Hypertension: angioplasty is little better than drug therapy for controlling renovascular hypertension

Clinical bottom line (level 1b)

  1. Patients with hypertension due to atherosclerotic renal artery stenosis who have balloon angioplasty compared with drug therapy have no clear reduction in systolic or diastolic blood pressure at 3 months.
  2. Patients who receive angioplasty compared with drug therapy have a small improvement in creatinine clearance (around 11 ml/min), and take on one fewer dose of medication per day.
  3. Patients who receive angioplasty compared with drug therapy are less likely to undergo an invasive intervention (NN T = 3 at 3 months) .
van Jaarsveld et al: New England Journal of Medicine 2000; 342 : 1007-1014
Expires April 2003

The study

Unblinded ?concealed randomised trial with intention-to-treat
Setting: 26 acute hospitals, the Netherlands

106 patients (aged mean 60, 61% male) with atherosclerotic renal-artery stenosis (defined as a decrease in luminal diameter of 50% or more, and a serum creatinine of 200 micromol/l or less) and hypertension resistant to 2 antihypertensive drugs, or with renal function impairment on ACE inhibitors (> 20 micromol/l increase in creatinine).

Excluded if
  • single function kidney and serum creatnine > 150 micromol/l
  • affected kidney < 8.0 cm long on ultrasonography
  • total occlusion of renal artery
  • aortic aneurysm requiring surgery
  • renal artery stenosis due to fibromuscular dysplasia
  • aged < 18, > 75
  • pregnant
  • cancer
  • hypertension caused by a condition other than renovascular disease (e.g. renal parenchymal disease, primary aldosteronism, hypercortisolism)
  • unstable coronary artery disease or heart failure

    Note:
  • Patients were stratified for serum creatinine concentration, type of antihypertensive drug used, and the extent of renal artery stenosis before randomisation.

    Control Group: (n = 50, 50 analysed): drug therapy (amlodipine and atenolol, or enalapril and hydrochlorothiazide). Patients underwent balloon angioplasty after 3 months, if diastolic pressure > 95 mmHg despite treatment with 3 or more drugs, or there was evidence of progressive renovascular occlusive disease.
    Experimental Group: (n = 56, 56 analysed): transluminal renal angioplasty. Patients received 300 mg aspirin daily for 6 months. Antihypertensive therapy was discontinued on the day of the procedure, and subsequently resumed if necessary. Patients could have a second angioplasty, stent insertion or surgery after 3 months, if diastolic pressure was > 95 mmHg or serum creatinine levels were rising.

    100% followed for 12 months
    Outcome notes:
    • further intervention required : surgery following angioplasty; or angioplasty following failed medical therapy

    The evidence

    Outcome Time to outcome CER EER RRR
    (95% CI)    		 ARR
    (95% CI)    		 NN T
    (95% CI)
    further intervention required 3 months 50
    (44.0%)    		 3
    (5.36%)    		 88%
    (62% to 96%)    		 38.6%
    (23.7% to 53.6%)    		 3
    (2 to 4)

    Outcome Control Group
    (SD)    		 Experimental Group
    (SD)    		 Mean Difference
    (95% CI)
    systolic hypertension (mmHg) at 3 months 176
    (31)     		169
    (28)     		7
    (-4 to 18)
    diastolic blood pressure (mmHg) at 3 months 101
    (14)     		99
    (12)     		2
    (-3 to 7)
    daily doses of medication 3.2
    (1.5)     		2.1
    (1.3)     		1.1
    (0.56 to 1.6)
    creatinine clearance (ml/min) at 3 months 59
    (23)     		70
    (25)     		11
    (2 to 20)

    Comments

    1. Patients were randomised in blocks.
    2. 44% of drug therapy patients were treated with angioplasty at 3 months - consequently comparisons from this point on are difficult to make.
    3. The short follow-up and the small numbers involved make these results less certain.

    Citation

    1. van Jaarsveld BC, Krijnen P, Pietermann H, et al: the effect of balloon angioplasty on hypertension in atherosclerotic renal-artery stenosis. New England Journal of Medicine 2000; 342 : 1007-1014
    Search Terms: hand-searched
    Contributor: Chris Ball, April 2000
    Reviewer:

    Clinical Question.
    Patient renovascular hypertension due to atherosclerosis
    Intervention or Exposure balloon angioplasty
    Comparison drug therapy
    Outcome control of hypertension
    		•