Conflict of interest: Robert M. Bersin, Gary Ansel, Anthony Rizzo, H. Bob Smouse, and Gary S. Roubin have served as consultants to Cook Medical in the past 24 months. The other authors do not have not any conflict of interest.
Peripheral Vascular Disease
Nine-month results of the REFORM study
A prospective, single-arm, multicenter clinical study of the safety and effectiveness of the formula™ balloon-expandable stent for treatment of renal artery stenosis
Article first published online: 25 MAR 2013
© 2013 Wiley Periodicals, Inc.
Catheterization and Cardiovascular Interventions
Volume 82, Issue 2, pages 266–273, 1 August 2013
How to Cite
Bersin, R. M., Ansel, G., Rizzo, A., Bob Smouse, H., Sinha, S., Sachar, R., Dave, R., Weinstock, B. S., Feldman, R. and Roubin, G. S. (2013), Nine-month results of the REFORM study. Cathet. Cardiovasc. Intervent., 82: 266–273. doi: 10.1002/ccd.24481
- Issue published online: 22 JUL 2013
- Article first published online: 25 MAR 2013
- Accepted manuscript online: 14 MAY 2012 04:48AM EST
- Manuscript Accepted: 6 MAY 2012
- Manuscript Received: 27 APR 2012
- Cook Medical, Bloomington, IN
- renal artery disease;
- renal stent;
- ischemic nephropathy;
- renal failure
To evaluate the 9-month safety and effectiveness outcomes of the Formula™ balloon-expandable renal stent (Cook Medical, Bloomington, IN) for the treatment of atherosclerotic renal artery stenosis (RAS) following suboptimal angioplasty.
Atherosclerotic RAS can cause hypertension and ischemic nephropathy. When clinically indicated, an interventional approach with renal angioplasty and stent implantation is the preferred method for revascularization of atherosclerotic renal artery stenoses.
The REFORM study is a prospective, multicenter, single-arm study of stent implantation following suboptimal PTRA using the Formula stent. One hundred patients with atherosclerotic ostial renal artery lesions =18 mm in length with a >50% residual stenosis following PTA were enrolled. The primary endpoint was 9-month primary patency.
The 9-month primary patency rate was 91.7%. The 9-month major adverse event rate was 2.2%. Mean systolic blood pressure was significantly decreased at follow-up (from 150 ± 21 mm Hg at baseline to 141 ± 21 mm Hg at 9 months; P = 0.003). Mean serum creatinine (SCr) level and mean estimated glomerular filtration rate (eGFR) were not significantly different at 9 months. A clinically meaningful improvement in renal function (i.e., =25% increase in eGFR or =0.5 mg/dl decrease in SCr) was observed in 9% of patients at 1 month and 12% of patients at 9 months. A clinically meaningful decline in renal function (i.e., =25% decrease in eGFR or =0.5 mg/dl increase in SCr) was observed in only 3% of patients at 1 month and 7% of patients at 9 months.
The Formula stent was safe and effective in treating atherosclerotic RAS following suboptimal angioplasty. © 2013 Wiley Periodicals, Inc.