Proper patient selection yields significant and sustained reduction in systolic blood pressure following renal artery stenting in patients with uncontrolled hypertension: long-term results from the HERCULES trial

Abstract

The Safety and Effectiveness Study of the Herculink Elite Renal Stent to Treat Renal Artery Stenosis (HERCULES) trial is a prospective, multicenter trial evaluating the safety, effectiveness, and durability of the RX Herculink Elite renal stent system (Abbott Vascular, Abbott Park, IL) in select patients with atherosclerotic renal artery stenosis and uncontrolled hypertension. A total of 202 patients were enrolled between August 2007 and October 2009. The primary endpoint, 9-month binary restenosis, was 10.5% determined by core laboratory adjudicated duplex ultrasound and/or angiography. Additional analyses included changes in blood pressure, antihypertensive medications, renal function (RF), major adverse events (MAEs) (death, ipsilateral nephrectomy, and embolic events resulting in kidney damage), and clinically driven target lesion revascularization (CD-TLR) between baseline and 36 months. Freedom from MAE was 98.5% at 30 days. At 36 months, freedom from death, nephrectomy, and CD-TLR were 90.1%, 100%, and 91.8%, respectively. After 30 days there were no site-reported embolic events resulting in kidney damage. The mean baseline systolic blood pressure of 162±18 mm Hg significantly decreased postprocedure and through 36 months (mean systolic blood pressure 141 mm Hg [P<.0001] and 146 mm Hg [P<.0001], respectively). No differences were noted in antihypertensive medications or RF compared with baseline. The HERCULES trial demonstrated sustained clinically and statistically significant reduction in SBP in patients with uncontrolled HTN. Coupled with the low core laboratory-adjudicated in-stent restenosis, acceptable procedural complication rates (1.5%), and <10% CD-TLR, the study suggests that there may be a role for renal artery stenting using contemporary stent technology.

Figure 1

Kaplan‐Meier survival curve: freedom from death through 3 years. Note: Patients at risk gives the number of patients at risk for an event at the start of the interval, while patients censored and number of events are the incremental counts of patients censored or with events during the interval. The intervals are denoted as half‐open bracket expression, where the start of interval “is exclusive and the end of the interval” is inclusive.

Figure 2

Kaplan‐Meier survival curve: freedom from clinically driven target lesion revascularization through 3 years. Note: Lesions at risk gives the number of lesions at risk for an event at the start of the interval, while lesions censored and number of events are the incremental counts of lesions censored or with events during the interval. The intervals are denoted as half‐open bracket expression, where the start of interval “is exclusive and the end of the interval” is inclusive.