Efficiency and safety of the sirolimus eluting stent in complex coronary artery lesions after cessation of dual antiplatelet therapy: fifteen months clinical outcome of the randomised Stenting Coronary Arteries in Non-stress/benestent Disease (SCANDSTENT) trial

Abstract

The randomised Stenting Coronary Arteries in Non-stress/benestent Disease (SCANDSTENT) trial reported considerably less angiographic restenosis after implantation of sirolimus-eluting stents (SES) vs bare metal stents (BMS) in patients with complex coronary lesions. The purpose of this study was to evaluate the clinical outcome after a majority of the SCANDSTENT patients had stopped the dual antiplatelet therapy. The SCANDSTENT trial randomly assigned 322 patients with symptomatic complex coronary artery disease (occlusions, bifurcations, ostial or angulated lesions) to receive SES or BMS. At 15 months after stent implantation, when 80% of the patients had stopped taking clopidogrel, six patients in the SES group and 10 in the BMS group had died or suffered a myocardial infarction (non significant [NS]). Compared with BMS, SES reduced the rate of target vessel revascularisation (TVR) from 33.1% to 5.6% (P<0.001) and the frequency of major adverse cardiac events from 35.7% to 8.6% (p<0.001). Definite stent thrombosis was observed in five patients in the BMS group, and two cases of probable and possible stent thrombosis were observed in the SES group (NS). One case of possible SES thrombosis occurred more than one year after stent implantation. Compared with BMS, SES markedly reduced the frequency of TVR and MACE within 15 months in SCANDSTENT patients with complex coronary artery lesions without development of delayed restenosis.