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).


METHODS
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.


METHODS
Patients who were at high risk for ischaemic complications after PTCA, treated in the standard manner.


METHODS
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.
Aristides
M
M
Medical Technology Assessment Group, Sydney, Australia.
Gliksman
M
M
Rajan
N
N
Davey
P
P
D000077284:Abciximab; D015906:Angioplasty, Balloon, Coronary; D000911:Antibodies, Monoclonal / Q000191:economics* / Q000627:therapeutic use; D003131:Combined Modality Therapy; D003327:Coronary Disease / Q000401:mortality / Q000517:prevention & control* / Q000628:therapy; D003362:Cost-Benefit Analysis; D018572:Disease-Free Survival; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000191:economics* / Q000627:therapeutic use; D007275:Injections, Intravenous; D008297:Male; D008390:Markov Chains; D010975:Platelet Aggregation Inhibitors / Q000191:economics* / Q000627:therapeutic use; D011446:Prospective Studies; D012008:Recurrence; D018570:Risk Assessment; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D007140:Immunoglobulin Fab Fragments; D010975:Platelet Aggregation Inhibitors; D000077284:Abciximab