We sought to evaluate the long-term safety and efficacy of drug-eluting stent in large vessels compared with bare metal stent.
Drug-eluting stent (DES) has been proved to reduced restenosis rate dramatically compared to bare metal stent (BMS). However, the long-term safety of DES is still uncertain. Recent meta-analysis showed that very late stent thrombosis rate was higher in DES group although overall mortality was similar between 2 groups. The safety issue of DES was first suggested in the BASKET-LATE study, which compared cobalt chromium alloy BMS (VISION®, Guidant, USA) with sirolimus- or paclitaxel-coated DES. The study showed a significantly higher rate of death or myocardial infarction in the DES group between 7 and 18 month after the procedure (BMS 1.3%, DES 4.9%, p=0.01). Moreover, benefit to reduce target vessel revascularization was not found and there was even the possibility of late harm in patients treated with DES in large native vessels. We perform a multicenter prospective randomized study comparing paclitaxel-eluting stent with cobalt chromium stent several years, originally to see whether major adverse cardiac event is significantly lower in DES compared to thin-strut BMS in the non-complex lesion subset. In this article, we would like to investigate the 2-year clinical events in DES and BMS groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
Stenting with Paclitaxel-eluting coronary stent system for coronary lesions with \> 50% diameter stenosis with ischemic symptoms or positive functional study, or \> 70% diameter stenosis without ischemic symptoms or positive functional study
Stenting with VISION coronary stent system for coronary lesions with \> 50% diameter stenosis with ischemic symptoms or positive functional study, or \> 70% diameter stenosis without ischemic symptoms or positive functional study
Samsung Medical Center
Seoul, South Korea
RECRUITINGMajor adverse cardiac event (MACE: cardiac death, myocardial infarction, or target vessel revascularization)
Time frame: 1 year
MACE and stent thrombosis by the criteria of Academic Research Consortium
Time frame: 2 years
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