Arterial stenting and balloon angioplasty in ostial atherosclerotic renovascular disease: a randomised trial

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1 Early reports Arterial stenting and balloon angioplasty in ostial atherosclerotic renovascular disease: a randomised trial Peter J G van de Ven, Robert Kaatee, Jaap J Beutler, Frederick J A Beek, Arend-Jan J Woittiez, Erik Buskens, Hein A Koomans, Willem P Th Mali Summary Background Percutaneous transluminal angioplasty (PTA) for ostial atherosclerotic renal-artery stenosis has poor results. Angioplasty with stent placement (PTAS) may be more effective. We undertook a randomised prospective study to compare PTA with PTAS in patients with ostial atherosclerotic renal-artery stenosis. Methods Patients with ostial atherosclerotic renal-artery stenosis were assigned to receive PTA or PTAS. Secondary PTAS was allowed if PTA failed immediately or during 6 months follow-up. Analysis was by intention to treat. Findings 42 patients were assigned PTA and 43 were assigned PTAS, but one patient in the PTAS group was excluded from the study. Primary success rate (<50% residual stenosis) of PTA was 57% (24 patients) compared with 88% (37 patients) for PTAS (difference between groups 31% [95% CI 12 50]). Complications were similar. At 6 months, the primary patency rate was 29% (12 patients) for PTA, and 75% (30 patients) for PTAS (46% [24 68]). Restenosis after a successful primary procedure occurred in 48% of patients for PTA and 14% for PTAS (34% [11 58]). 12 patients underwent secondary stenting for primary or late failure of PTA within the follow-up period: success was similar to that of primary PTAS. Evaluation based on intention to treat showed no difference in clinical results at six months for PTA or PTAS. Interpretation PTAS is a better technique than PTA to achieve vessel patency in ostial atherosclerotic renalartery stenosis. Primary PTAS and primary PTA plus PTAS as rescue therapy have similar outcomes. However, the burden of reintervention after PTA outweighs the potential saving in stents, so primary PTAS is a better approach to use. Lancet 1999; 353: Department of Nephrology and Hypertension, and Department of Radiology, Julius Center for Patient Orientated Research, University Hospital Utrecht, Netherlands (P J G van de Ven MD, R Kaatee MD, J J Beutler MD, F J A Beek MD, A-J J Woittiez MD, E Buskens MD, H A Koomans MD, W P Th Mali MD) Correspondence to: Dr Jaap J Beutler, Department of Nephrology and Hypertension, University Hospital Utrecht, PO Box 85500, 3584 GA Utrecht, Netherlands ( j.j.beutler@digd.azu.nl) Introduction Atherosclerotic renal-artery stenosis is associated with hypertension and progressive loss of renal function. Despite antihypertensive therapy, atherosclerotic stenosis tends to progress, leading to renal ischaemia and loss of renal mass. 1 Ischaemic nephropathy may be one of the most important causes of terminal renal failure in the elderly. 2 Restoration of vessel patency reduces the need for antihypertensive medication 3,4 and may slow the progression of renal failure. 5,6 Atherosclerotic stenosis located in the truncus of the renal artery can be successfully treated by standard percutaneous transluminal angioplasty (PTA) in most patients. 3,7 Ostial stenosis is less easy to treat, although the rate of acute failure varies between 9% and 76% 7 13 and rates of late retenosis vary between 25% and 45%. 10,12,14 Angioplasty with balloon-expandable stent placement (PTAS) is more successful, with an acute failure rate of only 0 4% and secondary restenosis rate of 3 39%. 5,15 19 Whether this technique also has greater clinical benefit is less clear. Angioplasty cures or ameliorates hypertension in 23 90% of patients and is followed by stable or improved renal function in 54 96% of patients, 10,12,13 compared with 39 78% and %, respectively, for intra-arterial stent placement. 