Randomized Comparison of xiEnce and visioN Coronary Stents in the sAme muLtivessel Patient With Chronic kiDnEy diSease

A Multicenter, Randomized Trial to Compare Xience and Vision Coronary Stents in the Same Multivessel Patient With Chronic Kidney Disease

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.

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