Outcomes at 1 year and economic implications of platelet glycoprotein IIb/IIIa blockade in patients undergoing coronary stenting: results from a multicentre randomised trial

Background We assessed in a randomised trial the long-term outcomes for pot ent adjunctive antiplatelet therapy given at the time of coronary stenting. Methods In 63 hospitals in the USA and Canada, 2399 patients were randomly assigned stenting with abciximab, stenting with placebo, or balloon angiopl asty with abciximab. Standard adjunctive therapy with aspirin, ticlopidine, and heparin was used. The major outcomes of death and myocardial infarctio n were assessed at 1-year follow-up by intention to treat. We also investig ated the 1-year cost-effectiveness of combined stenting and abciximab thera py. Findings At 1-year follow-up, eight (1.0%) of 794 patients in the stent plu s abciximab group had died, compared with 19 (2.4%) of 809 in the stent plu s placebo group (hazard ratio 0.43 [95% CI 0.19-0.97], p=0.037). The combin ed endpoint of death or large myocardial infarction occurred in 42 (5.3%) a nd 89 (11.0%), respectively (0.46 [0.32-0.67], p<0.001). By multivariate mo delling, the factors independently associated with improved survival were a ssignment to stenting with abciximab (p=0.027) and greater preprocedural st enosis (p=0.002); those associated with worse survival were age greater tha n 70 years (p<0.001), previous heart failure (p=0.001), diabetes treated wi th insulin (p=0.02), and postprocedural occlusion (p<0.001). Relative to st enting plus placebo and balloon angioplasty plus abciximab, the incremental 1-year costs of stenting plus abciximab were US$581 and $932. The correspo nding cost-effectiveness ratios were US$5291 and $6213 per added life-year. Interpretation Coronary stenting with abciximab, compared with stenting alo ne or balloon angioplasty with abciximab, is associated with improved survi val and is an economically attractive therapy by conventional standards.