Safety and efficacy of a novel device for treatment of thrombotic and atherosclerotic lesions in native coronary arteries and saphenous vein grafts: results from the multicenter X-Sizer for treatment of thrombus and atherosclerosis in coronary applications trial (X-TRACT) study.

Intervention in thrombotic lesions and diseased saphenous vein grafts frequently results in thromboembolic complications, including no-reflow, distal branch occlusion, periprocedural MI, and death. The utility of a novel thromboatherectomy device, the X-Sizer, was tested in 50 consecutive patients at nine U.S. centers. A total of 61 lesions were treated in 31 vein grafts and 19 native coronary arteries; thrombus was present in 78% of lesions, and TIMI 0-1 flow in 21%. TIMI 3 flow improved from 57% at baseline to 94% postprocedure. No patient developed visible distal thromboemboli, side-branch occlusion, or reduced antegrade flow. Thirty-day events included one death (2.0%), Q- or non-Q-wave MI in 4.0%, TVR in 6.0%, and any MACE in 6.0%. We conclude that the use of the X-Sizer prior to percutaneous intervention is safe in high-risk vein grafts and thrombotic lesions and results in a low rate of adverse events compared to historical controls.