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HERCULES: BNP not predictive of reduced systolic BP in stented renal artery stenosis patients

Issue: June 2011

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Society for Cardiovascular Angiography and Interventions 2011 Scientific Sessions

BALTIMORE — Results presented in a late-breaking trial session demonstrated that elevated pretreatment brain natriuretic peptides were not predictive of reduction in systolic BP in patients treated with renal artery stenting.

“The results are disappointingly negative,” said HERCULES trial investigator Michael R. Jaff, DO, medical director of the Vascular Center at Massachusetts General Hospital in Boston, and a member of the Cardiology Today Editorial Board, while presenting the findings at the 2011 Society for Cardiovascular Angiography and Interventions Scientific Sessions. “I must tell you, this is a field struggling for predictive help,” Jaff said, “but we weren’t able to find it.”

The prospective, multicenter trial evaluating the safety and effectiveness of the RX Herculink Elite Renal Stent System (Abbott Vascular) reviewed outcomes for 202 patients (241 lesions, 39 bilateral lesions) with uncontrolled hypertension who were treated with a renal artery stent between August 2007 and October 2009.

The primary endpoint was a 9-month binary restenosis rate as determined by duplex ultrasound or angiographic analysis; the performance goal was 28.6%. Secondary endpoints were changes in systolic BP, antihypertensive medications and renal function between baseline and 9 months. Measurements of brain natriuretic peptide (BNP) were taken at baseline, 24 hours and 30 days’ post-procedure.

The investigators found that systolic BP decreased after stenting with no adjustment to medications. A BNP level of more than 80 pg/mL was found in 66% of patients; baseline serum creatinine was 1.2 ± 0.4; 61.5% of participants had an estimated glomerular filtration rate (eGFR) of less than 60. At 9 months, eGFR was stable. Despite a reduction in mean systolic BP, mean BNP levels remained elevated at 1 month.

There was no correlation between BNP levels at baseline and systolic BP reduction, nor between BNP reduction and systolic BP response. The restenosis rate was 10.5% at 9 months (P<.0001). The study device, procedure and clinical success rates were 96%, 99.2% and 98%, respectively. Freedom from medical error and reintervention was 94.8%.

“The clinical results are promising, as we found very low restenosis rates and a significant drop in BP following renal artery stenting,” Jaff said in a press release, but because the study’s goal was to help predict which patients will have the best outcomes after the procedure, “the search must continue.” – by Whitney McKnight

Disclosure: Dr. Jaff is a non-compensated consultant for Abbott Vascular and the medical director of CasCore at Massachusetts General Hospital in Boston.

For more information:

• Jaff MR. LBCT I. Presented at: Society of Cardiovascular Angiography and Interventions Scientific Sessions; May 4-7, 2011; Baltimore.

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