Prospective randomized trial of operative vs interventional treatment for renal artery ostial occlusive disease (RAOOD).

INTRODUCTION AND OBJECTIVES: Patients with either renovascular hypertension (RVH) and/or renal insufficiency (RI) due to renal artery ostial occlusive disease (RAOOD) can successfully undergo an open surgical reconstruction procedure (OSRP), but since the publication of Blum et al(1) percutaneous balloon stent angioplasty (PTRA + stent) leaving a small part of the stent within the aorta has become very popular. However, balloon dilatation and stenting does not remove the atherosclerotic plaque, which is often heavily calcified but leads to disruption of the plaque causing myointimal hyperplasia and recurrent stenosis. Therefore, a comparison of the two treatment modalities concerning complications and durability in a prospective randomized design was felt to bring more insight to the discussion. METHODS: From 1998 to 2004, we performed OSRP in 330 patients with RVH and/or RI for various locations of RAOOD. During this time period, 50 patients (female 18, male 32, mean age 64.4 years) with RAOOD of at least 70% stenosis (DSA and duplex criteria) in one or both renal arteries, who did not require other aorto/mesenteric/iliac reconstructive procedures agreed and were randomized to either OSRP (n = 25 patients, 49 arteries) or PTRA + stent (n = 25 patients, 28 arteries). Two patients crossed over to surgical treatment. Patients were followed on a regular basis for 4 years and longer. Endpoints were re-occurrence of RAOOD and impairment of either kidney function or RVH. RESULTS: We approached 77 arteries. There was no early mortality in either group, but directly procedure-related morbidity was 13% in the interventional group and 4% in the surgical group. Four-year follow-up mortality was 18% in the interventional group and 25% in the surgical group. Both groups showed significant improvement of RVH (P < .001 in each group) as well as improvement or stabilization in patients with insufficient renal function. Freedom from recurrent RAOOD (>70%) was achieved in 90.1% of the surgical group and 79.9% of the interventional group. CONCLUSION: Both treatment modalities showed good early results concerning RVH, kidney function, and renal perfusion. Despite a higher number of bilateral renal artery reconstructions in patients undergoing OSRP, which was probably due to the preferred technique of transaortic endarterectomy eliminating the plaque originating in the aorta and usually extending into both renal arteries, mortality was not higher and procedure-related morbidity was even lower compared to PTRA + stent. These findings and also longer durability of OSRP imply that surgical reconstruction remains the gold standard for patients with RAOOD before PTRA + stent may be considered.