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Rationale and pathways forward in the implementation of coronary artery calcium-based enrichment of randomized trials
MiguelCainzos-AchiricaMD, MPH, PhDabDixithaAnugulaMDcReedMszarMPHdGowthamGrandhiMD, MPHeKershaw V.PatelMDaMarcio S.BittencourtMD, MPH, PhDfRonBlanksteinMDgMichael J.BlahaMD, MPHhiRoger S.BlumenthalMDhKausik K.RayMD, MPhiljDeepak L.BhattMD, MPHgKhurramNasirMD, MPH, MScab
doi : 10.1016/j.ahj.2021.09.006
Volume 243, January 2022, Pages 54-65
The Food and Drug Administration recommends prognostic enrichment of randomized controlled trials (RCTs), aimed at restricting the study population to participants most likely to have events and therefore derive benefit from a given intervention. The coronary artery calcium (CAC) score is powerful discriminator of cardiovascular risk, and in this review we discuss how CAC may be used to augment widely used prognostic enrichment paradigms of RCTs of add-on therapies in primary prevention. We describe recent studies in this space, with special attention to the ability of CAC to further stratify risk among guideline-recommended candidates for add-on risk-reduction therapies. Given the potential benefits in terms of sample size, cost reduction, and overall RCT feasibility of a CAC-based enrichment strategy, we discuss approaches that may help maximize its advantages while minimizing logistical barriers and other challenges. Specifically, use of already existing CAC data to avoid the need to re-scan participants with previously documented high CAC scores, use of increasingly available, large clinical CAC databases to facilitate the identification of potential RCT participants, and implementation of machine learning approaches to measure CAC in existing computed tomography images performed for other purposes, will most likely boost the implementation of a CAC-based enrichment paradigm in future RCTs.
Left atrial appendage occlusion vs novel oral anticoagulation for stroke prevention in atrial fibrillation: rationale and design of the multicenter randomized occlusion-AF trial
KasperKorsholmMD, PhDabDorteDamgaardMD, PhDcJan BrinkValentinMScdErik Jerome StenePackerMDeJacobOdenstedtMD, PhDfJuhaSinisaloMD, PhDgJukkaPutaalaMDhHalvorNæssMD, PhDiMohammad AhmadAl-JaziMDjJan-ErikKarlssonMD, PhDkJacobPontoppidanMD, PhDlBorisModrauMDmJakobHjortMPHnKristina LautMatzenRN, PhDaSøren PaaskeJohnsenMD, PhDdJens ErikNielsen-KudskMD, DMSca
doi : 10.1016/j.ahj.2021.08.020
Volume 243, January 2022, Pages 28-38
The NHLBI Study on Long-terM OUtcomes after the Multisystem Inflammatory Syndrome In Children (MUSIC): Design and Objectives
Dongngan T.TruongMD, MSaFelicia L.TrachtenbergPhDbGail D.PearsonMDcAudreyDionneMDdMatthew D.EliasMDeKevinFriedmanMDdKerri H.HayesbLynnMahonyMDfBrian W.McCrindleMD, MPHgMatthew E.OsterMD, MPHhVictoriaPembertonRNC, MScAndrew J.PowellMDdMark W.RussellMDiLara S.ShekerdemianMDjMary BethSonMDdMichaelTaylorMDkJane W.NewburgerMD, MPHd
doi : 10.1016/j.ahj.2021.08.003
Volume 243, January 2022, Pages 43-53
Rationale and design of the SMall Annuli Randomized To Evolut or SAPIEN Trial (SMART Trial)
Howard C.HerrmannMDaMohamedAbdel-WahabMDbGuilherme F.AttizzaniMDcWayneBatchelorMDdSabineBleizifferMDeSarahVerdolivaMSfYanpingChangMSfHemalGadaMD, MBAgLindaGillamMD, MPHhMayraGuerreroMDiPaul D.MahoneyMDjAnna SoniaPetronioMDkTobyRogersMDlmJoshuaRovinMDnMollySzerlipMDoBrianWhisenantMDpRoxanaMehranMDqDidierTchetcheMDr
doi : 10.1016/j.ahj.2021.09.011
Volume 243, January 2022, Pages 92-102
The importance of the design of observational studies in comparative effectiveness research: Lessons from the GARFIELD-AF and ORBIT-AF registries
Alfredo E.FarjatPhDaSaverioVirdoneMScaLaine E.ThomasPhDbAjay K.KakkarPhDaKaren S.PieperMScaJonathan P.PicciniMDc
Rationale and Design of the Groningen Intervention Study for the Preservation of Cardiac Function with Sodium Thiosulfate after St-segment Elevation Myocardial Infarction (GIPS-IV) trial
