Abstract
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.
Original language | English |
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Pages (from-to) | 779-789 |
Number of pages | 11 |
Journal | Catheterization and Cardiovascular Interventions |
Volume | 78 |
Issue number | 5 |
DOIs | |
State | Published - 1 Nov 2011 |
Externally published | Yes |
Keywords
- bare metal stents
- renal artery stenosis
- resistant hypertension
ASJC Scopus subject areas
- Radiology Nuclear Medicine and imaging
- Cardiology and Cardiovascular Medicine