Gastrointestinal Bleeding in Patients With Acute Coronary Syndromes: Incidence, Predictors, and Clinical Implications Analysis From the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) Trial

Objectives We assessed the incidence, predictors, and outcomes of gastrointestinal bleeding (GIB) in patients with acute coronary syndromes (ACS). Background GIB is a potential hemorrhagic complication in patients with ACS treated with antithrombotic and/or antiplatelet medications. The clinical outcomes associated with GIB in this setting have not been systematically studied. Methods In the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial, 13,819 patients with moderate-and high-risk ACS, enrolled at 450 centers in 17 countries between August 2003 and December 2005, were randomized to the open-label use of 1 of 3 antithrombin regimens (heparin plus a glycoprotein IIb/IIIa inhibitor, bivalirudin plus a glycoprotein IIb/IIIa inhibitor, or bivalirudin monotherapy). Results GIB within 30 days occurred in 178 patients (1.3%). Older age, baseline anemia, longer duration of study drug administration before angiogram, smoking, ST-segment deviation >= 1 mm, and diabetes were identified as independent predictors of GIB. On multivariable analysis, GIB was strongly associated with 30-day all-cause mortality (hazard ratio [HR]: 4.87 [interquartile range (IQR) 2.61 to 9.08], p < 0.0001), cardiac mortality (HR: 5.35 [IQR 2.71 to 10.59], p < 0.0001), and composite ischemia (HR: 1.94 [IQR 1.14 to 3.30], p = 0.014), as well as with 1-year all-cause mortality (HR: 3.97 [IQR 2.64 to 5.99], p < 0.0001), cardiac mortality (HR: 3.77 [IQR 2.14 to 6.63], p < 0.0001), myocardial infarction (HR: 1.74 [IQR 1.01 to 3.02], p = 0.047), and composite ischemia (HR: 1.90 [IQR 1.37 to 2.64], p = 0.0001). Patients who experienced GIB had significantly higher rates of stent thrombosis compared with patients without GIB (5.8% vs. 2.4%, p = 0.009). Conclusions GIB is a serious condition in the scenario of ACS and is independently associated with mortality and ischemic complications. (J Am Coll Cardiol 2009; 54: 1293-302) (C) 2009 by the American College of Cardiology Foundation