Abciximab bolus with optional infusion in intervention for ST-elevation myocardial infarction.

OBJECTIVES: The standard abciximab regimen is a bolus dose followed by a 12-h infusion. Whether the bolus dose alone is sufficient for ST-elevation myocardial infarction patients receiving a high loading dose of clopidogrel is unknown. DESIGN: In an observational study, 693 consecutive patients were treated with abciximab during percutaneous coronary intervention for ST-elevation myocardial infarction. Totally 354 patients received standard strategy of abciximab bolus and infusion followed by 339 patients that recieved abciximab bolus only (271 patients) or bolus and infusion if suboptimal result (68 patients) in combination with a higher loading dose of clopidogrel (600 mg) - the modified strategy. RESULTS: The two groups were similar regarding baseline characteristics and in hospital bleeding events. At 30 days, the composite of death, re-infarction or target vessel revascularization was 9.1% in the standard and 7.5% in the modified strategy (p = 0.45). The rate of stent thrombosis was lower in the modified strategy group with 0% and 2.3% in the standard group (p < 0.001) and the mean total medical cost was lower in the modified strategy group with €8032 and €8665 in the standard group (p < 0.001). CONCLUSIONS: In primary percutaneous coronary intervention with a loading dose of 600 mg clopidogrel, it seems safe and cost-saving to give abciximab bolus with optional infusion.

Certolizumab pegol compared to natalizumab in patients with moderate to severe Crohn's disease: results of a decision analysis.

INTRODUCTION: A significant proportion of patients with Crohn's disease (CD) lose response to antibodies directed against tumor necrosis factor α (TNF). Prior TNF-antagonist failure is associated with lower rates of response to subsequent TNF-antagonist therapy. In patients failing two anti-TNF agents, a choice exists between using a third-anti-TNF therapy or natalizumab (NAT), an α-4 integrin inhibitor. A cost-effectiveness analysis comparing these competing strategies has not been performed. METHODS: A decision analytic model was constructed to compare the performance of certolizumab pegol (CZP) versus NAT in patients with moderate to severe CD. Previously published estimates of efficacy of third-line anti-TNF therapy and NAT were used to inform the model. Costs were expressed in 2010 US dollars. A 1-year time frame was used for the analysis. RESULTS: In the base case estimate, use of NAT was only marginally more effective [0.71 vs. 0.70 quality adjusted life-years (QALYs)] than CZP but was expensive with an incremental cost-effectiveness ratio (ICER) of $381,678 per QALY gained. For CZP 2 months response rate of at least 24%, NAT had an ICER above the willingness-to-pay (WTP) threshold. The model was sensitive to the costs of both therapies; for all CZP costs below $2,300 per dose, NAT had higher ICER than the WTP threshold. Substituting adalimumab for CZP resulted in similar ICER estimates and thresholds for NAT use. CONCLUSIONS: In patients with moderate to severe CD failing two TNF-antagonists, using a third TNF-antagonist therapy appears to be a cost-effective strategy without significantly compromising treatment efficacy.

Crotalidae Polyvalent Immune Fab and Cost-Effective Management of Hospital Admissions for Snakebites.

BACKGROUND: Venomous snakebites are a common clinical scenario in the Southeastern United States. CroFab® (Crotalidae Polyvalent Immune Fab (Ovine), BTG, Wales, UK) antivenom is indicated in cases involving pit vipers and is known to be expensive. The treatment protocol for snakebites is based on clinically subjective measures triggering the application, or escalation of, antivenom administration. The purpose of this study is to characterize the use of CroFab at our institution and to evaluate the impact of its use regarding cost and overall outcomes. We suspect that it is often used but potentially less often needed. We hypothesized that CroFab use was associated with increased length of stay (LOS) without an observed difference in patient outcomes. MATERIALS AND METHODS: A retrospective chart review of snakebite patients at our level-1 trauma center from 2000 to 2016 was performed. Snakebite location, snake species, number of vials of CroFab administered, hospital LOS, intensive care unit (ICU) LOS, and complications were identified for each patient. Patients were divided into CroFab (C) and no CroFab (NC) groups. RESULTS: One hundred ninety patients with venomous snakebites were included. 53.7% of patients received CroFab. There was no difference in the complication rate of C versus NC groups, (P = .1118). CroFab use was associated with longer hospital LOS (P < .0001) and ICU LOS (P < .0001). DISCUSSION: CroFab use was associated with increased LOS in our patient population. There was no difference in observed outcomes between the C and NC groups. These findings imply that CroFab is potentially over-used in our patient population.

