Randomized Evaluation of the Effect of Mechanical Reduction of Distal Embolization by Thrombus-Aspiration in Primary and Rescue Angioplasty - REMEDIA

Description:

The goal of the REMEDIA trial was to evaluate the efficacy of percutaneous coronary intervention (PCI) with thrombus aspiration compared with PCI alone among patients with ST elevation MI.

Study Design

Study Design:

Patients Enrolled: 99

Patient Populations:

ST elevation myocardial infarction

Primary Endpoints:

1) Myocardial blush grade 2 or 3 post-PCI; 2) ST resolution ≥70%

Drug/Procedures Used:

Patients at a single center were randomized to PCI alone (n=49) or PCI with thrombus aspiration (n=50). The aspiration system was 6 French compatible.

Principal Findings:

Baseline characteristics were similar between the two randomized groups, with abciximab used in 68% of the aspiration group and 63% of the PCI alone group, and failed thrombolysis in 32% and 25%, respectively. Direct stenting was more frequent in the aspiration group (66% vs 24%, p<0.001). There was no difference in peak CKMB (256 mg/mL for aspiration group vs 283 mg/mL, p=0.47).

Myocardial blush grade 2 or 3 occurred more frequently among patients in the aspiration group (68.0% vs 44.9% for PCI alone, odds ratio [OR] 2.6, p=0.020). ST resolution ≥70% also occurred more frequently in the aspiration group (58.0% vs 36.7%, OR 2.4, p=0.034). Benefit was observed in the subgroups of age, time from symptom onset, culprit vessel, primary vs rescue PCI, abciximab use, but the greatest benefit was observed in patients with an occluded artery (TFG 0/1) and those with large thrombus (grades 3-4). There was no difference in clinical outcomes.

Interpretation:

Among patients with ST elevation MI, use of thrombus aspiration prior to PCI was associated with improvements in myocardial blush grade and ST resolution compared with PCI alone. These benefits did not translate into a clinical benefit at 30 days, although the trial enrolled only 99 patients and was not powered to detect a clinical difference. These data differ from the results of the much larger EMERALD trial, which showed no benefit of thrombus aspiration prior to PCI compared with PCI alone in patients with ST elevation MI. However, similar results were reported in the small (n=50) Export trial.

References:

Burzotta F, et al. Manual Thrombus-Aspiration Improves Myocardial Reperfusion: The REMEDIA trial. J Am Coll Cardiol 2005;46:371–6. Presented by Dr. Burzotta at the EuroPCR meeting, Paris, France, May 2005.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: Odds Ratio, Myocardial Infarction, Platelet Aggregation Inhibitors, Thrombosis, Immunoglobulin Fab Fragments, Angioplasty, Balloon, Coronary, Myocardial Reperfusion, Stents


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