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血管腔内斑块旋切术治疗严重肢体缺血的胫骨介入治疗中并不优于球囊血管成形术。

Atherectomy offers no benefits over balloon angioplasty in tibial interventions for critical limb ischemia.

机构信息

Division of Vascular Surgery, Eastern Virginia Medical School, Norfolk, Va.

出版信息

J Vasc Surg. 2013 Oct;58(4):941-8. doi: 10.1016/j.jvs.2013.04.024. Epub 2013 Jun 4.

Abstract

BACKGROUND

Endovascular adjuncts, like atherectomy, were developed to improve outcomes of endovascular arterial interventions. The true impact of atherectomy on endovascular outcomes remains to be determined, and little data exist on the influence of atherectomy on tibial interventions. Our study compares early and late outcomes of tibial intervention with angioplasty vs atherectomy-assisted interventions.

METHODS

We completed a retrospective review of all tibial interventions between 2008 and 2010. Outcomes were analyzed using single and multivariate analysis, Cox regression, and Kaplan-Meier curves. Primary outcomes were primary, primary assisted, and secondary patency rates, as well as limb salvage and survival rates.

RESULTS

Over a 2-year period, 480 tibial interventions were completed for 421 patients. Eighty-seven percent (n = 418) of interventions were performed for critical limb ischemia (CLI) and 13% (n = 62) for claudication. The CLI cohort of 418 interventions was analyzed. These patients had a mean age of 71 years with a mean follow-up time of 16 ± 15 months (range, 0-59 months). Of the 418 interventions, 339 underwent percutaneous transluminal angioplasty (PTA): 333 PTA alone, six PTA + stent. The remaining 79 interventions received atherectomy: 33 laser, 13 directional, and 33 orbital either alone or in conjunction with PTA (11 atherectomy only, 68 atherectomy + PTA). The groups did not differ significantly in terms of demographics, risk factors, or technical success. The atherectomy group had more TASC B lesions (54% vs 38%; P = .013), while the PTA-alone group had more TASC D lesions (25% vs 13%; P = .004). TASC A and C lesions did not differ significantly between the groups. No significant differences existed with respect to the early (30-day) outcomes of loss of patency (11% vs 13%; P = .699), complications (8% vs 13%; P = .292), or major amputation (17% vs 13%; P = .344) in the PTA-alone group vs the atherectomy-assisted group. Kaplan-Meier analysis revealed no difference for all primary outcomes of PTA alone vs the atherectomy-assisted group at 12 and 36 months: primary patency (69%, 55% vs 61%, 46%; P = .158), primary assisted patency (83%, 71% vs 85%, 67%; P = .801), secondary patency (94%, 89% vs 95%, 89%; P = .892), limb salvage (79%, 70% vs 81%, 77%; P = .485), or survival (77%, 56% vs 80%, 50%; P = .944).

CONCLUSIONS

The adjunctive use of atherectomy offered no improvement in primary outcomes over PTA alone in either early or late outcomes in CLI patients who underwent endovascular tibial interventions. Considering the additional cost and increased procedural time, these findings put into question the routine use of adjunctive atherectomy.

摘要

背景

为了提高血管内动脉介入治疗的效果,开发了血管内辅助治疗方法,如旋切术。旋切术对血管内治疗效果的实际影响仍有待确定,关于旋切术对胫骨介入治疗影响的数据很少。我们的研究比较了血管成形术与旋切术辅助介入治疗的胫骨介入的早期和晚期结果。

方法

我们对 2008 年至 2010 年期间所有的胫骨介入进行了回顾性分析。使用单变量和多变量分析、Cox 回归和 Kaplan-Meier 曲线分析结果。主要结果是主要、辅助主要和次要通畅率,以及肢体存活率和生存率。

结果

在 2 年期间,为 421 名患者完成了 480 例胫骨介入。87%(n=418)的介入是为严重肢体缺血(CLI)患者进行的,13%(n=62)是为跛行患者进行的。分析了 418 例 CLI 介入患者。这些患者的平均年龄为 71 岁,平均随访时间为 16±15 个月(0-59 个月)。在 418 例介入中,339 例行经皮腔内血管成形术(PTA):333 例单独 PTA,6 例 PTA+支架。其余 79 例接受旋切术:33 例激光,13 例定向,33 例轨道,单独或与 PTA 联合使用(11 例旋切术仅,68 例旋切术+PTA)。两组在人口统计学、危险因素或技术成功率方面无显著差异。旋切术组 TASC B 病变较多(54%比 38%;P=0.013),而单纯 PTA 组 TASC D 病变较多(25%比 13%;P=0.004)。两组 TASC A 和 C 病变无显著差异。在单纯 PTA 组与旋切术辅助组之间,30 天内(30 天)的通畅率(11%比 13%;P=0.699)、并发症(8%比 13%;P=0.292)或主要截肢(17%比 13%;P=0.344)等早期结果无显著差异。Kaplan-Meier 分析显示,12 个月和 36 个月时,单纯 PTA 组与旋切术辅助组的所有主要结局均无差异:主要通畅率(69%,55%比 61%,46%;P=0.158)、辅助主要通畅率(83%,71%比 85%,67%;P=0.801)、次要通畅率(94%,89%比 95%,89%;P=0.892)、肢体存活率(79%,70%比 81%,77%;P=0.485)或生存率(77%,56%比 80%,50%;P=0.944)。

结论

在接受血管内胫骨介入治疗的 CLI 患者中,旋切术辅助治疗与单纯 PTA 相比,在早期或晚期结果中均未改善主要结果。考虑到额外的成本和增加的手术时间,这些发现对旋切术的常规使用提出了质疑。

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