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Objective performance goals of safety and blood pressure efficacy for clinical trials of renal artery bare metal stents in hypertensive patients with atherosclerotic renal artery stenosis.

Publication ,  Journal Article
Rocha-Singh, KJ; Novack, V; Pencina, M; D'Agostino, R; Ansel, G; Rosenfield, K; Jaff, MR
Published in: Catheter Cardiovasc Interv
November 1, 2011

OBJECTIVE: To provide safety and performance goals for prospective single-arm trials of bare metal renal artery stenting in patients with resistant hypertension associated with high grade atherosclerotic renal artery stenosis. BACKGROUND: To date, there have been no US Pre-Market Approval (PMA) bare metal renal stent device trials which have focused on improvement of blood pressure control as a primary effectiveness endpoint. METHODS: Analysis of subject-level data from three large industry sponsored pre-market approval (PMA) trials was performed. Hypertensive patients (≥ 155 mmHg) with a ≥ 50% atherosclerotic renal artery stenosis were included. Thirty day and 9-month systolic and diastolic blood pressure measurements, renal function and 9-month duplex ultrasound assessment of renal artery patency were analyzed. RESULTS: Initial data analysis of 600 patients from the 3 PMA trials identified 286 patients who met inclusion criteria. The mean baseline systolic blood pressure was 177.8 ± 19.3 mmHg with a mean 68.1% diameter renal artery stenosis. Nine months after successful stenting, the mean SBP was 156.7 ± 24.1 mmHg; the 9 month restenosis rate was 14.4%. CONCLUSION: Based on the statistical modeling of these data and a priori established performance criteria, the co-primary endpoints of 9 month reduction in blood pressure and in-stent restenosis are proposed. The reduction in blood pressure will be analyzed as a continuous variable and will be compared to this performance goal.

Duke Scholars

Published In

Catheter Cardiovasc Interv

DOI

EISSN

1522-726X

Publication Date

November 1, 2011

Volume

78

Issue

5

Start / End Page

779 / 789

Location

United States

Related Subject Headings

  • Ultrasonography, Doppler, Duplex
  • Treatment Outcome
  • Time Factors
  • Stents
  • Research Design
  • Renal Artery Obstruction
  • Registries
  • Recurrence
  • Prospective Studies
  • Patient Safety
 

Citation

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Rocha-Singh, K. J., Novack, V., Pencina, M., D’Agostino, R., Ansel, G., Rosenfield, K., & Jaff, M. R. (2011). Objective performance goals of safety and blood pressure efficacy for clinical trials of renal artery bare metal stents in hypertensive patients with atherosclerotic renal artery stenosis. Catheter Cardiovasc Interv, 78(5), 779–789. https://doi.org/10.1002/ccd.23055
Rocha-Singh, Krishna J., Victor Novack, Michael Pencina, Ralph D’Agostino, Gary Ansel, Kenneth Rosenfield, and Michael R. Jaff. “Objective performance goals of safety and blood pressure efficacy for clinical trials of renal artery bare metal stents in hypertensive patients with atherosclerotic renal artery stenosis.Catheter Cardiovasc Interv 78, no. 5 (November 1, 2011): 779–89. https://doi.org/10.1002/ccd.23055.
Rocha-Singh KJ, Novack V, Pencina M, D’Agostino R, Ansel G, Rosenfield K, et al. Objective performance goals of safety and blood pressure efficacy for clinical trials of renal artery bare metal stents in hypertensive patients with atherosclerotic renal artery stenosis. Catheter Cardiovasc Interv. 2011 Nov 1;78(5):779–89.
Rocha-Singh, Krishna J., et al. “Objective performance goals of safety and blood pressure efficacy for clinical trials of renal artery bare metal stents in hypertensive patients with atherosclerotic renal artery stenosis.Catheter Cardiovasc Interv, vol. 78, no. 5, Nov. 2011, pp. 779–89. Pubmed, doi:10.1002/ccd.23055.
Rocha-Singh KJ, Novack V, Pencina M, D’Agostino R, Ansel G, Rosenfield K, Jaff MR. Objective performance goals of safety and blood pressure efficacy for clinical trials of renal artery bare metal stents in hypertensive patients with atherosclerotic renal artery stenosis. Catheter Cardiovasc Interv. 2011 Nov 1;78(5):779–789.
Journal cover image

Published In

Catheter Cardiovasc Interv

DOI

EISSN

1522-726X

Publication Date

November 1, 2011

Volume

78

Issue

5

Start / End Page

779 / 789

Location

United States

Related Subject Headings

  • Ultrasonography, Doppler, Duplex
  • Treatment Outcome
  • Time Factors
  • Stents
  • Research Design
  • Renal Artery Obstruction
  • Registries
  • Recurrence
  • Prospective Studies
  • Patient Safety