Direct coronary stent implantation does not reduce the incidence of in-stent restenosis or major adverse cardiac events: Six month results of a randomized trial

Study objectives To compare the tong-term angiographic, clinical and economic outcome of direct stenting vs stenting after balloon predilatation. Patient population and methods Four hundred patients with coronary stenoses in a single native vessel were randomized to direct stenting vs stenting after predilatation. A major adverse cardiac and cerebral event (MACCE) was defined as death, myocardial infarction, stent thrombosis, target restenosis, repeat target- and non-target vesselrelated percutaneous coronary intervention, target Lesion revascularization, coronary artery bypass surgery and stroke. Results Stents were successfully implanted in 98.3% of patients randomized to direct stenting vs 97.8% randomized to stenting preceded by preditatation. The primary success rate of direct stenting was 88.3%, vs 97.8% for stenting preceded by balloon dilatation (P=0.01). The angiographic follow-up at 6 months included 333 of the 400 patients (83%). The binary in-stent restenosis rate was 23.1% of 163 patients randomized to direct stenting vs 18.8% of 166 patients randomized to balloon predilatation (P=0.32). By 185±25 days, MACCE had occurred in 31 of 200 (15.5%) patients randomized to direct stenting, vs 33 of 200 (16.5%) randomized to predilatation (P=0.89). At 6 months, costs associated with the direct stenting strategy (Euros 3222/patient) were similar to those associated with predilatation (Euros 3428/patient, P=0.43). However, procedural costs were significantly lower. It is noteworthy that, on multivariate analysis, a baseline C-reactive protein level > 10 mg l^-1 was a predictor of restenosis (odds ratio: 2.10, P=0.025) as well as of MACCE (odds ratio: 1.94, P=0.045). Conclusions Compared to stenting preceded by balloon predilatation, direct stenting was associated with similar 6-month restenosis and MACCE rates. Procedural, but not overall 6-month costs, were reduced by direct stenting. An increased baseline CRP level was an independent predictor of adverse long-term outcome after coronary stent implantation.