Lack of association between dual antiplatelet therapy use and stent thrombosis between 1 and 12 months following resolute zotarolimus-eluting stent implantation

Eur Heart J. 2014 Aug 1;35(29):1949-56. doi: 10.1093/eurheartj/ehu026. Epub 2014 Feb 7.

Abstract

Aim: The optimal duration of dual antiplatelet therapy (DAPT) following the use of new generation drug-eluting stents is unknown.

Methods and results: The association between DAPT interruption and the rates of stent thrombosis (ST) and cardiac death/target-vessel myocardial infarction (CD/TVMI) in patients receiving a Resolute zotarolimus-eluting stent (R-ZES) was analysed in 4896 patients from the pooled RESOLUTE clinical programme. Daily acetylsalicylate (ASA) and a thienopyridine for 6-12 months were prescribed. A DAPT interruption was defined as any interruption of ASA and/or a thienopyridine of >1 day; long interruptions were >14 days. Three groups were analysed: no interruption, interruption during the first month, and >1-12 months. There were 1069 (21.83%) patients with a DAPT interruption and 3827 patients with no interruption. Among the 166 patients in the 1-month interruption group, 6 definite/probable ST events occurred (3.61%; all long DAPT interruptions), and among the 903 patients in the >1-12 months (60% occurred between 6 and 12 months) interruption group, 1 ST event occurred (0.11%; 2-day DAPT interruption). Among patients with no DAPT interruption, 32 ST events occurred (0.84%). Rates of CD/TVMI were 6.84% in the 1-month long interruption group, 1.41% in the >1-12 months long interruption group, and 4.08% in patients on continuous DAPT.

Conclusion: In a pooled population of patients receiving an R-ZES, DAPT interruptions within 1 month are associated with a high risk of adverse outcomes. Dual antiplatelet therapy interruptions between 1 and 12 months were associated with low rates of ST and adverse cardiac outcomes. Randomized clinical trials are needed to determine whether early temporary or permanent interruption of DAPT is truly safe. ClinicalTrials.gov Identifiers: NCT00617084; NCT00726453; NCT00752128; NCT00927940.

Keywords: Dual antiplatelet therapy; Resolute zotarolimus-eluting stent; Stent thrombosis.

Publication types

  • Meta-Analysis
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aspirin / therapeutic use
  • Blood Vessel Prosthesis*
  • Clinical Trials as Topic
  • Clopidogrel
  • Coronary Thrombosis / prevention & control*
  • Death, Sudden, Cardiac / etiology
  • Drug-Eluting Stents*
  • Female
  • Fibrinolytic Agents / therapeutic use*
  • Graft Occlusion, Vascular / prevention & control
  • Humans
  • Male
  • Middle Aged
  • Multicenter Studies as Topic
  • Myocardial Infarction / etiology
  • Platelet Aggregation Inhibitors / therapeutic use*
  • Prospective Studies
  • Prosthesis Failure / adverse effects*
  • Sirolimus / analogs & derivatives
  • Sirolimus / therapeutic use
  • Ticlopidine / analogs & derivatives
  • Ticlopidine / therapeutic use
  • Time Factors
  • Treatment Outcome
  • Withholding Treatment*

Substances

  • Fibrinolytic Agents
  • Platelet Aggregation Inhibitors
  • Clopidogrel
  • zotarolimus
  • Ticlopidine
  • Aspirin
  • Sirolimus

Associated data

  • ClinicalTrials.gov/NCT00617084
  • ClinicalTrials.gov/NCT00726453
  • ClinicalTrials.gov/NCT00752128
  • ClinicalTrials.gov/NCT00927940