Prospective, randomized evaluation of thrombectomy prior to percutaneous intervention in diseased saphenous vein grafts and thrombus-containing coronary arteries.
OBJECTIVE
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.
Stone
Gregg W
GW
Cardiovascular Research Foundation and Lenox Hill Hospital, New York, New York 10022, USA. gstone@crf.org
Cox
David A
DA
Babb
Joseph
J
Nukta
Dean
D
Bilodeau
Luc
L
Cannon
Louis
L
Stuckey
Thomas D
TD
Hermiller
James
J
Cohen
Eric A
EA
Low
Reginald
R
Bailey
Steven R
SR
Lansky
Alexandra J
AJ
Kuntz
Richard E
RE
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001026:Coronary Artery Bypass; D003328:Coronary Thrombosis / Q000601:surgery; D003331:Coronary Vessels / Q000473:pathology / Q000601:surgery*; D018572:Disease-Free Survival; D005260:Female; D006083:Graft Occlusion, Vascular / Q000473:pathology / Q000601:surgery; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000150:complications / Q000601:surgery; D011446:Prospective Studies; D012086:Reoperation; D012501:Saphenous Vein / Q000473:pathology* / Q000601:surgery*; D015607:Stents; D017131:Thrombectomy; D016896:Treatment Outcome