5,15 19 Patency and clinical results of primary PTAS and primary PTA have not been compared in a randomised trial. Stent placement is more expensive, and may involve more intra-arterial manipulation and complications. Therefore, a logical treatment policy would be to try PTA first, and apply stents only after primary failure of PTA or after secondary restenosis. Whether this policy is better than primary stent placement depends on the number of patients who need secondary stenting. We undertook a randomised comparison of PTA and PTAS for the treatment of atherosclerotic ostial renal-artery stenosis. We studied whether PTAS has better primary success than PTA, whether there is less restenosis after PTAS during 6 months of follow-up, and whether improved radiographic results are associated with better clinical results. We also compared the two strategies in terms of efficacy and clinical outcomes. Patients and methods Patients Between December, 1993, and March, 1997, we recruited patients referred to Utrecht University Hospital who had confirmed ostial atherosclerotic renal-artery stenosis or patients in whom this disorder was diagnosed during angiography for suspected renal-artery stenosis. Ostial atherosclerotic renal-artery stenosis was defined as a reduction of 50% or more in luminal diameter within the first 10 mm of the aortic lumen, in 282 THE LANCET Vol 353 January 23, 1999

2 association with atherosclerotic changes of the abdominal aorta. 20 Patients were included only if they were hypertensive (blood pressure >160/95 mm Hg with or without medication), and if the stenosis was shown to affect renal function by positive captopril renography 21 or by an increase of 20% or more in plasma creatinine concentration during standardised use of an angiotensin-converting-enzyme (ACE) inhibitor. 22 Exclusion criteria were: a history of cholesterol embolism; a pole-to-pole distance of the affected kidney of 8 cm or less on ultrasonography plus 25% renal function or less in renography; or a renal tumour. Informed consent was obtained, and the study was approved by the hospital s ethics committee. Methods We measured the patients blood pressure and plasma creatinine concentrations before clinical intervention. Patients continued to take their regular medication, but had stopped taking ACE inhibitors at least 2 weeks before the assessment. After confirmation of ostial atherosclerotic renal-artery stenosis during angiography, patients were randomly assigned PTA or PTAS. Block randomisation (blocks of 40 consecutive patients) was used to balance the intake in each study group. Blocks of 40 masked lots (20 for each group) were made, and lots were drawn by a nurse not involved in the investigation. PTA was done according to the technique described by Tegtmeyer and colleagues. 23 Stent placement was done as described by Rees and colleagues. 5 During these procedures heparin was given (5000 IU intravenously), and continued until adequate anticoagulation had been achieved by use of oral warfarin. After 3 months, warfarin was replaced by aspirin 100 mg daily. The procedure was judged successful if the residual stenosis was less than 50% of luminal diameter. During the procedure, immediate restenosis was defined as a restenosis of 50% or more by elastic recoil. In such cases, the patients allocated PTA underwent stent placement. Patients attended an outpatient clinic at 1 month, 3 months, and 6 months for measurement of blood pressure and plasma creatinine concentration. Renal angiography was repeated at 6 months. For patients in whom cholesterol embolism was suspected, angiography was replaced by spiral computed tomographic angiography. Angiography was repeated earlier if restenosis was suspected on clinical grounds, based on an increase in diastolic blood pressure of at least 15 mm Hg during unchanged antihypertensive medication, or an increase in plasma creatinine of at least 20% that developed spontaneously or after the start of treatment with ACE inhibitors. In the PTA group, restenosis was defined as a reduction of 50% or more in luminal diameter, and was treated by stent placement. In the PTAS group, restenosis was treated by PTA in the stent, and angiography was repeated 6 months after the primary procedure, or in a few cases somewhat later, but always within 6 months of previous angiography. Results of angiography were assessed in consensus reading by two experienced vascular radiologists who were not involved in the treatment procedures. The diameter of the first normal segment distal to the stenosis was used for reference. Clinical success at 6 months was classified according to the guidelines of the Practice Committee of the Society of Cardiovascular and Interventional Radiology. 