Sensitivity analysis for causal inference using inverse probability weighting.

Evaluation of impact of potential uncontrolled confounding is an important component for causal inference based on observational studies. In this article, we introduce a general framework of sensitivity analysis that is based on inverse probability weighting. We propose a general methodology that allows both non-parametric and parametric analyses, which are driven by two parameters that govern the magnitude of the variation of the multiplicative errors of the propensity score and their correlations with the potential outcomes. We also introduce a specific parametric model that offers a mechanistic view on how the uncontrolled confounding may bias the inference through these parameters. Our method can be readily applied to both binary and continuous outcomes and depends on the covariates only through the propensity score that can be estimated by any parametric or non-parametric method. We illustrate our method with two medical data sets.

Bolus-only versus bolus + infusion of glycoprotein IIb/IIIa inhibitors during percutaneous coronary intervention.

BACKGROUND: The present study was done to analyze if glycoprotein IIb/IIIa inhibitors (GPI) bolus-only will reduce vascular/bleeding complications and cost with similar major adverse cardiac events (MACE) when compared with GPI bolus + infusion. Evidence-based therapy of GPI inhibitors during percutaneous coronary intervention (PCI) incorporates intravenous bolus followed by 12 to 18 hours of infusion. However, GPI bolus + infusion may increase vascular/bleeding complications and may not reduce MACE when compared with GPI bolus-only. METHODS: From January 1, 2003, to December 31, 2004, 2,629 consecutive patients received GPI during PCI at a single center. Of these, 1,064 patients received GPI bolus + infusion in 2003 and were compared with 1,565 patients that received GPI bolus-only in 2004. Baseline characteristics were similar in both groups. RESULTS: Patients receiving GPI bolus-only had reduced vascular/bleeding complications when compared with bolus + infusion (4.9% vs 7%, P < .05, odds ratio 0.62, 95% confidence interval 0.45-0.89). Furthermore, ischemic complications were similar in both groups, including periprocedural creatine kinase-MB enzyme release (12.8% vs 15.3%, P = NS), MACE at 30 days (3.2% vs 3%, P = NS), and death and myocardial infarction at 1 year (7.1% vs 7.8%, P = NS). In addition, GPI bolus-only reduced cost in US dollars ($323 vs $706, P < .001) and increased ambulatory PCI (13.1% vs 3.2%, P < .01), with reduced length of stay (1.1 vs 1.6 days, P < .01), when compared with GPI bolus + infusion. CONCLUSIONS: Glycoprotein inhibitor bolus-only reduces vascular/bleeding complications with similar MACE and reduced cost when compared with GPI bolus + infusion. In addition, GPI bolus-only improved ambulatory PCI and reduced length of stay. These results are consistent with a safer and cost-effective strategy for bolus-only when GPI therapy is considered during PCI.

A longitudinal analysis of outcomes associated with abciximab and eptifibatide in a consecutive series of 3074 percutaneous coronary interventions.

BACKGROUND: Although the efficacy of platelet glycoprotein IIb/IIIa inhibitors (GPIIb/IIIa) in reducing complication rates during percutaneous coronary intervention (PCI) is well established, comparative studies assessing currently approved agents as administered in current practice are limited. We studied the clinical and length of stay (LOS) outcomes of patients undergoing PCI who received either abciximab or eptifibatide. METHODS: All patients undergoing elective, urgent, or emergency PCI at Mayo Clinic Rochester between November 17, 2000 and August 31, 2004 who received either abciximab or eptifibatide were included. Clinical, angiographic, and follow-up data were prospectively recorded in the Mayo Clinic PCI Registry; administrative data recorded LOS. We used logistic and Cox proportional hazard models to estimate the risk of adverse events and generalized linear modeling to predict LOS. Propensity score and standard risk adjustments were used to account for baseline differences. RESULTS: A total of 2123 PCI patients received eptifibatide and 951 received abciximab. The adjusted odds ratio for in-hospital death and myocardial infarction (MI) with eptifibatide was 0.80 (95% CI 0.56-1.14, P = 0.21) versus abciximab. Adjusted hazard ratios for death and MI and for death, MI, or target vessel revascularization during a median follow-up of 24.6 months were 0.84 (95% CI 0.68-1.02, P = 0.08) and 0.95 (95% CI 0.81-1.11, P = 0.53), respectively. Adjusted postprocedural LOS was similar at 3.4 days. CONCLUSION: This large observational study found no evidence of a clinical or LOS advantage to physician choice of either abciximab or eptifibatide during PCI in contemporary practice.

