Rundback John H, Sacks David, Kent K Craig, Cooper Christopher, Jones Daniel, Murphy Timothy, Rosenfield Kenneth, White Christopher, Bettmann Michael, Cortell Stanley, Puschett Jules, Clair Daniel G, Cole Patricia
Columbia Presbyterian Medical Center, Milstein Pavilion, Vascular and Interventional Radiology, New York, NY 10032, USA.
J Vasc Interv Radiol. 2002 Oct;13(10):959-74. doi: 10.1016/s1051-0443(07)61860-0.
Although the treatment of atherosclerotic renal artery stenosis with use of percutaneous angioplasty, stent placement, and surgical revascularization has gained widespread use, there exist few prospective randomized controlled trials (RCTs) comparing these techniques to each other or against the standard of medical management alone. To facilitate this process as well as help answer many important questions regarding the appropriate application of renal revascularization, well-designed and rigorously conducted trials are needed. These trials must have clearly defined goals and must be sufficiently sized and performed so as to withstand intensive outcomes assessment. Toward this end, this document provides guidelines and definitions for the design, conduct, evaluation, and reporting of renal artery revascularization RCTs. In addition, areas of critically necessary renal artery revascularization investigation are identified. It is hoped that this information will be valuable to the investigator wishing to conduct research in this important area.
尽管经皮血管成形术、支架置入术和外科血管重建术治疗动脉粥样硬化性肾动脉狭窄已得到广泛应用，但很少有前瞻性随机对照试验（RCT）比较这些技术相互之间或与单纯药物治疗标准的差异。为推动这一进程并帮助解答许多有关肾血管重建术适当应用的重要问题，需要精心设计并严格开展试验。这些试验必须有明确界定的目标，且规模要足够大、实施要得当，以便能够承受深入的结果评估。为此，本文档提供了肾动脉血管重建术RCT的设计、实施、评估和报告的指南及定义。此外，还确定了急需进行肾动脉血管重建术研究的领域。希望这些信息对希望在这一重要领域开展研究的人员有价值。
