This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Despite the increase in renal artery interventional procedures for the treatment of atherosclerotic renal artery stenosis (RAS) in the UnitedStates, the clinical advantages of revascularization with angioplasty have not been proved, and the outcomes of patients with RAS treated by rigorous medical intervention alone have not been systematically evaluated. Randomized clinical trials comparing percutaneous transluminal renal angioplasty (PTRA) without stent placement with medical therapy have reported no benefit in blood pressure. To date, no large trials of RAS have been completed that evaluate hard clinical endpoints. A randomized clinical trial, Angioplasty and Stent for Renal Atherosclerotic Lesions (ASTRAL), is ongoing in the United Kingdom for patients with atherosclerotic RAS but not necessarily hypertension,which will use renal function as its primary endpoint.There have been three randomized clinical trials that compared renal artery angioplasty with medical therapy for blood pressure control for patients with atherosclerotic RAS. None of these studies showed a statistically significant difference in systolic blood pressure between treatment groups. Of these three studies, the Dutch Renal Artery Stenosis Intervention Cooperative (DRASTIC) Study randomized 106 patients. At 3 months, there appeared to be some benefit of PTRA. However, at 12 months, the authors reported 'little benefit' of angioplasty over medical therapy for their patients. There were criticisms of the study methods. By design, medical therapy in the PTRA group was restricted, but 44% of the 'refractory' medical therapy patients were allowed to crossover and receive PTRA after 3 months while still being analyzedas medical therapy patients on the basis of intention-to-treat. Althoughthe authors reported 'little benefit' from angioplasty, their data indicate that patients in the PTRA group were significantly more likely to have improvement in blood pressure control (68% vs 38%; P < 0.005), more likely to be cured (7% vs 0%; P < 0.07), and less likely to have either a worsening of blood pressure control (9% vs 33%; P < 0.002) or develop renal artery occlusion (0% vs 16%; P < 0.002) during the 12 months of follow up.None of the studies comparing PTRA and medical therapy to date have included stents. Renal artery stent placement is considered to be the current standard today for the endovascular treatment of atherosclerotic RAS and improves technical and longterm clinical outcomes when compared with angioplasty alone, especially for ostial stenoses, which comprise 80% of atherosclerotic stenoses. In one meta-analysis of 1,322 patients, stent placement had a higher technical success rate and a lower restenosis rate than did PTRA (98% vs 77% and 17% vs 26%, respectively; P < 0.001), as well as a higher cure rate for hypertension.The CORAL Study is a multicenter, randomized, unblinded, two-arm clinical trial designed to test the hypothesis that medical therapy with stent placement of hemodynamically significant atherosclerotic RAS in patients with refractory systolic hypertension reduces the incidence of adverse cardiovascular and renal events compared with optimal medical therapy alone. Enrollment began in spring of 2005 and is expected to be completed in 2009. A total of 1,080 patients at approximately 100 hospitals in the United States and 100 hospitals outside the United States will be randomized and closely monitored for blood pressure control and management of other risk factors for a minimum of 1.5 years. A subgroup of 400 patients will undergo renal artery duplex ultrasound (US) at baseline, 1 year, and termination for measurement of renal resistive indexes and evaluation of stenosis. All patients will have quality of life measures performed. Data will be collected for cost effectiveness analyses. Study completion is anticipated by 2010.(modified from Murphy TP et al. 'The Cardiovascular Outcomes with Renal Atherosclerotic Lesions (CORAL) Study: Rationale and Methods', J Vasc Interv Radiol 2005; 16:1295-1300)
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