2025
Robotic-Assisted Percutaneous Coronary Intervention: Final Results of the PRECISION and PRECISION GRX Studies
Mahmud E, Madder R, Wohns D, Schussler J, Salisbury A, Campbell P, Patel T, Lombardi W, Nicholson W, Parikh M, Kelm N, Waksman R, Lansky A, Weisz G. Robotic-Assisted Percutaneous Coronary Intervention: Final Results of the PRECISION and PRECISION GRX Studies. Journal Of The Society For Cardiovascular Angiography & Interventions 2025, 103655. DOI: 10.1016/j.jscai.2025.103655.Peer-Reviewed Original ResearchTechnical success rateR-PCIPercutaneous coronary interventionTechnical successClinical successSuccess rateCoronary interventionCalcific lesionsLack of clinical dataSymptomatic coronary artery diseaseClinical success rateSingle-arm studyAdverse cardiovascular eventsCoronary artery diseaseBifurcation lesionsManual PCIMulticenter experienceComplex lesion typePatient cohortCardiovascular eventsResidual stenosisClinical dataRobotic percutaneous coronary interventionArtery diseaseLesions
2024
Novel Mechanical Aspiration Thrombectomy in Patients With Acute Pulmonary Embolism: Results From the Prospective APEX-AV Trial
Ranade M, Foster M, Brady P, Sokol S, Butty S, Klein A, Maholic R, Safar A, Patel T, Zlotnick D, Gans D, Pollak J, Ferrera D, Stegman B, Basra S, Moriarty J, Keeling B, Investigators A. Novel Mechanical Aspiration Thrombectomy in Patients With Acute Pulmonary Embolism: Results From the Prospective APEX-AV Trial. Journal Of The Society For Cardiovascular Angiography & Interventions 2024, 4: 102463. PMID: 40061412, PMCID: PMC11887559, DOI: 10.1016/j.jscai.2024.102463.Peer-Reviewed Original ResearchAcute intermediate-risk PEMechanical aspiration thrombectomyIntermediate-risk PEPulmonary embolismAspiration thrombectomyRV/LV ratioClot burdenAdverse eventsMm HgLow rate of adverse eventsMean pulmonary artery pressureEnd pointsRate of adverse eventsAcute pulmonary embolismPulmonary artery pressureSafety end pointDevice-related deathsTreat pulmonary embolismSingle-arm studyEffectiveness end pointAccess site bleedingStatistically significant reductionCardiac injuryClinical deteriorationArterial pressureA review of the isocitrate dehydrogenase inhibitors in management of adult patients with AML and MDS
Norman M, Yamartino K, Gerstein R, Shallis R, Mendez L, Podoltsev N, Stahl M, Eighmy W, Zeidan A. A review of the isocitrate dehydrogenase inhibitors in management of adult patients with AML and MDS. Expert Review Of Hematology 2024, 17: 755-767. PMID: 39474840, DOI: 10.1080/17474086.2024.2422554.Peer-Reviewed Original ResearchDiagnosed AMLSurvival benefitManagement of acute myeloid leukemiaDevelopment of oral therapiesIsocitrate dehydrogenase inhibitorsNewly diagnosed AMLManagement of adult patientsPost-transplant maintenanceAcute myeloid leukemiaSingle-arm studyExcellent response ratesIDH inhibitorsRelapsed AMLHypomethylating agentsInhibitor therapyMyelodysplastic syndromeOral therapyCombination therapyPost-transplantMyeloid leukemiaImproved survivalSingle-armAdult patientsAzacitidineRandomized studyNeoadjuvant vidutolimod and nivolumab in high-risk resectable melanoma: A prospective phase II trial
