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?