Comparison of abciximab with "high-dose" tirofiban in patients undergoing percutaneous coronary intervention.

BACKGROUND: The TARGET study has been criticised for sub-optimal platelet inhibition with tirofiban. We aimed to compare a high-dose bolus regimen of tirofiban (hd-tirofiban) to standard dose of abciximab for patients undergoing percutaneous coronary intervention (PCI). METHODS: We assessed consecutive patients who received either hd-tirofiban (25 mcg/kg bolus followed by 0.15 mcg/kg/min infusion for 18 h) or standard dose abciximab. In-hospital and 6-month outcomes were obtained in all cases. RESULTS: Over an 18-month period, 109 patients who received hd-tirofiban were compared with 110 patients who received abciximab. Both hd-tirofiban and abciximab groups had acute coronary syndromes in 86% and 80% and diabetes in 10% and 13% respectively. Most patients had coronary stent implantation (96% vs. 98%). Thrombocytopenia (platelet count< 100,000) developed in 0.9% of patients receiving hd-tirofiban and 2% of patients receiving abciximab (p = 0.566). Bleeding requiring transfusion occurred in 7.3% and 3% of patients respectively (p = 0.118). Peri-procedural troponin rise was 0.9% in patients receiving hd-tirofiban and 5.5% in patients receiving abciximab (p = 0.07). MACE (Myocardial infarction, Stroke, Revascularisation and Death) at 6 months was 23% in the hd-tirofiban group and 20% in the abciximab group (p = 0.711). The pharmaceutical costs were AUD 322 for hd-tirofiban (one ampoule) and AUD 1,350 for abciximab (3 ampoules). CONCLUSION: There was a small increase in bleeding requiring transfusion and a lower rate of peri-procedural troponin rise in the hd-tirofiban group however, the overall 6-month MACE rates were similar in both groups. There was a considerable cost-saving with the use of hd-tirofiban. A prospective randomised trial of hd-tirofiban vs. abciximab is warranted.

Cost-effectiveness of coronary stenting and abciximab for patients with acute myocardial infarction: results from the CADILLAC (Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications) trial.

BACKGROUND: Both stenting and the glycoprotein IIb/IIIa inhibitor abciximab improve outcomes for patients undergoing primary angioplasty for acute myocardial infarction (AMI). However, the cost-effectiveness of these strategies is unknown. METHODS AND RESULTS: We performed a prospective cost-utility analysis among US participants in the CADILLAC trial. Patients with AMI (n=1703) were randomized to stenting versus balloon angioplasty (PTCA) and abciximab versus no abciximab according to a 2-by-2 factorial design. Total 1-year costs and lifetime incremental cost-effectiveness ratios, measured as cost per quality-adjusted year of life (QALY) gained, were calculated. Compared with PTCA, stenting increased procedural costs by 1148 dollars and initial hospital costs by 1384 dollars (both P<0.001). By 1-year, stenting led to fewer repeat revascularization procedures and reduced follow-up medical care costs by 1215 dollars, such that aggregate costs were similar for the PTCA and stent groups (18 690 dollars versus 18 859 dollars, P=0.75). The cost-effectiveness ratio for stenting versus PTCA was favorable at 11 237 dollars/QALY gained and remained <20 000 dollars/QALY in sensitivity analyses. Compared with standard anticoagulation, abciximab increased initial procedural costs by 1122 dollars (P<0.001). By facilitating accelerated hospital discharge, abciximab reduced length of stay by approximately 0.6 days, offsetting most of the drug costs. These cost offsets were not maintained, however; aggregate 1-year costs for the abciximab group were 1244 dollars greater than for standard therapy (19 389 dollars versus 18 145 dollars , P=0.02). Abciximab was reasonably cost-effective (cost-effectiveness ratio 21 305 dollars/QALY) only if nonsignificant differences in 1-year mortality (3.7% versus 4.3%, P=0.62) were incorporated in the analysis. CONCLUSIONS: Primary stenting is a highly cost-effective treatment for AMI. The cost-effectiveness of abciximab in this setting is uncertain and depends primarily on whether long-term survival is enhanced.

