Localized intracoronary gamma-radiation therapy to inhibit the recurrence of restenosis after stenting.
Localized intracoronary gamma-radiation therapy to inhibit the recurrence of restenosis after stenting.
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DOI：
10.1056/nejm200101253440402
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发表时间：
2001-01-25
影响因子：
158.5
通讯作者：
Kuntz, RE
中科院分区：
文献类型：
--
作者：
Leon, MB;Teirstein, PS;Kuntz, RE
背景资料：虽然冠状动脉成形术后再狭窄的频率通过支架植入术降低，但当支架内发生再狭窄时，随后再狭窄的风险大于50%。我们报告了一项冠状动脉内放射治疗治疗支架内再狭窄的多中心、双盲、随机试验。方法：在252名符合条件的支架内再狭窄患者中，131名患者被随机分配接受含有密封铱-192源的冠状动脉内留置带，121名患者被分配接受外观相似的非放射性带（安慰剂）。结果：在9个月的随访中，主要终点是死亡、心肌梗死和需要对靶病变进行重复血运重建的复合终点，发生在53名安慰剂组患者（43.8%）和37名铱-192组患者（28.2%，P = 0.02）中。然而，主要不良心脏事件发生率的降低仅取决于靶病变血运重建需求的减少，而不是死亡或心肌梗死发生率的降低。铱-192组晚期血栓形成发生率为5.3%，而安慰剂组为0.8%（P = 0.07），导致铱-192组晚期心肌梗死发生率更高（9.9% vs. 4.1%，P = 0.09）。晚期血栓形成仅发生在口服抗血小板治疗停止后的放射病人（与噻氯匹定或氯吡格雷），并且仅在放射治疗时接受新支架的患者中。冠状动脉内铱-192照射导致较低的临床和血管造影再狭窄率，尽管它也与较高的晚期血栓形成率相关，导致心肌梗塞的风险增加。如果支架内晚期血栓形成的问题可以克服，冠状动脉内照射与铱-192可能成为一个有用的方法来治疗支架内再狭窄。（N Engl J Med 2001;344：250-6.）版权所有（C）2001马萨诸塞州医学会。
Background: Although the frequency of restenosis after coronary angioplasty is reduced by stenting, when restenosis develops within a stent, the risk of subsequent restenosis is greater than 50 percent. We report on a multicenter, double-blind, randomized trial of intracoronary radiation therapy for the treatment of in-stent restenosis.Methods: Of 252 eligible patients in whom in-stent restenosis had developed, 131 were randomly assigned to receive an indwelling intracoronary ribbon containing a sealed source of iridium-192, and 121 were assigned to receive a similar-appearing nonradioactive ribbon (placebo).Results: The primary end point, a composite of death, myocardial infarction, and the need for repeated revascularization of the target lesion during nine months of follow-up, occurred in 53 patients assigned to placebo (43.8 percent) and 37 patients assigned to iridium-192 (28.2 percent, P = 0.02). However, the reduction in the incidence of major adverse cardiac events was determined solely by a diminished need for revascularization of the target lesion, not by reductions in the incidence of death or myocardial infarction. Late thrombosis occurred in 5.3 percent of the iridium-192 group, as compared with 0.8 percent of the placebo group (P = 0.07), resulting in more late myocardial infarctions in the iridium-192 group (9.9 percent vs. 4.1 percent, P = 0.09). Late thrombosis occurred in irradiated patients only after the discontinuation of oral antiplatelet therapy (with ticlopidine or clopidogrel) and only in patients who had received new stents at the time of radiation treatment.Conclusions: Intracoronary irradiation with iridium-192 resulted in lower rates of clinical and angiographic restenosis, although it was also associated with a higher rate of late thrombosis, resulting in an increased risk of myocardial infarction. If the problem of late thrombosis within the stent can be overcome, intracoronary irradiation with iridium-192 may become a useful approach to the treatment of in-stent restenosis. (N Engl J Med 2001;344:250-6.) Copyright (C) 2001 Massachusetts Medical Society.