Abciximab (ReoPro) in coronary artery disease

Findings by SBU Alert

Version: 1

Method and target group

Monoclonal antibodies (Abciximab) are used as adjuvant therapy with heparin and acetylsalicylic acid (ASA) to counteract the formation of blood clots during various coronary artery procedures involving catheters (Percutaneous intervention, ie, PCI). PCI covers a range of methods, eg, balloon angioplasty (PTCA) and stent placement. The size of the primary target group is estimated at approximately 3500 patients annually.

Patient benefits, complications, and side effects

Several large randomized studies have shown that adjuvant therapy with abciximab in conjunction with coronary artery procedures via catheters reduces complications and improves long-term outcomes. Patients experiencing ongoing blood clot formation in the coronary arteries or patients with complicated and difficult-to-treat stenoses are thought to derive the greatest benefit from this treatment in conjunction with PCI. Particularly good results have been found in patients who also have diabetes.

Economic aspects

Data from the United States show that the total cost for coronary artery procedures in a 6- to 12-month timeframe is somewhat higher with abciximab. The widespread use of abciximab as adjuvant treatment in PCI is expected to increase the pharmaceutical costs in Sweden by 30 to 40 million SEK annually.

Scientific evidence

Alert finds that there is good* scientific documentation on the benefits of abciximab in coronary artery procedures using catheters in defined groups. There is moderate* documentation on long-term results, and poor* documentation on cost effectiveness.

Abciximab has also been tested as adjuvant treatment in PCI for acute myocardial infarction and in primary treatment of unstable coronary artery disease. It has not yet been scientifically established that abciximab benefits these indications. Preliminary data suggest that abciximab in unstable coronary artery disease does not yield any desirable effects. Its use should be limited to evidence-based indications or followed up so that better knowledge can be obtained about the effects of the drug. Using data from ongoing research, the cost effectiveness of abciximab should be studied under Swedish conditions.

*This assessment by SBU Alert uses a 4-point scale to grade the quality and evidence of the scientific documentation. The grades indicate: (1) good, (2) moderate, (3) poor, or (4) no scientific evidence on the subject.

This summary is based on a report prepared at SBU in collaboration with Assoc. Prof. Lars Grip, Sahlgrenska University Hospital, Göteborg and has been reviewed by Assoc. Prof. Kurt Boman, Skellefteå Hospital, Skellefteå.

The complete report is available in Swedish only.

Alert is a joint effort by the Swedish Council on Technology Assessment in Health Care (SBU), the Medical Products Agency, the National Board of Health and Welfare, and the Federation of Swedish County Councils.

References

1. The Capture investigators. Randomised placebo-controlled trial of abciximab before and during coronary intervention in refractory unstable angina: The CAPTURE study. The Lancet 1997;349:1429-35.
2. The Impact II investigators. Randomised placebo-controlled trial of effect of eptifibatide on complications of percutaneous coronary intervention: IMPACT II. Lancet 1997;349:1422-8.
3. The EPIC investigator group. Long-term protection from myocardial ischemic events in a randomized trial of brief integrin ß3 blockade with percutaneous coronary intervention. JAMA 1997;278:479-84.
4. The EPIC investigators. Use of monoclonal antibody directed against the platelet glycoprotein IIb/IIIa receptor in high-risk coronary angioplasty. N Engl J Med 1994;330:956-61.
5. The Epilog Investigators. Platelet glycoprotein IIb/IIIa receptor blockade and low-dose heparin during percutaneous coronary revascularisation. N Engl J Med 1997;336:1689-96.
6. The Epistent Investigators. Randomised placebo-controlled and balloon-angioplasty-controlled trial to assess safety of coronary stenting with use of platelet glycoprotein-IIb/IIIa blockade. The Lancet 1998;352:87-92.
7. The PRISM-PLUS Study Investigators. Inhibition of the platelet glycoprotein IIb/IIIa receptor with tirofiban in unstable angina and non-q-wave myocardial infarction. N Engl J Med 1998;338:1488-97.
8. Brener SJ, Barr LA, Burchenal JEB et al. Randomized, placebo-controlled trial of platelet glycoprotein IIb/IIIa blockade with primary angioplasty for acute myocardial infarction. Circulation 1998;98:734-41.
9. Goklaney AK, Murphy JD, Hillegass WBJr: Abciximab therapy in percutaneous intervention: Economic issues in the United States. Am Heart J 1998; 135: 590-97.
10. Lincoff AM, Tcheng JE, Califf RM et al. Sustained suppression of ischemic complications of coronary intervention by platelet GP IIb/IIIa blockade with abciximab: One-year outcome in the EPILOG trial. Circulation 1999;99:1951-1958.
11. Mark DB, Simons TA. Use of abciximab: Comparative economic data. Am Heart J 1999;137:S123-S125.
12. Marso SP, Lincoff M, Ellis SG et al. Optimizing the percutaneous interventional outcomes for patients with diabetes mellitus: Results of the EPISTENT diabetic substudy.Circulation 1999;100:2477.
13. Topol EJ, Mark DB, Lincoff AM et al. Outcomes at 1 year and economic implications of platelet glycoprotein IIb/IIIa blockade in patients undergoing coronary stenting: results from a multicentre randomised trial. EPISTENT investigators. Evaluation of platelet IIb/IIIa inhibitor for stenting. Lancet 1999;354:2019-2024.