Journal of the American College of Cardiology
ReplyHigh Risk of Gastrointestinal Bleeding on Dual Antiplatelet Treatment
Author + information
- Muthiah Vaduganathan, MD, MPH,
- Deepak L. Bhatt, MD, MPH∗ (dlbhattmd{at}post.harvard.edu),
- Byron L. Cryer, MD,
- Yuyin Liu, MS,
- Wen-Hua Hsieh, PhD,
- Gheorghe Doros, 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,
- Loren Laine, MD,
- Christopher P. Cannon, MD,
- COGENT Investigators
- ↵∗Brigham and Women’s Hospital, Heart & Vascular Center, 75 Francis Street, Boston, Massachusetts 02115
We thank Dr. Atay for his interest in our work (1). The COGENT (Clopidogrel and the Optimization of Gastrointestinal Events Trial; NCT00557921) trial demonstrated that omeprazole safely attenuated major gastrointestinal (GI) events at 180 days compared with placebo in patients with coronary artery disease requiring dual antiplatelet therapy (DAPT) (2). Randomization in COGENT was stratified by serologic positivity for Helicobacter pylori. A similar proportion of patients had positive or intermediate H. pylori results on screening in the omeprazole and placebo arms (47.8% vs. 48.3%) (2). Although treatment eradication of H. pylori was not confirmed in COGENT, there was no heterogeneity observed in gastroprotective benefits of omeprazole by H. pylori serologic status (p = 0.47 for interaction) (2). Consistent with current expert consensus documents (3,4), proton pump inhibitor gastroprotection should be strongly considered in appropriately selected patients deemed high risk for GI bleeding on DAPT. Factors that may influence clinician decision-making regarding use of proton pump inhibitor prophylaxis during DAPT include H. pylori serologic status, older age, select concomitant medications (anticoagulants, nonsteroidal anti-inflammatory drugs, or corticosteroids), history of alcoholism, and recent upper GI bleeding or peptic ulcer disease. In addition to pharmacologic gastroprotective strategies, physicians should be aware of and attempt to minimize other alternative sources of GI bleeding in DAPT candidates. We agree with Dr. Atay that H. pylori detection and its eradication (as appropriate) represents an important adjunct to reducing upper GI bleeding risk in this population. However, we acknowledge the diagnostic complexity, pragmatic barriers to delaying potentially urgent DAPT, and practical challenges with patient adherence to multidrug treatment of H. pylori. As such, it is important to recognize that short-term prophylactic administration of proton pump inhibitor therapy in appropriately selected patients represents a simple, effective, and safe approach to reducing GI complications on DAPT, irrespective of H. pylori status.
Footnotes
Please note: The COGENT trial was funded by Cogentus Pharmaceuticals. The study investigators had full access to the trial database and retained complete control on the decision to pursue publication. The sponsor did not have the right to review or approve this letter. A full list of the COGENT investigators can be found in Bhatt DL et al. N Engl J Med 2010;363:1909-1917. Dr. Bhatt is on the advisory boards of Cardax, Elsevier Practice Update Cardiology, Medscape Cardiology, and Regado Biosciences; the board of directors of Boston VA Research Institute and Society of Cardiovascular Patient Care; is chair of the American Heart Association Quality Oversight Committee; is on the data monitoring committees of Duke Clinical Research Institute, Harvard Clinical Research Institute, Mayo Clinic, and Population Health Research Institute; has received honoraria from the American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org), Belvoir Publications (Editor-in-Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees), Harvard Clinical Research Institute (clinical trial steering committee), HMP Communications (Editor-in-Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), Population Health Research Institute (clinical trial steering committee), Slack Publications (Chief Medical Editor, Cardiology Today’s Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), and WebMD (CME steering committees); has a relationship with Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering Committee (Vice-Chair), and VA CART Research and Publications Committee (Chair); has received research funding from Amarin, Amgen, AstraZeneca, Bristol-Myers Squibb, Eisai, Ethicon, Forest Laboratories, Ischemix, Medtronic, Pfizer, Roche, Sanofi, and The Medicines Company; has received royalties from Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease); is site co-investigator for Biotronik, Boston Scientific, and St. Jude Medical; is a trustee of the American College of Cardiology; and has performed unfunded research for Cogentus (Chair of COGENT), FlowCo, PLx Pharma, and Takeda. Dr. Cryer has served as a consultant to Cogent Pharmaceuticals. Dr. Lanas has received an investigator-initiated grant from and served on advisory boards for Bayer Pharma AG. Dr. Shook is an employee of PAREXEL International. Dr. Lapuerta is an employee of Lexicon Pharmaceuticals. Dr. Goldsmith is an employee of Constellation Pharmaceuticals. Dr. Laine has served on the data safety monitoring boards for studies sponsored by Bayer and Bristol-Myers Squibb. Dr. Cannon has served on advisory boards of Bristol-Myers Squibb, Lipimedix, and Pfizer; and has received research funding from Accumetrics, Arisaph, AstraZeneca, Boehringer-Ingelheim, CSL Behring, Essentialis, GlaxoSmithKline, Janssen, Merck, Regeneron, Sanofi, and Takeda. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- American College of Cardiology Foundation
