2024
Win Ratio Analyses Using a Modified Hierarchical Composite Outcome: Insights from PARAGLIDE-HF
Shoji S, Cyr D, Hernandez A, Velazquez E, Ward J, Williamson K, Sarwat S, Starling R, Desai A, Zieroth S, Solomon S, Mentz R. Win Ratio Analyses Using a Modified Hierarchical Composite Outcome: Insights from PARAGLIDE-HF. American Heart Journal 2024 PMID: 39505123, DOI: 10.1016/j.ahj.2024.10.020.Peer-Reviewed Original ResearchNT-proBNPComposite outcomeRenal outcomesEjection fractionHeart failureN-terminal pro-B-type natriuretic peptidePro-B-type natriuretic peptideNT-proBNP thresholdsNT-proBNP changesClinically significant eventsNatriuretic peptideAssessment of treatment effectsHF hospitalizationCardiovascular deathTreatment effectsTreatment benefitComprehensive assessment of treatment effectsPrimary analysisValsartanHF visitsSecondary analysisPatientsHierarchical outcomesOutcomes
2023
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
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
2019
In‐hospital initiation of sacubitril/valsartan in acute decompensated heart failure: being in the right place at the right time
Ambrosy AP, DeVore AD, Velazquez EJ. In‐hospital initiation of sacubitril/valsartan in acute decompensated heart failure: being in the right place at the right time. European Journal Of Heart Failure 2019, 21: 1008-1011. PMID: 31218805, DOI: 10.1002/ejhf.1540.Peer-Reviewed Original ResearchClinical Outcomes in Patients With Acute Decompensated Heart Failure Randomly Assigned to Sacubitril/Valsartan or Enalapril in the PIONEER-HF Trial
Morrow DA, Velazquez EJ, DeVore AD, Desai AS, Duffy CI, Ambrosy AP, Gurmu Y, McCague K, Rocha R, Braunwald E. Clinical Outcomes in Patients With Acute Decompensated Heart Failure Randomly Assigned to Sacubitril/Valsartan or Enalapril in the PIONEER-HF Trial. Circulation 2019, 139: 2285-2288. PMID: 30955360, DOI: 10.1161/circulationaha.118.039331.Peer-Reviewed Original Research
2010
Departures from the protocol during conduct of a clinical trial: a pattern from the data record consistent with a learning curve
Taekman J, Stafford-Smith M, Velazquez E, Wright M, Phillips-Bute B, Pfeffer M, Sellers M, Pieper K, Newman M, Van de Werf F, Diaz R, Leimberger J, Califf R. Departures from the protocol during conduct of a clinical trial: a pattern from the data record consistent with a learning curve. BMJ Quality & Safety 2010, 19: 405. PMID: 20702441, PMCID: PMC3258507, DOI: 10.1136/qshc.2008.028605.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionMyocardial infarctionClinical trial researchLearning curvePatient rankMulticentre trialSlow enrollmentAcademic research organizationsPatient deathClinical trialsPatientsTrial conductTrial researchClinical researchPatient safetyPatient ordersTrialsInfarctionValsartanFirst yearDeathRecruitment ratesSimilar patternStart dateSafetyAtrial fibrillation management strategies and early mortality after myocardial infarction: results from the Valsartan in Acute Myocardial Infarction (VALIANT) Trial
Nilsson KR, Al-Khatib SM, Zhou Y, Pieper K, White HD, Maggioni AP, Kober L, Granger CB, Lewis EF, McMurray JJ, Califf RM, Velazquez EJ. Atrial fibrillation management strategies and early mortality after myocardial infarction: results from the Valsartan in Acute Myocardial Infarction (VALIANT) Trial. Heart 2010, 96: 838. PMID: 20406769, DOI: 10.1136/hrt.2009.180182.Peer-Reviewed Original ResearchConceptsRhythm control strategyAcute Myocardial Infarction trialMyocardial Infarction trialAtrial fibrillationMyocardial infarctionRate control strategyEarly mortalityAnti-arrhythmic drug therapyTreatment of AFPeri-infarct periodIncidence of strokeManagement of patientsRisk of deathLate mortalityPatient populationDrug therapyCox modelPatientsMortalityInfarctionStrokeValsartanTrialsDeathDays
