Department of Surgery, Cooper University Hospital, Camden, NJ.
Department of Surgery, Massachusetts General Hospital, Boston, Mass.
J Vasc Surg. 2014 Jun;59(6):1544-54. doi: 10.1016/j.jvs.2013.12.038. Epub 2014 Feb 19.
The purpose of this study is to report updated clinical and aortic remodeling results from the Study for the Treatment of complicated Type B Aortic Dissection using Endoluminal repair (STABLE) trial, a prospective, multicenter study evaluating safety and effectiveness of a pathology-specific endovascular system (proximal stent graft and distal bare metal stent) for the treatment of complicated type B aortic dissection.
All 86 enrolled patients (mean age, 59 years; 73.3% men) were treated within 90 days of symptom onset (55 with acute dissections and 31 with nonacute dissections). Inclusion criteria were branch vessel obstruction/compromise, impending rupture as evidenced by periaortic effusion/hematoma, resistant hypertension, persistent pain/symptoms, or aortic growth ≥5 mm within 3 months (or transaortic diameter ≥40 mm). Remodeling of the dissected aorta, including thrombosis of the false lumen and changes in the true lumen, false lumen, and transaortic diameter, were assessed in patients with available computed tomographic imaging through 2 years.
The 30-day mortality rate was 4.7% (4/86) in the overall patient group (5.5% in acute patients and 3.2% in non-acute patients). Freedom from all-cause mortality was 88.3% at 1 year and 84.7% at 2 years (no significant difference between acute and nonacute patients). From baseline to 2 years, the true lumen diameter increased significantly in the descending thoracic aorta and the more distal abdominal aorta, along with a decrease in the false lumen diameter in both aortic segments. A majority of patients had either a stable or shrinking transaortic diameter in the thoracic (80.3% at 1 year and 73.9% at 2 years) or abdominal aorta (79.1% at 1 year and 66.7% at 2 years). Transaortic growth (>5 mm) occurred predominantly in acute dissections. Consistently, a shorter time from symptom onset to treatment was found to predict transaortic growth in the abdominal aorta (P = .03).
Endovascular repair of complicated type B aortic dissection with the use of a composite construct demonstrates favorable early clinical outcomes and aortic remodeling. However, patients treated in the acute setting may be prone to aortic growth and may require close observation. Follow-up through 5 years is ongoing.
本研究旨在报告一项使用腔内修复治疗复杂型 B 型主动脉夹层的前瞻性、多中心研究（STABLE 研究）的最新临床和主动脉重塑结果，该研究评估了一种针对特定病变的腔内系统（近端支架移植物和远端裸金属支架）治疗复杂型 B 型主动脉夹层的安全性和有效性。
所有 86 名入组患者（平均年龄 59 岁；73.3%为男性）均在症状发作后 90 天内接受治疗（55 例急性夹层，31 例非急性夹层）。纳入标准为分支血管阻塞/损伤、证据表明有即将破裂的情况（如主动脉旁积液/血肿）、难治性高血压、持续性疼痛/症状、或 3 个月内主动脉直径增大≥5mm（或跨主动脉直径≥40mm）。通过 2 年的计算机断层扫描影像学检查评估主动脉夹层的重塑情况，包括假腔血栓形成和真腔、假腔和跨主动脉直径的变化。
在整体患者组中，30 天死亡率为 4.7%（4/86）（急性患者为 5.5%，非急性患者为 3.2%）。1 年和 2 年的全因死亡率无显著差异，分别为 88.3%和 84.7%。从基线到 2 年，降胸主动脉和更下游的腹主动脉的真腔直径显著增加，同时两个主动脉节段的假腔直径减小。大多数患者的胸主动脉（1 年时为 80.3%，2 年时为 73.9%）或腹主动脉（1 年时为 79.1%，2 年时为 66.7%）的跨主动脉直径保持稳定或缩小。跨主动脉增大（>5mm）主要发生在急性夹层中。从症状发作到治疗的时间较短与腹主动脉跨主动脉增大有关（P=0.03）。
使用复合结构治疗复杂型 B 型主动脉夹层的腔内修复术显示出良好的早期临床结果和主动脉重塑。然而，在急性情况下接受治疗的患者可能容易发生主动脉生长，需要密切观察。随访时间超过 5 年仍在继续。
