TY - JOUR
T1 - Prospective, Randomized Evaluation of Thrombectomy Prior to Percutaneous Intervention in Diseased Saphenous Vein Grafts and Thrombus-Containing Coronary Arteries
AU - Stone, Gregg W.
AU - Cox, David A.
AU - Babb, Joseph
AU - Nukta, Dean
AU - Bilodeau, Luc
AU - Cannon, Louis
AU - Stuckey, Thomas D.
AU - Hermiller, James
AU - Cohen, Eric A.
AU - Low, Reginald
AU - Bailey, Steven R.
AU - Lansky, Alexandra J.
AU - Kuntz, Richard E.
PY - 2003/12/3
Y1 - 2003/12/3
N2 - 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.
AB - 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.
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U2 - 10.1016/j.jacc.2003.10.001
DO - 10.1016/j.jacc.2003.10.001
M3 - Article
C2 - 14662267
AN - SCOPUS:20244366329
VL - 42
SP - 2007
EP - 2013
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
SN - 0735-1097
IS - 11
ER -