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

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

Research output: Contribution to journalArticle

9 Citations (Scopus)

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).

Original languageEnglish
Pages (from-to)310-317
Number of pages8
JournalJournal of Cardiovascular Medicine
Volume11
Issue number4
DOIs
Publication statusPublished - Apr 2010

Fingerprint

Drug-Eluting Stents
Chronic Renal Insufficiency
Stents
Metals
Coronary Artery Disease
Percutaneous Coronary Intervention
Sample Size
Hyperplasia
Ischemia
Incidence

Keywords

  • Chronic kidney disease
  • Drug-eluting stent
  • Multivessel disease
  • Percutaneous coronary intervention
  • Renal insufficiency

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

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.

In: Journal of Cardiovascular Medicine, Vol. 11, No. 4, 04.2010, p. 310-317.

Research output: Contribution to journalArticle

Tomai, Fabrizio ; Petrolini, Alessandro ; De Luca, Leonardo ; Nudi, Francesco ; Lanza, Gaetano ; Vassanelli, Corrado ; Ribichini, Flavio. / 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. In: Journal of Cardiovascular Medicine. 2010 ; Vol. 11, No. 4. pp. 310-317.
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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).",
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T1 - 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

AU - Tomai, Fabrizio

AU - Petrolini, Alessandro

AU - De Luca, Leonardo

AU - Nudi, Francesco

AU - Lanza, Gaetano

AU - Vassanelli, Corrado

AU - Ribichini, Flavio

PY - 2010/4

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AB - 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).

KW - Chronic kidney disease

KW - Drug-eluting stent

KW - Multivessel disease

KW - Percutaneous coronary intervention

KW - Renal insufficiency

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