24 In these guidelines, cure of hypertension is defined as a diastolic blood pressure of 90 mm Hg or less without hypertensive medication. Improvement is defined as a diastolic pressure of 90 mm Hg or less, or at least a 15 mm Hg reduction in diastolic pressure if the dose of antihypertensive medication is maintained or lowered but not increased. Any other result is classed as failure. Improvement in renal function is defined as at least 20% decrease in plasma creatinine concentration, and deterioration is defined as at least 20% increase in plasma creatinine concentration. Any other result is defined as unchanged renal function. Statistical analysis To calculate the optimum size of the study sample, we defined the number of patients needed to show a significant difference in 85 patients eligible 42 assigned PTA 43 assigned PTAS 42 assigned PTA 42 assigned PTAS 1 died 41 followed up at 6 months 1 excluded 40 followed up at 6 months 2 lost to follow-up 1 multiple myeloma 1 cerebrovascular accident Trial profile occurrence of restenosis after a successful primary intervention. For PTA and PTAS we estimated that restenosis would occur in 45% and 15% of patients, respectively. To show a significant difference between these proportions at p=0 05 and with a power of 80% we required 42 patients in each group to have a successful primary procedure. Since we assumed a primary failure rate of 40% in the PTA group, we needed to enter at least 70 patients in that group. We therefore decided that 150 patients should be included in the study in total, but that an interim analysis was needed after 70 patients had been included for whom results at 6 months were available. Since there were significant differences in primary success and restenosis between groups in the interim analysis, we decided to stop recruitment and to assess the patients that had been included up to that time. Results Study population 85 patients were included in the study. 42 patients were assigned PTA and 43 PTAS (figure), but one of the patients allocated PTAS was excluded from the study because of the risk that stent placement would occlude a branch artery. We reasoned that inclusion of the data from this patient was not justified, although we continued to regard the study as an intention-to-treat analysis. Baseline characteristics were similar in the two groups (table 1). There were more men in the PTAS group than in the PTA group. About 20% of the patients had had PTA in the past. The two groups were similar in distribution of unilateral renal-artery stenosis and bilateral renal-artery stenosis, including stenosis to a single functioning kidney, and the mean degree of stenosis. Immediate results of treatment In the 42 patients assigned PTA, 51 renal arteries (50 kidneys) were dilated. Dilation without immediate restenosis was successful in 24 (57%) patients (table 2) and 31 (63%) arteries. Acute restenosis occurred in five patients (five arteries) and was treated with stent placement in the same session. In ten other patients the stenosis remained around 50% of lumen diameter. Although classified as unsuccessful, this outcome was managed conservatively by the radiologist and left as it was. In three patients, catheterisation of one of the renal arteries was not successful because of technical failure, leading to occlusion in one case. With the inclusion of all successful and unsuccessful PTA procedures in the study, the mean reduction in stenosis was 33% (SD 20). In the 42 patients assigned PTAS, 52 renal arteries (52 kidneys) were stented. Revascularisation was successful in THE LANCET Vol 353 January 23,

3 Characteristic Treatment group PTA (n=42) PTAS (n=42) Total (n=84) Demographic Sex (M/F) 19/23 27/15 46/38 Mean (SD) age (years) 64 8 (8 0) 65 6 (7 3) 65 2 (7 6) Clinical Median (IQR) plasma 136 ( ) 154 ( ) 139 ( ) creatinine ( mol/l) Number with plasma 23 (55%) 30 (71%) 53 (63%) creatinine >124 mol/l Mean (SD) blood pressure (mm Hg) Systolic 182 (21) 189 (27) 186 (24) Diastolic 101 (11) 104 (13) 103 (12) Median (IQR) number 2 (1 3) 2 (1 3) 2 (1 3) of antihypertensive drugs taken History Diabetes 3 ( 7%) 3 ( 7%) 6 ( 7%) Hypercholesterolaemia 26 (62%) 22 (52%) 48 (57%) Atherosclerotic disease 31 (74%) 29 (69%) 60 (71%) Cardial 14 (33%) 19 (45%) Cerebral 12 (29%) 8 (19%) Peripheral 24 (57%) 21 (50%) Current smoker 25 (60%) 23 (55%) 48 (57%) History of smoking 4 (10%) 5 (12%) Previous PTRA 6 (14%) 9 (21%) 15 (18%) Type of stenosis Unilateral 23 (55%) 20 (48%) 43 (51%) Bilateral 8 (19%) 10 (24%) 18 (21%) In single kidney 3 ( 7%) 1 ( 2%) 4 ( 5%) With contralateral 8 (19%) 11 (26%) 19 (23%) occlusion Mean (SD) severity of 77 (14) 76 (15) 76 (15) stenosis (%) PTRA=percutaneous transluminal renal angioplasty. Table 1: Baseline characteristics 37 (88%) patients (table 2) and in 47 (90%) arteries. In one patient, residual stenosis of 50% appeared