Consequences of major bleeding in hospitalized patients with non-ST segment elevation acute coronary syndromes receiving injectable anticoagulants^*

ABSTRACT

Objective: To evaluate the burden of major bleed in patients with non-ST segment elevation acute coronary syndromes (NSTE ACS) receiving injectable anticoagulation from the hospital perspective.

Methods: Retrospective analysis of inpatient medical and pharmacy data from the Premier Perspective Comparative Database between 1/1/2003 and 3/31/2006. Hospitalized patients aged ≥18 years with a diagnosis of UA or NSTEMI who received an injectable anticoagulant agent during the same hospital stay were stratified into two cohorts: those who experienced a major bleed during hospitalization and those who did not, defined by the presence of ≥1 pre-specified ICD-9 codes. Length of hospital stay (LOS), inpatient mortality, 30-day readmissions, and hospitalization costs over 30 days were assessed between the cohorts using statistical models to control for covariates which may have impacted the outcomes.

Results: Patients with a major bleed had significantly longer length of stay (13.8 days vs 5.6 days), higher readmission rates (31.3% vs 14.7%), and increased all-cause mortality (15.0% vs 4.5%) compared with patients who did not bleed. After controlling for covariates, major bleeding was significantly associated with increased length of stay, readmission rate, and mortality. Adjusted costs were $13 856 higher on average for patients with a major bleed (95% CI: $13 828–$18 884; p < 0.0001). Subanalyses conducted on patients aged ≥65 years and those undergoing invasive procedures demonstrated higher occurrence of bleed than the general population and a similar impact on outcomes assessed.

Conclusion: In conclusion, the study showed that patients with UA or NSTEMI who experience a major bleed have significantly longer hospital stays, higher readmission rates, increased costs, and increased mortality than those without a major bleed. These data emphasize the importance of considering the safety profile in context of the efficacy of the recommended agents. The findings from this study are limited by the retrospective study design and certain endpoints, such as readmissions, may have been underreported.

Key words: :

• Anticoagulants
• Major bleed
• Resource utilization
• Unstable angina/NSTEMI

Acknowledgments

Declaration of interest: Funding for this study was provided by GlaxoSmithKline. S.V.R. provided supervision, analysis and interpretation of the data, and critical revision of the manuscript content. He received consulting fees for his time advising on this study and serves as a consultant to a number of companies, including GlaxoSmithKline, sanofi-aventis, Bristol Myers Squibb, and The Medicines Company. He also discloses receipt of grants/funding from Momenta Pharmaceuticals, Portola Pharmaceuticals, and Cordis Corporation. R.H. and L.M. are employees of GlaxoSmithKline. R.H.'s intellectual contributions to this study included conception and design; data acquisition; analysis and interpretation; drafting of the manuscript; obtaining funding; administrative and technical support; and supervision. L.M.'s contributions included study conception and design; data analysis and interpretation; drafting of the manuscript; obtaining funding; and supervision. M.F., O.E.L., and L.E.H. are employees of Xcenda, LLC, a consulting firm that conducts health economics and outcomes research and quality improvement studies for healthcare companies. Xcenda was contracted by GlaxoSmithKline to conduct the study presented in this manuscript. M.F.'s contributions included analysis and interpretation of the data and drafting of the manuscript. O.E.L.'s contributions included analysis and interpretation of the data, statistical analysis, and critical revision of the manuscript. O.E.L. had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. L.E.H.'s contributions included conception and design; analysis and interpretation; drafting of the manuscript; and statistical analysis.

Notes

* This study was selected for a poster presentation at the American College of Cardiology 57th Annual Scientific Session, Chicago, IL, USA, March 29–April 1, 2008

* The Charlson Index contains categories of comorbidities primarily derived from ICD-9 codes and was calculated during the index hospitalization plus the 3 months prior. Each category is weighted based on the adjusted risk of 1 year mortality. The overall comorbidity score reflects the cumulative increased likelihood of 1 year mortality. A higher score is indicative of a higher comorbidity burden.