Marie-Sophie LYde KoningMDaPaulienvan DorpMDaSolmazAssaMD, PhDaMinke HTHartmanMD, PhDaMichielVoskuilMD, PhDbRutger LAnthonioMD, PhDcDucoVeenPhDdGabijaPundziute-Do PradoMD, PhDaTimLeinerMD, PhDeHarryvan GoorPhDfPetervan der MeerMD, PhDaDirk Jvan VeldhuisenMD, PhDaRobinNijveldtMD, PhDgErikLipsicMD , PhDaPimvan der HarstMD, PhDab
doi : 10.1016/j.ahj.2021.08.012
Volume 243, January 2022, Pages 167-176
Catheter ablation for persistent atrial fibrillation: A multicenter randomized trial of pulmonary vein isolation (PVI) versus PVI with posterior left atrial wall isolation (PWI) - The CAPLA study
DavidChiengMBBSabcdHariharanSugumarMBBS, PhDabcdLiang-HanLingMBBS, PhDabchLouiseSeganMBBSabcdSoniaAzzopardiRNabSandeepPrabhuMBBS, PhDabcgAhmedAl-KaiseyMBBScfAleksandrVoskoboinikMBBS, PhDabcdRamanathanParameswaranMBBS, PhDcfJoseph BMortonMBBS, PhDcfBhupeshPathikMBBS, PhDcfAlex JMcLellanMBBS, PhDcfhGeoffreyLeeMBChD, PhDcfMichaelWongMBBS, PhDcfiSueFinchPhDcRajeev KPathakMBBS, PhDjkDeep ChandhRajaMBBS, MDjkPrashanthanSandersMBBS, PhDl…Peter MKistlerMBBS, PhD, FHRSabcdep
doi : 10.1016/j.ahj.2021.09.015
Volume 243, January 2022, Pages 210-220
The COVID-19 pandemic and cardiovascular issues in clinical trials: Practical and regulatory issues in remote monitoring of cardiac safety
JonathanSeltzerMD, FACCaFortunatoSenatoreMD, PhD, FACCbKenFaulknerPhDcKenneth MartinSteinMDdLt StephenBrowningBSePolinaVoloshkoMDfElektra J.PapadopoulosMD, MPHg
doi : 10.1016/j.ahj.2021.09.005
Volume 243, January 2022, Pages 122-126
Relationship of ejection fraction and natriuretic peptide trajectories in heart failure with baseline reduced and mid-range ejection fraction
Kenneth C.BilchickMD, MSaPatrickStaffordMDaOlusolaLajaMDaComfortElumogoMDaPerseyBediakoMDaNoraTolbertMDaDouglasSawchMDaSthuthiDavidMD, MSaNishthaSodhiMDaAnitaBarberBSaYounghoonKwonMDbNishakiMehtaMDcBrandyPattersonMDaKhadijahBreathettMD, MSdSulaMazimbaMD, MPHa
doi : 10.1016/j.ahj.2021.08.015
Volume 243, January 2022, Pages 1-10
The prognostic importance of trajectories of neurohormones relative to left ventricular function over time in heart failure with reduced and mid-range EF (HFrEF and HFmrEF) is poorly defined.
Population health management of low-density lipoprotein cholesterol via a remote, algorithmic, navigator-executed program
JorgePlutzkyMDaMark D.BensonMDaKiraChaneyMPHaTiffany V.BuiMPHaMichaelKraftPhDaLinaMattaPharmDaMarianMcPartlinBAaDavidZelleBAaChristopher P.CannonMDaAntonDodekMDbThomas A.GazianoMDaAkshay S.DesaiMDaCalum A.MacRaeMDPhDaBenjamin M.SciricaMDa#
doi : 10.1016/j.ahj.2021.08.017
Volume 243, January 2022, Pages 15-27
In vivo evidence of atherosclerotic plaque erosion and healing in patients with acute coronary syndrome using serial optical coherence tomography imaging
YanweiYinMD*ChaoFangMD*SenqingJiangMD*JifeiWangMDYidanWangMDJunchenGuoMDFangmengLeiMDSiboSunMDXueyingPeiMDRuyiJiaMDLuluLiMScYiniWangMDHuaiYuMDJiannanDaiMD, PhDBoYuMD, PhD
doi : 10.1016/j.ahj.2021.09.007
Volume 243, January 2022, Pages 66-76
Effect of intensive versus limited monitoring on clinical trial conduct and outcomes: A randomized trial
Neel M.ButalaMDMBAabcYangSongMSaChangyuShenPhDadDavid J.CohenefRobert W.YehMDMScac
doi : 10.1016/j.ahj.2021.09.002
Volume 243, January 2022, Pages 77-86
Trends in hospitalizations for heart failure, acute myocardial infarction, and stroke in the United States from 2004 to 2018
Husam M.SalahMDaAbdul Mannan KhanMinhasMDbMuhammad ShahzebKhanMD, MSccgSafi U.KhanMDdAndrew P.AmbrosyMDefVanessaBlumerMDgMuthiahVaduganathanMDhStephen J.GreeneMDgiAmbarishPandeyMDjMaratFudimMD, MHSgi
doi : 10.1016/j.ahj.2021.09.009
Volume 243, January 2022, Pages 103-109
To determine the trends in hospitalizations for heart failure (HF), acute myocardial infarction (AMI), and stroke in the United States (US).