Davar D, Morrison R, Dzutsev A, Karunamurthy A, Chauvin J, Amatore F, Deutsch J, Das Neves R, Rodrigues R, McCulloch J, Wang H, Hartman D, Badger J, Fernandes M, Bai Y, Sun J, Cole A, Aggarwal P, Fang J, Deitrick C, Bao R, Duvvuri U, Sridharan S, Kim S, A Choudry H, Holtzman M, Pingpank J, O'Toole J, DeBlasio R, Jin Y, Ding Q, Gao W, Groetsch C, Pagliano O, Rose A, Urban C, Singh J, Divarkar P, Mauro D, Bobilev D, Wooldridge J, Krieg A, Fury M, Whiteaker J, Zhao L, Paulovich A, Najjar Y, Luke J, Kirkwood J, Taube J, Park H, Trinchieri G, Zarour H. Neoadjuvant vidutolimod and nivolumab in high-risk resectable melanoma: A prospective phase II trial. Cancer Cell 2024, 42: 1898-1918.e12. PMID: 39486411, PMCID: PMC11560503, DOI: 10.1016/j.ccell.2024.10.007.Peer-Reviewed Original ResearchConceptsPlasmacytoid dendritic cellsHigh-risk resected melanomaResected melanomaCD8<sup>+</sup> tumor-infiltrating lymphocytesAnti-PD-1 nivolumabAnti-tumor immune responseProspective phase II trialAnti-PD-1Associated with gene signaturesTumor-infiltrating lymphocytesPhase II trialResponse to therapySingle-arm studyAssociated with necrosisGut microbiotaClinical responseII trialPrimary endpointDendritic cellsTLR9 agonistsTumor microenvironmentT cellsMyeloid cellsPathological responseImmune activationTwelve-month health status response after peripheral vascular intervention for femoropopliteal lesions using Zilver PTX databases focusing on the role of preprocedural health status, comorbid risks, and global setting
Smolderen K, Romain G, Cleman J, Callegari S, Peri-Okonny P, Mena-Hurtado C. Twelve-month health status response after peripheral vascular intervention for femoropopliteal lesions using Zilver PTX databases focusing on the role of preprocedural health status, comorbid risks, and global setting. Journal Of Vascular Surgery 2024, 81: 210-220.e7. PMID: 39214426, DOI: 10.1016/j.jvs.2024.08.035.Peer-Reviewed Original ResearchMinimal clinically important differenceEQ-5D indexHealth statusPeripheral vascular interventionsPeripheral arterial diseaseEQ-5DNon-respondersValue-based careEuroQol-5D-3LClinically important differenceSecondary data analysisFemoropopliteal peripheral vascular interventionsStable health statusLogistic regression modelsArtery diseaseSymptomatic peripheral arterial diseaseStatus responseTailored resourcesVascular interventionsSingle-arm studyImportant differenceCarotid artery diseaseComorbidity riskEnrolling centersPatient characteristicsA Novel Sirolimus-Coated Balloon for the Treatment of Femoropopliteal Lesions The SELUTION SFA Japan Trial
Iida O, Soga Y, Saito S, Mano T, Hayakawa N, Ichihashi S, Kawasaki D, Suzuki K, Yamaoka T, Fujihara M, Nakama T, Nakamura M, Horie K, Shah T, Lansky A, Kozuki A. A Novel Sirolimus-Coated Balloon for the Treatment of Femoropopliteal Lesions The SELUTION SFA Japan Trial. JACC Cardiovascular Interventions 2024, 17: 1547-1556. PMID: 38842992, DOI: 10.1016/j.jcin.2024.03.029.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAngioplasty, BalloonCardiovascular AgentsCoated Materials, BiocompatibleEquipment DesignFemaleFemoral ArteryHumansJapanMaleMiddle AgedPeripheral Arterial DiseasePopliteal ArteryProspective StudiesRecurrenceRisk FactorsSirolimusTime FactorsTreatment OutcomeVascular Access DevicesVascular PatencyConceptsSirolimus-coated balloonFP diseaseTreatment optionsJapan trialPrespecified performance goalTreatment of femoropopliteal lesionsClinical events committeePrimary patency rateImaging core laboratoryPeak systolic velocity ratioEffective treatment optionSingle-arm studyAdverse event ratesTarget lesion revascularizationSystolic velocity ratioAnkle-brachial index dataChronic total occlusionPrimary endpointPrimary patencySymptomatic patientsEvents committeeDays postprocedureCD-TLRDuplex ultrasoundFemoropopliteal lesionsA Safety and Feasibility Single-Arm Study of a Novel Catheter Thrombectomy Device for the Treatment of Pulmonary Embolism (ENGULF)
