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QUARTERLY FOCUS ISSUE: PREVENTION/OUTCOMES: OUTCOMES IN ACS

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

Eugenia Nikolsky, MD, PhD^_*,_*, Gregg W. Stone, MD^_*, Ajay J. Kirtane, MD, SM^_*, George D. Dangas, MD, PhD^_*, Alexandra J. Lansky, MD^_*, Brent McLaurin, MD, A. Michael Lincoff, MD, Frederick Feit, MD, Jeffrey W. Moses, MD^_*, Martin Fahy, MSc^_*, Steven V. Manoukian, MD^||, Harvey D. White, MD^_**, E. Magnus Ohman, MD^¶, Michel E. Bertrand, MD, David A. Cox, MD^# and Roxana Mehran, MD^_*

^_* Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York
New York University, New York, New York
AnMed Health, Anderson, South Carolina
The Cleveland Clinic, Cleveland, Ohio
^|| Sarah Cannon Research Institute and Hospital Corporation of America, Inc., Nashville, Tennessee
^¶ Duke University, Durham, North Carolina
^# Lehigh Valley Hospital, Allentown, Pennsylvania
^_** Auckland City Hospital, Auckland, New Zealand
Hopital Cardiologique, Lille, France

Manuscript received April 14, 2009; revised manuscript received July 8, 2009, accepted July 12, 2009.

^_* Reprint requests and correspondence: Dr. Eugenia Nikolsky, Director, Academic Affairs, Cardiovascular Research Foundation, 111 East 59th Street, 11th Floor, New York, New York 10022 (Email: enikolsky{at}crf.org).

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.

Key Words: gastrointestinal • hemorrhage • bleeding • coronary disease

Abbreviations and Acronyms   ACS = acute coronary syndrome   CABG = coronary artery bypass grafting   GIB = gastrointestinal bleeding   GPI = glycoprotein IIb/IIIa inhibitor   IQR = interquartile range   MI = myocardial infarction   PCI = percutaneous coronary intervention   TIMI = Thrombolysis In Myocardial Infarction

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