Randomised placebo-controlled and balloon-angioplasty-controlled trial to assess safety of coronary stenting with use of platelet glycoprotein-IIb/IIIa blockade.
BACKGROUND
Coronary stenting with use of heparin, aspirin, and ticlopidine for thromboprophylaxis is performed in more than 500,000 patients per year worldwide. We did a randomised controlled trial to assess the role of platelet glycoprotein-IIb/IIIa blockade for use in elective stenting.


METHODS
At 63 hospitals in the USA and Canada, 2399 patients with ischaemic heart disease and suitable coronary-artery lesions were randomly assigned stenting plus placebo (n=809), stenting plus abciximab, a IIb/IIIa inhibitor (n=794), or balloon angioplasty plus abciximab (n=796). The primary endpoint was a combination of death, myocardial infarction, or need for urgent revascularisation in the first 30 days. All patients received heparin, aspirin, and standard pharmacological therapy.


RESULTS
The primary endpoint occurred in 87 (10.8%) of 809 patients in the stent plus placebo group, 42 (5.3%) of 794 in the stent plus abciximab group (hazard ratio 0.48 [95% CI 0.33-0.69] p<0.001), and 55 (6.9%) of 796 in the balloon plus abciximab group (0.63 [0.45-0.88] p=0.007). The main outcomes that occurred less with abciximab were death and large myocardial infarction--7.8% in the placebo group, 3.0% for stent plus abciximab (p<0.001), and 4.7% for balloon angioplasty plus abciximab (p=0.01). Major bleeding complications occurred in 2.2% of patients assigned stent plus placebo, 1.5% assigned stent plus abciximab, and 1.4% assigned balloon angioplasty plus abciximab (p=0.38).


CONCLUSIONS
Platelet glycoprotein-IIb/IIIa blockade with abciximab substantially improves the safety of coronary-stenting procedures. Balloon angioplasty with abciximab is safer than stenting without abciximab.
D000077284:Abciximab; D015906:Angioplasty, Balloon, Coronary; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D001241:Aspirin / Q000627:therapeutic use; D003327:Coronary Disease / Q000401:mortality / Q000628:therapy*; D003328:Coronary Thrombosis / Q000517:prevention & control; D004359:Drug Therapy, Combination; D005260:Female; D006470:Hemorrhage / Q000453:epidemiology; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000627:therapeutic use*; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology / Q000517:prevention & control; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors*; D011183:Postoperative Complications / Q000453:epidemiology; D012086:Reoperation / Q000706:statistics & numerical data; D013988:Ticlopidine / Q000627:therapeutic use
D000911:Antibodies, Monoclonal; D007140:Immunoglobulin Fab Fragments; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D013988:Ticlopidine; D001241:Aspirin; D000077284:Abciximab