Risk factors for stent thrombosis after implantation of sirolimus-eluting stents in diabetic and nondiabetic patients: the EVASTENT Matched-Cohort Registry

J Am Coll Cardiol. 2007 Aug 7;50(6):501-8. doi: 10.1016/j.jacc.2007.04.051. Epub 2007 Jul 23.


Objectives: We sought to assess the frequency and causes of stent thrombosis in diabetic and nondiabetic patients after implantation of sirolimus-eluting stents.

Background: Safety concerns about late stent thrombosis have been raised, particularly when drug-eluting stents are used in less highly selected patients than in randomized trials.

Methods: The EVASTENT study is a matched multicenter cohort registry of 1,731 patients undergoing revascularization exclusively with sirolimus stents; for each diabetic patient included (stratified as single- or multiple-vessel disease), a nondiabetic patient was subsequently included. Patients were treated with aspirin + clopidogrel for at least 3 months and were followed for 465 (range 0 to 1,062) days (1-year follow-up in 98.5%). The primary end point was a composite of stent thrombosis (according to Academic Research Consortium definitions), cardiovascular death, and nonfatal myocardial infarction (major adverse cardiac events [MACE]).

Results: During follow-up, MACE occurred in 78 patients (4.5%), cardiac death in 35 (2.1%), and stent thrombosis in 45 (2.6%): 30 definite, 23 subacute, and 22 late, including 9 at >6 months. In univariate analysis, the 1-year stent thrombosis rate was 1.8 times higher in diabetic than in nondiabetic patients (3.2% vs. 1.7%; log rank p = 0.03), with diabetic patients with multiple-vessel disease experiencing the highest rate and nondiabetic single-vessel disease patients the lowest (4.3% vs. 0.8%; p < 0.001). In multivariate analysis, in addition to the interruption of antithrombotic treatment, independent stent thrombosis predictors were previous stroke, renal failure, lower ejection fraction, calcified lesion, length stented, and insulin-requiring diabetes.

Conclusions: The risk of sirolimus stent thrombosis is higher for multiple-vessel disease diabetic patients.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Angioplasty, Balloon, Coronary / adverse effects*
  • Antibiotics, Antineoplastic / administration & dosage
  • Blood Vessel Prosthesis Implantation / adverse effects*
  • Case-Control Studies
  • Coronary Disease / complications
  • Coronary Disease / therapy*
  • Diabetic Angiopathies / complications
  • Diabetic Angiopathies / drug therapy
  • Diabetic Angiopathies / therapy*
  • Disease-Free Survival
  • Drug Delivery Systems
  • Female
  • Humans
  • Insulin / therapeutic use
  • Male
  • Middle Aged
  • Prospective Studies
  • Registries
  • Risk Factors
  • Sirolimus / administration & dosage
  • Stents / adverse effects*
  • Thrombosis / epidemiology
  • Thrombosis / etiology*
  • Thrombosis / prevention & control
  • Treatment Outcome


  • Antibiotics, Antineoplastic
  • Insulin
  • Sirolimus