Kobayashi T, Secemsky E, Klein A, Faintuch S, Bulman J, Weinstein J, Bitton-Faiwiszewski Y, Bisharat M, Metzger D, Rosenberg R, Weinberg I, Vadlamudi V, Matthai W, Saleh A, Cristea E, Lansky A, Giri J. A Safety and Feasibility Single-Arm Study of a Novel Catheter Thrombectomy Device for the Treatment of Pulmonary Embolism (ENGULF). Journal Of The Society For Cardiovascular Angiography & Interventions 2024, 3: 102049. PMID: 39132596, PMCID: PMC11307881, DOI: 10.1016/j.jscai.2024.102049.Peer-Reviewed Original ResearchIntermediate-risk PELife-threatening bleedingPulmonary embolismRV/LV ratioAcute PEAdverse eventsThrombectomy catheterPostprocedure computed tomography angiographyTreatment of acute PEDevice-related serious adverse eventsTreatment of pulmonary embolismFirst-in-human studyPreprocedural computed tomography angiographyCatheter-directed embolectomyRight ventricle/left ventricleSecondary safety outcomesVARC-2 criteriaSerious adverse eventsDays post-procedureSingle-arm studyRisk of mortalityPrimary efficacyVARC-2Embolectomy devicesHours postprocedureReinterventions After CoreValve/Evolut Transcatheter or Surgical Aortic Valve Replacement for Treatment of Severe Aortic Stenosis
Grubb K, Lisko J, O'Hair D, Merhi W, Forrest J, Mahoney P, Van Mieghem N, Windecker S, Yakubov S, Williams M, Chetcuti S, Deeb G, Kleiman N, Althouse A, Reardon M. Reinterventions After CoreValve/Evolut Transcatheter or Surgical Aortic Valve Replacement for Treatment of Severe Aortic Stenosis. JACC Cardiovascular Interventions 2024, 17: 1007-1016. PMID: 38573257, DOI: 10.1016/j.jcin.2024.01.292.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAortic ValveAortic Valve StenosisFemaleHeart Valve ProsthesisHeart Valve Prosthesis ImplantationHumansIncidenceMalePostoperative ComplicationsProsthesis DesignRandomized Controlled Trials as TopicRetreatmentRisk AssessmentRisk FactorsSeverity of Illness IndexTime FactorsTranscatheter Aortic Valve ReplacementTreatment OutcomeConceptsSurgical aortic valve replacementTranscatheter aortic valve replacementIncidence of reinterventionAortic valve replacementCumulative incidence of reinterventionValve replacementValve reinterventionCumulative incidenceCoreValve transcatheter aortic valve replacementLow incidence of reinterventionSurgical aortic valve replacement patientsSingle-arm studyFirst-generation CoreValveEvolut R/ProParavalvular regurgitationReinterventionRandomized trialsLow incidenceCoreValvePooled dataTranscatheterIncidenceTreatmentYearsEndocarditis
2023
Surrogacy and the Valuation of ATMPs: Taking Our Place in the Evidence Generation/Assessment Continuum
Gladwell D, Ciani O, Parnaby A, Palmer S. Surrogacy and the Valuation of ATMPs: Taking Our Place in the Evidence Generation/Assessment Continuum. PharmacoEconomics 2023, 42: 137-144. PMID: 37991631, DOI: 10.1007/s40273-023-01334-y.Peer-Reviewed Original ResearchAdvanced therapy medicinal productsTherapy medicinal productsSurrogate primary endpointTrial-level correlationSingle-arm studyMedicinal productsMechanism of actionHealth technology assessmentPrimary endpointPatient relevanceNovel interventionsAdvanced therapiesTreatment effectsEndpointTechnology assessmentSurrogacy relationshipsSurrogate relationshipsMedical technologyTherapyAdditional avenuesIdentifying Pregnancies at Higher Risk for HPA-1a Alloimmunization and Fetal/Neonatal Alloimmune Thrombocytopenia (FNAIT): An International, Prospective, Natural History Study
