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血管内修复 B 型主动脉夹层:主动脉夹层支架置入治疗随机试验的长期结果。

Endovascular repair of type B aortic dissection: long-term results of the randomized investigation of stent grafts in aortic dissection trial.

机构信息

University of Rostock, Heart Center and Institute for Biostatistics, Rostock, Germany.

出版信息

Circ Cardiovasc Interv. 2013 Aug;6(4):407-16. doi: 10.1161/CIRCINTERVENTIONS.113.000463. Epub 2013 Aug 6.

Abstract

BACKGROUND

Thoracic endovascular aortic repair (TEVAR) represents a therapeutic concept for type B aortic dissection. Long-term outcomes and morphology after TEVAR for uncomplicated dissection are unknown.

METHODS AND RESULTS

A total of 140 patients with stable type B aortic dissection previously randomized to optimal medical treatment and TEVAR (n=72) versus optimal medical treatment alone (n=68) were analyzed retrospectively for aorta-specific, all-cause outcomes, and disease progression using landmark statistical analysis of years 2 to 5 after index procedure. Cox regression was used to compare outcomes between groups; all analyses are based on intention to treat. The risk of all-cause mortality (11.1% versus 19.3%; P=0.13), aorta-specific mortality (6.9% versus 19.3%; P=0.04), and progression (27.0% versus 46.1%; P=0.04) after 5 years was lower with TEVAR than with optimal medical treatment alone. Landmark analysis suggested a benefit of TEVAR for all end points between 2 and 5 years; for example, for all-cause mortality (0% versus 16.9%; P=0.0003), aorta-specific mortality (0% versus 16.9%; P=0.0005), and for progression (4.1% versus 28.1%; P=0.004); Landmarking at 1 year and 1 month revealed consistent findings. Both improved survival and less progression of disease at 5 years after elective TEVAR were associated with stent graft induced false lumen thrombosis in 90.6% of cases (P<0.0001).

CONCLUSIONS

In this study of survivors of type B aortic dissection, TEVAR in addition to optimal medical treatment is associated with improved 5-year aorta-specific survival and delayed disease progression. In stable type B dissection with suitable anatomy, preemptive TEVAR should be considered to improve late outcome.

CLINICAL TRIAL REGISTRATION URL

http://www.clinicaltrials.gov. Unique identifier: NCT01415804.

摘要

背景

胸主动脉腔内修复术(TEVAR)是治疗 B 型主动脉夹层的一种治疗方法。TEVAR 治疗单纯性 B 型主动脉夹层的长期结果和形态尚不清楚。

方法和结果

对 140 例先前随机接受最佳药物治疗和 TEVAR(n=72)与单纯最佳药物治疗(n=68)的稳定型 B 型主动脉夹层患者进行回顾性分析,以评估主动脉特异性、全因结局和疾病进展情况。采用 landmark 统计分析方法对索引手术后 2 至 5 年的患者进行分析。采用 Cox 回归比较两组之间的结局;所有分析均基于意向治疗。5 年后,TEVAR 组全因死亡率(11.1%比 19.3%;P=0.13)、主动脉特异性死亡率(6.9%比 19.3%;P=0.04)和进展率(27.0%比 46.1%;P=0.04)均低于单纯最佳药物治疗组。landmark 分析表明,在 2 至 5 年内,TEVAR 对所有终点均有获益,例如,全因死亡率(0%比 16.9%;P=0.0003)、主动脉特异性死亡率(0%比 16.9%;P=0.0005)和进展率(4.1%比 28.1%;P=0.004);在 1 年 1 个月时进行 landmark 分析,也得出了一致的结论。在接受选择性 TEVAR 治疗的 B 型主动脉夹层幸存者中,90.6%的患者出现支架移植物诱导的假腔血栓形成,这与 5 年后的生存改善和疾病进展延缓有关(P<0.0001)。

结论

在这项 B 型主动脉夹层幸存者的研究中,TEVAR 联合最佳药物治疗可改善 5 年的主动脉特异性生存率,并延迟疾病进展。在适合解剖结构的稳定型 B 型夹层中,应考虑预防性 TEVAR 以改善晚期结局。

临床试验注册网址

http://www.clinicaltrials.gov。唯一标识符:NCT01415804。

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