Prospective, Randomized Evaluation of Thrombectomy Prior to Percutaneous Intervention in Diseased Saphenous Vein Grafts and Thrombus-Containing Coronary Arteries

Gregg W. Stone, David A. Cox, Joseph Babb, Dean Nukta, Luc Bilodeau, Louis Cannon, Thomas D. Stuckey, James Hermiller, Eric A. Cohen, Reginald Low, Steven R. Bailey, Alexandra J. Lansky, Richard E. Kuntz

Research output: Contribution to journalArticle

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)2007-2013
Number of pages7
JournalJournal of the American College of Cardiology
Volume42
Issue number11
DOIs
StatePublished - Dec 3 2003
Externally publishedYes

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Thrombectomy
Saphenous Vein
Coronary Vessels
Thrombosis
Transplants
Equipment and Supplies
Myocardial Infarction
Stents
Disease-Free Survival
Percutaneous Coronary Intervention
Creatine Kinase
Isoenzymes
Canada
Odds Ratio
Confidence Intervals
Safety

ASJC Scopus subject areas

  • Nursing(all)

Cite this

Prospective, Randomized Evaluation of Thrombectomy Prior to Percutaneous Intervention in Diseased Saphenous Vein Grafts and Thrombus-Containing Coronary Arteries. / 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.

In: Journal of the American College of Cardiology, Vol. 42, No. 11, 03.12.2003, p. 2007-2013.

Research output: Contribution to journalArticle

Stone, GW, Cox, DA, Babb, J, Nukta, D, Bilodeau, L, Cannon, L, Stuckey, TD, Hermiller, J, Cohen, EA, Low, R, Bailey, SR, Lansky, AJ & Kuntz, RE 2003, 'Prospective, Randomized Evaluation of Thrombectomy Prior to Percutaneous Intervention in Diseased Saphenous Vein Grafts and Thrombus-Containing Coronary Arteries', Journal of the American College of Cardiology, vol. 42, no. 11, pp. 2007-2013. https://doi.org/10.1016/j.jacc.2003.10.001
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. / Prospective, Randomized Evaluation of Thrombectomy Prior to Percutaneous Intervention in Diseased Saphenous Vein Grafts and Thrombus-Containing Coronary Arteries. In: Journal of the American College of Cardiology. 2003 ; Vol. 42, No. 11. pp. 2007-2013.
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abstract = "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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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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