
Zeng M, Zhao C, Bao X, Liu M, He L, Xu Y, Meng W, Qin Y, Weng Z, Yi B, Zhang D, Wang S, Luo X, Lv Y, Chen X, Sun Q, Feng X, Gao Z, Sun Y, Demuyakor A, Li J, Hu S, Guagliumi G, Mintz G, Jia H, Yu B. Clinical Characteristics and Prognosis of MINOCA Caused by Atherosclerotic and Nonatherosclerotic Mechanisms Assessed by OCT. JACC Cardiovascular Imaging 2022, 16: 521-532. PMID: 36648054, DOI: 10.1016/j.jcmg.2022.10.023.Peer-Reviewed Original ResearchConceptsMajor adverse cardiac eventsOptical coherence tomographyTarget lesion revascularizationCardiac deathLesion revascularizationPredictors of Major Adverse Cardiac EventsAssociated with worse outcomesSpontaneous coronary artery dissectionClinical diagnosis of MIPrognosis of MINOCAMechanisms of MINOCAAdverse cardiac eventsNonobstructive coronary arteriesPrognosis of patientsCoronary artery dissectionDiagnosis of MIOCT findingsAtherosclerotic causeCardiac eventsClinical characteristicsClinical outcomesArtery dissectionComposite endpointMINOCACoronary spasmSafety and Efficacy of the Supreme Biodegradable Polymer Sirolimus-Eluting Stent in Patients With Diabetes Mellitus
Thomas A, Kereiakes D, Baumbach A, Windecker S, Pietras C, Dressler O, Issever M, Curtis M, Bertolet B, Zidar J, Smits P, Díaz V, McLaurin B, Cequier Á, Takahashi A, Cannon L, Amoroso G, Kakuta T, Saito S, Leon M, Lansky A. Safety and Efficacy of the Supreme Biodegradable Polymer Sirolimus-Eluting Stent in Patients With Diabetes Mellitus. Journal Of The Society For Cardiovascular Angiography & Interventions 2022, 1: 100033. PMID: 39132558, PMCID: PMC11307809, DOI: 10.1016/j.jscai.2022.100033.Peer-Reviewed Original ResearchTarget vessel myocardial infarctionVessel myocardial infarctionDiabetes mellitusDP-EESLesion failureIII trialsCardiac deathMyocardial infarctionBiodegradable Polymer Sirolimus-Eluting StentBiodegradable polymer sirolimus-eluting stentsTarget lesion failureTarget lesion revascularizationPercutaneous coronary interventionSirolimus-eluting stentsLong-term inflammatory responseDiabetic subgroupsLesion revascularizationNondiabetic patientsSecondary endpointsBackground PatientsCoronary interventionPrespecified analysisComposite endpointPrimary safetyWorse outcomesAn Explainable Machine Learning Approach Reveals Prognostic Significance of Right Ventricular Dysfunction in Nonischemic Cardiomyopathy
Fahmy A, Csecs I, Arafati A, Assana S, Yankama T, Al-Otaibi T, Rodriguez J, Chen Y, Ngo L, Manning W, Kwong R, Nezafat R. An Explainable Machine Learning Approach Reveals Prognostic Significance of Right Ventricular Dysfunction in Nonischemic Cardiomyopathy. JACC Cardiovascular Imaging 2022, 15: 766-779. PMID: 35033500, DOI: 10.1016/j.jcmg.2021.11.029.Peer-Reviewed Original ResearchConceptsNonischemic dilated cardiomyopathyBeth Israel Deaconess Medical CenterComposite endpointRight ventricular (RV) dysfunctionCardiovascular hospitalizationRisk prediction modelAdverse outcomesRisk markersMarker of adverse outcomeCardiac magnetic resonance markersRisk stratification of patientsRight ventricular dysfunctionRV ejection fractionMedical CenterFollow-up durationCardiac magnetic resonanceEnd-diastolic volumeStratification of patientsArea under the curveAll-cause deathHigh-risk thresholdVentricular dysfunctionEjection fractionNonischemic cardiomyopathyPrognostic significance
2021
Risk factor identification and predictive models for central line requirements for patients on vasopressors
Haimovich AD, Jiang R, Taylor RA, Belsky JB. Risk factor identification and predictive models for central line requirements for patients on vasopressors. Anaesthesia And Intensive Care 2021, 49: 275-283. PMID: 34392707, DOI: 10.1177/0310057x211024258.Peer-Reviewed Original ResearchConceptsCentral venous cathetersIntensive care unitVenous cathetersComposite endpointCare unitLogistic regression modelsCatheter requirementRisk factorsIntensive care unit settingFuture prospective trialsImportant risk factorStudy inclusion criteriaMedical Information MartRisk factor identificationMore vasopressorsMultiple vasopressorsSingle vasopressorRenal impairmentPeripheral administrationProspective trialRegression modelsRetrospective studyIntensive careUnit settingHigh prevalenceSpot urine sodium in acute heart failure: differences in prognostic value on admission and discharge
Biegus J, Zymliński R, Fudim M, Testani J, Sokolski M, Marciniak D, Ponikowska B, Guzik M, Garus M, Urban S, Ponikowski P. Spot urine sodium in acute heart failure: differences in prognostic value on admission and discharge. ESC Heart Failure 2021, 8: 2597-2602. PMID: 33932273, PMCID: PMC8318409, DOI: 10.1002/ehf2.13372.Peer-Reviewed Original ResearchConceptsHazard ratioComposite endpointAHF rehospitalizationPrognostic significancePrognostic utilityAcute heart failure hospitalizationSpot urine sodiumAcute heart failureHeart failure hospitalizationMortality hazard ratioCourse of hospitalizationConfidence intervalsDifferent prognostic significanceEarly phaseAHF patientsOral furosemideCause mortalityFailure hospitalizationIndex hospitalizationUrine sodiumSodium excretionHeart failureStudy endpointClinical statusPrognostic valueComputational prediction of protein subdomain stability in MYBPC3 enables clinical risk stratification in hypertrophic cardiomyopathy and enhances variant interpretation
Thompson AD, Helms AS, Kannan A, Yob J, Lakdawala NK, Wittekind SG, Pereira AC, Jacoby DL, Colan SD, Ashley EA, Saberi S, Ware JS, Ingles J, Semsarian C, Michels M, Mazzarotto F, Olivotto I, Ho CY, Day SM. Computational prediction of protein subdomain stability in MYBPC3 enables clinical risk stratification in hypertrophic cardiomyopathy and enhances variant interpretation. Genetics In Medicine 2021, 23: 1281-1287. PMID: 33782553, PMCID: PMC8257482, DOI: 10.1038/s41436-021-01134-9.Peer-Reviewed Original ResearchConceptsHypertrophic cardiomyopathyClinical riskMissense variantsSarcomeric Human Cardiomyopathy RegistryHigh clinical riskClinical risk stratificationAdverse eventsComposite endpointRisk stratificationHCM patientsCommon causePatientsLoss of functionUncertain significanceMYBPC3Missense VUSCardiomyopathyHigh rateSubstantial numberSupportive evidenceVUSRiskVariant interpretationEvent analysisMethodsAmong
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