Antiplatelet Therapy for Reduction of Myocardial Damage During Angioplasty-RELOAD - ARMYDA-RELOAD — Presented at SCAI-ACC i2 Summit/ACC 2008

Description:

The goal of this trial was to evaluate the safety and efficacy of an additional 600 mg clopidogrel dose prior to percutaneous coronary intervention (PCI) compared with placebo in patients undergoing revascularization.

Hypothesis:

The addition of 600 mg of clopidogrel to chronic clopidogrel therapy will be more effective in reducing major adverse cardiac events (MACE).

Study Design

Study Design:

Patients Enrolled: 436
Mean Follow Up: 30 days
Mean Patient Age: 66
Female: 31
Mean Ejection Fraction: 53%

Patient Populations:

Patients undergoing PCI for stable angina or non–ST-elevation ACS on chronic clopidogrel therapy for at least 10 days

Exclusions:

• Primary PCI
• Thrombocytopenia (<70,000/ml)
• Patients with high risk for bleeding
• Coronary artery bypass grafting in the last 3 months

Primary Endpoints:

Major adverse cardiac events: defined as death, myocardial infarction, or target vessel revascularization

Secondary Endpoints:

• Post-procedural increase of cardiac biomarkers above the upper limit of normal
• Any vascular or bleeding complication
• "Point of care" evaluation of platelet reactivity at different time points in the reload and placebo arms

Drug/Procedures Used:

Patients on chronic clopidogrel therapy (>10 days) undergoing PCI were randomized to an additional 600 mg clopidogrel dose (n = 285) or placebo (n = 283).

Principal Findings:

Among the stable angina population, DES were used in 54% of the reload group and 47% of the placebo group. With ACS, DES were used in 22% of the reload group and 26% of the placebo group. Among the stable angina population, GP IIb/IIIa inhibitors were used in 5% of the reload group and 4% of the placebo group. With ACS, GP IIb/IIIa inhibitors were used in 20% of the reload group and 21% of the placebo group.

For the entire study population, the incidence of the primary outcome, MACE, was 7% of the reload group versus 9% of the placebo group (p = 0.70). Among stable angina patients, MACE was 8% versus 4% (p = 0.23), and among ACS patients, MACE was 7% versus 18% (p = 0.035), respectively. There were no major bleeding episodes in either group. Minor bleeding was 5% in both groups (p = 1.0).

Interpretation:

Among stable and unstable patients on chronic clopidogrel therapy, an additional 600 mg loading dose failed to reduce MACE at 30 days. Post-hoc analysis, however, revealed benefit with an additional 600 mg loading dose among patients with an ACS. Although plausible, this finding will need to be verified by future studies specifically testing this patient population. Additional clopidogrel loading did not increase major or minor bleeding.

References:

Clopidogrel Reloading Before Percutaneous Coronary Intervention Improves Outcome in Patients With Acute Coronary Syndromes Receiving Chronic Clopidogrel Therapy: Results of the ARMYDA-RELOAD (Antiplatelet Therapy for Reduction of Myocardial Damage During Angioplasty-RELOAD) Randomized Trial. Presented by Dr. Germano Di Sciascio at the SCAI-ACC i2 Summit/American College of Cardiology Annual Scientific Session, Chicago, IL, March/April 2008.

Clinical Topics: Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Heart Failure and Cardiac Biomarkers, Chronic Angina

Keywords: Platelet Aggregation Inhibitors, Pyridinolcarbamate, Angina, Stable, Coronary Disease, Ticlopidine, Platelet Membrane Glycoprotein IIb, Percutaneous Coronary Intervention, Platelet Glycoprotein GPIIb-IIIa Complex


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