Park Seong-Wook, Lee Seung-Whan, Koo Bon Kwon, Park Duk-Woo, Lee Se-Whan, Kim Young-Hak, Lee Cheol Whan, Hong Myeong-Ki, Kim Jae-Joong, Mori Ken, Lansky Alexandra J, Mintz Gary S, Lee Myoung-Mook, Park Seung-Jung
Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, 388-1 Poongnap-dong, Songpa-gu, Seoul, 138-736, Republic of Korea.
Int J Cardiol. 2008 Dec 17;131(1):70-7. doi: 10.1016/j.ijcard.2007.09.003. Epub 2008 Jan 10.
We compared sirolimus-eluting stent (SES) implantation and intracoronary brachytherapy (ICBT) for diffuse bare metal in-stent restenosis (ISR) to identify more effective treatment modality.
Patients (n=129) with diffuse ISR (lesion length > or = 10 mm) were randomly assigned to either SES implantation (n=65, group I) or beta-radiation with 188Re-MAG(3)-filled balloon (n=64, group II). The radiation dose was 20 Gy at a depth of 1.0 mm into the vessel wall. The primary end point was late loss in analysis segment at 6 months. The secondary end points were 6-month angiographic restenosis and 1-year major adverse cardiac events (MACE) including myocardial infarction (MI), cardiac death, and target lesion revascularization (TLR).
Baseline characteristics were similar between two groups. The lesion length was 27.52+/-13.98 mm in group I and 27.75+/-14.25 mm in group II (p=0.927). Late loss in analysis segment at 6 months was smaller in group I than in group II (0.15+/-0.62 vs. 0.55+/-0.69 mm, p=0.003). Angiographic restenosis for analysis segment at 6 months was 8.0% (4/50) in group I and 30.2% (16/53) in group II (p=0.006). One MI and two deaths (all from group I) occurred during follow-up. TLR (4.6% vs. 18.8%, p=0.014) and MACEs (7.7% vs. 18.8%, p=0.073) were lower in group I than group II at 1 year.
Compared to ICBT, SES implantation for diffuse bare metal ISR showed less late loss, lower restenosis, and a trend toward lower 1-year MACEs. SES implantation appears to be superior to ICBT for treating diffuse ISR.
我们比较了西罗莫司洗脱支架（SES）植入术和冠状动脉内近距离放射治疗（ICBT）用于弥漫性裸金属支架内再狭窄（ISR）的疗效，以确定更有效的治疗方式。
129例弥漫性ISR（病变长度≥10mm）患者被随机分为SES植入组（n = 65，I组）或接受用188Re - MAG(3)填充球囊进行β射线放射治疗组（n = 64，II组）。放射剂量为血管壁深度1.0mm处20Gy。主要终点是6个月时分析节段的晚期管腔丢失。次要终点是6个月时的血管造影再狭窄以及1年时的主要不良心脏事件（MACE），包括心肌梗死（MI）、心源性死亡和靶病变血管重建（TLR）。
两组的基线特征相似。I组病变长度为27.52±13.98mm，II组为27.75±14.25mm（p = 0.927）。I组6个月时分析节段的晚期管腔丢失小于II组（0.15±0.62 vs. 0.5±0.69mm，p = 0.003）。I组6个月时分析节段的血管造影再狭窄率为8.0%（4/50）,II组为30.2%（16/53）（p = 0.006）。随访期间发生1例MI和2例死亡（均来自I组）。1年时I组的TLR（4.6% vs. 18.8%，p = 0.014）和MACE（7.7% vs. 18.8%，p = 0.073）低于II组。
与ICBT相比，SES植入术治疗弥漫性裸金属ISR显示出更少的晚期管腔丢失、更低的再狭窄率以及1年MACE有降低趋势。SES植入术在治疗弥漫性ISR方面似乎优于ICBT。