Long-term outcomes in patients treated with flecainide for atrial fibrillation with stable coronary artery disease
Tyson S.BurnhamBSaHeidi T.MayPhD, MSPHbTami L.BairBSbJeffrey A.AndersonMDbBrian G.CrandallMDbMichael J.CutlerDO, PhDbJohn D.DayMDbRoger A.FreedmanMDaKirk U.KnowltonMDbJoseph B.MuhlesteinMDaLeenhapongNavaravongMDaRavi A.RanjanMD, PhDaBenjamin A.SteinbergMD, MHSaT. JaredBunchMDa
doi : 10.1016/j.ahj.2021.08.013
Volume 243, January 2022, Pages 127-139
Temporal trends in utilization of transcatheter aortic valve replacement and patient characteristics: A nationwide study
Jarl E.StrangeMDaCarolineSindet-PedersenMSc, PhDabGunnar H.GislasonMD, PhDabcChristianTorp-PedersenMD, DMScdeKristian H.KragholmMD, PhDeCamillaLundahlMBeEmil L.FosbølMD, PhDfJawad H.ButtMDfLarsKøberMD, DMScfLarsSøndergaardMD, DMScfJonas B.OlesenMD, PhDa
doi : 10.1016/j.ahj.2021.09.010
Volume 243, January 2022, Pages 140-146
Inhibition of p38 MAP kinase in patients with ST-elevation myocardial infarction – findings from the LATITUDE–TIMI 60 trial
Matthew ACavenderMD, MPHaMichelle L.O'DonoghueMD, MPHbcAntonioAbbateMD, PhDdPhilipAylwardBM, BCh, PhDeKeith AAFoxfRuchira XGlaserMD, MSCEgJeong-GunParkPhDbcJoseLopez-SendonhPh GabrieleStegiMarc SSabatineMD, MPHbcDavid AMorrowMD, MPHbc
doi : 10.1016/j.ahj.2021.08.022
Volume 243, January 2022, Pages 147-157
Prevalent pharmacotherapy of US Fontan survivors: A study utilizing data from the MarketScan Commercial and Medicaid claims databases
Michael L.O'ByrneMD, MSCEabcJennifer A.FaerberPhDdHannahKatcoffMPHdJingHuangPhDaeJonathan B.EdelsonMDacDavid M.FinkelsteinMDaBethan A.LemleyMDaChristopher M.JansonMDaCatherine M.AvitabileMDaAndrew C.GlatzMD, MSCEabDavid J.GoldbergMDa
doi : 10.1016/j.ahj.2021.09.012
Volume 243, January 2022, Pages 158-166
Stopping renin-angiotensin system inhibitors after hyperkalemia and risk of adverse outcomes
YangXuPharm, PhDabEdouard L.FuMDbcMarcoTrevisanBiostatbTomasJernbergMD, PhDdArvidSjölanderBiostat, PhDbCatherine MClaseMD, PhDeJuan-JesusCarreroPharm, PhDb
doi : 10.1016/j.ahj.2021.09.014
Volume 243, January 2022, Pages 177-186
Predictors of outcome in the ISCHEMIA-CKD trial: Anatomy versus ischemia
Kevin R.BaineyMD, MScaJerome L.FlegMDbJudith S.HochmanMDcDennis F.KunichoffMPHcRebeccaAnthopolosDrPHcAlexander M.ChernyavskiyMD, PhDdMarcinDemkowMDeJuan-ManuelLopez-QuijanoMD, MsCfJorgeEscobedoMDgKian KeongPohMDhRuben B.RamosMDiEduardo G.LimaMD, PhDjHerwigSchuchlenzMDkZiad A.AliMD, DPhillmnGregg W.StoneMDoDavid J.MaronMDpSean M.O'BrienPhDqJohn A.SpertusMD, MPHrSripalBangaloreMD, MHAc
doi : 10.1016/j.ahj.2021.09.008
Volume 243, January 2022, Pages 187-200
Associations between neighborhood socioeconomic cluster and hypertension, diabetes, myocardial infarction, and coronary artery disease within a cohort of cardiac catheterization patients
