Syeda Bonni, Schukro Christoph, Kirisits Christian, Lang Irene, Siostrzonek Peter, Gottsauner-Wolf Michael, Pokrajac Boris, Schmid Rainer, Yahya Nabil, Pötter Richard, Glogar Dietmar
Division of Cardiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria.
Radiother Oncol. 2006 Jan;78(1):60-6. doi: 10.1016/j.radonc.2005.10.012. Epub 2005 Nov 22.
We report a double-blind, randomized clinical trial of intracoronary beta-radiation for prevention of restenosis after stent implantation in native coronary de novo lesions in diabetic patients.
After successful stent implantation in native coronary de novo lesions, 106 lesions in 89 diabetic patients were randomly allocated to treatment with beta-radiation with 18 Gy at 1 mm vessel depth (n = 53) or placebo treatment (n = 53).
Angiographic analysis at 9 month follow-up revealed a late lumen loss of 0.7+/-0.9 mm in the radiotherapy group versus 1.2+/-0.8 mm in the control group at the injured segment (P = 0.006), 0.9+/-1.0 versus 1.3+/-0.7 mm at the radiated segment (P = 0.02), and 0.9+/-1.0 versus 1.3+/-0.7 mm at the target segment (P = 0.04) (defined as active source length plus 5mm on proximal and distal sites). Binary restenosis rates were significantly lower in the radiation group in all subsegments (injured segment: 10.9 versus 37.3%, P = 0.003; radiated segment: 21.7 versus 49.0%, P = 0.005; target segment: 23.9 versus 49.0%, P = 0.01). Target lesion revascularization for restenosis was required in nine lesions (17.6%) in the radiotherapy group versus 18 (34.0%) in the placebo group (P = 0.05). Late thrombosis occurred in four radiated patients (after premature discontinuation of antiplatelet therapy in all), resulting in a major adverse clinical event rate of 37.2% in the brachytherapy group versus 38.6% in the placebo group (P = ns).
In diabetic patients with de novo coronary lesions, intracoronary radiation after stent implantation significantly reduced restenosis. However, this clinical benefit was reduced by the frequent occurrence of late thrombosis.
我们报告一项关于冠状动脉内β射线放射治疗预防糖尿病患者原发性冠状动脉新发病变支架植入术后再狭窄的双盲随机临床试验。
在原发性冠状动脉新发病变成功植入支架后，89例糖尿病患者的106个病变被随机分配接受血管深度1毫米处18 Gy的β射线放射治疗（n = 53）或安慰剂治疗（n = 53）。
9个月随访时的血管造影分析显示，放疗组损伤节段的晚期管腔丢失为0.7±0.9毫米，而对照组为1.2±0.8毫米（P = 0.006）；放射节段为0.9±1.0毫米对1.3±0.7毫米（P = 0.02）；靶节段（定义为放射源长度加上近端和远端各5毫米）为0.9±1.0毫米对1.3±0.7毫米（P = 0.04）。所有亚节段的二元再狭窄率在放射治疗组显著更低（损伤节段：10.9%对37.3%，P = 0.003；放射节段：21.7%对49.0%，P = 0.005；靶节段：23.9%对49.0%，P = 0.01）。放疗组有9个病变（17.6%）因再狭窄需要进行靶病变血管重建，而安慰剂组为18个（34.0%）（P = 0.05）。4例接受放射治疗的患者发生晚期血栓形成（均在过早停用抗血小板治疗后），导致近距离放射治疗组的主要不良临床事件发生率为37.2%，安慰剂组为38.6%（P = 无显著性差异）。
在患有原发性冠状动脉病变的糖尿病患者中，支架植入术后冠状动脉内放射治疗显著降低了再狭窄。然而，这种临床益处因晚期血栓形成的频繁发生而降低。
