Scarpioni R, Michieletti E, Cristinelli L, Ugolotti U, Scolari F, Venturelli C, Cancarini G, Pecchini P, Malberti F, Maroldi R, Rozzi G, Olivetti L
Division of Nephrology and Dialysis, "da Saliceto" Hospital, Piacenza - Italy.
J Nephrol. 2005 Jul-Aug;18(4):423-8.
Many studies suggest a major prevalence of atherosclerotic renovascular disease (ARVD), caused by mono or bilateral renal artery stenosis (RAS). Unfortunately, there is no definite therapy to cure this disease to date; therefore, ARVD is burdened by important clinical complications with high social and economic costs. The last few years have seen important advancements in both medical therapy and in interventional radiology (for example, percutaneous transluminal renal artery stenting (PTRS)). All of them could affect, in some way, the natural history of ARVD, but to date the optimal strategy has not been established.
The protocol of a prospective, multicenter, randomized trial "Nephropathy Ischemic Therapy (NITER)" is presented. It enrolls patients with stable renal failure (glomerular filtration rate (GFR) >or=30 ml/min) and hypertension, and hemodynamically significant atherosclerotic ostial RAS (>or=70%) diagnosed by duplex Doppler (DD) ultrasonography and confirmed by magnetic resonance angiography (MRA). This study aims to evaluate whether medical therapy plus interventional PTRS is superior to medical therapy alone according to the following combined primary endpoint: death or dialysis initiation or reduction by >20% in estimated GFR after 0.5, 1, and 2 yrs of follow-up and an extended follow-up until the 4th year. Medical therapy means drugs to control hypertension, improve dyslipidemia and optimize platelet anti-aggregant therapy. The sample size is estimated in 50 patients per group to achieve a statistical significance of 0.05 in case of a reduction by 50% in the combined endpoints.
许多研究表明，由单侧或双侧肾动脉狭窄（RAS）引起的动脉粥样硬化性肾血管疾病（ARVD）十分常见。遗憾的是，迄今为止尚无明确的治愈该疾病的疗法；因此，ARVD伴有严重的临床并发症，社会和经济成本高昂。在过去几年中，药物治疗和介入放射学（例如经皮腔内肾动脉支架置入术（PTRS））均取得了重要进展。所有这些进展都可能在某种程度上影响ARVD的自然病程，但迄今为止尚未确立最佳策略。
本文介绍了一项前瞻性、多中心、随机试验“肾病缺血治疗（NITER）”的方案。该试验纳入患有稳定肾功能衰竭（肾小球滤过率（GFR）≥30 ml/min）和高血压，且经双功多普勒（DD）超声诊断并经磁共振血管造影（MRA）证实存在血流动力学显著的动脉粥样硬化性肾动脉开口处狭窄（≥70%）的患者。本研究旨在根据以下联合主要终点评估药物治疗加介入性PTRS是否优于单纯药物治疗：随访0.5、1和2年以及直至第4年的延长随访期后，死亡或开始透析或估计GFR降低>20%。药物治疗是指用于控制高血压、改善血脂异常和优化血小板抗聚集治疗的药物。每组估计样本量为50例患者，以便在联合终点降低50%的情况下达到0.05的统计学显著性。
