Premium
Nine‐month results of the REFORM study
Author(s) -
Bersin Robert M.,
Ansel Gary,
Rizzo Anthony,
Bob Smouse H.,
Sinha Shantanu,
Sachar Ravish,
Dave Rajesh,
Weinstock Barry S.,
Feldman Robert,
Roubin Gary S.
Publication year - 2013
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.24481
Subject(s) - medicine , renal function , angioplasty , renal artery stenosis , cardiology , creatinine , stent , renal artery , clinical endpoint , revascularization , blood pressure , stenosis , restenosis , surgery , urology , kidney , clinical trial , myocardial infarction
Objectives 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. Background 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. Methods 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. Results 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. Conclusions The Formula stent was safe and effective in treating atherosclerotic RAS following suboptimal angioplasty. © 2013 Wiley Periodicals, Inc.