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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
Author(s) -
Stone Gregg W.,
Cox David A.,
Low Reginald,
Cates Christopher U.,
Satler Lowell,
Bailey Steven R.,
Kuntz Richard E.,
Lansky Alexandra J.
Publication year - 2003
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.10511
Subject(s) - medicine , timi , mace , thrombus , percutaneous coronary intervention , coronary arteries , cardiology , surgery , occlusion , artery , myocardial infarction
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. Cathet Cardiovasc Intervent 2003;58:419–427. © 2003 Wiley‐Liss, Inc.