Impact of major bleeding on 30-day mortality and clinical outcomes in patients with acute coronary syndromes: an analysis from the ACUITY Trial.
OBJECTIVE
The purpose of this study was to determine the predictors of major bleeding and the impact of major bleeding on outcomes, including mortality, in acute coronary syndromes (ACS).


BACKGROUND
Whether major bleeding independently predicts mortality in patients with ACS undergoing an early invasive strategy is undefined.


METHODS
Patients (n = 13,819) with moderate- and high-risk ACS were randomized to heparin (unfractionated or enoxaparin) plus glycoprotein IIb/IIIa inhibition (GPI), bivalirudin plus GPI, or bivalirudin monotherapy (plus provisional GPI). Logistic regression was used to determine predictors of 30-day major bleeding and mortality.


RESULTS
Major bleeding rates in patients treated with heparin plus GPI were higher versus bivalirudin monotherapy (5.7% vs. 3.0%, p < 0.001) and similar versus bivalirudin plus GPI (5.7% vs. 5.3%, p = 0.38). Independent predictors of major bleeding were advanced age, female gender, diabetes, hypertension, renal insufficiency, anemia, no prior percutaneous coronary intervention, cardiac biomarker elevation, ST-segment deviation >/=1 mm, and treatment with heparin plus GPI versus bivalirudin monotherapy. Patients with major bleeding had higher 30-day rates of mortality (7.3% vs. 1.2%, p < 0.0001), composite ischemia (23.1% vs. 6.8%, p < 0.0001), and stent thrombosis (3.4% vs. 0.6%, p < 0.0001) versus those without major bleeding. Major bleeding was an independent predictor of 30-day mortality (odds ratio 7.55, 95% confidence interval 4.68 to 12.18, p < 0.0001).


CONCLUSIONS
Major bleeding is a powerful independent predictor of 30-day mortality in patients with ACS managed invasively. Several factors independently predict major bleeding, including treatment with heparin plus GPI compared with bivalirudin monotherapy. Knowledge of these findings might be useful to reduce bleeding risk and improve outcomes in ACS.
Manoukian
Steven V
SV
Department of Medicine, Emory University School of Medicine, Atlanta, Georgia 30308, USA. steven.manoukian@emory.edu
Feit
Frederick
F
Mehran
Roxana
R
Voeltz
Michele D
MD
Ebrahimi
Ramin
R
Hamon
Martial
M
Dangas
George D
GD
Lincoff
A Michael
AM
White
Harvey D
HD
Moses
Jeffrey W
JW
King
Spencer B
SB
Ohman
E Magnus
EM
Stone
Gregg W
GW
D000208:Acute Disease; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003327:Coronary Disease / Q000188:drug therapy / Q000401:mortality* / Q000503:physiopathology; D005260:Female; D006470:Hemorrhage / Q000401:mortality* / Q000503:physiopathology; D006493:Heparin / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D013577:Syndrome; D013997:Time Factors; D016896:Treatment Outcome
D006493:Heparin