2009
Usefulness of Beta Blockers in High-Risk Patients After Myocardial Infarction in Conjunction With Captopril and/or Valsartan (from the VALsartan In Acute Myocardial Infarction [VALIANT] Trial)
Califf RM, Lokhnygina Y, Velazquez EJ, McMurray JJ, Leimberger JD, Lewis EF, Diaz R, Murin J, Pfeffer MA. Usefulness of Beta Blockers in High-Risk Patients After Myocardial Infarction in Conjunction With Captopril and/or Valsartan (from the VALsartan In Acute Myocardial Infarction [VALIANT] Trial). The American Journal Of Cardiology 2009, 104: 151-157. PMID: 19576338, DOI: 10.1016/j.amjcard.2009.03.020.Peer-Reviewed Original ResearchMeSH KeywordsAcute DiseaseAdrenergic beta-AntagonistsAgedAngiotensin-Converting Enzyme InhibitorsAntihypertensive AgentsCaptoprilDrug Therapy, CombinationFemaleHumansMaleMiddle AgedMultivariate AnalysisMyocardial InfarctionProspective StudiesRisk AssessmentRisk FactorsSurvival AnalysisTetrazolesTreatment OutcomeValineValsartanConceptsBeta blockersHeart failureMyocardial infarctionBaseline characteristicsAcute Myocardial Infarction trialAngiotensin receptor blocker valsartanCombination of valsartanNonfatal cardiovascular eventsAngiotensin receptor blockersBeta-blocker useMyocardial Infarction trialVentricular systolic dysfunctionHigh-risk patientsRisk of deathSignificant survival advantageCardiovascular eventsSystolic dysfunctionVentricular dysfunctionVentricular functionSurvival advantageLower riskPatientsMortality rateBlockersValsartan
2006
The Effect of Valsartan, Captopril, or Both on Atherosclerotic Events After Acute Myocardial Infarction An Analysis of the Valsartan in Acute Myocardial Infarction Trial (VALIANT)
McMurray J, Solomon S, Pieper K, Reed S, Rouleau J, Velazquez E, White H, Howlett J, Swedberg K, Maggioni A, Køber L, Van de Werf F, Califf R, Pfeffer M. The Effect of Valsartan, Captopril, or Both on Atherosclerotic Events After Acute Myocardial Infarction An Analysis of the Valsartan in Acute Myocardial Infarction Trial (VALIANT). Journal Of The American College Of Cardiology 2006, 47: 726-733. PMID: 16487836, DOI: 10.1016/j.jacc.2005.09.055.Peer-Reviewed Original ResearchMeSH KeywordsAgedAngina PectorisAngiotensin II Type 1 Receptor BlockersAngiotensin-Converting Enzyme InhibitorsAtherosclerosisCaptoprilCardiovascular DiseasesDisease-Free SurvivalDrug Therapy, CombinationFemaleHumansMaleMiddle AgedMyocardial InfarctionRandomized Controlled Trials as TopicRecurrenceStrokeTetrazolesValineValsartanConceptsAngiotensin receptor blockersAcute Myocardial Infarction trialMyocardial Infarction trialAtherosclerotic eventsMyocardial infarctionACE inhibitorsValsartan groupReceptor blockersEnzyme inhibitorsNon-fatal myocardial infarctionAngiotensin-converting enzyme inhibitorAnti-infarction effectSecondary preventive treatmentEffect of valsartanRenin-angiotensin systemBlood pressure differenceEffects of captoprilAcute myocardial infarctionCaptopril groupCombination groupPreventive treatmentLower riskEvidence gapsCaptoprilValsartan
2005
Resource use, costs, and quality of life among patients in the multinational Valsartan in Acute Myocardial Infarction Trial (VALIANT)
