[name of file], 1

From Cardiac Safety To SAFE PCI

Mitchell W. Krucoff, MD, FACC

Professor, Medicine/CardiologyDuke University Medical Center

Director, Cardiovascular Devices UnitCo-Director, CSRC

Duke Clinical Research Institute

Cardiac Safety Research Consortium

Cardiac Safety Research Consortium

Cardiac Safety Research Consortium (CSRC):A Critical Path Public Private Partnership FDA-Duke Memo Of Understanding 2005

http://www.fda.gov/oc/initiatives/criticalpath/

http://www.cardiac -safety.org

http://www.fda.gov/oc/initiatives/criticalpath/

http://www.cardiac -safety.org

Pre-competitive focus

Multi-stakeholder perspectives

Regulatory/public health landscape

“Thinktank-incubator” processes:

1. Barrier identification

2. Prioritization

3. Partnered solutions

4. Proof-of-concept projects

[name of file], 3

Trans-Radial Education, Assessment &Training

The TREAT Initiative

Obligatory Device-Drug Safety Interaction:

Impact of device technique on drug safety

www.cardiac-safety.orgwww.cardiac-safety.org

*CSRC SOC Approved Research Project

*

The TREAT Initiative Launch 2010

www.cardiac-safety.orgwww.cardiac-safety.org

TransRadial Education, Assessment & Therapy:June 2010

Regulatory FDA:

CDER CDRH OC OWH

Regulatory FDA:

CDER CDRH OC OWH

Academia Duke Harvard Cleveland Clinic Columbia Emory Johns Hopkins Mayo Clinic Wash Hrt Ctr

Academia Duke Harvard Cleveland Clinic Columbia Emory Johns Hopkins Mayo Clinic Wash Hrt Ctr

Industry Abbott Medtronic Terumo Cordis/J&J The MEDCO Eli Lilly

(Daichi) Sanofi/BMS

Industry Abbott Medtronic Terumo Cordis/J&J The MEDCO Eli Lilly

(Daichi) Sanofi/BMS

Societies ACC SCAI ESC SOLACI

Societies ACC SCAI ESC SOLACI

Federal NIH AHRQ

Federal NIH AHRQ

www.cardiac-safety.orgwww.cardiac-safety.org

http://www.clinicaltrials.gov/ct2/show/NCT01406236?term=safe+pci+for+women&rank=1

Fruit of pre-competitive PPP (cardiac safety FDA-Duke critical path program)

First & only USA PCI study of women

Unique public health concern

POC for unique research infrastructure

CSRC Consensus White Papers

www.cardiac-safety.orgwww.cardiac-safety.org

NIH-NCRI: Linking to the ACC-NCDR for SAFERCT Efficiency in a “River” of E-Information

Index hosp:

Pt descriptors

Medications

Procedural details

Adverse events

65% workload reduction

Building on SAFE PCI for Women:SAFE STEMI for Seniors

Public health: Radial vs. Femoral Intervention Women Seniors

Regulatory: OWH IDE extension

RCT operations: linked registry efficiencies Short term F/U: NCRI-NCDR Cath PCI

Index hosp: descriptors, meds, procedure, SAEs Long term F/U: CMS Claims Data (Seniors)

1 year death, MI, stroke Collaborating Partners:

ACC, CSRC, DCRI, FDA-OWH, NIH, Medical Device & Drug Industry

ACC, CMS, CSRC, DCRI, FDA-CDRH, NHLBI, NIA, Medical Device & Drug Industry

http://www/fda/gov/MDEpiNet

MDEpiNet

Dr. Danica Marinac-Dabic (FDA)

Dr. Arthur Sedrakyan (Cornell)

Dr. Sharon-Lise Normand (Harvard)

Dr. Mitchell Krucoff (Duke)

Overview of Today’s Agenda

Plenary: Partnered Approaches to Improving Data Quality & Efficiency

SAFE PCI for Women Lunch SAFE STEMI for Seniors

Scientific issues Operational issues

[name of file], 12

From Cardiac Safety To SAFE PCI

Mitchell W. Krucoff, MD, FACC

Professor, Medicine/CardiologyDuke University Medical Center

Director, Cardiovascular Devices UnitCo-Director, CSRC

Duke Clinical Research Institute

Cardiac Safety Research Consortium

Cardiac Safety Research Consortium