1. on Behalf of the COGENT Investigators
The COGENT Trial
Deepak L. Bhatt MD, MPH, Byron Cryer MD, Charles F. Contant PhD, Marc Cohen MD, Angel Lanas MD, DSc, Thomas J. Schnitzer MD, PhD, Thomas L. Shook MD, Pablo Lapuerta MD, Mark A. Goldsmith, MD, PhD, Benjamin Scirica MD, Robert Giugliano MD, Christopher P. Cannon MD,
on Behalf of the COGENT Investigators

2. Disclosure for Dr. Bhatt
Dr. Bhatt has served as a consultant to: Arena, Astra Zeneca, Bristol-Myers Squibb, Cardax, Cogentus, Daiichi Sankyo, Eli Lilly, Eisai, Glaxo Smith Kline, Johnson & Johnson, Medtronic, Millennium, Otsuka, Paringenix, PDL, Philips, Portola, sanofi aventis, Schering Plough, Takeda, The Medicines Company, Vertex.
Principal Investigator for several potentially related studies. His institution has received funding from Bristol Myers Squibb, Eisai, Ethicon, Heartscape, Sanofi Aventis, The Medicines Company.
This presentation discusses off-label and/or investigational uses of various drugs and devices.
The trial was funded by Cogentus, though no funding received for these analyses.

3. Results 3627 patients (above the initial target of 3200) 393 sites
Median follow-up 133 days (maximum 362 days)
136 adjudicated cardiovascular events (preliminary)
105 adjudicated GI events (preliminary)

4. Placebo: 67 events, 1821 at risk Treated: 69 events, 1806 at risk
HR = % CI = 0.70; 1.51
Adjustment through Cox Proportional Hazards Model Adjusted to Positive NSAID Use and Positive H. Pylori Status

5. Composite Cardiovascular Event Hazard Ratios for Baseline Variables
Vertical Line is Overall Hazard

6. HR = 0.55 95% CI = 0.36; 0.85 p=0.007 (preliminary)
Placebo: events, 1895 at risk Treated: 38 events, 1878 at risk

7. Conclusions
COGENT is the first, randomized assessment of clopidogrel and PPIs on clinical events
The data provide strong reassurance that there is no clinically relevant adverse cardiovascular interaction between clopidogrel and PPIs
The results call into question the exact relationship between ex vivo platelet assays and clinical outcomes, especially with respect to assessing drug interactions
Platelet assays and observational data are not a substitute for RCT data
Further research is needed to define the optimal strategy to reduce GI events in patients on antithrombotic therapy, though prophylactic PPIs seem very promising