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.
Stone
Gregg W
GW
The Cardiovascular Research Foundation and Lenox Hill Heart and Vascular Institute, New York, New York 10021, USA. gstone@crf.org
Cox
David A
DA
Low
Reginald
R
Cates
Christopher U
CU
Satler
Lowell
L
Bailey
Steven R
SR
Kuntz
Richard E
RE
Lansky
Alexandra J
AJ
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation* / Q000379:methods; D017225:Atherectomy, Coronary / Q000379:methods*; D016009:Chi-Square Distribution; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D003328:Coronary Thrombosis / Q000000981:diagnostic imaging / Q000628:therapy*; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000000981:diagnostic imaging / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011336:Probability; D018570:Risk Assessment; D012501:Saphenous Vein / Q000473:pathology / Q000637:transplantation*; D018709:Statistics, Nonparametric; D015607:Stents; D017131:Thrombectomy / Q000379:methods*; D016896:Treatment Outcome