[name of file], 1

Mitchell W. Krucoff, MD, FACCProfessor, Medicine/CardiologyDuke University Medical Center

Director, Cardiovascular Devices UnitDirector, MDEpiNet Coordinating Center

Duke Clinical Research Institute

Study of Access For Enhancementof STEMI for Seniors:

The SAFE STEMI for Seniors Protocol

What is SAFE STEMI for Seniors? Public health clinical trial: >65 y.o STEMI

All Rights Reserved, Duke Medicine 2007

3

SAFE STEMI for Seniors: Study DesignU.S. TRI in Seniors RIVAL RIFLE STEACS MATRIX

IDE

All Rights Reserved, Duke Medicine 2007

4

Patient Flows IDE

MV PCI in STEMI PRAMI CvLPRIT

A Registry-Based Randomized TrialComparing Radial and Femoral

Approaches In WomenUndergoing Percutaneous CoronaryIntervention: The Study of Access

Enhancement of PCI forWomen (SAFE-PCI for Women) Trial

Sunil V. Rao MD, Connie N. Hess MD, Britt Barham, Laura H. Aberle,Kevin Anstrom PhD, Tejan B. Patel MD, Jesse P. Jorgensen MD,Ernest L. Mazzaferri MD, Sanjit S. Jolly MD, Alice Jacobs MD, L.

Kristin Newby MD, C. Michael Gibson MD, David F. Kong MD, RoxanaMehran MD, Ron Waksman MD, Ian C. Gilchrist MD, Brian J. McCourt,

Eric D. Peterson MD MPH, Robert A. Harrington MD, Mitchell W.Krucoff MD on behalf of the SAFE-PCI for Women Investigators

TCT 2013 Featured LBCT

Rao S et al JACC Cardiovascular Int 7(8)2014

SAFE-PCI for Women workflow

Demographics

Medical Hx

Procedural data

Index Hosp MACE

Autopopulate

Part 11 Compliant

Analytic

Database

Unique pages for trial

Randomization

65% site coordinatorworkload reduction

Efficiency Accelerates Enrollment

September 2013

Hess C et al, Am Heart J 2013

Rao S et al JACC Cardiovascular Int 7(8)2014

Lauer M et al, NEJM 2013 http://www.forbes.com/sites/larryhusten/2013/09/01/a-disruptive-taste-of-the-future/

SAFE STEMI for Seniors:Linked NCDR-Claims Data “CRN” Structure

9

1mo MonthsIndex AMI

Hospitalization

Clinical Follow-up:

CRF data fromClinical Registry

IndexProcedure

1 yr 2 yrs 3 yrs 4 yrs 5 yrs

Administrative Data

www.mdepinet.org

Strategically Coordinated Registry NetworksStrategically Coordinated Registry Networks

Krucoff MW, Normand SL et al, JAMA 2015

Partnered Problem SolvingPartnered Problem Solving

Lesson learned for registry networksLesson learned for registry networks

CathPCI Registry

SAFE STEMI enrollment timeline

CathPCI Registry

SAFE STEMI enrollment timeline

CathPCI v4.4

CathPCI v5.0 “clone” CRF CathPCI v5.0

What is SAFE STEMI for Seniors? Public health clinical trial:

Radial access PCI in seniors Multivessel PCI in seniors

IDE(s) clinical trial: DES labelling for STEMI (Medtronic) iFR guided multivessel PCI (Volcano-

Philips)

Registry-based CRN randomized trial: Index procedure (NCDR Cath-PCI) Long term follow up (Claims data)

Lesson in partnered problem solving

[name of file], 15

Mitchell W. Krucoff, MD, FACCProfessor, Medicine/CardiologyDuke University Medical Center

Director, Cardiovascular Devices UnitDirector, MDEpiNet Coordinating Center

Duke Clinical Research Institute

Study of Access For Enhancementof STEMI for Seniors:

The SAFE STEMI for Seniors Protocol