Comparison of early and late efficacy of percutaneous transluminal renal angioplasty with or without subsequent brachytherapy: the effect on blood pressure in patients with renovascular hypertension.

BACKGROUND Scarce data exist concerning the long-term effect of percutaneous transluminal renal angioplasty (PTRA) enhanced with intravascular gamma brachytherapy (IVBT) in patients with renovascular hypertension. METHODS Seventy one patients aged 52 +/- 8 years with refractory renovascular hypertension were randomized to Group I (PTRA + IVBT) or Group II (PTRA). For the IVBT procedure, the PARIS catheter and Microselectron HDR (Nucletron) system was employed. Both baseline and 9-month follow-up quantitative computerized angiography (QCA) and ambulatory blood pressure monitoring analysis was performed to assess luminal parameters of restenosis and the effect of treatment on blood pressure. RESULTS Thirty three patients from Group I and 29 patients from Group II underwent successful procedure. During nine months of follow-up, three patients died; including two patients in Group I (cardiac causes) and one patient in Group II (stroke). The follow-up lumen diameter stenosis was 30.6 +/- 13.7% and 40.4 +/- 11% in Groups I and II, respectively (p = 0.004). Late lumen loss in quantitative computerized angiography was 1.2 +/- 0.7 mm and 1.7 +/- 0.7 mm in Groups I and II, respectively (p = 0.004). CONCLUSIONS Intravascular gamma brachytherapy using self-centering source performed after balloon angioplasty is a safe and effective method of prevention of restenosis after PTRA in patients with renovascular hypertension.