Division of Vascular and Interventional Radiology, University of Maryland Medical Center, 22 S. Greene St., GK214, Baltimore, MD 21201, USA.
N Engl J Med. 2010 Feb 11;362(6):494-503. doi: 10.1056/NEJMoa0902045.
The leading cause of failure of a prosthetic arteriovenous hemodialysis-access graft is venous anastomotic stenosis. Balloon angioplasty, the first-line therapy, has a tendency to lead to subsequent recoil and restenosis; however, no other therapies have yet proved to be more effective. This study was designed to compare conventional balloon angioplasty with an expanded polytetrafluoroethylene endovascular stent graft for revision of venous anastomotic stenosis in failing hemodialysis grafts.
We conducted a prospective, multicenter trial, randomly assigning 190 patients who were undergoing hemodialysis and who had a venous anastomotic stenosis to undergo either balloon angioplasty alone or balloon angioplasty plus placement of the stent graft. Primary end points included patency of the treatment area and patency of the entire vascular access circuit.
At 6 months, the incidence of patency of the treatment area was significantly greater in the stent-graft group than in the balloon-angioplasty group (51% vs. 23%, P<0.001), as was the incidence of patency of the access circuit (38% vs. 20%, P=0.008). In addition, the incidence of freedom from subsequent interventions at 6 months was significantly greater in the stent-graft group than in the balloon-angioplasty group (32% vs. 16%, P=0.03 by the log-rank test and P=0.04 by the Wilcoxon rank-sum test). The incidence of binary restenosis at 6 months was greater in the balloon-angioplasty group than in the stent-graft group (78% vs. 28%, P<0.001). The incidences of adverse events at 6 months were equivalent in the two treatment groups, with the exception of restenosis, which occurred more frequently in the balloon-angioplasty group (P<0.001).
In this study, percutaneous revision of venous anastomotic stenosis in patients with a prosthetic hemodialysis graft was improved with the use of a stent graft, which appears to provide longer-term and superior patency and freedom from repeat interventions than standard balloon angioplasty. (ClinicalTrials.gov number, NCT00678249.)
人造动静脉血液透析通路移植物失效的主要原因是静脉吻合口狭窄。球囊血管成形术作为一线治疗方法，往往会导致随后的回缩和再狭窄；然而，目前还没有其他治疗方法被证明更有效。本研究旨在比较传统的球囊血管成形术与扩张聚四氟乙烯血管内支架移植物治疗人造血液透析移植物失败时静脉吻合口狭窄。
我们进行了一项前瞻性、多中心试验，将 190 名接受血液透析且存在静脉吻合口狭窄的患者随机分为球囊血管成形术组或球囊血管成形术加支架移植物组。主要终点包括治疗区域通畅率和整个血管通路通畅率。
在 6 个月时，支架组治疗区域通畅率显著高于球囊血管成形术组（51%比 23%，P<0.001），通路通畅率也显著高于球囊血管成形术组（38%比 20%，P=0.008）。此外，在 6 个月时，支架组无后续干预的发生率显著高于球囊血管成形术组（32%比 16%，对数秩检验 P=0.03，Wilcoxon 秩和检验 P=0.04）。在 6 个月时，球囊血管成形术组的二元再狭窄发生率高于支架组（78%比 28%，P<0.001）。两组 6 个月时的不良事件发生率相当，除了球囊血管成形术组更常见的再狭窄（P<0.001）。
在这项研究中，经皮治疗人造血液透析移植物患者静脉吻合口狭窄，使用支架移植物可改善疗效，与标准球囊血管成形术相比，支架移植物提供了更长时间和更好的通畅率，且重复干预的发生率更低。（ClinicalTrials.gov 编号，NCT00678249）