during revision of the angiography series, and was left as it was. In a second patient, acute thrombosis occurred in the stent but this was resolved with intra-arterial streptokinase and systemic heparin treatment. Both patients were included in the follow-up but their primary treatment was classed as unsuccessful. In three patients, catheterisation of the renal artery was not successful, with subsequent occlusion in one case that required surgical intervention. The rate of primary success with PTAS was significantly higher than that of PTA (88 vs 57%, difference between groups 31% [95% CI 12 50], table 2). The mean decrease in stenosis diameter after PTAS was 65% (SD 26), significantly more than that after PTA (difference between groups 32% [23 41]). PTA had as many procedural complications as PTAS. Bleeding occurred once in a region of psoas muscle and once around a kidney after PTA. All other bleeding occurred in the arterial puncture-site in the groin. Four patients in each group developed signs of cholesterol embolism. Renal failure induced by cholesterol embolism defined as at least 20% increase in plasma creatinine concentration maintained for 1 month or longer, occurred in three patients in the PTAS group and in two patients in the PTA group, one of whom had terminal renal failure. Transient decrease in renal function of at least 20%, probably due to radiography contrast agent, occurred in ten (24%) patients after PTA, and in nine (21%) patients after PTAS (difference between groups 3% [ 15 to 21]). Results during follow-up Of the 24 patients with primary successful PTA, one died after 1 month from heart failure. Two patients had a 20% Primary procedure PTA (n=42) PTAS (n=42) Percentage difference (95% CI) Success Primary success 24 (57%) 37 (88%) 31 (12 to 50) Technical failure 3 (7%) 3 (7%) 0 ( 11 to 11) Acute restenosis 15 (36%) 2 (5%) 31 (14 to 48) Complications Bleeding 8 (19%) 8 (19%) 0 ( 17 to 17) Femoral-artery aneurysm* 2 (5%) 3 (7%) 2 ( 12 to 8) Renal-artery injury 2 (5%) 3 (7%) 2 ( 12 to 8) Dissection 1 1 Occlusion/thrombosis 1 2 Cholesterol embolism 4 (10%) 4 (10%) 0 ( 13 to 13) *Arteriovenous fistula in one patient in the PTAS group. Table 2: Success and complications of the primary procedure increase or more in plasma creatinine concentration in 2 months. In both cases, restenosis was confirmed by angiography and treated successfully with PTAS. In the other patients, routine angiography at 6 months showed restenosis in nine cases. Thus 11 (48%) patients with successful PTA developed restenosis within 6 months. Of the five patients who immediately received an arterial stent after unsuccessful PTA, one showed restenosis at routine 6-month angiography. Of the ten patients in whom the residual stenosis of around 50% after PTA was left untreated, five were stented within 6 months because of deterioration in renal function or poor blood-pressure control. In one case this situation was complicated by dissection. In two cases, stenosis in the stent was found at 6 months. Thus, 12 patients received stents, during a second intervention in seven cases. Of the 37 patients with successful primary PTAS, two were lost to follow-up owing to multiple myeloma (one) and cerebrovascular accident (one). Of the remaining 35 patients, five (14%) developed restenosis, shown by routine angiography at 6 months. In both patients in whom primary PTAS was unsuccessful, the treated artery was patent at 6 months. No patient had undergone a second intervention. The primary patency rate at 6 months was higher in the PTAS group than in the PTA group (30 [75%] vs 12 [29%]; difference 46% [24 68], table 3). In terms of the number of patent arteries, the primary patency rates were 39 (79%) of 50 arteries and 14 (28%) of 50 arteries, respectively. The secondary patency rates were also higher in the PTAS group than in the PTA group, both for numbers of patients (32 [80%] vs 21 [51%]) and for numbers of arteries (41 [82%] vs 23 [46%]). PTA (n=41) PTAS (n=40) Difference (%) Patency rates Primary patency 12 (29%) 30 (75%) 46 (24 68) Secondary patency 21 (51%) 32 (80%) 29 (8 50) Renal function (all patients) Improved Unchanged Deteriorated Renal function (patients with impaired function at baseline)* Improved Unchanged Deteriorated Hypertension (all patients) Cured Improved Failing *n=22 (PTA), 29 (PTAS). 95% CI. Table 3: Outcomes at 6 months (intention to treat) 284 THE LANCET Vol 353 January 23, 1999

