(MedPage Today) — Renal artery stenting appears to improve the outlook for patients with renal artery stenosis and hypertension that’s difficult to manage, the single-arm HERCULES trial showed.
The procedure resulted in a significant drop in blood pressure accompanied by low rates of in-stent restenosis and other complications, according to Michael Jaff, DO, of Massachusetts General Hospital in Boston, and colleagues.
The average systolic blood pressure at baseline was 162 mm Hg among patients taking an average of 3.4 antihypertensives, and within 1 month of stenting it had declined to 145 mm Hg, an effect sustained through 9 months (P<0.0001), the researchers reported online in Catheterization and Cardiovascular Interventions.
The study, which was initially reported at the Society for Cardiovascular Angiography and Interventions meeting last year, “highlights that when appropriate patients are selected for renal artery stenting, impressive reductions in blood pressure may be anticipated,” the authors wrote.
HERCULES was a multicenter, single-arm trial that evaluated use of the RX Herculink Elite Renal Stent System by Abbott Vascular — which sponsored the study — in patients with atherosclerotic renal artery stenosis and uncontrolled hypertension. Patients were enrolled between 2007 and 2009.
It included 202 patients with 241 total lesions, including 78 bilateral lesions. The patients had a systolic blood pressure of 140 mm Hg or higher or a diastolic pressure of 90 mm Hg or high despite using maximal doses of at least two antihypertensives; about 70% of patients were taking three or more medications.
The patients also had renal artery stenosis remaining after a suboptimal revascularization result from percutaneous transluminal angioplasty using a standard balloon dilatation catheter.
At baseline, average serum creatinine was 1.2 mg/dL and 61.5% of patients had an estimated glomerular filtration rate less than 60 mL/min/1.73 m2.
The in-stent restenosis rate determined by duplex ultrasound, angiography, or both at 9 months after the procedure — the primary outcome — was 10.5%. The upper limit of the confidence interval was 14.7%, indicating a successful outcome because it was lower than the performance goal of 28.6%.
There was a significant drop in blood pressure during follow-up, with the greatest reductions seen in patients with the highest readings at baseline. Medication use and renal function did not change.
The researchers also measured brain natriuretic peptide as a possible predictor for response to stenting. Levels of the biomarkers decreased during the study, but neither baseline level nor the change in levels was related to the observed blood pressure response.
Loading ...
Loading ...