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

Gregg W. Stone, David A. Cox, Reginald Low, Christopher U. Cates, Lowell Satler, Steven R Bailey, Richard E. Kuntz, Alexandra J. Lansky

Research output: Contribution to journalArticle

29 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)419-427
Number of pages9
JournalCatheterization and Cardiovascular Interventions
Volume58
Issue number4
DOIs
StatePublished - Apr 1 2003

Fingerprint

Saphenous Vein
Coronary Artery Disease
Coronary Vessels
Thrombosis
Transplants
Safety
Equipment and Supplies
Veins
Therapeutics

Keywords

  • Saphenous vein graft
  • Stent
  • Thrombectomy
  • Thrombus

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Radiology Nuclear Medicine and imaging

Cite this

@article{e53da72239d041ae95820562bb11b768,
title = "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",
abstract = "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.",
keywords = "Saphenous vein graft, Stent, Thrombectomy, Thrombus",
author = "Stone, {Gregg W.} and Cox, {David A.} and Reginald Low and Cates, {Christopher U.} and Lowell Satler and Bailey, {Steven R} and Kuntz, {Richard E.} and Lansky, {Alexandra J.}",
year = "2003",
month = "4",
day = "1",
doi = "10.1002/ccd.10511",
language = "English (US)",
volume = "58",
pages = "419--427",
journal = "Catheterization and Cardiovascular Interventions",
issn = "1522-1946",
publisher = "Wiley-Liss Inc.",
number = "4",

}

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

UR - http://www.scopus.com/inward/record.url?scp=12244299832&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=12244299832&partnerID=8YFLogxK

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 -