Two-Year Data Presented for HERCULES Study of Renal Stenting for Hypertension

October 10, 2012—The HERCULES trial is a prospective, multicenter, single-arm clinical study of patients with significant renal artery stenosis (≥ 60%) and uncontrolled hypertension (HTN) treated with the RX Herculink Elite renal stent system (Abbott Vascular, Santa Clara, CA). George Chrysant, MD, presented 2-year results from HERCULES during a Late-Breaking Trials session at the VIVA 2012: Vascular InterVentional Advances meeting in Las Vegas.

The HERCULES study included 202 patients with 241 total lesions, including 78 bilateral lesions. Eligible patients included those with systolic blood pressure (SBP) ≥ 140 mm Hg or diastolic blood pressure (DBP) ≥ 90 mm Hg, despite maximal doses of at least two antihypertensive agents in appropriate combinations (the average was 3.4 medications).

The patient population was elderly (mean age, 72 years), were predominately women (62%), and had several risk factors for atherosclerotic disease (approximately 67% had concomitant coronary artery disease). Baseline SBP and DBP were 162 ± 19/78 ± 12 mm Hg, respectively. The mean baseline percent diameter stenosis was 81.3% as determined by the site (66% as determined by the independent angiographic core laboratory [VasCore at Massachusetts General Hospital in Boston]).

The primary endpoint was the 9-month binary restenosis rate compared to a performance goal that was based on the published literature of renal artery stenting for atherosclerotic renal artery stenosis. The primary endpoint of restenosis at 9 months was 10.5% (P < .0001).

At 2 years, the mean SBP and DBP were 144 ± 23/74 ± 12 mm Hg, respectively, which was statistically significant (P < .0001). The number of antihypertensive medications and renal function were both unchanged. The magnitude of absolute reduction in SBP was related to the severity of baseline SBP.

The significant and persistent reduction in SBP in patients with multidrug HTN observed at 9 months was sustained at 2 years. Freedom from clinically driven target lesion revascularization at 2 years was 92.9%. Dr. Chrysant concluded that renal artery stenting remains a vital treatment for appropriately selected patients with uncontrolled HTN who have physiologically significant renal artery stenosis.