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EXPEDITED REVIEW

Prospective, randomized evaluation of thrombectomy prior to percutaneous intervention in diseased saphenous vein grafts and thrombus-containing coronary arteries

Gregg W. Stone, MD, FACC^*,*, David A. Cox, MD, FACC, Joseph Babb, MD, FACC, Dean Nukta, MD, FACC, Luc Bilodeau, MD^||, Louis Cannon, MD, FACC^¶, Thomas D. Stuckey, MD, FACC^#, James Hermiller, MD, FACC^**, Eric A. Cohen, MD, Reginald Low, MD, FACC, Steven R. Bailey, MD, FACC, Alexandra J. Lansky, MD, FACC^*, Richard E. Kuntz, MD, FACC^|||| for the X-TRACT Investigators

^* Cardiovascular Research Foundation and Lenox Hill Hospital, New York, New York, USA
Mid Carolina Cardiology, Charlotte, North Carolina, USA
Pitt County Memorial Hospital, Greenville, North Carolina, USA
Fairview Hospital, Cleveland, Ohio, USA
^|| Montreal Heart Institute, Montreal, Canada
^¶ St. Mary’s Hospital, Saginaw, Michigan, USA
^# Moses Cone Hospital, Greensboro, North Carolina, USA
^** St. Vincent’s Hospital, Indianapolis, Indiana, USA
Sunnybrook and Women’s College Health Sciences Center, Toronto, Canada
Mercy Hospital, Sacramento, California, USA
University of Texas Health Sciences Center, San Antonio, Texas, USA
^|||| Brigham and Women’s Hospital, Boston, Massachusetts, USA

Manuscript received August 15, 2003; revised manuscript received September 23, 2003, accepted September 30, 2003.

^* Reprint requests and correspondence: Dr. Gregg W. Stone, The Cardiovascular Research Foundation, 55 East 59th Street, 6th Floor, New York, New York 10022, USA.
gstone{at}crf.org

OBJECTIVES: We sought to determine whether routine thrombectomy prior to stent implantation in diseased saphenous vein grafts (SVGs) and thrombus-containing native coronary arteries would reduce peri-procedural myonecrosis and subsequently enhance event-free survival.

BACKGROUND: Percutaneous coronary intervention in diseased SVGs and thrombotic native coronary arteries is complicated by a high rate of peri-procedural myocardial infarction (MI). Thrombectomy prior to intervention may enhance the safety of intervention and improve early and late outcomes in these high-risk patients.

METHODS: At 60 centers in the U.S. and Canada, 797 patients with 839 diseased SVGs or thrombus-containing native coronary arteries were prospectively randomized to stent implantation with versus without prior thrombectomy with the X-SIZER device (ev3, Plymouth, Minnesota).

RESULTS: Peri-procedural MI occurred in 15.8% of patients assigned to the X-SIZER device compared with 16.6% of control patients (p = 0.77), although the rate of large MI (pre-specified as the development of new pathologic Q waves or creatine phosphokinase-MB isoenzyme elevation >8 x upper limits of normal) was reduced with X-SIZER device use from 9.6% to 5.5% (multivariate risk ratio 0.35 [95% confidence interval 0.18 to 0.66], p = 0.002). Major adverse cardiac events (cardiac death, MI, or repeat target vessel revascularization) occurred in 16.8% of X-SIZER patients versus 17.1% of control patients at 30 days (p = 0.92), and in 31.3% of X-SIZER patients versus 28.2% of control patients at 1 year (p = 0.35).

CONCLUSIONS: Thrombectomy with the X-SIZER device prior to stent implantation in high-risk diseased SVGs and thrombus-containing native coronary arteries may reduce the extent, but not the occurrence, of myonecrosis. Early and late event-free survival, however, were not improved by routine thrombectomy with this device.

Abbreviations and Acronyms   CPK = creatine phosphokinase   GP = glycoprotein   MACE = major adverse cardiac events   MI = myocardial infarction   PCI = percutaneous coronary intervention   SVG = saphenous vein graft   TIMI = Thrombolysis In Myocardial Infarction   TVR = target vessel revascularization   ULN = upper limit of normal   X-TRACT = X-SIZER for Treatment of Thrombus and Atherosclerosis in Coronary Interventions Trial

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