Randomized Comparison of XiEnce-V and Multi-link VisioN Coronary Stents in the sAme muLtivessel Patient with Chronic kiDnEy diSease (RENAL-DES) Study
Background—Percutaneous coronary interventions (PCI) in patients with chronic kidney disease (CKD) have shown suboptimal results. Drug-eluting stents (DES) might reduce the rate of target vessel revascularization compared to bare metal stent (BMS) in CKD patients. However, given the multiple concomitant individual variables present in such patients, the comparison of neointimal growth after PCI is complex and difficult to assess.
Methods and Results—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 identical design (Multi-link Vision), both implanted in the same patient with multivessel coronary artery disease and CKD (estimated glomerular filtration rate <60ml/min). The primary endpoint of the study was the ischemia-driven target vessel revascularization (ID-TVR) 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 ID-TVR for DES and BMS groups was 2.7% [95% confidence interval (CI): 1.1-5.6%] and 11.4% (95% CI: 7.8-16%) respectively, p<0.001. For the multivariate analysis, independent predictors of the ID-TVR were BMS implantation (OR: 4.95;95% CI:2.1-11.6; p<0.001) and vessel size (OR: 0.32;95% CI: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 compared to the BMS of equal design, in CKD patients with multivessel coronary artery disease.
Clinical Trial Registration Information—www.clinicaltrials.gov. Identifier: NCT00818792
- Received July 19, 2013.
- Revision received November 11, 2013.
- Accepted November 14, 2013.