Stadler Peter, Schäfer Christof, Chaber Silvia, Putnik Kurt, Treutwein Marius, Koelbl Oliver, Muders Frank
Department of Radiotherapy and Radiation Oncology, University Hospital, Regensburg, Germany.
Strahlenther Onkol. 2006 Jun;182(6):312-7. doi: 10.1007/s00066-006-1488-x.
Treatment of in-stent restenosis (ISR) with percutaneous coronary intervention (PCI) alone is often followed by early re-restenosis. The present study focused on the effect of intracoronary brachytherapy (ICBT) on multiple in-stent restenosis (MISR) after repeated PCI.
40 patients (27 male, 13 female, age: 66 +/- 9 years) with MISR (two to six ISRs, median three ISRs) were retrospectively analyzed. All patients were treated by using the Novoste((R)) Beta-Cathtrade mark 3.5F System after PCI. The target vessel received 18.4-25.3 Gy of radiation at a depth of 2 mm from the center of the source. The restenosis-free survival and overall survival were calculated by Kaplan-Meier analysis (log-rank). The time interval between last PCI without ICBT and the consecutive recurrence was compared with the follow-up time after PCI with ICBT.
The 3-year overall survival rate after ICBT was 93%. The 0.5-, 1-, 2-, and 3-year ISR-free survival rates after PCI + ICBT were 81%, 72%, 52%, and 38%, respectively. After PCI alone, the 0.5-, 1-, and 2-year ISR-free survival rates were 30%, 13%, and 0%, respectively. This difference was highly significant (p < 0.0001). Patients with more than three ISRs before ICBT had a better outcome (3-year ISR-free survival: 80%) than patients with only two or three ISRs before ICBT (3-year ISR-free survival: 25%; p < 0.05).
ICBT is highly effective and safe in patients with ISR. The results of this study are in accordance with the WRIST and BETA-WRIST data. After 6 months both studies revealed an ISR-free survival rate of 86% (WRIST) and 66% (BETA-WRIST), respectively. The ISR rates in the own control group (70%) were comparable to the placebo groups in WRIST (68%) and BETA-WRIST (72%). Interestingly, patients with more than three ISRs before ICBT had the lowest ISR rate after ICBT.
单纯经皮冠状动脉介入治疗（PCI）治疗支架内再狭窄（ISR）后常出现早期再狭窄。本研究聚焦于冠状动脉内近距离放射治疗（ICBT）对重复PCI后多处支架内再狭窄（MISR）的影响。
对40例患有MISR（2至6处ISR，中位数为3处ISR）的患者（27例男性，13例女性，年龄：66±9岁）进行回顾性分析。所有患者在PCI后使用诺沃斯特（Novoste）Beta-Cath商标3.5F系统进行治疗。靶血管在距源中心2毫米深处接受18.4 - 25.3 Gy的辐射。通过Kaplan-Meier分析（对数秩检验）计算无再狭窄生存率和总生存率。比较未进行ICBT的最后一次PCI与连续复发之间的时间间隔以及进行ICBT的PCI后的随访时间。
ICBT后的3年总生存率为93%。PCI + ICBT后的0.5年、1年、2年和3年无ISR生存率分别为81%、72%、52%和38%。单纯PCI后，0.5年、1年和2年无ISR生存率分别为30%、13%和0%。这种差异具有高度显著性（p < 0.0001）。ICBT前有超过三处ISR的患者比ICBT前仅有两处或三处ISR的患者预后更好（3年无ISR生存率：80%对25%；p < 0.05）。
ICBT对ISR患者高效且安全。本研究结果与WRIST和BETA-WRIST数据一致。两项研究在6个月后分别显示无ISR生存率为86%（WRIST）和66%（BETA-WRIST）。本自身对照组的ISR率（70%）与WRIST（68%）和BETA-WRIST（72%）的安慰剂组相当。有趣的是，ICBT前有超过三处ISR的患者在ICBT后ISR率最低。
