Systematic primary aspiration in acute myocardial percutaneous intervention: a multicentre randomised controlled trial of the export aspiration catheter.

AIMS

It is unclear whether primary aspiration can prevent distal embolisation and thereby improve myocardial perfusion in patients presenting with acute myocardial infarction (AMI) within 12 hours after onset.

METHODS AND RESULTS

At 24 centres in Europe and India, 249 AMI patients were randomised to primary aspiration with the Export aspiration catheter (Medtronic Vascular, Santa Rosa, CA, U.S.A.) followed by stenting (N=120) or to conventional stenting without primary aspiration (N=129). There were no significant differences between the 2 groups in baseline characteristics or target lesion TIMI scores. Procedure time was 36.7 +/- 18.0 minutes for primary aspiration followed by stenting versus 34.5 +/- 21.5 minutes for conventional stenting (P=0.08). Debris was obtained by primary aspiration from 85.3% of the arteries. The use of a bailout technique was significantly lower for primary aspiration than for conventional stenting (5.8% vs. 14.7%, P=0.02). For the primary endpoint of the combined rate of myocardial blush grade 3 and/or ST-segment resolution >50% to assess myocardial perfusion, primary aspiration followed by stenting was superior to conventional stenting (85.0% vs. 71.9%, P=0.025). Immediately postprocedure, the rate of myocardial blush grade 3 was 35.8% for primary aspiration followed by stenting versus 25.4% for conventional stenting (P=0.094). At 60 minutes post procedure, the rate of ST-segment resolution >50% was 73.5% for primary aspiration followed by stenting versus 64.8% for conventional stenting (P=0.218). Primary aspiration was also associated with a significantly higher postprocedure corrected TIMI frame count than conventional stenting (20 +/- 14.9 vs. 22.8 +/- 14, P=0.02). At 30 days, there were no differences between the treatments in the rate of major adverse cardiac and cerebral events.

CONCLUSIONS

Compared with conventional stenting, primary aspiration with the Export aspiration catheter followed by stenting improved myocardial reperfusion in AMI patients presenting with TIMI flow grade 0 to 1. Further study of primary aspiration involving larger numbers of patients is warranted to assess its effect on longer-term clinical outcome.