RANDOMIZED 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 ticlopi dine for thromboprophylaxis is performed in more than 500 000 patients per year worldwide. We did a randomised controlled trial to assess th e 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 wer e randomly assigned stenting plus placebo (n=809), stenting plus abcix imab, a IIb/IIIa inhibitor (n=794), or balloon angioplasty plus abcixi mab (n=796). The primary endpoint was a combination of death, myocardi al infarction, or need for urgent revascularisation in the first 30 sa ys, All patients received heparin, aspirin, and standard pharmacologic al therapy. Findings The primary endpoint occurred in 87 (10.8%) of 80 9 patients in the stent plus placebo group, 42 (5.3%) of 794 in the st ent 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 [0.4 5-0.88] 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 angiopla sty 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). Interpretation Platelet glycoprotein-IIb/IIIa blockade with abcix imab substantially improves the safety of coronary-stenting procedures . Balloon angioplasty with abciximab is safer than stenting without ab ciximab.