Economic assessment of platelet glycoprotein IIb/IIIa receptor blockade with abciximab and low-dose heparin during percutaneous coronary revascularization: results from the EPILOG randomized trial. Evaluation in PTCA to Improve Long-term Outcome with abciximab GP IIb/IIIa blockade.

BACKGROUND: In the EPILOG trial (Evaluation in PTCA to Improve Long-term Outcome with abciximab GP IIb/IIIa blockade), abciximab administered with weight-adjusted heparin diminished the risk of ischemic complications within 30 days by 56% among patients undergoing percutaneous coronary revascularization, without increased bleeding complications. METHODS AND RESULTS: A prospective economic assessment was performed in the 2792 patients enrolled in EPILOG. Patients were randomized to receive placebo with standard-dose weight-adjusted heparin, abciximab with low-dose weight-adjusted heparin, or abciximab with standard-dose weight-adjusted heparin during percutaneous coronary intervention. Hospital billing data for the baseline hospitalization were collected for 2581 patients (92.4% of total) and imputed for the remainder, with physician fees estimated from the Medicare Fee Schedule. For the baseline hospitalization, medical costs (hospitalization and physician fees) averaged $9632 for the placebo arm compared with $8758 (P:=0.005) and $9092 (P:=0.176) for the abciximab with low-dose and standard-dose heparin arms, respectively. Inclusive of average drug cost ($1454 to $1457), the net incremental baseline cost of these 2 abciximab strategies was $583 with low-dose weight-adjusted heparin and $914 with standard-dose weight-adjusted heparin. During 6-month follow-up, average hospital costs were not significantly different in the 3 treatment groups; cumulative net incremental costs were $1236 and $1268 in the abciximab with low-dose and standard-dose heparin groups, respectively. CONCLUSIONS: Treatment with abciximab and low-dose, weight-adjusted heparin during percutaneous coronary revascularization reduces ischemic events and associated costs, thereby offsetting some of the cost of the drug. The suppression of bleeding complications associated with this agent by heparin dose reduction optimizes the economic attractiveness of this treatment strategy.

Economic analysis of the Assessment of the Safety and Efficacy of a New Thrombolytic Regimen (ASSENT-3) study: costs of reperfusion strategies in acute myocardial infarction.

BACKGROUND: The ASSENT-3 study examined the safety and efficacy of 3 alternative regimens for ST-elevation acute myocardial infarction: full-dose tenecteplase (TNK-tPA) plus enoxaparin; half-dose TNK-tPA plus unfractionated heparin plus abciximab; and full-dose TNK-tPA plus unfractionated heparin. OBJECTIVE: The aim of the study was to examine the resource and economic effects of the 3 regimens in ASSENT-3 using empirically collected data from the trial. METHODS: Cost estimates for each resource use component collected in ASSENT-3 were derived from Medicare reimbursement rates and from detailed billing data collected as part of a previous study. Costs of study drugs were estimated using average wholesale prices. All analyses were by intention to treat. Resource use and medical costs were examined first in the United States alone, and then in the entire cohort. RESULTS: Differences in costs across treatment arms were primarily due to differences in cost of study medication. Irrespective of source of cost weights, the least expensive alternative among the 3 treatment regimens was TNK-tPA and enoxaparin. Although not statistically significant, in 80% of 1000 bootstrap replications, the TNK-tPA enoxaparin arm was associated with 30-day cost savings relative to the unfractionated heparin arm. CONCLUSION: The favorable clinical outcomes demonstrated for enoxaparin arm relative to the unfractionated heparin arm in ASSENT-3 were accompanied by a favorable distribution of costs and support the designation of this regimen as economically attractive by conventional benchmarks.

Glycoprotein IIb-IIIa inhibition with abciximab and postprocedural risk assessment: lessons from the evaluation of platelet IIb/IIIa inhibitor for stenting trial and implication for ad hoc use of glycoprotein IIb-IIIa antagonists.

