Abstract

BACKGROUND
Diabetic patients respond less favorably to revascularization and have poorer long-term outcomes. Our main aim was to evaluate the angiographic efficacy of XIENCE V (everolimus-eluting stent, or EES) in diabetic patients compared with TAXUS Liberté (paclitaxel-eluting stent, or PES).
METHODS
The SPIRIT V Diabetic Study was a prospective, single-blind, randomized study that enrolled 324 diabetic (insulin and non-insulin dependent) patients at 28 sites in Europe and Asia Pacific. Randomization was 2:1 between EES (n = 218) and PES (n = 106). The primary end point was sequential noninferiority and superiority of EES for in-stent late loss at 9 months. Secondary clinical end points included stent thrombosis, death, myocardial infarction, and revascularization rates up to 1 year.
RESULTS
Everolimus-eluting stent was superior to PES for in-stent late loss at 9 months (0.19 mm vs 0.39 mm, respectively; P(superiority) = .0001). The composite rate of death, myocardial infarction, and target vessel revascularization was the same in the 2 groups at 1 year (16.3% vs 16.4%). No stent thromboses (Academic Research Consortium definite and probable) were seen through 1 year with EES compared with 2 of 104 (2%) with PES (P = .11).
CONCLUSION
In this prospective, randomized trial in a high-risk group of diabetic patients, implantation of EES compared with PES resulted in significantly better inhibition of intimal hyperplasia with a comparable safety outcome.

Links

Publisher Full Text

Authors

Grube E, Chevalier B, Guagliumi G, Smits PC, Stuteville M, Dorange C, Papeleu P, Kaul U, Džavík V

Institution

Department of Cardiology,University Hospital Bonn, Bonn, Germany. GrubeE@aol.com

Source

American heart journal 163:5 2012 May pg 867-875.e1

MeSH

Aged
Angioplasty, Balloon, Coronary
Asia
Coronary Angiography
Coronary Artery Disease
Diabetes Mellitus, Type 2
Diabetic Angiopathies
Drug-Eluting Stents
Europe
Evaluation Studies as Topic
Female
Humans
Kaplan-Meier Estimate
Male
Middle Aged
Prognosis
Prospective Studies
Risk Assessment
Single-Blind Method
Sirolimus
Statistics, Nonparametric
Survival Analysis
Taxus
Treatment Outcome

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22607866