Copyright © 2003 by the European Society of Cardiology.
Regular Articles
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
a Amsterdam Department of Interventional Cardiology, OLVG-Hospital, 1eOosterparkstraat 279,1090 HM, Amsterdam, The Netherlands
b Department of Interventional Cardiology, Thoraxcenter, University Hospital Dijkzigt, Rotterdam,The Netherlands
c Department of Physiology, Vrije Universiteit Medical Center, Amsterdam, The Netherlands
* Corresponding author. Tel.: +31-20-5993032; fax: 31-20-5993997
E-mail address: a.j.j.ijsselmuiden{at}olvg.nl
Received 17 August 2002; accepted 18 September 2002
Study objectives To compare the long-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 vessel-related 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 predilatation. The primary success rate of direct stenting was 88.3%, vs 97.8% for stenting preceded by balloon dilatation 
. 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 
. 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 
. At 6 months, costs associated with the direct stenting strategy (Euros 3222/patient) were similar to those associated with predilatation (Euros 3428/patient, 
). However, procedural costs were significantly lower. It is noteworthy that, on multivariate analysis, a baseline C-reactive protein level >10mgl–1was a predictor of restenosis (odds ratio: 2.10, 
) as well as of MACCE (odds ratio: 1.94, 
).
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.
Key Words: Coronary stent • Direct stenting • Predilatation • Restenosis • Coronary artery disease • Coronary revascularization cost
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