BACKGROUND: Angiographic features of vessels in which stents have been deployed can be used to predict the risk of postprocedural ischemic events. The purpose of this study was to compare the effects of abciximab in patients with and without high-risk postprocedure features. METHODS AND RESULTS: Protocol-mandated stent implantation was performed in 1586 patients in the Evaluation of Platelet IIb/IIIa Inhibitor for Stenting trial, 783 of whom received abciximab, and was successful in 97% of the patients. High-risk features were defined as the presence of Thrombolysis In Myocardial Infarction (TIMI) flow <3, presence of thrombus or major dissection, or residual stenosis >10%. The primary endpoint was a composite of death, myocardial infarction, and urgent target vessel revascularization at 30 days. High-risk features were present in 21% of the patients. In patients without high-risk features after stent placement, abciximab reduced the primary endpoint from 9.0% to 3.9% (P <.001) compared with 16.2% to 8.6% (P =.046) in patients in whom high-risk features were present. There was no statistical evidence of interaction between abciximab treatment and the presence or absence of high-risk features. CONCLUSION: Glycoprotein IIb-IIIa antagonism with abciximab is equally effective in prevention of a composite of ischemic events in patients with and without high-risk features after stent placement. However, patients in whom high-risk features are present after stent placement are at increased risk of ischemic cardiac events even with abciximab treatment.

Abciximab provides cost-effective survival advantage in high-volume interventional practice.

BACKGROUND: Placebo-controlled randomized trials of platelet glycoprotein (GP) IIb/IIIa blockade during percutaneous coronary intervention have demonstrated efficacy of these agents for reducing the risk of periprocedural ischemic events. However, cost-effectiveness of this adjunctive pharmacotherapy has been scrutinized. Extrapolation of cost-efficacy observations from clinical trials to "real world" interventional practice is problematic. METHODS: Consecutive percutaneous coronary interventions (n = 1472) performed by Ohio Heart Health Center operators at The Christ Hospital, Cincinnati, Ohio, in 1997 were analyzed for procedural and long-term (6-month) outcomes and charges. Observations on cost and efficacy (survival) were adjusted for nonrandomized abciximab allocation by means of "propensity scoring" methods. RESULTS: Abciximab therapy was associated with a survival advantage to 6 months after percutaneous coronary intervention. The average reduction in mortality rate at 6 months was 3.4% (unadjusted) and 4.9% when adjusted for nonrandomization. The average charge increment to 6 months was $1512 (unadjusted) and $950 when adjusted for nonrandomization. Patients deriving the greatest reduction in mortality rates also had a reduction in total cardiovascular charges to 6 months. Distinguishing demographics of this population included multivessel coronary intervention, coronary stent deployment, intervention within 1 week of myocardial infarction, and lower left ventricular ejection fraction. The average cost per life-year gained in this study was $2875 for all patients (unadjusted) and $1243 when adjusted for nonrandomization. CONCLUSIONS: Abciximab provides a cost-effective survival advantage in high-volume interventional practice that compares favorably with currently accepted standards. Clinical and procedural demographics associated with increased cost-effectiveness included multivessel coronary intervention, stent deployment, recent (<1 week) myocardial infarction, and impaired left ventricular function.

Effectiveness and cost effectiveness of single bolus treatment with abciximab (Reo Pro) in preventing restenosis following percutaneous transluminal coronary angioplasty in high risk patients.

OBJECTIVE: To assess the clinical effectiveness and cost effectiveness of abciximab in preventing restenosis after percutaneous transluminal coronary angioplasty (PTCA). DESIGN: Data from a previous study, the EPIC trial, were used because only this trial was able to provide event data capable of constructing a cost effectiveness analysis over six months. All other study data reviewed supported the findings of the EPIC trial. To provide indicative results on long term health outcomes, survival and event-free survival were extrapolated using US epidemiological data in a Markov modelling process. SETTING AND PATIENTS: Patients who were at high risk for ischaemic complications after PTCA, treated in the standard manner. INTERVENTIONS: Abciximab was added to the regimen of intravenous heparin and aspirin. RESULTS: The EPIC study (n = 2099) indicated an 8.1% absolute reduction in serious cardiovascular events (95% confidence interval 3.1% to 12.7%) and a 23% relative risk reduction (p = 0.001). Based on the six month trial period, the additional cost per patient free from a serious event (Australian dollars) is $13,012 and for a special risk/benefit measure of outcome, the additional cost is $14,243. Epidemiological data support extended survival and ischaemic event-free survival with clinically successful PTCA. The results of the modelled analysis indicate a cost per additional life-year gained of $5547 and a cost per additional year event-free of $4285. CONCLUSIONS: At up to six months abciximab offers improvements in clinically important outcomes. A modelling exercise explores and highlights the likelihood of significant long term health benefits. The analysis provides information for decision makers and funders to consider the value for money of abciximab.