Reed SD, Radeva JI, Weinfurt KP, McMurray JJ, Pfeffer MA, Velazquez EJ, Allsbrook JS, Masselink LE, Sellers MA, Califf RM, Schulman KA, Investigators F. Resource use, costs, and quality of life among patients in the multinational Valsartan in Acute Myocardial Infarction Trial (VALIANT). American Heart Journal 2005, 150: 323-329. PMID: 16086938, DOI: 10.1016/j.ahj.2004.08.037.Peer-Reviewed Original ResearchMeSH KeywordsAmbulatory CareAngiotensin II Type 1 Receptor BlockersAngiotensin-Converting Enzyme InhibitorsCaptoprilDrug CostsGlobal HealthHealth Care CostsHealth ResourcesHeart FailureHospital CostsHospitalizationHumansMyocardial InfarctionProspective StudiesQuality of LifeTetrazolesValineValsartanVentricular Dysfunction, LeftConceptsQuality of lifeMyocardial infarctionAcute Myocardial Infarction trialLower medication costsMyocardial Infarction trialHealth-related qualityLinear mixed-effects regression analysisMultinational clinical trialsMixed-effects regression analysisCaptopril groupStudy medicationCardiovascular morbidityVentricular dysfunctionMost patientsHeart failureACE inhibitorsMedication costsProspective economic evaluationClinical trialsHigh riskPatientsValsartanResource useCaptoprilSignificant differences
2004
Multinational economic evaluation of valsartan in patients with chronic heart failure: results from the Valsartan Heart Failure Trial (Val-HeFT)
Reed SD, Friedman JY, Velazquez EJ, Gnanasakthy A, Califf RM, Schulman KA. Multinational economic evaluation of valsartan in patients with chronic heart failure: results from the Valsartan Heart Failure Trial (Val-HeFT). American Heart Journal 2004, 148: 122-128. PMID: 15215801, DOI: 10.1016/j.ahj.2003.12.040.Peer-Reviewed Original ResearchMeSH KeywordsAdrenergic beta-AntagonistsAgedAngiotensin II Type 1 Receptor BlockersAngiotensin-Converting Enzyme InhibitorsAntihypertensive AgentsCost-Benefit AnalysisDrug Therapy, CombinationFemaleFollow-Up StudiesHealth Care CostsHealth ResourcesHeart FailureHospitalizationHumansMaleMiddle AgedOutcome Assessment, Health CareProportional Hazards ModelsRandomized Controlled Trials as TopicTetrazolesValineValsartanConceptsValsartan Heart Failure TrialHeart failure hospitalizationHeart Failure TrialHeart failureACE inhibitorsFailure hospitalizationFailure TrialNew York Heart Association class IIIncremental costChronic heart failureMean incremental costOutpatient physician servicesBackground therapyCardiovascular medicationsNet incremental costClinical benefitPrescribed therapyClinical signsAmbulance transportationPatientsUnit cost estimatesHealth outcomesPlaceboValsartanClass IIValsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both
Pfeffer M, McMurray J, Velazquez E, Investigators V. Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both. ACC Current Journal Review 2004, 13: 31. DOI: 10.1016/j.accreview.2003.12.039.Commentaries, Editorials and Letters
2003
VALsartan In Acute myocardial iNfarcTion (VALIANT) trial: baseline characteristics in context
Velazquez EJ, Pfeffer MA, McMurray JV, Maggioni AP, Rouleau J, Van de Werf F, Kober L, White HD, Swedberg K, Leimberger JD, Gallo P, Sellers MA, Edwards S, Henis M, Califf RM, Investigators F. VALsartan In Acute myocardial iNfarcTion (VALIANT) trial: baseline characteristics in context. European Journal Of Heart Failure 2003, 5: 537-544. PMID: 12921816, DOI: 10.1016/s1388-9842(03)00112-0.Peer-Reviewed Original ResearchMeSH KeywordsAgedAngiotensin Receptor AntagonistsCaptoprilDouble-Blind MethodFemaleGlyceraldehyde-3-Phosphate DehydrogenasesHeart FailureHumansMaleMiddle AgedMulticenter Studies as TopicMyocardial InfarctionPeptide FragmentsRandomized Controlled Trials as TopicTetrazolesValineValsartanVentricular Dysfunction, LeftConceptsAcute Myocardial Infarction trialAngiotensin receptor blockadeMyocardial Infarction trialHeart failureMyocardial infarctionACEI trialsRenin-angiotensin system blockadePlacebo-controlled trialVentricular systolic dysfunctionActive-controlled trialEvidence-based careHigh-risk populationEvidence-based therapiesCardiovascular outcomesSystem blockadeSystolic dysfunctionBaseline characteristicsStandard treatmentRepresentative cohortPatientsMI trialsTrialsValsartanACEIsLVSD