4 Median (IQR) PTA (n=41) PTAS (n=40) Mean change after PTA or PTAS Before After Before After (95% CI) Plasma creatinine ( mol/l) 132 ( ) 134 ( ) 155 ( ) 140 ( ) 24 ( 2 to 50) Systolic blood pressure (mm Hg) 180 ( ) 165 ( ) 180 ( ) 160 ( ) 19 ( 13 to 25) Diastolic blood pressure (mm Hg) 100 (95 110) 90 (80 100) 105 (95 100) 90 (86 100) 12 ( 9 to 15) Medication (number of drugs taken)* 1 7 (1 2) 1 8 (1 0) 1 8 (1 1) 1 5 (1 0).. *Mean (SD), p=0 24 (Wilcoxon s matched-pairs signed ranks test). One-sample t test. Table 4: Clinical results at 6 months (intention to treat) Clinical results at 6 months based on intention to treat (including the results of secondary stenting for failure of PTA) were available for 41 patients in the PTA group and 40 patients in the PTAS group (tables 3 and 4). There was no change in plasma creatinine concentrations. Multivariate linear regression analysis showed no difference between PTA or PTAS, and no effect of any of the baseline characteristics in table 1. There was no difference between the groups in the distribution of patients with improved, unchanged, or worse renal function, for the whole study population (p=0 98) or for those with impaired function at baseline (p=0 95). Overall, systolic and diastolic blood pressure decreased. Multivariate linear regression analysis showed no difference in blood pressure with PTA or stent placement, but there was an effect of baseline blood pressure. There was a fall in systolic blood pressure of 0 50 mm Hg (95% CI ), and a fall in diastolic blood pressure of 0 52 mm Hg ( ) for every mm Hg rise in baseline pressure. The number of antihypertensive drugs used did not change. The numbers of patients with cured or improved antihypertension or failing antihypertensive effect did not differ between the groups (p=0 20). Cure or improvement occurred in 49% of patients with PTA and 58% of patients with PTAS (difference 9% [CI 31 to 13]). Discussion The rate of primary success of 88% for PTAS is somewhat lower than the rates of % in previous studies. 5,15 19 There may have been more extensive renovascular disease in our patients, since there was a larger proportion of patients with bilateral disease (49%) and renal dysfunction (63%) than in most previous studies, However, the restenosis rate of 14% after 6 months follow-up is similar to the 3 39% restenosis 5, rate within 6 12 months reported elsewhere. We used short, non-articulated stents, which may preserve long-term patency better than longer stents. 19 For PTA, we showed a primary success rate of 57% and a late restenosis rate of 48%. Data for success after PTA are quite varied The cumulative primary patency at 6 months is much better than the rate in the PTA group (75 vs 29%), and also better than results of PTA for ostial lesions reported elsewhere. 10,12,14 Our protocol stated that stents could be placed as secondary therapy after primary or late failure of PTA. In the 12 cases in which this procedure was necessary, the degree of early and late success was similar to that after primary PTAS. PTAS was a successful second intervention after primary or late PTA failure. Intra-stent PTA can also be successful when stenosis develops in an arterial stent. 5,17,25 but that procedure was not necessary since no such stenosis was detected within 6 months of the primary procedure in the PTAS group. The patency rates in the two study groups at 6 months allow an assessment of the cost-efficacy of the two treatments. At 6 months, 14 (34%) more patients in the PTA group were eligible for secondary stenting, and three (7%) patients were eligible for a third intervention. In the stent group, five (12%) patients were eligible for a secondary intervention. Secondary patency at 6 months, if all the procedures were successful, would increase to around 92% in both the PTA and the PTAS groups. However, this assumption implies that 26 (62%) patients in the PTA group would eventually receive a stent, and that 24 (57%) would undergo a second or third intervention, whereas in the PTAS group only 12% of patients would need reintervention. Consequently, to achieve a similar result, use of PTA to start with would save stents in about 40% of the patients, but 45% more hospital admissions would be needed for reinterventions, and reinterventions would probably lead to a proportionate increase in complications. Thus, a policy of primary stenting is more efficient. The 6-month clinical assessment confirmed previous findings of stable renal function in most patients. On average, blood pressure was improved, and the proportion of patients with cured or improved hypertension was also similar to that reported by others for PTAS and for PTA. 5,8 13,15 19 However, the results for PTA and PTAS did not differ, even though the patency rate was better for PTAS. In addition, most cases of restenosis were discovered by routine angiography and not by aggravation of clinical symptoms: a similar observation has been made elsewhere. 