Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: An intention-to-treat analysis of amputation-free and overall survival in patients randomized to a bypass surgery-first or a balloon angioplasty-first revascularization strategy
Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: An intention-to-treat analysis of amputation-free and overall survival in patients randomized to a bypass surgery-first or a balloon angioplasty-first revascularization strategy
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DOI：
10.1016/j.jvs.2010.01.073
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发表时间：
2010-05-01
影响因子：
4.3
通讯作者：
Raab, Gillian M.
中科院分区：
文献类型：
--
作者：
Bradbury, Andrew W.;Adam, Donald J.;Raab, Gillian M.
背景：2005年一项对重度腿部缺血的搭桥和血管成形术(BASIL)试验的中期分析显示，在腹股沟下疾病引起的严重下肢缺血(SLI；静息痛、溃疡、坏疽)患者中，搭桥手术(BSX)优先和球囊血管成形术(BAP)优先血管再造术策略导致类似的短期临床结果，尽管BSX费用高约三分之一，发病率更高。我们又对患者进行了2.5年的监测，现在报告了一项关于无截肢生存率(AFS)和总生存率(OS)的最终意向治疗(ITT)分析。方法：在27家英国医院的452名登记患者中，228人被随机分为BSX优先组和BAP优先血运重建组。结果：随访结束时，死亡250例(56%)，未截肢存活168例(38%)，截肢存活30例(7%)。有四人失去了后续行动。在随机化治疗期间，AFS和OS没有差别。然而，对于那些从随机化中存活2年的患者来说，在调整后的、与时间相关的Cox比例风险模型中，首次BSX血运重建与随后的AFS(95%可信区间，0.5-1.07；P=.108)和后续OS的0.61(95%可信区间，0.50-0.75；P=0.009)的风险比(HR)降低相关。对于那些在随机化后存活2年的患者，在随后的平均3.1年(范围1-5.7年)的随访中，最初采用BSX优先血运重建策略的患者的限制性平均总生存期增加7.3个月(95%CI，1.2-13.4个月，P=0.02)，限制性平均AFS增加5.9个月(95%CI，0.2-12.0个月，P=0.06)。结论：总的来说，两种策略的AFS或OS没有显著差异。然而，对于那些在随机分组后存活至少2年的患者，BSX优先血运重建策略与随后OS的显著增加和AFS改善的趋势相关。(《花瓶外科杂志》2010；51：5s-17s。)
Background: A 2005 interim analysis of the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial showed that in patients with severe lower limb ischemia (SLI; rest pain, ulceration, gangrene) due to infrainguinal disease, bypass surgery (BSX)-first and balloon angioplasty (BAP)-first revascularization strategies led to similar short-term clinical outcomes, although BSX was about one-third more expensive and morbidity was higher. We have monitored patients for a further 2.5 years and now report a final intention-to-treat (ITT) analysis of amputation-free survival (AFS) and overall survival (OS).Methods: Of 452 enrolled patients in 27 United Kingdom hospitals, 228 were randomized to a BSX-first and 224 to a BAP-first revascularization strategy. All patients were monitored for 3 years and more than half for >5 years.Results: At the end of follow-up, 250 patients were dead (56%), 168 (38%) were alive without amputation, and 30 (7%) were alive with amputation. Four were lost to follow-up. AFS and OS did not differ between randomized treatments during the follow-up. For those patients surviving 2 years from randomization, however, BSX-first revascularization was associated with a reduced hazard ratio (HR) for subsequent AFS of 0.85 (95% confidence interval [CI], 0.5-1.07; P = .108) and for subsequent OS of 0.61 (95% CI, 0.50-0.75; P = .009) in an adjusted, time-dependent Cox proportional hazards model. For those patients who survived for 2 years after randomization, initial randomization to a BSX-first revascularization strategy was associated with an increase in subsequent restricted mean overall survival of 7.3 months (95% CI, 1.2-13.4 months, P = .02) and an increase in restricted mean AFS of 5.9 months (95% CI, 0.2-12.0 months, P = .06) during the subsequent mean follow-up of 3.1 years (range, 1-5.7 years).Conclusions: Overall, there was no significant difference in AFS or OS between the two strategies. However, for those patients who survived for at least 2 years after randomization, a BSX-first revascularization strategy was associated with a significant increase in subsequent OS and a trend towards improved AFS. (J Vase Surg 2010;51:5S-17S.)