The Dutch Renal Artery Stenosis Intervention Cooperative (DRASTIC) Study: rationale, design and inclusion data

RATIONALE: Renal artery stenosis may lead to renovascular hypertension, risking multiple organ damage including damage to the contralateral kidney. Progression of stenosis may impair the function of the affected kidney. It is important to identify individuals with this disease among hypertensive patients. The first aim of the Dutch Renal Artery Stenosis Intervention Cooperative (DRASTIC) study is to assess the prevalence of renal artery stenosis in patients with well-defined forms of drug-resistant hypertension, and to determine the predictive value of clinical characteristics and diagnostic tests in these pre-selected patients. With regard to treatment, the effect of renal angioplasty on hypertension is disappointing in atherosclerotic stenosis and technical failure frequently occurs. Therefore, the second aim is to compare the effects of balloon angioplasty and antihypertensive medication on blood pressure in patients with atherosclerotic renal artery stenosis. DESIGN HYPERTENSIVE: patients receiving standard antihypertensive medication in whom diastolic blood pressure remained > or =95 mmHg during three consecutive visits to the outpatient clinic underwent full diagnostic work-up, including renal arteriography. The prevalence of renal artery stenosis in this well-defined patient group was then established, and the predictive value of the various diagnostic tests was assessed. Patients with an atherosclerotic renal artery stenosis of > or =50% were then randomly assigned to balloon angioplasty or to treatment with antihypertensive drugs. After 1 year of intensive follow-up of blood pressure and renal function, re-arteriography was performed. CONCLUSION: In total, 1205 patients have been included in the study, about 500 have received diagnostic work-up, and it is expected that 100 patients will be randomly assigned for renal angioplasty or medical treatment.