Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty - ARMYDA-8 RELOAD-ACS

Description:

The goal of the trial was to evaluate a clopidogrel reload among patients with non–ST-segment elevation myocardial infarction (NSTEMI) on chronic clopidogrel therapy undergoing percutaneous coronary intervention (PCI) compared with placebo.

Hypothesis:

A clopidogrel reload will reduce adverse outcomes.

Study Design

  • Placebo Controlled
  • Randomized
  • Blinded
  • Parallel

Patient Populations:

  • Patients with NSTEMI on chronic clopidogrel therapy (>10 days) undergoing PCI

    Number of enrollees: 242
    Duration of follow-up: 30 days
    Mean patient age: 66 years
    Percentage female: 23%

Exclusions:

  • STEMI
  • Thrombocytopenia
  • Coronary artery bypass grafting in the last 3 months
  • Chronic warfarin therapy
  • Bleeding problem

Primary Endpoints:

  • Death, MI, or TVR at 30 days

Secondary Endpoints:

  • Major bleeding
  • Minor bleeding

Drug/Procedures Used:

Patients with NSTEMI on chronic clopidogrel therapy undergoing PCI were randomized to clopidogrel reload (600 mg) 4-8 hours before coronary angiography (n = 122) versus placebo (n = 120).

Concomitant Medications:

 N/A

Principal Findings:

Overall, 242 patients were randomized. The mean age was 66 years, 23% were women, 27% had diabetes, mean body mass index was 24 kg/m2, mean left ventricular ejection fraction was 57%, glycoprotein inhibitors were used in 11%, and drug-eluting stents were used in 47%.

The primary outcome of death, MI, or target vessel revascularization (TVR) at 30 days occurred in 4.1% of the reload group versus 14.1% of the placebo group (p = 0.013).

- Death: 0 vs. 0.8%
- MI: 4.1% vs. 13.3%
- TVR: 0 vs. 0
- Major bleeding: 0 vs. 0
- Minor bleeding: 2.5% vs. 3.3%, respectively, for reload vs. placebo

Platelet reactivity units changed from 238 at baseline to 199 at PCI among the reload group (p = 0.02), and from 228 at baseline to 224 at PCI among the placebo group (p = 0.52).

Interpretation:

Among patients with NSTEMI on a background of chronic clopidogrel therapy undergoing PCI, a reload of clopidogrel 600 mg reduced the outcome of death, MI, or TVR at 30 days compared with placebo. This was due to a reduction in periprocedural MI. Major bleeding was not increased with a clopidogrel reload. It is uncertain if a more potent antiplatelet agent (i.e., prasugrel or ticagrelor) would have resulted in greater clinical benefit in this patient population compared with clopidogrel.

References:

Patti G, Pasceri V, Mangiacapra F, et al., on behalf of the ARMYDA-8 RELOAD-ACS Investigators. Efficacy of Clopidogrel Reloading in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention During Chronic Clopidogrel Therapy (from the Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty [ARMYDA-8 RELOAD-ACS] Trial). Am J Cardiol 2013;112:162-8.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Interventions and Imaging, Angiography, Nuclear Imaging

Keywords: Myocardial Infarction, Body Mass Index, Platelet Aggregation Inhibitors, Coronary Angiography, Drug-Eluting Stents, Stroke Volume, Ticlopidine, Piperazines, Diabetes Mellitus, Percutaneous Coronary Intervention


< Back to Listings