TY - JOUR
T1 - Safety and efficacy of a novel device for treatment of thrombotic and atherosclerotic lesions in native coronary arteries and saphenous vein grafts
T2 - Results from the multicenter X-sizer for treatment of thrombus and atherosclerosis in coronary applications trial (X-TRACT) study
AU - Stone, Gregg W.
AU - Cox, David A.
AU - Low, Reginald
AU - Cates, Christopher U.
AU - Satler, Lowell
AU - Bailey, Steven R.
AU - Kuntz, Richard E.
AU - Lansky, Alexandra J.
PY - 2003/4/1
Y1 - 2003/4/1
N2 - 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.
AB - 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.
KW - Saphenous vein graft
KW - Stent
KW - Thrombectomy
KW - Thrombus
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U2 - 10.1002/ccd.10511
DO - 10.1002/ccd.10511
M3 - Article
C2 - 12652487
AN - SCOPUS:12244299832
VL - 58
SP - 419
EP - 427
JO - Catheterization and Cardiovascular Interventions
JF - Catheterization and Cardiovascular Interventions
SN - 1522-1946
IS - 4
ER -