Roll-in Experience from the Cardiovascular Outcomes with Renal Atherosclerotic Lesions (CORAL) Study

Efficiency of Percutaneous Stent Angioplasty in Renal Artery Stenosis – 15 Years of Experience at a Single Center

“…RAS represents a complex entity with increasingly divergent results in the literature as to whether the revascularization is or is not associated with an improvement in renal function and BP control. CORAL, a recent large randomized clinical trial for RAS, similarly showed a statistically significant improvement in BP as well as a reduction in medical therapy in patients undergoing revascularization [13]. From the 47 studies reviewed by Mousa et al,37 (78.7 %) showed an improvement in BP control after revascularization [14].…”

Renal artery stenosis

“…Review of ARVD lesions by the angiographic core laboratory for CORAL for 239 “roll-in” patients downgraded estimates of stenosis from 73% lesion occlusion to 66% on average, leaving fewer than 20% of subjects in this trial with occlusive lesions above 80%. In this trial, the correlation between severity of vascular stenosis and translesional pressure gradients was low (r=0.21, p=.06) (16). As many authors have observed, the hemodynamic properties of the renal vessels are not the sole determinant of clinical manifestations related to ARVD (17).…”

“…This was in contradistinction to the Roll-In phase of the trial where 239 patients were evaluated by the angiographic core. In this group, 13% (n=28) experienced “major” angiographic complications including dissection (n=11; 4.5%), embolus (n=9; 3.7%), occlusion (n=9; 3.7%), thrombus (n=3; 1.2%), vessel rupture (n=2; 0.8%), wire perforation of a branch artery (n=2; 0.8%), and pseudoaneurysm (n=1; 0.4%) (16). Many of the initial complications were attributed to concurrent use of a large distal protection device (Angiogard) initially required for the trial.…”

Approach to atherosclerotic renovascular disease: 2016

“…Angiography is also vulnerable to interobserver variability and performer bias. In the STAR trial, 12 of the 64 patients assigned to the percutaneous transluminal renal angioplasty (PTRA) arm did not receive the allocated treatment at the time of the procedure, as the stenosis was found to be <50% [ 33 ], and in the CORAL roll-in period, stenosis was decreased by core laboratory from an average of 72.5% to 67.3% [ 43 ]. On the other hand, the ASTRAL trial did not have a core laboratory confirmation of angiographic imaging.…”