Randomized Comparison of xiEnce and visioN Coronary Stents in the sAme muLtivessel Patient With Chronic kiDnEy diSease (RENAL-DES)

European Hospital

Status and phase: Completed; Phase 2

Conditions: Chronic Kidney Disease; Multivessel Coronary Artery Disease

Treatments: Device: Coronary stent

Study type: Interventional

Funder types: Other

Identifiers

NCT00818792

RENAL-DES

Details and patient eligibility

About

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.

Enrollment: 215 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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215 participants in 2 patient groups

Drug-eluting stent Xience V

Active Comparator group

Treatment:

Device: Coronary stent

Bare-metal stent Vision

Active Comparator group

Treatment:

Device: Coronary stent