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Sirolimus eluting stent implantation for patients with multivessel disease: rationale for the arterial revascularisation therapies study part II (ARTS II)
  1. P W Serruys1,
  2. P A Lemos1,
  3. B A van Hout2,
  4. on behalf of the ARTS II Steering Committee and Investigators
  1. 1Erasmus Medical Center, Thoraxcenter, Rotterdam, The Netherlands
  2. 2Universitair Medisch Centrum, Julius Centrum, Utrecht, The Nertherlands
  1. Correspondence to:
    Professor Patrick W Serruys
    Thoraxcenter, Bd-406, Dr. Molewaterplein 40, 3015-GD Rotterdam, Netherlands; p.w.j.c.serruyserasmusmc.nl

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In-stent restenosis and the need of repeat revascularisation remain the major limitations of coronary angioplasty for patients with multivessel disease.1,2 Utilisation of drug eluting stents in this context is expected to have a major impact on the effectiveness of percutaneous treatment. Sirolimus eluting stent implantation has recently been shown to significantly reduce coronary restenosis, with zero angiographic restenosis3,4 and persistent long term neointimal inhibition.4 Moreover, sirolimus eluting stents were proven to be as safe as bare metal stents at 30 days in a group of patients with acute coronary syndromes and a high frequency of multivessel disease.5 However, currently the effect of this device on long term outcomes of patients with multivessel disease is largely unknown.

EARLY CLINICAL EXPERIENCE: THE RESEARCH STUDY

The sirolimus eluting stent received Conformité Européenne mark approval in April 2002, since when it has been available for routine use in Europe. From 16 April 2002, it has been the policy of our institution to utilise sirolimus eluting stents as the device of choice for all percutaneous coronary interventions, as part of the RESEARCH (rapamycin-eluting stent evaluated at Rotterdam Cardiology Hospital) study, which is a single centre registry conducted with the main purpose of evaluating the efficacy of sirolimus eluting stent implantation in the “real world”.5

In a preliminary analysis, the first 150 patients with multivessel disease included in the RESEARCH study were compared to a control group formed by 150 consecutive patients treated with bare stents in the period immediately before. Both groups were similar at baseline regarding the frequency of previous bypass surgery (19% v 18%, respectively; p  =  1.0), three vessel disease (32% v 35%, respectively; p  =  0.6), and diabetes (27% v 22%, respectively; p  =  0.4). At six months follow up, the cumulative incidence of major adverse cardiac events (death, myocardial …

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