Clinical trial NCT00818792: Randomized Comparison of xiEnce and visioN Coronary Stents in the sAme muLtivessel Patient With Chronic kiDnEy diSease
Official title: A Multicenter, Randomized Trial to Compare Xience and Vision Coronary Stents in the Same Multivessel Patient With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Kidney Disease
Multivessel Coronary Artery Disease
Keywords: Percutaneous coronary intervention
Drug-eluting stent
Chronic kidney disease
Restenosis
Lead sponsor: European Hospital
Sponsor class: OTHER
First posted: 2009-01-08
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Percutaneous coronary intervention (PCI) with bare metal stent (BMS) in patients with renal insufficiency has shown unsatisfactory results. Indeed, drug-eluting stents (DES) might reduce the incidence of restenosis and therefore of target lesion revascularization procedures in these patients.

We therefore designed 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 bare-metal stent (Vision) (both 2nd-generation DES and BMS, respectively), both implanted in the same patient with multivessel disease and renal insufficiency in order to obviate for the multiple and unpredictable characteristics of this high-risk population.


Eligibility criteria: Inclusion Criteria:

* chronic renal insufficiency (creatinine clearance \<60 ml/min, in dialysis patients included) with at least two significant (\>70%) coronary lesions in two major coronary vessels.

Exclusion Criteria:

* Age \>85 years
* left main coronary artery disease
* saphenous vein graft disease
* ST-elevation MI (\<3 days)
* coronary vessel diameter \<2.5 or \> 4 mm
* contraindication to long-term double antiplatelet therapy
* CABG indication by consensus (cardiovascular team)
* severe valvular heart disease
* informed consent not obtained

Primary outcomes:
measure: Ischemia-driven target vessel revascularization
timeFrame: 9 months
Secondary outcomes:
measure: Incidence of death and myocardial infarction
timeFrame: in-hospital, 30 days, 9 and 12 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: European Hospital
city: Verona
country: Italy
facility: Azienda Ospedaliera Istituti Ospitalieri di Verona
Study officials:
affiliation: Department of Cardiovascular Sciences, European Hospital, Rome
name: Fabrizio Tomai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schiffrin EL, Lipman ML, Mann JF. Chronic kidney disease: effects on the cardiovascular system. Circulation. 2007 Jul 3;116(1):85-97. doi: 10.1161/CIRCULATIONAHA.106.678342.
citation: Tomai F, Reimers B, De Luca L, Galassi AR, Gaspardone A, Ghini AS, Ferrero V, Favero L, Gioffre G, Prati F, Tamburino C, Ribichini F. Head-to-head comparison of sirolimus- and paclitaxel-eluting stent in the same diabetic patient with multiple coronary artery lesions: a prospective, randomized, multicenter study. Diabetes Care. 2008 Jan;31(1):15-9. doi: 10.2337/dc07-1377. Epub 2007 Oct 1.
citation: Tomai F, Ribichini F, De Luca L, Petrolini A, Ghini AS, Weltert L, Spaccarotella C, Proietti I, Trani C, Nudi F, Pighi M, Vassanelli C. Randomized Comparison of Xience V and Multi-Link Vision Coronary Stents in the Same Multivessel Patient With Chronic Kidney Disease (RENAL-DES) Study. Circulation. 2014 Mar 11;129(10):1104-12. doi: 10.1161/CIRCULATIONAHA.113.005186. Epub 2013 Dec 19.
citation: Tomai F, Petrolini A, De Luca L, Nudi F, Lanza G, Vassanelli C, Ribichini F. 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. J Cardiovasc Med (Hagerstown). 2010 Apr;11(4):310-7. doi: 10.2459/JCM.0b013e3283347e24.