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From Cardiac Safety To SAFE PCI

Explore the journey from cardiac safety research to the development of SAFE PCI, a public-private partnership focused on improving data quality and efficiency in PCI procedures. Learn about the multi-stakeholder perspectives, regulatory landscape, and proof-of-concept projects involved in this innovative initiative.

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From Cardiac Safety To SAFE PCI

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  1. From Cardiac Safety To SAFE PCI Mitchell W. Krucoff, MD, FACC Professor, Medicine/Cardiology Duke University Medical Center Director, Cardiovascular Devices Unit Co-Director, CSRC Duke Clinical Research Institute Cardiac Safety Research Consortium

  2. Cardiac Safety Research Consortium (CSRC):A Critical Path Public Private Partnership FDA-Duke Memo Of Understanding 2005 • Pre-competitive focus • Multi-stakeholder perspectives • Regulatory/public health landscape • “Thinktank-incubator” processes: • Barrier identification • Prioritization • Partnered solutions • Proof-of-concept projects http://www.fda.gov/oc/initiatives/criticalpath/ http://www.cardiac -safety.org

  3. www.cardiac-safety.org * Trans-Radial Education, Assessment &TrainingThe TREAT Initiative Obligatory Device-Drug Safety Interaction: Impact of device technique on drug safety *CSRC SOC Approved Research Project

  4. www.cardiac-safety.org The TREAT Initiative Launch 2010

  5. Regulatory FDA: CDER CDRH OC OWH www.cardiac-safety.org TransRadial Education, Assessment & Therapy:June 2010 Societies • ACC • SCAI • ESC • SOLACI Academia • Duke • Harvard • Cleveland Clinic • Columbia • Emory • Johns Hopkins • Mayo Clinic • Wash HrtCtr Industry • Abbott • Medtronic • Terumo • Cordis/J&J • The MEDCO • Eli Lilly (Daichi) • Sanofi/BMS Federal • NIH • AHRQ

  6. SCREEN shot of webpage • 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

  7. www.cardiac-safety.org CSRC Consensus White Papers

  8. 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

  9. 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

  10. MDEpiNet • Dr. DanicaMarinac-Dabic (FDA) • Dr. Arthur Sedrakyan (Cornell) • Dr. Sharon-Lise Normand (Harvard) • Dr. Mitchell Krucoff (Duke) http://www/fda/gov/MDEpiNet

  11. 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

  12. From Cardiac Safety To SAFE PCI Mitchell W. Krucoff, MD, FACC Professor, Medicine/Cardiology Duke University Medical Center Director, Cardiovascular Devices Unit Co-Director, CSRC Duke Clinical Research Institute Cardiac Safety Research Consortium

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