Analysis of number needed to treat and cost of platelet glycoprotein IIb/IIIa inhibitors in percutaneous coronary interventions and acute coronary syndromes.

This retrospective review and analysis of pivotal clinical trials compared acquisition costs and outcomes of platelet glycoprotein IIb/IIIa inhibitors. Absolute reduction in the number of deaths and nonfatal myocardial infarctions at 30 days, number of patients that need to be treated to prevent one event, and drug costs expended to prevent one event were assessed. In patients undergoing percutaneous coronary intervention (PCI), abciximab is the better value, especially in high-risk patients. In those with unstable angina and non-Q wave myocardial infarction, costs of eptifibatide and tirofiban were not significantly different, but the cost of tirofiban was more variable. These agents have the potential to be cost-effective if administered to populations at high risk for adverse outcomes of acute coronary syndromes or PCI. Prospective methods to identify these high-risk patients are being developed.

Experimental assessment of a new, low-cost antivenom for treatment of carpet viper (Echis ocellatus) envenoming.

Morbidity and mortality due to envenoming by the carpet viper (Echis ocellatus) in northern Nigeria remains unacceptably high and constitutes a severe economic and public health problem to the local farming community in particular. The only effective treatment of systemic envenoming is antivenom, but supplies are very limited as the little that is available is either too expensive, ineffective or both. Here, we describe a new ovine antivenom, designed both to be effective and to be available at low cost. The antivenom, a polyclonal ovine Fab preparation, provides superior protection, both in vivo and in vitro, to the best alternatives, the monospecific South African Institute of Medical Research antivenom and the polyspecific Pasteur Isper Africa antivenom. Fab fragments, which have the advantages of large volumes of distribution and, theoretically, low immuno-reactivity, are produced by a reusable solid-phase papain matrix which eliminates enzyme contamination of the product and reduces cost. The antivenom is lyophilised for increased stability and extended shelf-life in tropical climates where it is often impossible to keep such products cool.

Glycoprotein IIb/IIIa receptor antagonists: a comparative review of their use in percutaneous coronary intervention.

Antiplatelet therapy is critical during percutaneous coronary intervention (PCI) as it reduces the incidence of abrupt closure and distal thrombi embolization, which are significant acute peri-procedural complications likely responsible for the clinical adverse outcomes with PCI, namely death, myocardial infarction or urgent target vessel revascularization. Glycoprotein (GP) IIb/IIIa receptor antagonists, potent antiplatelet agents, have been specifically tested during PCI. There are currently three commercially available GP IIb/IIIa receptor antagonists and results from more than ten randomized clinical PCI trials have established their clinical efficacy and tolerability during coronary intervention. There remain questions regarding variability in efficacy among individual clinical trials and among population subsets, potential clinical differences among the available agents, and their optimal use. This article will critically review the body of evidence for clinical efficacy and tolerability of each individual tested compound, highlight potential differences among agents, and raise important issues involving their use in clinical practice.

Impact of abciximab and coronary stenting on outcomes and costs of percutaneous coronary interventions in a community hospital.

OBJECTIVE: To assess costs and outcomes of coronary stenting and balloon angioplasty with and without adjunctive treatment with abciximab for 3758 consecutive elective percutaneous coronary interventions at a single community center over the 2.5-year period between 1 January 1995 and 30 June 1997. RESULTS: Abciximab was more common among patients who had recently suffered myocardial infarction, patients with unstable angina, and patients with more complex coronary lesions. Use of abciximab in conjunction with balloon angioplasty or stenting and stenting alone was associated with significant reductions in incidence of major adverse cardiovascular events in hospital. Multivariate analysis indicated that use of abciximab and stenting were associated with significant independent effects on risk of an event. Hospital costs were increased for patients administered abciximab, treated with stenting, or both. Total costs and costs inclusive of those incurred in catheterization laboratory and pharmacy increased significantly with increasing complexity of lesions. Multivariate regression analysis (baseline cost US$5621) identified death (US$16098), emergency revascularization (US$13678), usage of multiple stents (US$1423 for each stent), and use of abciximab (US$1269) as independent predictors of a greater cost. One-year follow-up revealed significant differences among treatment strategies in terms of risk of need for subsequent revascularization procedures. Lack of stenting but not use of abciximab was identified as a significant predictor of need for repeat revascularization procedures. CONCLUSIONS: Our findings are in general agreement with cost analyses of use of abciximab for populations in clinical trials and suggest that improvements of early clinical outcome with abciximab treatment and stenting justify the incremental cost of treatment in a community hospital setting.

