Bhnt
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The COGENT trial was a randomized controlled trial that investigated whether a fixed-dose combination of clopidogrel and omeprazole reduced gastrointestinal events compared to clopidogrel alone in patients receiving dual antiplatelet therapy. The trial found no significant difference in gastrointestinal bleeding events between the combination group and clopidogrel alone group. Additionally, the trial found no evidence that omeprazole increased the risk of cardiovascular events when combined with clopidogrel. In fact, preliminary results found the combination group had a lower risk of the composite cardiovascular endpoint compared to clopidogrel alone. The results provide reassurance that coadministration of clopidogrel and a proton pump inhibitor does not increase cardiovascular
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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 M. Scirica MD, Robert P. 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. Algorithm to Assess GI Risk With Antiplatelet Therapy GI bleeding Dual antiplatelet therapy Concomitant anticoagulant Assess GI risk factors History of ulcer complication History of ulcer disease (nonbleeding) Test for H pylori ; treat if infected More than one risk factor: Aged 60 years or more Corticosteroid use Dyspepsia or GERD symptoms Need for antiplatelet therapy Yes Yes No PPI Yes Yes Bhatt DL, Scheiman J, Abraham NS, et al. JACC 2008:52:1502–17. Circulation 2008. AJG 2008.
- 5. Risk of All-Cause Mortality and Recurrent ACS in Patients Taking Clopidogrel and PPI Ho PM, Maddox TM, Wang L, et al. JAMA. 2009;301(9):937-944. 0.70 0.60 0.50 0.40 0.30 0.20 0.10 0 0 90 180 270 360 450 540 630 720 810 900 990 1080 Days Since Discharge Proportion of Deaths or Recurrent ACS Neither clopidogrel nor PPI PPI without clopidogrel Clopidogrel + PPI Clopidogrel without PPI
- 6. CV death, MI or stroke Days CLOPIDOGREL PPI vs no PPI: Adj HR 0.94, 95% CI 0.80-1.11 PPI use at randomization (n= 4529) Clopidogrel Prasugrel PRASUGREL PPI vs no PPI: Adj HR 1.00, 95% CI 0.84-1.20 Primary endpoint stratified by use of a PPI O’Donoghue ML, Braunwald E, Antman EM, et al. Lancet . 2009.
- 13. Baseline Characteristics 0.061 1313 (69.6) 1251 (66.7) Sex – Male 0.655 29.2 kg/m 2 (5.3) 28.3 29.2 kg/m 2 (5.6) 28.4 BMI 0.984 67.2 years (11.1) 68.6 years 67.2 years (10.8) 68.7 years Age Mean (SD) Median Mean (SD) Median 0.757 114 (6.1) 208 (5.8) History of Stroke 0.426 158 (8.5) 172 (9.3) History of PAD 0.468 466 (25.0) 484 (26.1) History of MI 0.382 699 (37.5) 669 (36.1) History of ACS 0.808 1769/63/56 1756/68/51 White/Black/Other 0.456 105 (5.6) 116 (6.2) Used NSAIDs 0.938 926 (49.0) 923 (49.2) H. Pylori Positive p-value for difference Placebo n (%) Treated n (%) Variable
- 14. Adjustment through Cox Proportional Hazards Model Adjusted to Positive NSAID Use and Positive H. Pylori Status HR = 1.02 95% CI = 0.70; 1.51 Placebo: 67 events, 1821 at risk Treated: 69 events, 1806 at risk
- 15. Adjustment through Cox Proportional Hazards Model Adjusted to Positive NSAID Use and Positive H. Pylori Status HR = 0.96 95% CI = 0.59; 1.56 Placebo: 37 events, 1851 at risk Treated: 36 events, 1839 at risk
- 16. Adjustment through Cox Proportional Hazards Model Adjusted to Positive NSAID Use and Positive H. Pylori Status HR = 0.95 95% CI = 0.59; 1.55 Placebo: 67 events, 1821 at risk Treated: 69 events, 1806 at risk
- 17. Composite Cardiovascular Event Hazard Ratios for Baseline Variables Vertical Line is Overall Hazard
- 18. Composite Cardiovascular Event Hazard Ratios for Medical History Variables Vertical Line is Overall Hazard
- 19. HR = 0.55 95% CI = 0.36; 0.85 p=0.007 ( preliminary ) Placebo: 67 events, 1895 at risk Treated: 38 events, 1878 at risk
Editor's Notes
- According to the consensus document: If a patient needs antiplatelet therapy, the clinician should assess the patient’s GI risk factors. [Bhatt p7] If the patient has a history of ulcer complication or of nonbleeding ulcer disease, evaluate whether H pylori infection is present and treat if indicated, before starting chronic antiplatelet tharapy. [Bhatt p7,8] Proton pump inhibitors should be prescribed if the patient has GI bleeding, is receiving dual antiplatelet therapy, or is receiving a concomitant anticoagulant. [Bhatt p7] If none of these risk factors are present, the patient should still receive a proton pump inhibitor if more than one of the following apply: [Bhatt p7] The patient is age 60 or older The patient uses corticosteroids The patient has dyspepsia or symptoms of gastroesophageal reflux disease. Bhatt DL, Scheiman J, Abraham NS, et al. ACCF/ACG/AHA 2008 expert consensus document on reducing the gastrointestinal risks of antiplatelet therapy and NSAID use. Circulation 2008 in press; epub Oct 3 ahead of print.
- Poor responders = 16 placebo and 39 in omeprazole PRI was measured at Day 1 and omeprazole vs. placebo was given for 7 days plus clopidogrel, PRI rechecked Graph represents change from baseline; omeprazole clearly attenuates the antiplatelet effect of clopidogrel, but is this significant clinically?
- In this retrospective cohort study by Ho and colleagues, concomitant use of clopidogrel and a proton pump inhibitor (PPI) after hospital discharge for ACS was associated with an increased risk of adverse outcomes than use of clopidogrel without a PPI, suggesting that use of PPI may be associated with attenuation of benefits of clopidogrel after ACS. Of 8205 patients with ACS taking clopidogrel after hospital discharge, 63.9% (n=5244) were prescribed PPI at discharge, during follow-up, or both and 36.1% (n=2961) were not prescribed PPI. Median follow-up after hospital discharge was 521 days (interquartile range, 305-779 days). Death or rehospitalization for ACS occurred in 20.8% (n=615) of patients prescribed clopidogrel without PPI and 29.8% (n=1561) of patients prescribed clopidogrel plus PPI. In multivariable analysis, use of clopidogrel plus PPI at any point in time was associated with an increased risk of death or rehospitalization for ACS compared with use of clopidogrel without PPI (adjusted odds ratio, 1.25; 95% CI, 1.11-1.41). In multivariable analyses with medication use as a time-varying covariate, periods of use of clopidogrel without PPI were associated with a significantly lower risk of adverse events compared with periods without the use of either clopidogrel or PPI ( P <.001). However, this association appeared to be attenuated when comparing periods of use of clopidogrel plus PPI use with periods without use of either clopidogrel or PPI (shown in figure on slide). Ho PM, Maddox TM, Wang L, et al. Risk of adverse outcomes associated with concomitant use of clopidogrel and proton pump inhibitors following acute coronary syndrome. JAMA. 2009;301(9):937-944.