The SPIRIT V diabetic study: a randomized clinical evaluation of the XIENCE V everolimus-eluting stent vs the TAXUS Liberté paclitaxel-eluting stent in diabetic patients with de novo coronary artery lesions

Am Heart J. 2012 May;163(5):867-875.e1. doi: 10.1016/j.ahj.2012.02.006. Epub 2012 Apr 11.


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.

Trial registration: NCT00402272.

Publication types

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

MeSH terms

  • Aged
  • Angioplasty, Balloon, Coronary / methods*
  • Angioplasty, Balloon, Coronary / mortality
  • Asia
  • Coronary Angiography
  • Coronary Artery Disease / diagnostic imaging
  • Coronary Artery Disease / epidemiology
  • Coronary Artery Disease / therapy*
  • Diabetes Mellitus, Type 2 / diagnosis
  • Diabetes Mellitus, Type 2 / drug therapy
  • Diabetes Mellitus, Type 2 / epidemiology
  • Diabetic Angiopathies / diagnosis
  • Diabetic Angiopathies / epidemiology
  • Diabetic Angiopathies / therapy
  • Drug-Eluting Stents*
  • Europe
  • Evaluation Studies as Topic
  • Everolimus
  • Female
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Prognosis
  • Prospective Studies
  • Risk Assessment
  • Single-Blind Method
  • Sirolimus / analogs & derivatives*
  • Sirolimus / pharmacology
  • Statistics, Nonparametric
  • Survival Analysis
  • Taxus*
  • Treatment Outcome


  • Everolimus
  • Sirolimus

Associated data