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使用β射线成功减少长病变支架内再狭窄——来自RENO注册研究的亚分析

Successful reduction of in-stent restenosis in long lesions using beta-radiation--subanalysis from the RENO registry.

作者信息

Baumgart Dietrich, Bonan Raoul, Naber Christoph, Serruys Patrick, Colombo Antonio, Silber Sigmund, Eeckhout Eric, Urban Philip

机构信息

University Essen, Essen, Germany.

出版信息

Int J Radiat Oncol Biol Phys. 2004 Mar 1;58(3):817-27. doi: 10.1016/S0360-3016(03)01615-8.

Abstract

PURPOSE

Long lesions remain a challenging task in interventional cardiology, with a high propensity of restenosis, especially within the stented segment. Although intracoronary gamma-radiation has been proved to reduce diffuse in-stent restenosis in long lesions, such an effect remains to be determined using beta-radiation.

METHODS AND MATERIALS

Of 1098 consecutive patients at 46 European centers treated with localized beta-radiation ((90)Sr, Novoste Beta-Cath System), 139 patients (mean age 61.5 +/- 10.7 years, 84% male, 22% with diabetes mellitus) with lesions treated using a >40-mm source length underwent radiation using a single 60-mm source train (34%) or a stepping/pullback procedure with a 30-mm (12%) or 40-mm (87%) source length after conventional interventional procedures. The mean lesion length was 35.3 +/- 17.9 mm.

RESULTS

Technical success was achieved in 96% of cases. Geographic miss was noted in 9 patients (6.5%). The reference (placebo) group was obtained from the Washington Hospital Center for In-Stent Restenosis Trial (WRIST) and the WRIST Trial for long lesions (LONG WRIST) studies by selecting the cases (94 patients) that required a dummy source length >/=13 seeds (or >51 mm in length). Statistically significant improvement was noted in late angiographic restenosis (34.7% vs. 76.5%, p <0.0001), target vessel revascularization (14.9% vs. 60.6), and major adverse cardiac events (i.e., death, myocardial infarction, or total vessel revascularization) (17.9% vs. 64.9%, p <0.0001) at 6 months in reference to the nonradiation group.

CONCLUSION

This subanalysis from the Radiation in Europe with Novoste study confirms the safety and efficacy of beta-radiation combined with conventional interventional procedures in patients with diffuse, long, in-stent restenosis

摘要

目的

在介入心脏病学中,处理长病变仍然是一项具有挑战性的任务,其再狭窄倾向较高,尤其是在支架置入段内。尽管冠状动脉内伽马射线已被证明可减少长病变中弥漫性支架内再狭窄,但β射线的这种效果仍有待确定。

方法和材料

在欧洲46个中心接受局部β射线(锶 - 90,Novoste Beta - Cath系统)治疗的1098例连续患者中,139例患者(平均年龄61.5±10.7岁,84%为男性,22%患有糖尿病)的病变使用长度>40毫米的源进行治疗,在常规介入手术后,使用单个60毫米源序列(34%)或采用30毫米(12%)或40毫米(87%)源长度的步进/回撤程序进行放射治疗。平均病变长度为35.3±17.9毫米。

结果

96%的病例取得技术成功。9例患者(6.5%)出现边缘遗漏。通过选择需要虚拟源长度≥13颗种子(或长度>51毫米)的病例(94例患者),从华盛顿医院中心支架内再狭窄试验(WRIST)和长病变WRIST试验(LONG WRIST)研究中获得了对照(安慰剂)组。与非放射治疗组相比,6个月时晚期血管造影再狭窄(34.7%对76.5%,p<0.0001)、靶血管血运重建(14.9%对60.6%)以及主要不良心脏事件(即死亡、心肌梗死或全血管血运重建)(17.9%对64.9%,p<0.0001)有统计学意义的改善。

结论

来自欧洲Novoste放射治疗研究的这项亚组分析证实了β射线联合常规介入手术在弥漫性、长段支架内再狭窄患者中的安全性和有效性。

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