Vander Haar E, Ware C, Allen G, Armstrong R, Black D, Bombara M, Dhanraj D, Lawrence L, Miller R, Nanda S, Paidas M, Patki K, Sitras V, Skupski D, Swarup M, Thorp J, Tiller H, Verweij J, Bussel J. Identifying Pregnancies at Higher Risk for HPA-1a Alloimmunization and Fetal/Neonatal Alloimmune Thrombocytopenia (FNAIT): An International, Prospective, Natural History Study. Blood 2023, 142: 1224. DOI: 10.1182/blood-2023-177657.Peer-Reviewed Original ResearchFetal/Neonatal Alloimmune ThrombocytopeniaHPA-1a alloimmunizationNeonatal alloimmune thrombocytopeniaPregnant womenHuman platelet antigensNatural history studiesFetal deathNeonatal thrombocytopeniaSecond trimesterPlatelet countAlloimmune thrombocytopeniaRisk pregnanciesWeek 10HPA-1a negative womenAdministration of prophylaxisAntenatal intravenous immunoglobulinHPA-1bb womenLifelong neurological impairmentMultiple European centersSevere neonatal thrombocytopeniaHigh-risk womenSingle-arm studyFetal platelet countGestational weeks 10First epidemiological studySabatolimab in Combination with Hypomethylating Agents (HMAs) Was Safe in Patients (Pts) with Intermediate-, High-, or Very-High-Risk Myelodysplastic Syndrome (MDS)
Garcia-Manero G, Lyons R, Nandal S, Ashraf M, Thellaboina R, Ruckel-Kumar J, Menssen H, Zeidan A. Sabatolimab in Combination with Hypomethylating Agents (HMAs) Was Safe in Patients (Pts) with Intermediate-, High-, or Very-High-Risk Myelodysplastic Syndrome (MDS). Blood 2023, 142: 4606. DOI: 10.1182/blood-2023-186490.Peer-Reviewed Original ResearchHigh-risk myelodysplastic syndromeAdverse eventsHematologic improvementPartial remissionMyelodysplastic syndromeHypomethylating agentMarrow CRInterim analysisStable diseaseData cutoffLast doseInternational Prognostic Scoring System criteriaResponse rateCount decreaseCycle 1 day 1Second-line treatment optionExtension phaseHematologic adverse eventsNeutrophil count decreaseOral hypomethylating agentPhase Ib studySerious adverse eventsFatal adverse eventsMonths of treatmentSingle-arm studySafety and Glycemic Outcomes During the MiniMedTM Advanced Hybrid Closed-Loop System Pivotal Trial in Children and Adolescents with Type 1 Diabetes
Pihoker C, Shulman D, Forlenza G, Kaiserman K, Sherr J, Thrasher J, Buckingham B, Kipnes M, Bode B, Carlson A, Lee S, Latif K, Liljenquist D, Slover R, Dai Z, Niu F, Shin J, Jonkers R, Roy A, Grosman B, Vella M, Cordero T, McVean J, Rhinehart A, Vigersky R, Bode B, Buckingham B, Carlson A, Casaubon L, Christiansen M, Cordero T, Garg S, Grosman B, Kaiserman K, Kipnes M, Latif K, Lee S, Liljenquist D, Lintereur L, Liu M, McVean J, Parikh N, Peng F, Pihoker C, Philis-Tsimikas A, Pop-Busui R, Reed J, Rhinehart A, Roy A, Sherr J, Shin J, Shulman D, Singh K, Slover R, Thrasher J, Vella M, Vigersky R, Wu D. Safety and Glycemic Outcomes During the MiniMedTM Advanced Hybrid Closed-Loop System Pivotal Trial in Children and Adolescents with Type 1 Diabetes. Diabetes Technology & Therapeutics 2023, 25: 755-764. PMID: 37782145, DOI: 10.1089/dia.2023.0255.Peer-Reviewed Original ResearchConceptsDiabetic ketoacidosisSensor glucosePivotal trialsSevere hypoglycemiaPredictive low glucose managementSingle-arm studySensor-augmented pumpType 1 diabetesEnd of studyMean sensor glucoseEffectiveness endpointTreat populationGlycemic targetsGlucose targetsInvestigational centersPrimary safetyGlycemic outcomesMean TIRA1CType 1Higher TIRStudy periodClosed-loop useCoefficient of variationLower TBRSerial Assessment of Coronary Artery Healing of a Biodegradable Polymer Drug-Eluting Stent at 1, 2, and 3 Months by Optical Coherence Tomography (OCT)-The REPAIR Trial.
