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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,

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The COGENT Trial

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  1. 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 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

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

  6. HR = 0.5595% CI = 0.36; 0.85 p=0.007 (preliminary) Placebo: 67 events, 1895 at riskTreated: 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

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