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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Economic Evaluation of Bivalirudin With or Without Glycoprotein IIb/IIIa Inhibition Versus Heparin With Routine Glycoprotein IIb/IIIa Inhibition for Early Invasive Management of Acute Coronary Syndromes

Duane S. Pinto, MD, FACC^_*,_**,_*, Gregg W. Stone, MD, FACC, Chunxue Shi, MS^_**,, Elizabeth S. Dunn, MPH^_**, Matthew R. Reynolds, MD, MSc^_*,_**, Meghan York, MD^_*, Joshua Walczak, BA^_**, Ronna H. Berezin, MPH^_**, Roxana Mehran, MD, FACC, Brent T. McLaurin, MD, FACC, David A. Cox, MD, FACC^||, E. Magnus Ohman, MD, FACC^¶, A. Michael Lincoff, MD, FACC, David J. Cohen, MD, MSc, FACC^#,_** on behalf of the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) Investigators

^_* Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts
Columbia University Medical Center and Cardiovascular Research Foundation, New York, New York
Cleveland Clinic Foundation, Cleveland, Ohio
AnMed Health, Anderson, South Carolina
^|| Lehigh Valley Hospital, Allentown, Pennsylvania
^¶ Duke University Medical Center, Durham, North Carolina
^# Mid-America Heart Institute, Kansas City, Missouri
^_** Harvard Clinical Research Institute, Brookline, Massachusetts
i3 Statprobe/UHG, Ann Arbor, Michigan

Manuscript received January 14, 2008; revised manuscript received July 7, 2008, accepted August 11, 2008.

^_* Reprint requests and correspondence: Dr. Duane S. Pinto, Division of Cardiology, Beth Israel Deaconess Medical Center, 1 Deaconess Road, Boston, Massachusetts 02115 (Email: dpinto{at}bidmc.harvard.edu).

Objectives: The aim of this study was to determine the economic impact of several anticoagulation strategies for moderate- and high-risk non–ST-segment elevation acute coronary syndrome (NSTE-ACS) patients managed invasively.

Background: The ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial demonstrated that bivalirudin monotherapy yields similar rates of ischemic complications and less bleeding than regimens incorporating glycoprotein IIb/IIIa receptor inhibitors (GPI) for moderate- and high-risk NSTE-ACS.

Methods: In ACUITY, 7,851 U.S. patients were randomized to: 1) heparin (unfractionated or enoxaparin) + GPI; 2) bivalirudin + GPI; or 3) bivalirudin monotherapy. Patients assigned to GPI were also randomized to upstream GPI before catheterization or selective GPI only with percutaneous coronary intervention. Resource use data were collected prospectively through 30-day follow-up. Costs were estimated with standard methods including resource-based accounting, hospital billing data, and the Medicare fee schedule.

Results: At 30 days, ischemic events were similar for all groups. Major bleeding was reduced with bivalirudin monotherapy compared with heparin + GPI or bivalirudin + GPI (p < 0.001). Length of stay was lowest with bivalirudin monotherapy or bivalirudin + catheterization laboratory GPI (p = 0.02). Despite higher drug costs, aggregate hospital stay costs were lowest with bivalirudin monotherapy (mean difference range: $184 to $1,081, p < 0.001 for overall comparison) and at 30 days (mean difference range: $123 to $938, p = 0.005). Regression modeling demonstrated that hospital savings were primarily due to less major and minor bleeding with bivalirudin ($8,658/event and $2,282/event, respectively).

Conclusions: Among U.S. patients in the ACUITY trial, bivalirudin monotherapy compared with heparin + GPI resulted in similar protection from ischemic events, reduced bleeding, and shorter length of stay. Despite higher drug costs, aggregate hospital and 30-day costs were lowest with bivalirudin monotherapy. Thus bivalirudin monotherapy seems to be an economically attractive alternative to heparin + GPI for patients with moderate- and high-risk NSTE-ACS. (Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes [ACS]; NCT00093158)

Key Words: direct thrombin inhibition • economic analysis • non–ST-segment myocardial infarction

Abbreviations and Acronyms   CABG = coronary artery bypass graft surgery   GPI = glycoprotein IIb/IIIa receptor antagonist   LMWH = low-molecular weight heparin   LOS = length of stay   MI = myocardial infarction   NSTE-ACS = non–ST-segment elevation acute coronary syndrome   PCI = percutaneous coronary intervention   UFH = unfractionated heparin

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J. Am. Coll. Cardiol. 2008 52: A36. [Full Text] [PDF]