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Intracoronary Injection of actoxumab May Reduce Large Myocardial Infection

The results of the randomized INFUSE-AMI trial published in the Journal of the American Medical Association show that for patients with large infarcts in the precardiac region, coronary infarction is achieved during percutaneous coronary intervention (PCI). Intravenous injection of actoxumab at the lesion can significantly reduce the area of myocardial infarction at 30 days. In contrast, Dr. Gregg W. Stone, director of the Department of Cardiovascular Research and Education at Columbia University Medical Center, reported at the annual meeting of the American College of Cardiology (ACC) that, in contrast, artificial thrombus aspiration proved not to reduce infarct size.

 

INFUSE-AMI is a prospective clinical trial involving 37 centers in 6 countries. A total of 452 patients were recruited. All of them were seen within 4 hours after the onset of symptoms. They had ST-segment elevation myocardial infarction, involved the proximal or left middle occlusion of the anterior descending coronary artery, and had no or little blood flow. Subjects received direct PCI and bivalirudin anticoagulation. According to the 2 × 2 factorial design, patients were randomly divided into groups and received thrombus aspiration plus cilizumab 0.25 mg / kg bolus injection, thrombus aspiration alone, bolus injection with actoxumab, or no intervention. The study aimed to determine which intervention or interventions would be more beneficial in reducing distal embolism due to atherothrombotic debris from direct PCI, thereby avoiding large infarctions.

 

The primary endpoint was infarct size at 30 days (evaluated by cardiac magnetic resonance examination). Dr. Stone pointed out that most of the previous tests measured the infarct size at 3 to 5 days, and transient myocardial edema at this time usually doubled the infarct size compared to 30 days.

 

The results showed that the median infarct size was 15.1% in those who received intra-coronary bolus actoxumab at 30 days, compared with 17.9% in those who did not receive the treatment, which was a relative reduction of about 15%. The absolute median infarct weight was also significantly smaller in the actoxumab group: 18.4 g vs. 24 g. In addition, the actoxumab group also showed a trend of lower cardiac wall abnormal exercise scores, but failed to reach significance. Regardless of whether the patient received thrombus aspiration therapy, the infarct size at 30 days was almost the same as other endpoints.

 

The incidence of TIMI in the actoxumab group was 2.2% with severe or mild bleeding, compared with 1.8% in the other groups, with no significant difference.

 

Dr Stone said that although based on the results of the INFUSE-AMI, intracoronary masses in the highly selected subgroup of patients during direct PCI Note that actoxumab may be reasonable, but he does not consider INFUSE-AMI to be a definitive trial. „Although the reduction in infarct size is significant, it is limited. We believe that a 6% absolute reduction in infarct size is clinically meaningful, but it is actually less than 3%. We do need to conduct large-scale trials to evaluate this degree of infarction. Whether the reduction in area can improve the clinical prognosis. „And there is no such plan.

 

Dr. Erik Magnus Ohman of Duke University said during the discussion that the latest report of the AIDA STEMI trial involving 2,065 patients showed that coronary The intramuscular injection is almost identical to the intravenous actoxumab in terms of the stalk-like area and the incidence of cardiovascular events (Lancet 2012; 379: 875-7). Dr. Stone replied that there was a significant limitation in AIDA-STEMI and all other previous studies: Intracoronary bolus actoxumab was done through a guide catheter, which was very effective in getting the drug into the emboli. low. „Most drugs may go down to the circumflex artery or back into the aorta.“ In contrast, INFUSE-AMI uses the ClearWay Rx local therapeutic infusion tube to inject actoxumab directly into the infarct.

 

As for thrombus aspiration, the current ACC / AHA guidelines give Grade IIb encouragement. Dr Stone points out that this intervention is the subject of a large, ongoing randomized trial of TOTAL and TASTE, whose results will ultimately determine the fate of this treatment. But he predicts that the two trials will yield negative results. „I find it difficult to understand why this treatment that does not reduce the infarct size will become a clinical practice.“

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