8:00AM - Opening Remarks / Update since September 11, 2009 Meeting
Karen A. Hicks, MD
Medical Officer, Division of Cardiovascular and Renal Products (DCRP), CDER

8:10AM - Cases used for Adjudication
8:10AM - Adjudication Results
Karen A. Hicks, MD / H.M. James Hung, Director, Division of Biometrics I
OB/OTS/CDER, FDA

8:30AM - Final Discussion of Team 1 Definitions

• Myocardial Infarction
• Cardiovascular Death
• Non Cardiovascular Death
• Undetermined Cause of Death
• Bleeding

Ken William Mahaffey, MD
Associate Professor of Medicine: Faculty Director of Cardiovascular Mega-Trials; Director of Clinical Events Classification (CEC) Group, Duke Clinical Research Institute (DCRI)

9:30AM - Final Discussion of Team 2 Definitions

• Stroke
• Coronary Revascularization Procedure
• Peripheral Revascularization Procedure
• Stent Thrombosis

Roxana Mehran, MD
Associate Professor of Medicine, Director of Outcomes Research, Data Collection, and Analysis; Center for Interventional Vascular Therapies, Columbia University Medical Center; Joint Chief Scientific Officer, Cardiovascular Research Foundation

10:30AM - Final Discussion of Team 3 Definitions

• Hospitalization for Unstable Angina
• Hospitalization for Congestive Heart Failure

Steve Nissen, MD, MACC
Department of Cardiovascular Medicine, Cleveland Clinic

11:30AM - Data Standards: Future Plans
Bron Kisler, CDISC
Brian McCourt, DCRI

11:45AM - Women CRF
Roxana Mehran, MD / Karen A. Hicks, MD
Salma Lemtouni, MD, MPH
Medical Officer, Office of Women's Health

12:00 noon - Wrap-up / Future Plans / Adjournment
Karen A. Hicks, MD
Medical Officer, Division of Cardiovascular and Renal Products (DCRP), CDER