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

• Published in: Journal of the American College of Cardiology Vol. 42; no. 11; pp. 2007 - 2013
• Main Authors: Stone, Gregg W., Cox, David A., Babb, Joseph, Nukta, Dean, Bilodeau, Luc, Cannon, Louis, Stuckey, Thomas D., Hermiller, James, Cohen, Eric A., Low, Reginald, Bailey, Steven R., Lansky, Alexandra J., Kuntz, Richard E.
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 03.12.2003; Elsevier Science; Elsevier Limited
• Subjects: Adult; Aged; Aged, 80 and over; Biological and medical sciences; Cardiology; Cardiology. Vascular system; Clinical outcomes; Coronary Artery Bypass; Coronary Thrombosis - surgery; Coronary Vessels - pathology; Coronary Vessels - surgery; Disease-Free Survival; Female; Graft Occlusion, Vascular - pathology; Graft Occlusion, Vascular - surgery; Heart attacks; Humans; Male; Medical sciences; Middle Aged; Myocardial Infarction - complications; Myocardial Infarction - surgery; Prospective Studies; Reoperation; Saphenous Vein - pathology; Saphenous Vein - surgery; Stents; Thrombectomy; Treatment Outcome; Veins & arteries; TVR; MACE; SVG; TIMI; ULN; PCI; GP; X-TRACT; MI; CPK; Evaluation; Thrombus; Coronary artery; Phlebology; Percutaneous route; Prospective; Randomization; Thrombectomy; Treatment; Saphenous vein; Surgery; Graft; Circulatory system; Cardiology
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2003.10.001

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. 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. 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). 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 × 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). 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.