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HERCULES: Renal stenting appears promising for patients with uncontrolled hypertension
Study results have suggested a statistically significant reduction in systolic BP with a renal stent system among patients with uncontrolled hypertension, with low rates of in-stent restenosis and complications.
However, there was no correlation between systolic BP reduction and baseline brain natriuretic peptide (BNP) reduction.
Researchers enrolled 202 patients (241 total lesions; 78 bilateral lesions) in the prospective, multicenter HERCULES trial, which tested a renal stenting system (RX Herculink Elite, Abbott Vascular) in patients with uncontrolled hypertension and atherosclerotic renal artery stenosis from August 2007 to October 2009. Researchers looked for 9-month binary restenosis, and secondary endpoints of changes in BP, antihypertensive medications and renal function between baseline and 9 months. BNP was measured at baseline, 24 hours and 30 days after the procedure.
At baseline, mean systolic BP was 162 mm Hg, serum creatinine was 1.2 ± 0.4 and 61.5% of patients had estimated glomerular filtration less than 60. Nearly 70% of patients received three or more antihypertensive medications, with a mean of 3.4 medications per patient.
Follow-up at 9 months revealed a significant reduction in mean systolic BP to 145 mm Hg (paired t test P<.0001) among patients treated with renal stenting, with no change in medications. The restenosis rate at 9 months was 10.5% and the rate of freedom from major adverse events was 94.8%.
However, researchers were unable to find a correlation between systolic BP reduction and baseline BNP or BNP reduction.
Disclosure: Dr. Jaff is a non-compensated advisor for Abbott Vascular, Cordis, Covidien/eV3, Medtronic and VIVA Physicians.
Perspective
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There are two areas that the HERCULES trial covers. One is looking for biomarkers that may predict those who will respond to stenting. There was hope that the BNP, or some other easily available marker, would help differentiate patients. Clearly that did not work out, so we will have to continue to look for those markers. The second is the area of renal artery stenosis. This trial demonstrated that in patients who are carefully selected and are already failing good medical therapy, in this case defined as not responding appropriately to at least two antihypertensive medications, that those patients are likely to improve with renal vascular revascularization. This sets the stage for other trials that are also looking into this indication for stenting, including CORAL.