Pharmacoinvasive Management of Acute Coronary Syndrome in the Setting of Percutaneous Coronary Intervention: Evidence-Based, Sit

Volume 15 - Issue 11 - November, 2003
Posted on: 8/1/08
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Author(s):

1Dean J. Kereiakes, MD, 2James Tcheng, MD, 3Edward T.A. Fry, MD, 4Deepak L. Bhatt, MD, 5Gideon Bosker, MD,
6Jose G. Diez, MD, 7James J. Ferguson, III, MD, 8Glenn N. Levine, MD, 9Gary L. Schaer, MD, 10James Zidar, MD

The CATH (Cardiac Catheterization and Antithrombotic Therapy in the Hospital) Clinical Consensus Panel Report

A total of 5,225 patients were enrolled in the PARAGON B trial. Among these patients, the type of heparin used was known in 5,200 (99.5%). The median duration of therapy was 72.8 hours for UFH and 79.7 hours for LMWH. LMWH was used in about one-fifth of the study cohort. Of the 389 sites that participated, approximately 61% of the sites used UFH only, 10% used LMWH only, and 28% used either UFH or LMWH (at the discretion of the attending physician). Enoxaparin was used in 91% of the patients treated with LMWH.36 In the PARAGON B trial, use of the LMWH enoxaparin in conjunction with a GP IIb/IIIa inhibitor was safe and associated with a lower revascularization rate. The lower event rate for patients managed with LMWH in the lamifiban group was sustained at 6 months, with a lower revascularization rate (51.5% versus 42.8%) and a lower composite rate of death/MI (13.8% versus 11.9%). Bleeding was comparable in the 2 groups (1.4% with UFH versus 0.9% with LMWH). The propensity adjusted OR for 30-day revascularization was significantly lower with LMWH (OR, 0.67; 95% CI, 0.57–0.79; p < 0.001). There were no significant differences in death/MI/SRI at 30 days (p < 0.465), death/MI at 30 days (p < 0.264) and stroke at 30 days with the type of heparin used (p < 0.201) after propensity risk adjustment. These findings support the rationale for combining GP IIb/IIIa blockers and enoxaparin for interventional management of ACS.36
Pharmacoeconomic implications of the use of enoxaparin in ACS. A number of studies support the observation that enoxaparin reduces the incidence of adverse cardiovascular endpoints, including recurrent MI and the need for revascularization, without increasing major bleeding in patients with ACS, including unstable angina and acute STEMI.2,37–39 These clinical benefits are associated with economic benefits in terms of reduced expenditure on urgent revascularization procedures, the requirement for additional drug therapies, and drug administration. Accordingly, several pharmacoeconomic analyses have been conducted on the use of enoxaparin in ACS.40–43
Enoxaparin has been shown to be associated with cost-saving compared with UFH in the management of unstable angina and NSTEMI in health economic studies from Canada, the United States, the United Kingdom, South America and France.40–43 These cost savings accrue from a reduction in the cost of drug administration (primarily associated with subcutaneous dosing of enoxaparin compared with intravenous UFH), the amount of nursing time required (which increases the availability of nurses for other duties), elimination of monitoring, the need for revascularization procedures (and any complications arising from these procedures) and the duration of hospitalization.42
Glycoprotein (GP) IIb/IIIa receptor antagonists Currently, therapy with a GP IIb/IIIa antagonist for ACS patients without high-risk triggers is not supported by evidence-based trials.44 Particularly, the use of abciximab in patients being managed without revascularization may be associated with inferior outcomes.44 These observations are from the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO-IV) acute coronary syndrome trial44 and a detailed evaluation of medical therapy in previously reported GP IIb/IIIa agent trials.