Anne M.WeaverPhDaLaura A.McGuinnPhDbLucasNeasScDaRobert B.DevlinPhDaRadhikaDhingraPhDcCavin K.Ward-CavinessPhDaWayne E.CascioMDaWilliam E.KrausMDdElizabeth R.HauserPhDdDavidDiaz-SanchezPhDa
doi : 10.1016/j.ahj.2021.09.013
Volume 243, January 2022, Pages 201-209
The bleeding risk treatment paradox at the physician and hospital level: Implications for reducing bleeding in patients undergoing percutaneous coronary intervention
Amit P.AminMD, MSc, MBAaNathanFroggeMD, MBAbc$HemantKulkarniMDdGeneRidolfiRNcGregoryEwaldMDbcRachelMillerRN, MSNcBruceHallMD, PhDcSusanRogersRN, MSNeTyGluckmanMDfJepthaCurtisMDgFrederick A.MasoudiMD, MSPHhSunil V.RaoMDi
doi : 10.1016/j.ahj.2021.08.021
Volume 243, January 2022, Pages 221-231
Incidence rates and predictors of microvascular and macrovascular complications in patients with type 2 diabetes: Results from the longitudinal global discover study
Suzanne VArnoldMD, MHAabKamleshKhuntiFMedScicFengmingTangMSaHungtaChenPhDdJavierCid-RuzafaMD, DrPHeAndrewCooperPhDfPeterFeniciMDfMarilia BGomesMDgNiklasHammarPhDhLinongJiMDiGabriela LuporiniSaraivaMD, PhDdJesúsMedinaPhDjAntonioNicolucciMDkLarisaRamirezlWolfgangRathmannMD, MSPHmMarina VShestakovaMD, PhDnIichiroShimomuraMDoFilipSurmontMDg…MikhailKosiborodMDabr
doi : 10.1016/j.ahj.2021.10.181
Volume 243, January 2022, Pages 232-239
A global perspective of racial differences and outcomes in patients presenting with acute heart failure
JasperTrompMD PhDaWouterOuwerkerkPhDbcJohn G.F.ClelandMDdChanchalChandramouliPhDbChristiane E.AngermannMDeUlfDahlstromMDfGeorgErtlMDeMahmoudHassaneinMDgSergio V.PerroneMDhMathieuGhadanfarMDiAnjaSchweizerPhDjAchimObergfellMDjKennethDicksteinMD PhDkSean PCollinsMDlGerasimosFilippatosMDmCarolyn SPLamMBBS PhDn
doi : 10.1016/j.ahj.2021.09.001
Volume 243, January 2022, Pages 11-14
Important racial differences in characteristics, treatment, and outcomes of patients with acute heart failure (AHF) have been described. The objective of this analysis of the International Registry to assess medical Practice with longitudinal observation for Treatment of Heart Failure (REPORT-HF) registry was to investigate racial differences in patients with AHF according to country income level.
Impact of vomiting on P2Y12 platelet inhibition in patients with ST-elevation myocardial infarction: A prespecified subanalysis of the ON-TIME 3 trial
Anne  H.TavenierMDaRenicus  S.HermanidesMD, PhDaJan  Paul.OttervangerMD, PhDaSvetlana  V.BelitserMScbOlaf.  H.KlungelPharmD, PhDbArnoud  W.J.van ‘t HofMD, PhDacdON-TIME 3 investigators
doi : 10.1016/j.ahj.2021.08.011
Volume 243, January 2022, Pages 39-42
Trends in transcatheter and surgical aortic valve replacement in the United States, 2008-2018
Katherine AAClarkMD, MBAa1FouadChouairiBSb1BradleyKayMDaSamuel WReinhardtMDaP ElliottMillerMDaMichaelFueryMDcClancy WMullanMDdAvirupGuhaMDefTariqAhmadMDagNihar RDesaiMD, MPHag
doi : 10.1016/j.ahj.2021.03.017
Volume 243, January 2022, Pages 87-91
