Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) and the (hoped for) dawn of evidence-based treatment for advanced limb ischemia
Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) and the (hoped for) dawn of evidence-based treatment for advanced limb ischemia
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DOI：
10.1016/j.jvs.2010.02.001
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发表时间：
2010-05-01
影响因子：
4.3
通讯作者：
Conte, Michael S.
中科院分区：
文献类型：
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作者：
Conte, Michael S.
腿部严重缺血的搭桥术与血管成形术（BASIL）试验是迄今为止唯一一项比较开放手术搭桥术与血管内治疗严重肢体缺血（SLI）的随机对照试验（RCT）。在2005年的首次出版物中，BASIL研究者报告称，随机分配至血管成形术优先或旁路手术优先血运重建策略后2年的主要临床结局（总生存期和无截肢生存期）没有差异。然而，超过2年，开放式旁路手术似乎有好处，为扩展研究提供了动力。BASIL长期结果的最终分析现在在本评论中审查的一系列文章中介绍。初步随机化开放手术对生存≥ 2年的患者（BASIL队列的70%）的益处得到证实。当根据接受的治疗分析结果时，接受人工旁路移植术的患者（手术组的25%）比接受静脉旁路移植术的患者表现更差。在最初的血管成形术失败后接受外科搭桥手术的患者的情况也明显比那些最初接受搭桥手术治疗的患者差。总体而言，健康相关的生活质量指标和成本没有显著差异。有许多争议围绕BASIL审判及其解释，这是审查。这些因素包括研究人群的选择、检查的终点和所进行手术的性质。BASIL试验证实了大多数SLI患者采用静脉开放手术旁路的首要性，并提出了关于血管内介入治疗失败后遗症的问题。需要进一步的多中心试验来解决该患者人群中治疗选择证据的巨大差距。（J Vase Surg 2010;51：69S-75S.）
The Bypass versus Angioplasty in Severe Ischemia of the Leg (BASIL) trial is the only randomized controlled trial (RCT) to date comparing open surgical bypass with endovascular therapy for severe limb ischemia (SLI). In their initial 2005 publication, the BASIL investigators reported that the main clinical outcomes (overall survival and amputation-free survival) were no different at 2 years after randomization to angioplasty-first or bypass-first revascularization strategies. However, beyond 2 years there appeared to be a benefit for open bypass surgery, providing impetus for an extension study. The final analysis of the long-term outcomes from BASIL is now presented in a set of articles that are reviewed in this commentary. The benefit of initial randomization to open surgery for patients surviving >= 2 years (70% of the BASIL cohort) was confirmed. When outcomes were analyzed by treatment received, patients who had received prosthetic bypass grafts (25% of the surgical arm) fared much more poorly than those treated with a vein bypass. Patients who underwent surgical bypass after an initial failed angioplasty also fared significantly worse than those who were treated initially with bypass surgery. Health-related quality of life measures and costs were not significantly different overall. There are many controversies surrounding the BASIL trial and its interpretation, which are reviewed herein. These include the choice of study population, end points examined, and the nature of procedures performed. The BASIL trial confirms the primacy of open surgical bypass with vein for most patients with SLI and raises questions about the sequelae of failed endovascular interventions. Further multicenter trials are needed to address the large gap in evidence for treatment selection in this patient population. ( J Vase Surg 2010;51:69S-75S.)