Author + information
- Received August 15, 2003
- Revision received September 23, 2003
- Accepted September 30, 2003
- Published online December 3, 2003.
- 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
- ↵*Reprint requests and correspondence:
Dr. Gregg W. Stone, The Cardiovascular Research Foundation, 55 East 59th Street, 6th Floor, New York, New York 10022, USA.
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 × 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.
☆ This study was supported in part by ev3 (Plymouth, Minnesota). Drs. Stone and Cox are consultants to ev3; Dr. Bailey is an advisor to ev3; and Dr. Lansky has received unrestricted educational grants from eV3. The names of the investigators, research coordinators, and institutions participating in X-TRACT appear in the Appendix.
- Received August 15, 2003.
- Revision received September 23, 2003.
- Accepted September 30, 2003.
- American College of Cardiology Foundation