stenting and medical therapy for atherosclerotic renal-artery stenosis christopher j. cooper,...
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Stenting and Medical Therapyfor Atherosclerotic Renal-Artery
Stenosis
Christopher J. Cooper, Timothy P. Murphy,Donald E. Cutlip
NEJM Novembre 2013
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Introduction
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Epidémiologie
• 1-5% des hypertendus• Jusqu’à 7% des >65 ans
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Les débuts
Treatment of Renovascular Hypertension with Percutaneous Transluminal Dilatation of a Renal Artery Stenosis
Grüntzig A. et al
Lancet 1978, 801-807
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L'essor
• Diminution de la PA– Blum U, Krumme B, Flügel P, et al. Treatment of ostial renal-artery
stenoses with vascular endoprothesis after unsuccessful balloon angioplasty. NEJM 1997
• Stabilisation de la fonction rénale– Harden PN, Mac Leod MJ, Rodger RS, et al. Effect of renal artery
stenting on progression of renovascular renal failure. Lancet 1997
– > + 360% ATL entre 1996 et 2000– > mais essais non contrôlés !
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Le doute…
• La PA : – van Jaarsveld BC , Krijnen P, Pieterman H et al. The effect of balloon
angioplasty on hypertension in atherosclerosis renal-artery stenosis NEJM 2000
• La fonction rénale :– The ASTRAL investigators. Revascularization versus medical therapy
for renal artery stenosis. NEJM 2009– Bax L, Woittiez AJ, Kouwenberg HJ, et al. Stent placement in patients
with atherosclerotic renal artery stenosis and impaired renal function. Ann Intern Med 2009
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Et les effets cliniques ?
– > Objectif de cette étude : • Efficacité du stent en prévention des évènements
cardiovasculaires ou rénaux
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Matériel et Méthodes
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Étude CORAL
• Multicentrique• En ouvert• Randomisée• Contrôlée contre traitement médical seul• Mai 2005 à Septembre 2012
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Les sujets
• Sténose sévère :– >80 % du calibre de l’artère– ou >60% et gradient PA systolique > 20mmHg
• ET – HTA systolique malgré ≥2 antiHTA– ou DFG < 60 mL/min (MDRD)
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• Critères d’exclusion :– Sténose fibrodysplasique– Autre cause d’IRC– Cr > 354 µmol/L– Rein < 7cm– Impossibilité d'utiliser un seul stent
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Schéma de l’étude
• Randomisation 1:1
• Traitement médical– AAP– Atacand +/- HCTZ– Caduet (amlodipine – atorvastatine)
• Traitement médical + stent
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Critères de jugement
• Principal : survenue d’évènement CV ou rénal– IDM, AVC, OAP, progression IRC (DFG - 30%)
nécessité de greffe ou mort (de cause CV ou rénale)
• Secondaire– Évènements individuels– Mortalité (toutes causes confondues)
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Calcul du nombre de sujets
• Puissance 90%• α : 0.05• HR : 0.75 à 2 ans
– > 1080 participants
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Résultats
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Une différence significative !
• PA systolique : – 2.3 mmHg en moins dans le groupe stent !– p=0.03
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Discussion
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Étude d’excellente qualité
• Forte puissance : 950 patients, suivi médian : 43 mois
• Randomisée• Contrôlée contre traitement de référence• Analyse en ITT• Critère de jugement clinique, objectif et
reproductible
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Conclusion
• Pas de bénéfice clinique du stent dans la sténose athéromateuse des artères rénales
• indications limitées :– Fibrodysplasie ?– OAP flash ?– IRA ?