title: Gastrointestinal bleeding in high risk survivors of myocardial infarction: the VALIANT Trial.
abstract: OBJECTIVE
  The risk of gastrointestinal (GI) bleeding limits the use of antiplatelet and anticoagulant drugs. Risk factors for GI bleeding in post- myocardial infarction (MI) patients have not been well defined. We sought to identify risk factors for GI bleeding in patients following MI.
  
  
  RESULTS
  The VALsartan In Acute myocardial iNfarcTion trial (VALIANT) enrolled 14 703 post-MI patients with left ventricular dysfunction and/or heart failure and followed them for a median of 24.7 months. In the present secondary analysis, times from baseline to first GI bleeding were identified from the VALIANT serious adverse event database. Potential risk factors were explored from medical history, demographics, clinical profile, and medications, both at baseline and during follow-up. We also explored the relationship between the occurrence of GI bleeding and subsequent mortality. During follow-up, 98 (0.7%) patients had a serious GI bleeding event. These patients were older, had more comorbidities, were more likely to be taking additional antiplatelet drugs, and had worse left ventricular systolic and renal function. The Kaplan-Meier estimated rate of GI bleeding at 6 months was 0.37% (95% CI 0.27-0.47). In a multivariable Cox model, dual antiplatelet therapy was the most powerful predictor of GI bleeding, with an adjusted hazard ratio of 3.18 (95% CI 1.91-5.29). Other predictors were non-white race, history of alcohol abuse, increasing age, worse New York Heart Association class, anticoagulant therapy, diabetes, lower estimated glomerular filtration rate, and male sex. Gastrointestinal bleeding was associated with increased risk of death [adjusted hazard ratio 2.54 (95% CI 1.66-3.89)].
  
  
  CONCLUSIONS
  Following MI, clinical characteristics can identify patients with increased risk of GI bleeding. The use of dual antiplatelet agents appears to be the most profound risk factor. Whether these patients would benefit from GI prophylaxis therapy remains unknown.
authors: Division of Cardiovascular Diseases, Department of Internal Medicine, Brigham and Women's Hospital, Harvard Medical School, 75 Francis St, Boston, MA 02115, USA.
authors: George V
authors: GV
authors: Moukarbel
authors: James E
authors: JE
authors: Signorovitch
authors: Marc A
authors: MA
authors: Pfeffer
authors: John J V
authors: JJ
authors: McMurray
authors: Harvey D
authors: HD
authors: White
authors: Aldo P
authors: AP
authors: Maggioni
authors: Eric J
authors: EJ
authors: Velazquez
authors: Robert M
authors: RM
authors: Califf
authors: James M
authors: JM
authors: Scheiman
authors: Scott D
authors: SD
authors: Solomon
mesh_terms: D000368:Aged; D047228:Angiotensin II Type 1 Receptor Blockers / Q000009:adverse effects*; D000925:Anticoagulants / Q000627:therapeutic use; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000139:chemically induced* / Q000401:mortality; D006333:Heart Failure / Q000150:complications / Q000401:mortality; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000401:mortality; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D012307:Risk Factors; D013777:Tetrazoles / Q000009:adverse effects*; D014633:Valine / Q000009:adverse effects / Q000031:analogs & derivatives*; D000068756:Valsartan; D018487:Ventricular Dysfunction, Left / Q000150:complications / Q000401:mortality
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D000925:Anticoagulants; D010975:Platelet Aggregation Inhibitors; D013777:Tetrazoles; D000068756:Valsartan; D014633:Valine