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Nous mettons à votre disposition cette compilation des principales études randomisées en chirurgie vasculaire. Ces pages sont en anglais car c'est la langue des principales publications internationales. Cette revue de la littérature a été publiée sous forme de livre grace à l'aide de Cordis.
Jean-Pierre Becquemin, Julien Gaudric, Paris, 2006

This is a collection of recent abstracts from major randomised studies in the field of vascular surgery. We performed a literature search on the Medline using the terms “Randomised Controlled Studies” and “Vascular Surgery” and selected publications in English language. We also cross-checked in the Cochrane data base to ensure that all the key papers were included. The reference lists of all selected papers were also reviewed. Despite our best efforts there may be some inadvertant omissions and we apologise for this. This review has been published as a book with the help of Cordis. At a time when evidence based medecine is grounds for our daily practice we hope that this document will help vascular surgeons towards providing the best care for their patients.

 

Dernière modification le 17/12/2007

 
 

Angioplastie Rénale - Renal Artery Angioplasty

  1. van Jaarsveld BC et al. (2000). "The effect of balloon angioplasty on hypertension in atherosclerotic renal-artery stenosis. Dutch Renal Artery Stenosis Intervention Cooperative Study Group." N Engl J Med 342(14): 1007-14.
  2. van de Ven PJ et al. (1999). "Arterial stenting and balloon angioplasty in ostial atherosclerotic renovascular disease: a randomised trial." Lancet 353(9149): 282-6
  3. Webster J et al. (1998). "Randomised comparison of percutaneous angioplasty vs continued medical therapy for hypertensive patients with atheromatous renal artery stenosis. Scottish and Newcastle Renal Artery Stenosis Collaborative Group." J Hum Hypertens 12(5): 329-35.
  4. Plouin PF et al. (1998). "Blood pressure outcome of angioplasty in atherosclerotic renal artery stenosis: a randomized trial. Essai Multicentrique Medicaments vs Angioplastie (EMMA) Study Group." Hypertension 31(3): 823-9
  5. Weibull H et al. (1993). "Percutaneous transluminal renal angioplasty versus surgical reconstruction of atherosclerotic renal artery stenosis: a prospective randomized study." J Vasc Surg 18(5): 841-50; discussion 850-2

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1. van Jaarsveld, B. C., P. Krijnen, et al. (2000). "The effect of balloon angioplasty on hypertension in atherosclerotic renal-artery stenosis. Dutch Renal Artery Stenosis Intervention Cooperative Study Group." N Engl J Med 342(14): 1007-14.
BACKGROUND: Patients with hypertension and renal-artery stenosis are often treated with percutaneous transluminal renal angioplasty. However, the long-term effects of this procedure on blood pressure are not well understood. METHODS: We randomly assigned 106 patients with hypertension who had atherosclerotic renal-artery stenosis (defined as a decrease in luminal diameter of 50 percent or more) and a serum creatinine concentration of 2.3 mg per deciliter (200 micromol per liter) or less to undergo percutaneous transluminal renal angioplasty or to receive drug therapy. To be included, patients also had to have a diastolic blood pressure of 95 mm Hg or higher despite treatment with two antihypertensive drugs or an increase of at least 0.2 mg per deciliter (20 micromol per liter) in the serum creatinine concentration during treatment with an angiotensin-converting-enzyme inhibitor. Blood pressure, doses of antihypertensive drugs, and renal function were assessed at 3 and 12 months, and patency of the renal artery was assessed at 12 months. RESULTS: At base line, the mean (+/-SD) systolic and diastolic blood pressures were 179+/-25 and 104+/-10 mm Hg, respectively, in the angioplasty group and 180+/-23 and 103+/-8 mm Hg, respectively, in the drug-therapy group. At three months, the blood pressures were similar in the two groups (169+/-28 and 99+/-12 mm Hg, respectively, in the 56 patients in the angioplasty group and 176+/-31 and 101+/-14 mm Hg, respectively, in the 50 patients in the drug-therapy group; P=0.25 for the comparison of systolic pressure and P=0.36 for the comparison of diastolic pressure between the two groups); at the time, patients in the angioplasty group were taking 2.1+/-1.3 defined daily doses of medication and those in the drug-therapy group were taking 3.2+/-1.5 daily doses (P<0.001). In the drug-therapy group, 22 patients underwent balloon angioplasty after three months because of persistent hypertension despite treatment with three or more drugs or because of a deterioration in renal function. According to intention-to-treat analysis, at 12 months, there were no significant differences between the angioplasty and drug-therapy groups in systolic and diastolic blood pressures, daily drug doses, or renal function. CONCLUSIONS: In the treatment of patients with hypertension and renal-artery stenosis, angioplasty has little advantage over antihypertensive-drug therapy.

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2. van de Ven, P. J., R. Kaatee, et al. (1999). "Arterial stenting and balloon angioplasty in ostial atherosclerotic renovascular disease: a randomised trial." Lancet 353(9149): 282-6.
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 renal-artery 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.

