摘要Background:Despite great reduction of in-stent restenosis,first-generation drug-eluting stents (DESs) have increased the risk of late stent thrombosis due to delayed endothelialization.Arsenic trioxide,a natural substance that could inhibit cell proliferation and induce cell apoptosis,seems to be a promising surrogate of sirolimus to improve DES performance.This randomized controlled trial was to evaluate the efficacy and safety of a novel arsenic trioxide-eluting stent (AES),compared with traditional sirolimus-eluting stent (SES).Methods:Patients with symptoms of angina pectoris were enrolled and randomized to AES or SES group.The primary endpoint was target vessel failure (TVF),and the second endpoint includes rates of all-cause death,cardiac death or myocardial infarction,target lesion revascularization (TLR) by telephone visit and late luminal loss (LLL) at 9-month by angiographic follow-up.Results:From July 2007 to 2009,212 patients were enrolled and randomized 1 ∶1 to receive either AES or SES.At 2 years of follow-up,TVF rate was similar between AES and SES group (6.67％ vs.5.83％,P =0.980).Frequency of all-cause death was significantly lower in AES group (0 vs.4.85％,P =0.028).There was no significant difference between AES and SES in frequency of TLR and in-stent restenosis,but greater in-stent LLL was observed for AES group (0.29 ± 0.52 mm vs.0.1 0 ± 0.25 mm,P =0.008).Conclusions:After 2 years of follow-up,AES demonstrated comparable efficacy and safety to SES for the treatment of de novo coronary artery lesions.