Bavarian Reperfusion Alternatives Evaluation - BRAVE

Description:

The goal of the trial was to evaluate abciximab therapy alone versus reteplase plus abciximab administered during the time from diagnosis to angiography among patients with ST elevation myocardial infarction (MI).

Hypothesis:

Treatment with reteplase plus abciximab administered during the time from diagnosis to angiography will be associated with smaller infarct sizes compared with abciximab alone among patients with ST elevation MI.

Study Design

Study Design:

Patients Enrolled: 253
Mean Follow Up: 30 days
Mean Patient Age: mean age 63 years
Female: 24

Patient Populations:

Chest pain duration ≥20 minutes, presence of ST-segment elevation MI, presentation within 12 hours of symptom onset, and age 18-80 years

Primary Endpoints:

Final infarct size on SPECT 5-10 days post-MI

Secondary Endpoints:

Death, MI, or hemorrhagic stroke at 30 days; or major bleed per TIMI criteria

Drug/Procedures Used:

Patients were randomized to either reteplase (2 boluses of 5 U) plus 12-hour abciximab infusion (n=125), or 12-hour infusion alone (n=128). Patients were then transferred to the catheterization lab for angiography and percutaneous coronary intervention (PCI).

Principal Findings:

The majority of patients (76%) were transferred following randomization from treatment centers without PCI to centers with PCI. Median time from treatment to angiography was two hours.

Pre-PCI thrombolysis in MI (TIMI) grade 3 flow was present more frequently in the combination therapy arm versus the abciximab alone arm (40% vs. 18%), and TIMI grade 0 flow was present less frequently (25% vs. 50%, respectively; p<0.001). There was no difference in post-PCI TIMI grade 3 flow (87% each, p=0.73). The primary endpoint of final infarct size did not differ between treatment arms (13% in the combination arm vs. 11.5% in the abciximab alone arm, p=0.81).

There was also no difference in 30-day death (1.6% each); reinfarction (2.4% vs. 1.6%); or the combination of death, MI, or hemorrhagic stroke (3.2% vs 1.6%). Major bleed occurred in 5.6% of patients in the combination arm versus 1.6% of patients in the abciximab alone arm (p=0.16).

Interpretation:

Among patients with ST elevation MI undergoing PCI, treatment with reteplase plus abciximab was not associated with a significant reduction in the primary endpoint of final infarct size compared with treatment with abciximab alone during the time from diagnosis to angiography. While the results of the trial were negative, it should be noted that the sample size was relatively small and the duration from diagnosis to angiography was short, given that the majority of patients were transferred to a PCI center. The larger upcoming ASSENT-4 and PATCAR trials will provide additional information on treatment of ST-segment elevation MI patients with PCI and medical therapy.

References:

Kastrati A, et al. Early Administration of Reteplase Plus Abciximab vs Abciximab Alone in Patients With Acute Myocardial Infarction Referred for Percutaneous Coronary Intervention. JAMA 2004;291 947-954.

Presented by Dr. Adnan Kastrati at the November 2003 American Heart Association Annual Scientific Sessions, Orlando, FL.

Clinical Topics: Anticoagulation Management, Dyslipidemia, Invasive Cardiovascular Angiography and Intervention, Lipid Metabolism

Keywords: Stroke, Myocardial Infarction, Platelet Aggregation Inhibitors, Immunoglobulin Fab Fragments, Fibrinolytic Agents, Percutaneous Coronary Intervention, Chest Pain, Catheterization, Recombinant Proteins, Tissue Plasminogen Activator


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