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3. Webster, J., F. Marshall, et al. (1998). "Randomised comparison of percutaneous angioplasty vs continued medical therapy for hypertensive patients with atheromatous renal artery stenosis. Scottish and Newcastle Renal Artery Stenosis Collaborative Group." J Hum Hypertens 12(5): 329-35.
BACKGROUND: Data from randomised studies are lacking on the value of interventional procedures in the management of atheromatous renal artery stenosis. This randomised prospective trial compared the effects on blood pressure (BP) and renal function of percutaneous transluminal angioplasty vs medical therapy in hypertensive patients with both unilateral and bilateral disease. METHODS: A total of 135 eligible patients were identified, of whom 55 (44%) were randomised. Eligible patients had sustained hypertension, with a minimum diastolic BP of 95 mm Hg on at least two anti-hypertensive drugs. Renal artery stenosis was defined by renal angiography as at least 50% stenosis in the affected vessel. All patients were observed during an initial 4-week run-in period on a fixed drug regimen and subsequent changes measured from this 4-week baseline. RESULTS: Blood pressure fell during the run-in period in all groups. In patients with bilateral renal artery stenosis randomised to angioplasty, a statistically significant (P<0.05) fall in BP was observed at latest follow-up (range 3-54 months). The mean fall in BP at latest follow-up in the angioplasty group, corrected for the medical group response, was 26/10 mm Hg. In patients with unilateral renal artery stenosis, no statistically significant or clinically important differences in outcome were observed between the two groups. No significant differences or trends in serum creatinine were observed between or within any group during follow-up. Major outcome events (death, myocardial infarction, heart failure, stroke, dialysis) were similar in the angioplasty and medical groups during follow-up. In the 40/135 patients undergoing angioplasty, serious or potentially serious complications attributable to the procedure were observed in 11 patients, bleeding at the arterial site (8 patients) being the most frequent. CONCLUSIONS: In hypertensive patients with atheromatous renal artery stenosis, percutaneous renal angioplasty results in a modest improvement in systolic BP compared with medical therapy alone. This benefit was confined to patients with bilateral disease. No patient was 'cured', renal function did not improve, and intervention was accompanied by a significant complication rate.

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4. Plouin, P. F., G. Chatellier, et al. (1998). "Blood pressure outcome of angioplasty in atherosclerotic renal artery stenosis: a randomized trial. Essai Multicentrique Medicaments vs Angioplastie (EMMA) Study Group." Hypertension 31(3): 823-9.

Data for the effects on blood pressure of renal artery balloon angioplasty are mostly from uncontrolled studies. The aim of this study was to document the efficacy and safety of angioplasty for lowering blood pressure in patients with atherosclerotic renal artery stenosis. Patients were randomly assigned antihypertensive drug treatment (control group, n = 26) or angioplasty (n = 23). Twenty-four-hour ambulatory blood pressure, the primary end point, was measured at baseline and at termination. Termination took place 6 months after randomization or earlier in patients who developed refractory hypertension. In those allocated angioplasty, antihypertensive treatment was discontinued after the procedure but was subsequently resumed if hypertension persisted. Secondary end points were the treatment score and the incidence of complications. Two patients in the control group and 6 in the angioplasty group suffered procedural complications (relative risk, 3.4; 95% confidence interval, 0.8 to 15.1). Early termination was required for refractory hypertension in 7 patients in the control group. Antihypertensive treatment was resumed in 17 patients in the angioplasty group. Mean ambulatory blood pressure at termination did not differ between control (141+/-15/84+/-11 mm Hg) and angioplasty (140+/-15/81+/-9 mm Hg) groups. Angioplasty reduced by 60% the probability of having a treatment score of 2 or more at termination (relative risk, 0.4; 95% confidence interval, 0.2 to 0.7). There was 1 case of dissection with segmental renal infarction and 3 of restenosis in the angioplasty group. No patient suffered renal artery thrombosis. In unilateral atherosclerotic renal artery stenosis, angioplasty is a drug-sparing procedure that involves some morbidity. Previous uncontrolled and unblinded assessments of angioplasty overestimated its potential for lowering blood pressure.

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5. Weibull, H., D. Bergqvist, et al. (1993). "Percutaneous transluminal renal angioplasty versus surgical reconstruction of atherosclerotic renal artery stenosis: a prospective randomized study." J Vasc Surg 18(5): 841-50; discussion 850-2.
PURPOSE: The purpose of this prospective randomized study was to compare percutaneous transluminal renal angioplasty (PTRA) and operation as initial therapy with regard to technical results, primary and secondary patency, and effects on blood pressure and renal function in patients with atherosclerotic unilateral renal artery stenosis. METHODS: Fifty-eight patients who did not have diabetes, who were less than 70 years of age, and who had severe hypertension and significant stenosis were randomized to receive PTRA or operation. Angiography was performed 10 days, 1 year, and 2 years after treatment to verify patency, and blood pressure and renal function were simultaneously evaluated. RESULTS: Technically, PTRA was successful in 83% and operation in 97% of patients. The primary patency rate after 24 months was 75% in the PTRA group and 96% in the operative group in technically successful cases. The secondary patency rate in the PTRA group was 90% and in the surgical group 97%. To achieve these results four patients in the PTRA group required operation, and one patient in the surgical group required PTRA. Hypertension was cured or improved after additional treatment in 90% of the patients after PTRA and 86% after operation. The corresponding figures for improved or unchanged renal function were 83% and 72%, respectively. After additional treatment, effects on blood pressure and renal function did not differ. Seventeen percent of the patients treated with PTRA required surgical intervention. CONCLUSIONS: PTRA is recommended as first choice of therapy for atherosclerotic renal artery stenosis causing renovascular hypertension if combined with intensive follow-up and aggressive

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