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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

Tomai, Fabrizio; Petrolini, Alessandro; De Luca, Leonardo; Nudi, Francesco; Lanza, Gaetano; Vassanelli, Corrado; Ribichini, Flavio

Journal of Cardiovascular Medicine:
doi: 10.2459/JCM.0b013e3283347e24
Research trial protocols
Abstract

Background: 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.

Study design: 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.

Sample size: 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 patients (426 treated vessels) from five Italian centers. As 20% of the patients will likely require stent implantation in three vessels, approximately 500 treated vessels will be analyzed.

Conclusion: This intraindividual, randomized study will provide, for the first time, data on the efficacy, in the prevention of clinical restenosis, of DES compared to BMS in patients with multivessel coronary artery disease and CKD (ClinicalTrials.gov Identifier: NCT 00818792).

Author Information

aDivision of Cardiology, Department of Cardiovascular Sciences, European Hospital, Italy

bDivision of Nuclear Medicine, Madonna della Fiducia Clinic, Italy

cInstitute of Cardiology, Catholic University of the Sacred Heart, Rome, Italy

dDivision of Cardiology, University of Verona, Verona, Italy

Received 19 July, 2009

Revised 28 September, 2009

Accepted 22 October, 2009

Correspondence to Fabrizio Tomai, MD, FACC, FESC, Division of Cardiology, Department of Cardiovascular Sciences, European Hospital, Via Portuense 700, 00149 Rome, Italy Tel: +39 06 65975725; fax: +39 06 65975724; e-mail: f.tomai@tiscali.it

© 2010 Italian Federation of Cardiology. All rights reserved.