Silva G, Meneguz-Moreno R, Costa R, Chamié D, Dangas G, Manica A, Arruda J, Sousa A, Feres F, Costa J. Serial Assessment of Coronary Artery Healing of a Biodegradable Polymer Drug-Eluting Stent at 1, 2, and 3 Months by Optical Coherence Tomography (OCT)-The REPAIR Trial. Journal Of Invasive Cardiology 2023, 35: e225-e233. PMID: 36920890, DOI: 10.25270/jic/22.00349.Peer-Reviewed Original ResearchConceptsOptical coherence tomographyDrug-eluting stentsCoherence tomographyStrut coverageSerial optical coherence tomographyEarly strut coverageImaging follow-upSingle-arm studyAcute coronary syndromeLocal drug toxicityPercutaneous coronary interventionType 2 diabetesFirst-generation drug-eluting stentsOpen-labelOCT assessmentBiodegradable polymer drug-eluting stentsDrug toxicityCoronary syndromeFollow-upMean agePolymer drug-eluting stentsCoronary interventionStentHealing patternPatients
2022
Enrollment Lessons from a Biological Assignment Study of Marrow Transplantation versus Standard Care for Adolescents and Young Adults with Sickle Cell Disease: Considerations for Future Gene and Cellular Therapy Trials
Krishnamurti L, Neuberg D, Sullivan K, Smith S, Eapen M, Walters M. Enrollment Lessons from a Biological Assignment Study of Marrow Transplantation versus Standard Care for Adolescents and Young Adults with Sickle Cell Disease: Considerations for Future Gene and Cellular Therapy Trials. Transplantation And Cellular Therapy 2022, 29: 217-221. PMID: 36270432, PMCID: PMC10539686, DOI: 10.1016/j.jtct.2022.10.008.Peer-Reviewed Original ResearchConceptsBone marrow transplantationSickle cell diseaseMarrow transplantationNonmalignant diseasesCell diseaseAdult sickle cell diseaseMyeloablative bone marrow transplantationSingle-arm feasibility studyYoung adultsCellular therapy trialsMulticenter National InstituteRegimen-related toxicitySingle-arm studyFrequency of HLACoronavirus disease 2019 (COVID-19) pandemicAcademic medical centerDisease 2019 pandemicShort-term endpointsBMT centersBMT regimenCare armPain episodesPrimary endpointStandard careCurative therapySafety and performance of a novel cerebral embolic protection device for transcatheter aortic valve implantation: the PROTEMBO C Trial.
