Randomized Comparison of Xience V and Multi-Link Vision Coronary Stents in the Same Multivessel Patient With Chronic Kidney Disease (RENAL-DES) Study

Abstract

Background-Percutaneous coronary interventions in patients with chronic kidney disease have shown suboptimal results. Drug-eluting stents (DES) might reduce the rate of target vessel revascularization in comparison with baremetal stents (BMS) in patients with chronic kidney disease. However, given the multiple concomitant individual variables present in such patients, the comparison of neointimal growth after percutaneous coronary intervention is complex and difficult to assess. Methods and Results-Randomized Comparison of Xience V and Multi-Link Vision Coronary Stents in the SameMultivessel Patient with Chronic Kidney Disease (RENAL-DES) was a prospective, randomized, multicenter study to directly compare the efficacy in the prevention of clinical restenosis of everolimus-eluting stent (Xience V) and BMS with an identical design (Multi-Link Vision), both implanted in the same patient with multivessel coronary artery disease and chronic kidney disease (estimated glomerular filtration rate <60 mL/min). The primary end point of the study was the ischemia-driven target vessel revascularization as detected with myocardial scintigraphy at 12 months. In 215 patients, 512 coronary vessels were successfully treated with the randomly assigned DES (n=257) or BMS (n=255). At 1 year, the rate of ischemia-driven target vessel revascularization for DES and BMS groups was 2.7% (95% confidence interval, 1.1%-5.6%) and 11.4% (95% confidence interval, 7.8% to 16%), respectively, P<0.001. For the multivariate analysis, independent predictors of the ischemia-driven target vessel revascularization were BMS implantation (odds ratio, 4.95; 95% confidence interval, 2.1-11.6; P<0.001) and vessel size (odds ratio, 0.32; 95% confidence interval, 0.1-0.7; P=0.006). Conclusions-This is the first randomized trial showing a reduction of clinical restenosis with a new-generation DES in comparison with a BMS of equal design, in patients who have chronic kidney disease with multivessel coronary artery disease. Clinical Trial Registration-URL:http://.clinicaltrials.gov. Unique identifier: NCT00818792.

Intraindividual Comparison of Everolimus-Eluting Bioresorbable Vascular Scaffolds Versus Drug-Eluting Metallic Stents

“…14 Studies with intraindividual design are a valuable adding to investigations of device efficacy. [6][7][8] To the best of our knowledge, studies exploring BVS and DES in the same patient receiving multilesion PCI have not been performed. Against this background, this report investigates the intraindividual performance of BVS and DES in patients receiving multilesion PCI and subsequent angiographic surveillance.…”

“…5 Studies comparing intrapatient differences in stent outcomes remain an important tool for assessing comparative device efficacy: indeed, by excluding the baseline variability between patients (not completely eliminated even with a random allocation), the intraindividual design offers the advantage of a net-effect analysis of treatments. 6 Previous intraindividual studies of DES efficacy have generally shown similar outcomes to randomized trials comparing stents. [6][7][8] However, angiographic and clinical outcomes of BVS and DES in the same individual receiving multilesion percutaneous coronary intervention (PCI) have yet to be investigated.…”

“…6 Previous intraindividual studies of DES efficacy have generally shown similar outcomes to randomized trials comparing stents. [6][7][8] However, angiographic and clinical outcomes of BVS and DES in the same individual receiving multilesion percutaneous coronary intervention (PCI) have yet to be investigated.…”

Comparison of everolimus- and paclitaxel-eluting stents in dialysis patients

“…Therefore, no conclusions were made in terms of ESRD. RENAL-DES was the first randomized trial showing effectiveness in terms of clinical restenosis of second-generation EES in comparison with bare metal stent in patients with chronic kidney disease (CKD), and the efficacy of EES in preventing restenosis was independent of the severity of CKD, including severe CKD and kidney failure [8]. However, it remains unclear whether there are differences in clinical outcomes between EES and PES in patients with ESRD, especially those on dialysis.…”

Of Stents and Scaffolds

“…[1][2][3][4] Preferably, the influence of lesionrelated factors would be minimized by randomly allocating individual lesions to one or other treatment.…”