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The Cardiovascular Outcomes with Renal Atherosclerotic Lesions (CORAL) Study: Rationale and Methods

2005; Elsevier BV; Volume: 16; Issue: 10 Linguagem: Inglês

10.1097/01.rvi.0000176301.69756.28

1535-7732

Timothy P. Murphy, Christopher J. Cooper, Lance D. Dworkin, William L. Henrich, John H. Rundback, Alan H. Matsumoto, Kenneth Jamerson, Ralph B. D’Agostino,

Aortic aneurysm repair treatments

Despite the increase in renal artery interventional procedures for the treatment of atherosclerotic renal artery stenosis (RAS) in the United States ( 1 Murphy TP Soares G Kim M Increase in utilization of percutaneous renal artery interventions by medicare beneficiaries, 1996–2000. AJR Am J Roentgenol. 2004; 183: 561-568 Crossref PubMed Scopus (108) Google Scholar ), 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 (Table 1) ( 2 van Jaarsveld BC Krijnen P Pieterman H et al. The effect of balloon angioplasty on hypertension in atherosclerotic renal-artery stenosis. Dutch Renal Artery Stenosis Intervention Cooperative Study Group. N Engl J Med. 2000; 342: 1007-1014 Crossref PubMed Scopus (818) Google Scholar , 3 Plouin PF Chatellier G Darne B Raynaud A Blood pressure outcome of angioplasty in atherosclerotic renal artery stenosis: a randomized trial. Essai Multicentrique Medicaments vs Angioplastie (EMMA) Study Group. Hypertension. 1998; 31: 823-829 Crossref PubMed Scopus (569) Google Scholar , 4 Webster J Marshall F Abdalla M et al. 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. 1998; 12: 329-335 Crossref PubMed Scopus (495) Google Scholar ). 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. Table 1Results of Randomized Clinical Trials that Used Blood Pressure Endpoints * These studies are essentially comparisons of medical therapy with angioplasty of the renal artery (not stent placement). Trial/Lead Author Years N Population Intervention Endpoints Conclusion Comments Scottish/Webster ( 5 Leertouwer TC Gussenhoven EJ Bosch JL et al. Stent placement for renal arterial stenosis: where do we stand? A meta-analysis. Radiology. 2000; 216: 78-85 Crossref PubMed Scopus (372) Google Scholar ) N/A 55 Diastolic hypertension with unilateral or bilateral atherosclerotic RAS ≥ 50% Randomized to PTRA or medical therapy Difference in mean arterial blood pressure Blood pressure improvement limited to those with bilateral RAS Possible selection bias French/Plouin ( 3 Plouin PF Chatellier G Darne B Raynaud A Blood pressure outcome of angioplasty in atherosclerotic renal artery stenosis: a randomized trial. Essai Multicentrique Medicaments vs Angioplastie (EMMA) Study Group. Hypertension. 1998; 31: 823-829 Crossref PubMed Scopus (569) Google Scholar ) 1992–1995 49 Hypertension with unilateral atherosclerotic RAS ≥ 60% with lateralizing captopril scan or ≥ 75% without Randomized to medical therapy vs PTRA Change in diastolic blood pressure No difference between treatment groups 27% crossover from medical therapy to PTRA DRASTIC/van Jaarsveld ( 2 van Jaarsveld BC Krijnen P Pieterman H et al. The effect of balloon angioplasty on hypertension in atherosclerotic renal-artery stenosis. Dutch Renal Artery Stenosis Intervention Cooperative Study Group. N Engl J Med. 2000; 342: 1007-1014 Crossref PubMed Scopus (818) Google Scholar ) 1993–1998 106 Refractory HTN with at least one RAS > 50% of luminal diameter Randomized to PTRA vs medical therapy Systolic and diastolic blood pressure, number and doses of blood pressure medications and renal function “Little benefit” of PTRA at 12 months 44% crossover from medical therapy to PTRA analyzed as intention-to-treat; medical therapy restricted in PTRA group * These studies are essentially comparisons of medical therapy with angioplasty of the renal artery (not stent placement). Open table in a new tab