Jagielak D, Targonski R, Frerker C, Abdel-Wahab M, Wilde J, Werner N, Lauterbach M, Leick J, Grygier M, Misterski M, Erglis A, Narbute I, Witkowski AR, Adam M, Frank D, Gatto F, Schmidt T, Lansky AJ. Safety and performance of a novel cerebral embolic protection device for transcatheter aortic valve implantation: the PROTEMBO C Trial. EuroIntervention 2022, 18: 590-597. PMID: 35608032, PMCID: PMC10241272, DOI: 10.4244/eij-d-22-00238.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve implantationAortic valve implantationLesion volumeValve implantationTechnical successC trialSingle lesionCerebral embolic protection devicesPerformance endpointBrain diffusion-weighted magnetic resonance imagingLarge single lesionsPrimary safety endpointBrain lesion volumeDiffusion-weighted magnetic resonance imagingCerebral protection systemSingle-arm studyEmbolic protection devicesPrimary performance endpointRate of deathMagnetic resonance imagingTAVI casesTAVI patientsVARC-2Cerebrovascular eventsPrimary endpointSafety and Glycemic Outcomes With a Tubeless Automated Insulin Delivery System in Very Young Children With Type 1 Diabetes: A Single-Arm Multicenter Clinical Trial
Sherr JL, Bode BW, Forlenza GP, Laffel LM, Schoelwer MJ, Buckingham BA, Criego AB, DeSalvo DJ, MacLeish SA, Hansen DW, Ly TT, Sherr J, Weyman K, Tichy E, VanName M, Brei M, Zgorski M, Steffen A, Carria L, Bode B, Busby A, Forlenza G, Wadwa R, Slover R, Cobry E, Messer L, Laffel L, Isganaitis E, Ambler-Osborn L, Freiner E, Turcotte C, Volkening L, Schoelwer M, Brown S, Krauthause K, Emory E, Oliveri M, Buckingham B, Ekhlaspour L, Kingman R, Criego A, Schwartz B, Gandrud L, Grieme A, Hyatt J, DeSalvo D, McKay S, DeLaO K, Villegas C, MacLeish S, Wood J, Kaminski B, Casey T, Campbell W, Behm K, Adams R, Hansen D, Stone S, Bzdick S, Bulger J, Agostini L, Doolittle S, Kivilaid K, Kleve K, Ly T, Dumais B, Vienneau T, Huyett L, Lee J, O’Connor J, Benjamin E. Safety and Glycemic Outcomes With a Tubeless Automated Insulin Delivery System in Very Young Children With Type 1 Diabetes: A Single-Arm Multicenter Clinical Trial. Diabetes Care 2022, 45: 1907-1910. PMID: 35678724, PMCID: PMC9346983, DOI: 10.2337/dc21-2359.Peer-Reviewed Original ResearchConceptsInsulin delivery systemsSingle-arm studyLong-term complicationsMulticenter clinical trialType 1 diabetesSensor glucose levelsYoung childrenBaseline data collectionReduced hypoglycemiaDiabetic ketoacidosisGlycemic targetsUsual therapyGlycemic measuresSevere hypoglycemiaDelivery systemStudy endGlycemic outcomesClinical trialsGlucose levelsType 1HypoglycemiaInvestigational systemDlChildrenStudy phaseRisk-adapted modulation through de-intensification of cancer treatments: an ESMO classification
Trapani D, Franzoi M, Burstein H, Carey L, Delaloge S, Harbeck N, Hayes D, Kalinsky K, Pusztai L, Regan M, Sestak I, Spanic T, Sparano J, Jezdic S, Cherny N, Curigliano G, Andre F. Risk-adapted modulation through de-intensification of cancer treatments: an ESMO classification. Annals Of Oncology 2022, 33: 702-712. PMID: 35550723, DOI: 10.1016/j.annonc.2022.03.273.Peer-Reviewed Original ResearchConceptsNon-inferiority clinical trialClinical trialsESMO classificationCancer treatmentPrecision Medicine Working GroupSingle-arm studyHealth system burdenOngoing clinical trialsShorter treatment durationLevel of evidenceEvidence-based criteriaQuality of lifePublic health expertsMedicine Working GroupStandard regimensCohort investigationWorking GroupCumulative doseTreatment modalitiesTreatment modulationPatient representativesTreatment durationIntermittent scheduleFinancial toxicityEvidence of reduction
2021
