Design: Prospective, randomised single-centre pilot study comparing a beta with a gamma source and a sirolimus-eluting stent in patients with an estimated high risk of restenosis (40 to 50%).
Purpose: Although the majority of patients referred for revascularisation are now being treated with percutaneous coronary intervention (PCI) combined with stenting, a small number still suffer from recurrent restenosis which can be invalidating for the patient and frustrating for the cardiologist due to repeated PCIs. In this prospective single-centre pilot study we will test the hypothesis of three different treatment strategies to use in this special patient subset, to determine if we can find a positive 'trend' in one arm, in order to either make a selection for one of the treatment strategies, or to provide a base to expand the study into a larger multicentre randomised study.
Time course and enrollment: A total of 120 patients will be included, 40 in each treatment arm. All patients with either in-stent and/or native restenosis and/or diabetics and/or type C lesions (ACC/AHA) are eligible. The usual exclusion criteria for intracoronary brachytherapy and prolonged antiplatelet therapy are applied. All lesions <44 mm in length and with a vessel diameter 2.4>4.0 mm are suitable. Angiographic, intravascular ultrasound imaging and clinical follow-up at one year will become available in the first quarter of 2005.
Keywords: PTCA; brachytherapy; drug-eluting stents; restenosis.