Objective: The Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) trial, a multicenter randomized controlled trial, failed to demonstrate a benefit of renal artery stenting (RAS) over medical therapy in patients with renal artery stenosis and hypertension. However, there are patients for whom RAS is a consideration because of failure of medical therapy. Unfortunately, selection of patients for RAS is complicated by a lack of validated predictors of blood pressure (BP) response. A previous single-center study identified three preoperative markers of BP response to RAS: requirement for four or more antihypertensive medications, preoperative diastolic BP >90 mm Hg, and preoperative clonidine use. To date, these markers of outcome have not been independently validated. The aim of this study was to validate these markers using data from the CORAL trial.
Methods: All patients randomized in the CORAL trial to RAS were included. American Heart Association guidelines were used to categorize patients as BP responders or nonresponders to RAS. BP responders were defined by a postoperative BP <160/90 mm Hg with a reduced number of antihypertensive medications or a reduction in diastolic BP to <90 mm Hg with the same medications after RAS. Patients with stable or worsened BP were labeled nonresponders. Variables associated with a favorable BP response were identified by multivariable logistic regression analysis.
Results: There were 436 patients who underwent RAS with a median age of 70 years (interquartile range [IQR], 63-76 years). The median systolic and diastolic BPs of the stented cohort at baseline were 149 mm Hg (IQR, 132-164 mm Hg) and 78 mm Hg (IQR, 70-87 mm Hg), respectively. A positive BP response occurred in 284 of 436 (65.1%) stented patients. Multivariable logistic regression analysis identified three independent markers of a positive BP response: requirement for four or more medications (odds ratio, 5.9; P < .001), preoperative diastolic BP >90 mm Hg (odds ratio 13.9; P < .001), and preoperative clonidine use (odds ratio, 4.52; P = .008). The percentage of patients with a positive BP response increased incrementally as the number of markers per patient increased, based on the Cochran-Armitage test for trend (P < .0001).
Conclusions: In patients from the CORAL trial who underwent RAS, the previously reported clinical markers of BP response were validated. A prospective trial to validate their utility as predictors of BP response to RAS is warranted.
Keywords: Hypertension; Renal artery stenosis; Renal artery stenting; Renovascular.
Published by Elsevier Inc.