| 김중선¹, 고영국¹ ,최동훈¹ ,장양수¹ ,강웅철² ,안태훈² ,김병극³ ,오성진³ ,전동운³ ,양주영³ |
Background: The aim of this study is to compare of the clinical, angiographic and intravascular ultrasound (IVUS) parameters with two different drug-eluting stents, sirolimus eluting stent (SES) and paclitaxel eluting stent (PES) in after optimal post-stent balloon inflation. Methods: We conducted a prospective multicenter, randomized study to compare SES (n= 150) vs. PES (n=150) who underwent the elective coronary stenting for a de-novo lesion were included. Infarct-related lesions within 7 days were excluded. Among them, 250 patients (M:F = 177:124, age 61.5 ± 9.2 years), and performed follow-up angiography. Stent was serially expanded with gradual increase in balloon inflation pressures until optimal stent expansion (OSE) defined as the criteria of MUSIC study. IVUS was performed before, after procedure and at 9 month follow-up. Result: Baseline clinical, angiographic and IVUS characteristics of both groups showed no significant difference. The frequency of OSE was no different between two groups. [42 (37.5 %) and 38 (32.8 %) in SES and PES, p=453]. At 9 month follow-up, 2 cardiovascular death and 1 definite stent thrombosis by ARC definition occurred during 9 month follow-up. The rate of in-stent restenosis (ISR) and neointimal volume index (neointimal volume/stent length, mm2) were higher in PES [ISR: 2 (1.7 %) and 15 (12.2 %), p = 0.001, neointimal volume index: 0.21 ± 0.37 and 1.02 ± 0.99 mm2, p < 0.001 in SES and PES]. Especially, PES had significant higher ISR in diabetic patients but was not in non diabetic patients [subgroup with diabetes: 0 (0 %) and 12 (28.6 %), p < 0.001, non-diabetes: 2 (2.4 %) and 4 (4.5 %) p= 0.483 in SES and PES]. After controlling the clinical, angiographic and IVUS risk factor for ISR, Taxus stent [Odds ratio (OR): 8.7, 95 % C.I.: 1.8-42.5] and presence of diabetes [OR: 5.2, 95 % C.I.:1.6-16.7] was independent predictor for ISR but OSE was not significant predictor [OR: 0.70, 95 % C.I.: 0.2-2.3].Conclusion: Although OSE was similar between SES and PES, PES had a significantly higher ISR than SES, especially in subgroup with diabetes and higher neointimal volume at follow-up angiography after controlling the procedure factors. But OSE was not related with ISR.
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