26 We must be careful to assume that the improved blood pressure control is the result of the radiological interventions. 27 Renal dysfunction induced by ACE inhibitors was useful to detect bilateral restenosis, but gave a false-positive result in three of 18 patients. This finding was not surprising since such patients generally have nephrosclerosis which accompanies ischaemic nephropathy. 28 The latter findings were based on a small number of patients, but accord with our previous assessment of ACE inhibitors in a larger series of patients with renovascular disease. 22 The question remains whether radiological intervention for ostial atherosclerosis renal-artery stenosis can prevent or slow the deterioration of renal function. Our data suggest that PTAS gives better angiographic revascularisation than PTA in both the numbers of patients in whom the artery diameter can be widened at all and the absolute luminal diameter achieved, and that primary PTAS is a more efficient treatment than primary PTA followed by PTAS on indication. Thus, PTAS may give patients a better start, but long-term follow-up is needed to assess whether PTAS is beneficial in terms of renoprotection. Little is known on the long-term outcome for renal-artery stents. Blum and colleagues 19 showed that restenosis occurred in about 12% of patients within the THE LANCET Vol 353 January 23,

5 first year, and in only 3% in the second year, which suggested a declining risk of restenosis over time. A similar pattern of declining restenosis rates has been shown in patients treated with coronary-artery stents. 29 Two studies that presented follow-up in patients for at least 2 years after stent placement showed stable renal function and the preservation of preintervention renal function. 17,19 Harden and colleagues 6 showed that intraarterial stent placement may slow the progression of renal failure in patients with advanced renal dysfunction, but the median follow-up in that study was only 8 months. Whether patients with ostial atherosclerosis renal-artery stenosis should be treated at all is unclear. Ischaemic nephropathy is a multifactoral disease, involving stenosisrelated ischaemia and factors such as dyslipidaemia, nephrosclerosis, cholesterol embolism, and, in areas of preserved perfusion, the effect of hypertension. 28 In cases of advanced renal dysfunction, whether restoration of renal perfusion is sufficient to avert deterioration in the long-term, is also unclear. Complications of PTAS in these patients, many of whom have widespread atherosclerosis disease, are severe and include a substantial incidence of procedure-related dialysis dependency, and death. 5,6,15 Once renal failure is advanced, survival is poor even after successful PTAS. 6 Screening and intervention treatment involve substantial costs. We believe that a prospective comparative study of PTAS and medical treatment will show which groups of patients should receive PTAS. Contributors Study design and coordination was done by Jaap Beutler, Frederick Beek, Hein Koomans, and Willem Mali. Enrolment and follow-up of patients was done by Jaap Beutler and Arend-Jan Wottiez. Data collection and analysis was done by Peter van de Ven, Robert Kaatee, Jaap Beutler, Frederick Beek, and Arend-Jan Wottiez. Radiological studies and interventions were done by Robert Kaatee, Frederick Beek, and Willem Mali. Statistical analysis was done by Peter van de Ven and Erik Buskens. Peter van de Ven, Jaap Beutler, Hein Koomans, and Willem Mali wrote the paper. Acknowledgments This study was supported by the Dutch Kidney Foundation, grant C References 1 Zierler RE, Bergelin RO, Davidson RC, Cantwell-Gab K, Polissar NL, Strandess DE. A prospective study of disease progression in patients with atherosclerosis renal artery stenosis. Am J Hypertens 1997; 9: Textor SC. Atherosclerotic renovascular disease as a cause of endstage renal disease: cost considerations. Blood Purif 1996; 14: Geyskes GG. Treatment of renovascular hypertension with percutaneous transluminal renal angioplasty. Am J Kidney Dis 1988; 12: Ramsey LE, Waller PC. Blood