Serruys P W, Hamburger J N, Koolen J J, Fajadet J, Haude M, Klues H, Seabra-Gomes R, Corcos T, Hamm C, Pizzuli L, Meier B, Mathey D, Fleck E, Taeymans Y, Melkert R, Teunissen Y, Simon R
Department of Interventional Cardiology, Heart Centre of the University Hospital Rotterdam, Rotterdam, The Netherlands.
Eur Heart J. 2000 Nov;21(21):1797-805. doi: 10.1053/euhj.2000.2263.
A randomized trial was performed to assess the safety and efficacy of a laser guidewire, in the treatment of chronic coronary occlusions.
In 18 European centres, 303 patients with a chronic coronary occlusion were randomized to treatment with either the laser guidewire (n=144) or conventional guidewires (mechanical guidewire, n=159). The primary end-point of the study was treatment success, defined as reaching the true lumen distal to the occlusion by the allocated wire within 30 min of fluoroscopic time: laser guidewire vs mechanical guidewire; 52.8% (n=76) vs 47.2% (n=75), P=0.33. Serious adverse events following the initial guidewire attempt were 0% (laser guidewire) and 0.6% (mechanical guidewire), respectively. Angioplasty (performed following successful guidewire crossing) was successful in 179 patients (91%, laser guidewire n=79, mechanical guidewire n=100), followed by stent implantation in 149 (79%). At the 6-month angiographic follow-up, the difference in binary restenosis rate (laser guidewire vs mechanical guidewire; 45.5% vs 38.3 %, P=0.72) or reocclusion rate (25.8% vs 16.1%, P=0.15) did not reach statistical significance. At 1, 6 and 12 months, angina and event-free survival were 69%, 35% and 24% (laser guidewire) vs 74%, 40% and 31% (mechanical guidewire).
Although laser guidewire technology was safe, the increase in crossing success did not reach statistical significance.
进行一项随机试验，以评估激光导丝治疗慢性冠状动脉闭塞病变的安全性和有效性。
在18个欧洲中心，303例慢性冠状动脉闭塞患者被随机分为激光导丝治疗组（n = 144）和传统导丝治疗组（机械导丝，n = 159）。研究的主要终点是治疗成功，定义为在荧光透视时间30分钟内通过分配的导丝到达闭塞远端的真腔：激光导丝组与机械导丝组；52.8%（n = 76）对47.2%（n = 75），P = 0.33。首次导丝尝试后的严重不良事件分别为0%（激光导丝组）和0.6%（机械导丝组）。血管成形术（在导丝成功通过后进行）在179例患者中成功（91%，激光导丝组n = 79，机械导丝组n = 100），随后149例（79%）进行了支架植入。在6个月的血管造影随访中，二元再狭窄率（激光导丝组对机械导丝组；45.5%对38.3%，P = 0.72）或再闭塞率（25.8%对16.1%，P = 0.15）的差异未达到统计学意义。在1、6和12个月时，心绞痛和无事件生存率分别为69%、35%和24%（激光导丝组）对74%、40%和31%（机械导丝组）。
尽管激光导丝技术是安全的，但通过成功率的提高未达到统计学意义。
