Endoluminal beta-radiation therapy for the prevention of coronary restenosis after balloon angioplasty.

Endoluminal beta-radiation therapy for the prevention of coronary restenosis after balloon angioplasty.
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DOI:
10.1056/nejm200101253440401
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发表时间:
2001-01-25
影响因子:
158.5
通讯作者:
Wijns, W
Wijns, W
中科院分区:
医学1区
文献类型:
--
作者:
Verin, V;Popowski, Y;Wijns, W

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背景:β射线能有效减少球囊血管成形术引起的动物损伤后血管新生内膜增生。然而,最低剂量,可以防止冠状动脉成形术后再狭窄尚未determined.Methods:成功的球囊血管成形术后,以前未经治疗的冠状动脉狭窄,181例患者被随机分配到接受9,12,15,或18戈伊的辐射提供了一个中心的钇-90源。28%的患者需要辅助支架植入术。主要终点是治疗后6个月的最小管腔直径,作为辐射剂量的函数。结果:在随访冠状动脉造影时,9-戈伊组的平均最小管腔直径为1.67 mm,12-戈伊组为1.76 mm,15-戈伊组为1.83 mm,而18-戈伊组中为1.97 mm(9戈伊与18戈伊比较P = 0.06),导致再狭窄率分别为29%、21%、16%和15%(9戈伊与18戈伊比较P = 0.14)。当时,86%的患者没有严重的心脏事件。在130例接受球囊血管成形术而不使用支架的患者中,再狭窄率分别为28%、17%、16%和4%(9戈伊与18戈伊的比较P = 0.02)。在这些患者中,分别有28%、50%、45%和74%的患者出现剂量依赖性管腔扩大(P
Background: Beta radiation is effective in reducing vascular neointimal proliferation in animals after injury caused by balloon angioplasty. However, the lowest dose that can prevent restenosis after coronary angioplasty has yet to be determined.Methods: After successful balloon angioplasty of a previously untreated coronary stenosis, 181 patients were randomly assigned to receive 9, 12, 15, or 18 Gy of radiation delivered by a centered yttrium-90 source. Adjunctive stenting was required in 28 percent of the patients. The primary end point was the minimal luminal diameter six months after treatment, as a function of the delivered dose of radiation.Results: At the time of follow-up coronary angiography, the mean minimal luminal diameter was 1.67 mm in the 9-Gy group, 1.76 mm in the 12-Gy group, 1.83 mm in the 15-Gy group, and 1.97 mm in the 18-Gy group (P = 0.06 for the comparison of 9 Gy with 18 Gy), resulting in restenosis rates of 29 percent, 21 percent, 16 percent, and 15 percent, respectively (P = 0.14 for the comparison of 9 Gy with 18 Gy). At that time, 86 percent of the patients had had no serious cardiac events. In 130 patients treated with balloon angioplasty without a stent, restenosis rates were 28 percent, 17 percent, 16 percent, and 4 percent, respectively (P = 0.02 for the comparison of 9 Gy with 18 Gy). Among these patients, there was a dose-dependent enlargement of the lumen in 28 percent, 50 percent, 45 percent, and 74 percent of patients, respectively (P