Assessment by a double Randomization of a Conventional antiplatelet strategy versus a monitoring-guided strategy for drug-eluting stent implantation and, of Treatment Interruption versus Continuation one year after stenting - ARCTIC-INTERRUPTION

Description:

The goal of the trial was to evaluate treatment with 1 year of dual antiplatelet therapy compared with 2 years of therapy among patients who received a drug-eluting stent.

Hypothesis:

Two years of dual antiplatelet therapy will not be superior to 1 year of therapy.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Patients originally enrolled in the ARCTIC trial, and who had completed 12 months of follow-up

    Number of enrollees: 1,259
    Duration of follow-up: 18 months
    Mean patient age: 63 years

Primary Endpoints:

  • Death, MI, stroke, stent thrombosis, or urgent revascularization

Secondary Endpoints:

  • Any ischemic or safety event during the first year of follow-up
  • Any new revascularization
  • Contraindication to aspirin withdrawal

Drug/Procedures Used:

Patients originally enrolled in the ARTIC trial and who had completed 12 months of follow-up were randomized to stop clopidogrel (single antiplatelet therapy group; n = 624) versus continue clopidogrel for an additional year (dual antiplatelet therapy group; n = 635).

Principal Findings:

Overall, 1,259 patients were randomized. The mean age was 63 years, 33% had diabetes, and 31% had a prior myocardial infarction (MI).

The platelet reactivity unit on maintenance therapy was 147 in the 1-year clopidogrel group versus 144 in the 2-year clopidogrel group (p = NS).

The primary outcome of death, MI, stroke, stent thrombosis, or urgent revascularization at 18 months occurred in 4.3% of the single antiplatelet therapy group versus 3.8% of the dual antiplatelet therapy group (p = 0.58). Findings were similar among all tested subgroups.

- Any death: 1.4% vs. 1.1% (p = 0.58), respectively, for single vs. dual antitherapy

- MI: 1.4% vs. 1.4% (p = 0.94), respectively

- Stent thrombosis: 0.5% vs. 0, respectively

- Stroke/transient ischemic attack (TIA): 0.6% vs. 0.9% (p = 0.56), respectively

- Urgent revascularization: 1.4% vs. 1.3% (p = 0.74), respectively

- Major bleeding: 0.2% vs. 1.1% (p = 0.073), respectively

Interpretation:

Among patients who received a drug-eluting stent, 2 years of dual antiplatelet therapy was not superior to 1 year of therapy. Two years of therapy was associated with an increase in major bleeding. These patients were relatively low-risk since they had to be event-free for 1 year at the time of enrollment. The optimal duration of dual antiplatelet therapy after a drug-eluting stent is unknown; however, current data do not support continuing therapy beyond 1 year.

References:

Presented by Dr. Jean Philippe Collet at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2013), San Francisco, CA, October 31, 2013.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: Myocardial Infarction, Stroke, Ischemic Attack, Transient, Platelet Aggregation Inhibitors, Thrombosis, Drug-Eluting Stents, Ticlopidine, Diabetes Mellitus, Purinergic P2Y Receptor Antagonists, Stents


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