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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,

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the cogent trial
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

slide2

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.

results
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)
slide4

Placebo: 67 events, 1821 at riskTreated: 69 events, 1806 at risk

HR = 1.0295% CI = 0.70; 1.51

Adjustment through Cox Proportional Hazards ModelAdjusted to Positive NSAID Use and Positive H. Pylori Status

composite cardiovascular event hazard ratios for baseline variables
Composite Cardiovascular Event Hazard Ratios for Baseline Variables

Vertical Line is Overall Hazard

slide6

HR = 0.5595% CI = 0.36; 0.85

p=0.007

(preliminary)

Placebo: 67 events, 1895 at riskTreated: 38 events, 1878 at risk

conclusions
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