pressure response to percutaneous transluminal angioplasty for renovascular hypertension: an overview of published series. BMJ 1990; 300: Rees CR, Palmaz JC, Becker GJ, et al. Palmaz stent in atherosclerotic stenoses involving the ostia of the renal arteries: preliminary report of a multicenter study. Radiology 1991; 181: Harden PN, MacLeod MJ, Rodger RSC, et al. Effect of renal-artery stenting on progression of renovascular renal failure. Lancet 1997; 349: Losinno F, Zaccala A, Busato F, Zucchelli P. Renal artery angioplasty for renovascular hypertension and preservation of renal function: longterm angiography and clinical follow-up. Am J Roentgenol 1994; 162: Canzanello VJ, Millan VG, Spiegel JE, Ponce SP, Kopelman RI, Madias NE. Percutaneous transluminal renal angioplasty in management of atherosclerotic renovascular hypertension: results in 100 patients. Hypertension 1989; 13: Klinge J, Mali WPThM, Puijlaert CBAJ, Geyskes GG, Becking WB, Feldberg MAM. Percuteous transluminal renal angioplasty; initial and long-term results. Radiology 1989; 171: Weibull H, Berquist D, Jonsson K, Hulthen L, Mannhem P, Bergentz SE. Long-term results after percutaneous transluminal angioplasty of atherosclerotic renal artery stenosis: the importance of intensive follow-up. Eur J Vasc Surg 1991; 5: Martin LG, Cork RD, Kaufman SL. Long-tern results of angioplasty in 110 patients with renal artery stenosis. J Vasc Interv Radiol 1992; 3: Weibull H, Bergquist D, Bergentz SE, Jonsson K, Hulthen I, Manhem P. Percutaneous transluminal renal angioplasty versus surgical reconstruction of atheroscerosis renal artery stenosis: a prospective randomized study. J Vasc Surg 1993; 18: Jensen G, Zachrisson BF, Delin K, Volkmann R, Aurell M. Treatment of renovascular hypertension: one year results of renal agioplasty. Kidney Int 1995; 48: Plouin PF, Darne B, Chatellier G, et al. Restenosis after first percutaneous transluminal renal angioplasty. Hypertension 1993; 21: Dorros G, Jaff M, Jain A, Dufek C, Mathiak L. Follow-up of primary Palmaz-Schatz stent placement for atherosclerosis renal artery stenosis. Am J Cardiol 1995; 75: van de Ven PGJ, Beutler JJ, Kaatee, et al. Transluminal vascular stent for ostial atherosclerotic renal artery stenosis. Lancet 1995; 346: Henry M, Amor M, Henry I, et al. Stent placement in the renal artery: three-year experience with Palmaz stent. J Vasc Intern Radiol 1996; 7: Iannone LA, Underwood PL. Nath A, Tannenbaum MA, Ghali MGH, Clevenger LD. Effect of primary balloon-expandable renal artery stents on long-term patency, renal function, and blood pressure in hypertensive and renal insufficient patients with renal artery stenosis. Catheter Cardiovasc Diag 1996; 37: Blum U, Krumme B, Flügel P, et al. Treatment of ostial renal artery stenosis with vascular endoprotheses after unsuccessful balloon angioplasty. N Engl J Med 1997; 336: Kaatee R, Beek FJA, Verschuyl EJ, et al. Atherosclerotic renal artery stenosis; ostial or truncal? Radiology 1996; 199: Nally JV, Chen C, Fine E, et al. Diagnostic criteris for renovascular hypertension with captopril renography. Am J Hypertens 1991; 4: 749S 52S. 22 Ven van de PJG, Beutler JJ, Kaatee R, Beek FJA, Mali WPThM, Koomans HA. Angiotensin converting enzyme inhibitor-induced renal dysfunction in atherosclerotic renovascular disease. Kidney Int 1998; 53: Tegtmeyer CJ, Sos TA. Techniques of renal angioplasty. Radiology 1986; 161: Standards of Practice Committee of the Society of Cardiovascular and Interventional Radiology. Guidelines for percutaneous transluminal angioplasty. Radiology 1990; 177: Hennequin LM, Joffre FG, Rousseau HP, et al. Renal artery stent placement: long-term results with the Wallstent endoprothesis. Radiology 1994; 191: Tullis MJ, Zierler E, Glickerman DJ, Bergelin RO, Cantwell-Gab K, Strandess DE. Results of percutaneous transluminal angioplasty for atherosclerotic renal artery stenosis: a follow-up study with duplexultrasonography. J Vasc Surg 1997; 25: Plovin PF, Chatellier G, Darne B, Raynaud A, for the Essai Multicentrique Medicaments vs Angioplastie (EMMA) Study Group. Blood pressure outcome of angioplasty in atherosclerotic renal artery stenosis: a randomized trial. Hypertension 1998; 31: Shanley PF. The pathology of chronic renal ischemia. Semin Nephrol 1996; 16: Kimura T, Yokoi H, Nakagawa Y, et al. Three-year follow-up after implantation of metallic coronary-artery stents. N Engl J Med 1996; 334: THE LANCET Vol 353 January 23, 1999

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