Prospective randomised study to evaluate effectiveness of distal embolic protection compared to abciximab administration in reduction of microembolic complications of primary coronary angioplasty.

BACKGROUND: Myocardial reperfusion following primary percutaneous coronary intervention (pPCI) is limited due to, among other things, microembolic events. Abciximab and a mechanical system of distal protection both reduce their incidence during PCI.

AIM: Prospective, randomised study to compare effectiveness of abciximab and protection devices in reduction of microembolic complications during pPCI.

METHODS: One hundred and twenty consecutive patients with ST elevation acute myocardial infarction referred for pPCI after coronary angiography were randomly assigned to the following groups: Group A (n=63), treated with abciximab; and Group B (n=57), treated using the distal protection system. Primary endpoint was blood flow through the infarct-related artery (IRA) using TIMI grading after pPCI; secondary endpoints included myocardial perfusion assessment using myocardial blush grade (MBG), ST resolution and improvement of echocardiographic left ventricular ejection fraction (LVEF) after pPCI.

RESULTS: TIMI grade 3 flow after pPCI was obtained in 89% of patients in both groups, TIMI grade 2 flow in 5% (NS). Myocardial perfusion after pPCI assessed with MBG scored 3 in 66% of patients in group A and 62% of patients in group B (NS). ST resolution was present in 62% (26-84) in group A and 68% (41 - 86) in group B (NS). Logistic regression analysis showed no significant influence of selected variables on the primary endpoint. Analysis performed in the distal protection group revealed significant effects on the following factors on the final TIMI flow in IRA: presence of thrombus prior to pPCI (p=0.026), presence of residual thrombus after aspiration (p <0.001), and IRA diameter of > or =3.5 mm (p=0.01). Median LVEF in group A at sixth month of follow-up was 46% (44-50%), similar to group B - 46% (45-49%) (NS).

CONCLUSIONS: Use of the PercuSurge distal protection device during pPCI allows angiographic and electrocardiographic measures of reperfusion to be improved. It has a similar effect on left ventricular systolic function as administration of abciximab. The device seems to be useful in patients with culprit artery diameter of > or =3.0 mm, and optimally > or =3.5 mm and thrombus visible on angiography. Successful initial thrombectomy prior to deployment of stent seems particularly important when using the PercuSurge system.