TREAT Today and Tomorrow: Pilot program & Potential Nested ...€¦ · Rao SV, et. al., JACC 2010...
Transcript of TREAT Today and Tomorrow: Pilot program & Potential Nested ...€¦ · Rao SV, et. al., JACC 2010...
TREAT Today and TREAT Today and Tomorrow: Pilot program & Tomorrow: Pilot program &
Potential Nested StudiesPotential Nested Studies
Sunil V. Rao MDSunil V. Rao MDAssistant Professor of MedicineAssistant Professor of MedicineDuke University Medical CenterDuke University Medical Center
Durham VA Medical CenterDurham VA Medical CenterDuke Clinical Research InstituteDuke Clinical Research Institute
RationaleRationale
Bleeding is a common complicationBleeding is a common complication Bleeding is associated with shortBleeding is associated with short-- and longand long--
term morbidity and mortalityterm morbidity and mortality Bleeding most commonly occurs at the Bleeding most commonly occurs at the
vascular access site in pts undergoing PCIvascular access site in pts undergoing PCI Bleeding limits the clinical use of certain Bleeding limits the clinical use of certain
antithrombotic therapiesantithrombotic therapies
PCIPCI--related complications and costsrelated complications and costsN=335,477 Medicare pts undergoing PCI in 2002N=335,477 Medicare pts undergoing PCI in 2002
Kugelmass A, et. al. Kugelmass A, et. al. AJCAJC 20062006
Bleeding in PCI Trials: Frequency and site*Bleeding in PCI Trials: Frequency and site*
*All transfemoral access*All transfemoral access
Among bleedersAmong bleeders
Rao SV, et. al., Rao SV, et. al., JACCJACC 2010 (in press)2010 (in press)
TransradialTransradial access and outcomesaccess and outcomesN=21 studies, 5600 patientsN=21 studies, 5600 patients
1.01.0 Transfemoral betterTransfemoral betterTransradial betterTransradial better
PCI Failure PCI Failure
Access site crossover Access site crossover
Death Death
Death, CVA, or MI Death, CVA, or MI
Major bleeding Major bleeding
0.27 (0.160.27 (0.16--0.45)0.45)
0.71 (0.490.71 (0.49--1.01)1.01)
0.74 (0.420.74 (0.42--1.30)1.30)
3.82 (2.833.82 (2.83--5.15)5.15)
1.31 (0.871.31 (0.87--1.96)1.96)
Jolly SS, Jolly SS, AHJAHJ 20082008
The designThe design
The goal: Can The goal: Can transradialtransradial reduce bleeding with reduce bleeding with accepted/approved accepted/approved antithromboticsantithrombotics and and INFORM THE LABEL?INFORM THE LABEL?
TransRadialTransRadial EductionEduction And Therapy (TREAT) And Therapy (TREAT) ProgramProgram A series of programs that includes both A series of programs that includes both
prospective clinical investigations, educational prospective clinical investigations, educational programs, nested studiesprograms, nested studies
Prospective registryProspective registryUses NCDR Uses NCDR CathPCICathPCI as a backboneas a backboneSite identificationSite identificationData collection with 1Data collection with 1--2 unique pages 2 unique pages
TREAT Pilot Program Design AssumptionsTREAT Pilot Program Design Assumptions
Broad sampling of clinical practiceBroad sampling of clinical practice No exclusion criteriaNo exclusion criteria Multiple anticoagulant/Multiple anticoagulant/antiplateletantiplatelet strategiesstrategies
Concomitant femoral proceduresConcomitant femoral procedures Collect complications Collect complications –– ““costscosts”” of the radial of the radial
approachapproach
Potential for nested studiesPotential for nested studies
Collect resource useCollect resource use Evaluate new devices whether designed Evaluate new devices whether designed
specifically for radial approach or notspecifically for radial approach or not Catheters, GuidesCatheters, Guides HemostasisHemostasis devicesdevices Access kitsAccess kits
Incorporate new antithrombotic strategies Incorporate new antithrombotic strategies as commercially availableas commercially available TicagrelorTicagrelor, , VorapaxarVorapaxar XaXa inhibitors, oral inhibitors, oral DTIsDTIs
TREAT TREAT -- ChallengesChallenges
Low penetration of Low penetration of transradialtransradial in the USin the US ““EE”” part of the TREATpart of the TREAT
Sampling of various antithrombotic agents Sampling of various antithrombotic agents and class effect of radial?and class effect of radial? Does an effect in one agent translate to an Does an effect in one agent translate to an
effect in another in the same class?effect in another in the same class?
Is it reasonable to expect that data from a Is it reasonable to expect that data from a registry is sufficient to inform drug labeling?registry is sufficient to inform drug labeling?