Safety and Glycemic Outcomes During the MiniMed™ Advanced Hybrid Closed-Loop System Pivotal Trial in Adolescents and Adults with Type 1 Diabetes
Carlson AL, Sherr JL, Shulman DI, Garg SK, Pop-Busui R, Bode BW, Lilenquist DR, Brazg RL, Kaiserman KB, Kipnes MS, Thrasher JR, Reed JHC, Slover RH, Philis-Tsimikas A, Christiansen M, Grosman B, Roy A, Vella M, Jonkers RAM, Chen X, Shin J, Cordero TL, Lee SW, Rhinehart AS, Vigersky RA. Safety and Glycemic Outcomes During the MiniMed™ Advanced Hybrid Closed-Loop System Pivotal Trial in Adolescents and Adults with Type 1 Diabetes. Diabetes Technology & Therapeutics 2021, 24: 178-189. PMID: 34694909, PMCID: PMC8971997, DOI: 10.1089/dia.2021.0319.Peer-Reviewed Original ResearchConceptsAdvanced hybrid closed-loop systemMulticenter single-arm studyPredictive low glucose managementDiabetic ketoacidosis eventsSingle-arm studySensor-augmented pumpType 1 diabetesWilcoxon signed-rank testStudy phaseKetoacidosis eventsTreat populationHybrid closed-loop systemMean A1CGlycemic targetsGlucose targetsPivotal trialsStudy endpointGlucose managementGlycemic outcomesSigned-rank testAge groupsStudy participantsType 1Safety eventsA1CSafety and efficacy of dedicated guidewire, microcatheter, and guide catheter extension technologies for chronic total coronary occlusion revascularization: Primary results of the Teleflex Chronic Total Occlusion Study
Kandzari DE, Alaswad K, Jaffer FA, Brilakis E, Croce K, Kearney K, Spaedy A, Yeh R, Thompson C, Nicholson W, Wyman RM, Riley R, Lansky A, Buller C, Karmpaliotis D. Safety and efficacy of dedicated guidewire, microcatheter, and guide catheter extension technologies for chronic total coronary occlusion revascularization: Primary results of the Teleflex Chronic Total Occlusion Study. Catheterization And Cardiovascular Interventions 2021, 99: 263-270. PMID: 34582080, DOI: 10.1002/ccd.29962.Peer-Reviewed Original ResearchConceptsMyocardial infarctionGuidewire recanalizationProcedural successCatheter extensionChronic total coronary occlusion revascularizationChronic total occlusion (CTO) percutaneous revascularizationFavorable procedural successGuide catheter extensionHigher lesion complexityHospital cardiac deathProspective registration studyTotal Occlusion StudyTarget lesion revascularizationPrevalence of diabetesPrior myocardial infarctionSingle-arm studyTIMI grade 2Femoral arterial accessJ-CTO scorePrevious bypass surgeryNon-CTO PCIHospital MACELesion revascularizationCTO revascularizationHemodynamic instabilityProspective Study Testing a Simplified Paclitaxel Premedication Regimen in Patients with Early Breast Cancer
Barroso-Sousa R, Vaz-Luis I, Di Meglio A, Hu J, Li T, Rees R, Sinclair N, Milisits L, Leone JP, Constantine M, Faggen M, Briccetti F, Block C, Partridge A, Burstein H, Waks AG, Tayob N, Trippa L, Tolaney SM, Hassett MJ, Winer EP, Lin NU. Prospective Study Testing a Simplified Paclitaxel Premedication Regimen in Patients with Early Breast Cancer. The Oncologist 2021, 26: 927-933. PMID: 34472667, PMCID: PMC8571744, DOI: 10.1002/onco.13960.Peer-Reviewed Original ResearchConceptsGrade hypersensitivity reactionsHypersensitivity reactionsPaclitaxel cyclesCycle 3Breast cancerCycle 1Grade 2 hypersensitivity reactionGrade 3 hypersensitivity reactionDose-dense doxorubicinDose-dense paclitaxelGrade 3 eventsUse of corticosteroidsEarly breast cancerSingle-arm studyAdministration of antihistaminesHistamine H2 blockersCycle 2Corticosteroid premedicationDd ACDexamethasone premedicationPaclitaxel regimenPremedication protocolDexamethasone usePaclitaxel doseProtocol therapy
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