Stent thrombosis and bleeding complications after implantation of sirolimus-eluting coronary stents in an unselected worldwide population: a report from the e-SELECT (Multi-Center Post-Market Surveillance) registry

J Am Coll Cardiol. 2011 Mar 29;57(13):1445-54. doi: 10.1016/j.jacc.2010.11.028.

Abstract

Objectives: The aim of this study was to ascertain the 1-year incidence of stent thrombosis (ST) and major bleeding (MB) in a large, unselected population treated with sirolimus-eluting stents (SES).

Background: Stent thrombosis and MB are major potential complications of drug-eluting stent implantation. Their relative incidence and predisposing factors among large populations treated worldwide are unclear.

Methods: The SES were implanted in 15,147 patients who were entered in a multinational registry. We analyzed the incidence of: 1) definite and probable ST as defined by the Academic Research Consortium; and 2) MB, with the STEEPLE (Safety and efficacy of Enoxaparin in PCI) definition, together with their relation to dual antiplatelet therapy (DAPT) and to 1-year clinical outcomes.

Results: The mean age of the sample was 62 ± 11 years, 30.4% were diabetic, 10% had a Charlson comorbidity index ≥3, and 44% presented with acute coronary syndrome or myocardial infarction. At 1 year, the reported compliance with DAPT as recommended by the European Society of Cardiology guidelines was 86.3%. Adverse event rates were: ST 1.0%, MB 1.0%, mortality 1.7%, myocardial infarction 1.9%, and target lesion revascularization 2.3%. Multivariate analysis identified 9 correlates of ST and 4 correlates of MB. Advanced age and a high Charlson index were associated with an increased risk of both ST and MB. After ST, the 7-day and 1-year all-cause mortality was 30% and 35%, respectively, versus 1.5% and 10% after MB. Only 2 of 13,749 patients (0.015%) experienced both MB and ST during the entire 1-year follow-up period.

Conclusions: In this worldwide population treated with ≥1 SES, the reported compliance with DAPT was good, and the incidence of ST and MB was low. Stent thrombosis and MB very rarely occurred in the same patient. (The e-SELECT Registry: a Multicenter Post-Market Surveillance; NCT00438919).

MeSH terms

  • Acute Coronary Syndrome / epidemiology
  • Acute Coronary Syndrome / surgery*
  • Age Factors
  • Comorbidity
  • Coronary Thrombosis / epidemiology
  • Coronary Thrombosis / etiology*
  • Drug-Eluting Stents / adverse effects*
  • Female
  • Follow-Up Studies
  • Hemorrhage / epidemiology
  • Hemorrhage / etiology*
  • Humans
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Myocardial Infarction / epidemiology
  • Myocardial Revascularization / statistics & numerical data
  • Platelet Aggregation Inhibitors / administration & dosage
  • Registries
  • Sirolimus / administration & dosage

Substances

  • Platelet Aggregation Inhibitors
  • Sirolimus

Associated data

  • ClinicalTrials.gov/NCT00438919