Rationale and design of the Randomized comparison of XiEnce V and Multilink VisioN coronary stents in the sAme muLtivessel patient with chronic kiDnEy disease (RENAL-DES) study

Journal of Cardiovascular Medicine
Fabrizio TomaiFlavio Ribichini

Abstract

Percutaneous coronary intervention with bare metal stents (BMS) in patients with chronic kidney disease (CKD) has shown suboptimal results. Drug-eluting stents (DESs) might reduce the incidence of restenosis and therefore of target lesion revascularization in these patients. Of note, in patients with CKD, multiple concomitant individual variables may be responsible for neointimal hyperplasia after coronary stenting, thus making the comparison of BMS and DES in different patient groups difficult. The RENAL-DES is a prospective, randomized, multicenter, not-sponsored study to directly compare the efficacy in the prevention of clinical restenosis, of everolimus-eluting stent (Xience V) and BMS with identical design (Multilink Vision), both implanted in the same patient with multivessel coronary artery disease and CKD in order to obviate the multiple and unpredictable baseline differences. The primary endpoint of the study is 9-month ischemia-driven target vessel revascularization. The expected primary endpoint rates are 20% for BMS and 10% for DES. According to these estimates, with a significant level of 0.05, a sample size of 194 patients provides an 80% statistical power. Assuming a 10% dropout rate, the goal is to enroll 213 p...Continue Reading

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Citations

Dec 22, 2010·American Heart Journal·Leonardo De LucaGiuseppe De Luca
Feb 13, 2014·Journal of Nephrology·Flavio Ribichini, Corrado Vassanelli
Apr 24, 2013·Journal of Interventional Cardiology·Christophe J Van DyckChristiaan J Vrints
Jan 23, 2010·Journal of Cardiovascular Medicine·Vincenzo PasceriGiulio Speciale

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