Expedited Review
Impact of Major Bleeding on 30-Day Mortality and Clinical Outcomes in Patients With Acute Coronary Syndromes: An Analysis From the ACUITY Trial

https://doi.org/10.1016/j.jacc.2007.02.027Get rights and content
Under an Elsevier user license
open archive

Objectives

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.

Abbreviations and Acronyms

ACS
acute coronary syndromes
CABG
coronary artery bypass graft surgery
GRACE
Global Registry of Acute Coronary Events
GPI
glycoprotein IIb/IIIa inhibitor/inhibition
MI
myocardial infarction
PCI
percutaneous coronary intervention

Cited by (0)

The trial was funded by The Medicines Company, Parsippany, New Jersey, and Nycomed, Roskilde, Denmark. Drs. Manoukian, Mehran, Dangas, White, and Stone have received lecture fees from The Medicines Company. Drs. Manoukian and Stone have received lecture fees from Nycomed. Dr. Feit holds equity interests in The Medicines Company, Johnson & Johnson, and Millennium Pharmaceuticals. Drs. Feit, Ohman, White, and Stone have received consulting fees from The Medicines Company. Dr. Lincoff has received research support from The Medicines Company. Dr. White has received consulting fees and lecture fees from Sanofi-Aventis and grant support from The Medicines Company, Sanofi-Aventis, Proctor and Gamble, Schering Plough, and Eli Lilly. Dr. Moses has received consulting fees from Johnson & Johnson and is on the speaker’s bureau for Astra Zeneca. Dr. Ohman has received consulting fees from Sanofi-Aventis, Liposcience, Inovise Medical, Response Biomedical, and Savacor; holds equity interests in Medtronic and Savacor; received lecture fees from Schering Plough, Bristol Myers Squibb, and Datascope; and has received grant support from Schering Plough, Bristol Myers Squibb, and Berlex.