HERCULES Data Published for Abbott Vascular's RX Herculink Elite Renal Artery Stent

July 16, 2012—Michael R. Jaff, DO, et al published results from the HERCULES trial that demonstrate significant reduction in systolic blood pressure after renal artery stenting in patients with uncontrolled hypertension (HTN). The findings were recently made available online ahead of print in Catheterization and Cardiovascular Interventions.

The prospective, multicenter HERCULES trial is evaluating the safety and effectiveness of the RX Herculink Elite renal stent system (Abbott Vascular, Santa Clara, CA) in patients with uncontrolled HTN caused by atherosclerotic renal artery stenosis. The US Food and Drug Administration approved the RX Herculink Elite for renal artery stenting on August 11, 2011.

In Catheterization and Cardiovascular Interventions, the HERCULES investigators reported that a total of 202 patients (241 total lesions; 78 bilateral lesions) were enrolled between August 2007 and October 2009. The primary endpoint was 9-month binary restenosis determined by duplex ultrasound and/or angiography. Secondary endpoints included changes in blood pressure, antihypertensive medications, and renal function between baseline and 9 months. Brain natriuretic peptide (BNP) was measured at baseline, 24 hours, and 30 days postprocedure.

In the study, the patients' mean systolic blood pressure (BP) at baseline was 162 mm Hg. Approximately 70% of patients were receiving three or more antihypertensive medications (mean 3.4 medications per patient). Baseline serum creatinine was 1.2 ± 0.4 and 61.5% of subjects had estimated glomerular filtration < 60. The restenosis rate was 10.5% at 9 months. The study device, procedure, and clinical success rates were 96, 99.2, and 98%, respectively. Freedom from major adverse events was 94.8%. At 9 months, the mean systolic BP significantly decreased (mean 145, paired t test P < .0001) after stenting with no change in medications. There was no correlation between systolic BP reduction and baseline BNP or BNP reduction.

The investigators concluded that HERCULES demonstrates clinically and statistically significant systolic BP reduction in patients with uncontrolled HTN and low rates of in-stent restenosis and complications. They stated that the study highlights that when appropriate patients are selected for renal artery stenting, impressive reductions in blood pressure may be anticipated. Although the magnitude of absolute reduction in systolic BP was related to baseline systolic BP, elevated baseline BNP levels were not predictive of reduction in systolic BP. The investigators advised that further studies for predictors of clinical response following percutaneous renal revascularization are needed.