Association between abciximab and length of stay in intensive care for patients undergoing percutaneous coronary intervention. A 2-stage econometric model in a naturalistic setting.

OBJECTIVE: To examine the effect of abciximab treatment on intensive care length of stay for patients undergoing percutaneous coronary intervention (PCI). DESIGN AND SETTING: A retrospective study conducted in a naturalistic setting. METHODS: A 2-stage econometric model was used to control for the influence of possible selection bias across categories of patients and for both observable and unobservable factors correlated with each patient's treatment selection and length of stay in intensive care. Multivariate analysis was applied to control for a wide range of factors (patient demographics, insurance provider, health conditions, admission and discharge information, and hospital characteristics) that may influence intensive care length of stay. Retrospective data were obtained from HCIA's Clinical Pathways Database. PARTICIPANTS: Patients (n = 13,364) who were hospitalised in any of 87 hospitals across the US over the period from October 1, 1995 to December 1, 1996. RESULTS: After controlling for high-risk indications and selection bias, results indicated that administration of abciximab was associated with a significantly shorter length of stay in intensive care compared with not administering a GPIIb/IIIa inhibitor (0.45 fewer days; p < or = 0.0001). In a subgroup analysis of patients having an acute myocardial infarction (n = 4793), administration of abciximab was also associated with a significantly shorter intensive care stay (0.27 fewer days; p < 0.0001). CONCLUSION: Results of this study indicate that the administration of abciximab is associated with a reduction in the length of stay in intensive care. This reduction implies potential cost offsets for patients undergoing PCI who receive abciximab.

Economic value of thrombolysis with adjunctive abciximab in patients with subacute peripheral arterial occlusion.

BACKGROUND AND OBJECTIVE: Glycoprotein (GP) IIb/IIIa receptor inhibitors enhance thrombolysis in patients with acute coronary syndromes. This analysis evaluates the economic impact of abciximab, a GP IIb/IIIa inhibitor, as an adjunct to urokinase in peripheral artery occlusions of less than 6 weeks duration. STUDY DESIGN: A post-hoc economic analysis was performed using clinical data and inpatient resource utilisation derived from the prospective comparative phase II Platelet Receptor Antibodies in Order to Manage Peripheral Artery Thrombosis (PROMPT) pilot study. Study endpoints were amputation-free survival and survival without open surgery or major amputation after 90 days, and the rate of major complications at 30 days. PERSPECTIVE: Third-party payer and the societal perspective. PATIENTS AND METHODS: Seventy patients with lower extremity thrombi were randomised (2 : 5 ratio) to urokinase plus placebo or to urokinase plus abciximab. Economically relevant data were retrospectively derived from the clinical study database from a specific evaluation of patient records and from expert opinion. RESULTS: From the viewpoint of the society, average total per-patient direct and indirect costs accruing over 3 months were more favourable for treatment with abciximab plus urokinase than for urokinase alone [9723 euros (EUR) vs EUR10 322; 2000 values], despite higher initial hospitalisation costs of the combination therapy. Abciximab plus urokinase was the dominant strategy at 3 months due to a clinically higher rate of survival without amputation or bypass surgery coupled with a lower average per-patient cost. From the perspective of the third-party payer, treatment with abciximab plus urokinase was economically also superior to urokinase alone (EUR8773 vs EUR9663). CONCLUSIONS: Based on the preliminary findings of the PROMPT trial, the use of abciximab as an adjunct to urokinase in patients with subacute peripheral artery occlusions may be the favourable strategy compared with urokinase alone, in terms of clinical and economic outcomes. Further trials are needed to confirm these clinical and economic findings. The preliminary clinical benefits experienced by patients treated with abciximab plus urokinase in the PROMPT trial translated into cost savings in terms of reduced direct medical costs at 3 months. These cost savings more than offset the cost of abciximab. The use of abciximab as an adjunct to urokinase in patients with subacute peripheral artery occlusions may be the favourable strategy compared with urokinase-alone in terms of clinical and economic outcomes, but further trials are needed to confirm the these clinical and economic findings.