Feasibility trial of carotid stenting with and without an embolus protection device

Kenneth Ouriel, Mark H. Wholey, Pierre Fayad, Barry T. Katzen, Patrick Whitlow, Michael Frentzko, Richard E. Kuntz, Lawrence Wechsler, Nelson Hopkins, Lowell Satler, Greg Mishkel, Jay S. Yadav

Research output: Contribution to journalArticle

28 Citations (Scopus)

Abstract

Purpose: To evaluate the feasibility of stenting and cerebral protection in patients with carotid bifurcation disease. Methods: Carotid stenting with self-expanding nitinol stents was evaluated in 261 patients (157 men; mean age 70.9±9.7 years, range 41-90) treated at 33 clinical sites. Among these patients, 141 (54.3%) were symptomatic, and 71 (27.2%) had postendarterectomy restenotic lesions. An embolus protection device became available in the latter third of the study. The primary endpoint of the study was the 30-day composite occurrence of major adverse clinical events (all deaths, strokes, or myocardial infarctions [MI]). At 1 year, the endpoint included all deaths, strokes, or MIs at 30 days, plus all deaths or ipsilateral strokes between 31 days and 1 year. Results: SMART stents were placed in 147 (56%) patients and Precise stents in 107 (41%); 7 (3%) patients were treated with non-study stents. Lesion success, defined as <30% postprocedural residual stenosis, was achieved in 249 (95%). An AngioGuard filter was used in 85 patients; of 90 filters employed, 78 (87%) were successfully deployed and retrieved. Visible material was noted in 42 (54%) retrieved filters. One (0.4%) stent thrombosis occurred at <30 days, and no restenotic lesions >80% were noted in up to 1 year of follow-up. At 30 days, stroke occurred in 16 (6.1%) patients, MI in 1 (0.4%), and 2 (0.8%) patients died. The 30-day rate of stroke, MI, or death was 6.9%. Major ipsilateral stroke occurred in 4 (1.5%) patients between 0 and 30 days; no new major ipsilateral strokes were noted up to 1 year. By Kaplan-Meier analysis, the 1-year risk of stroke, MI, or death was 10.9%±2.0%. The 1-year risk of major ipsilateral stroke was significantly lower in patients treated with embolus protection devices (0.0% versus 2.3%, p=0.05). Conclusions: The use of nitinol self-expanding stents in the carotid position appears to be a safe and efficacious alternative for the treatment of carotid bifurcation disease. The addition of embolus protection devices may diminish the risk of postprocedural major ipsilateral strokes.

Original languageEnglish (US)
Pages (from-to)525-537
Number of pages13
JournalJournal of Endovascular Therapy
Volume12
Issue number5
DOIs
StatePublished - Oct 1 2005

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Embolic Protection Devices
Stroke
Stents
Myocardial Infarction
Kaplan-Meier Estimate

Keywords

  • Carotid artery
  • Embolus protection device
  • Nitinol stent
  • Occlusive disease
  • Outcome analysis

ASJC Scopus subject areas

  • Surgery
  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

Ouriel, K., Wholey, M. H., Fayad, P., Katzen, B. T., Whitlow, P., Frentzko, M., ... Yadav, J. S. (2005). Feasibility trial of carotid stenting with and without an embolus protection device. Journal of Endovascular Therapy, 12(5), 525-537. https://doi.org/10.1583/05-1573.1

Feasibility trial of carotid stenting with and without an embolus protection device. / Ouriel, Kenneth; Wholey, Mark H.; Fayad, Pierre; Katzen, Barry T.; Whitlow, Patrick; Frentzko, Michael; Kuntz, Richard E.; Wechsler, Lawrence; Hopkins, Nelson; Satler, Lowell; Mishkel, Greg; Yadav, Jay S.

In: Journal of Endovascular Therapy, Vol. 12, No. 5, 01.10.2005, p. 525-537.

Research output: Contribution to journalArticle

Ouriel, K, Wholey, MH, Fayad, P, Katzen, BT, Whitlow, P, Frentzko, M, Kuntz, RE, Wechsler, L, Hopkins, N, Satler, L, Mishkel, G & Yadav, JS 2005, 'Feasibility trial of carotid stenting with and without an embolus protection device', Journal of Endovascular Therapy, vol. 12, no. 5, pp. 525-537. https://doi.org/10.1583/05-1573.1
Ouriel, Kenneth ; Wholey, Mark H. ; Fayad, Pierre ; Katzen, Barry T. ; Whitlow, Patrick ; Frentzko, Michael ; Kuntz, Richard E. ; Wechsler, Lawrence ; Hopkins, Nelson ; Satler, Lowell ; Mishkel, Greg ; Yadav, Jay S. / Feasibility trial of carotid stenting with and without an embolus protection device. In: Journal of Endovascular Therapy. 2005 ; Vol. 12, No. 5. pp. 525-537.
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abstract = "Purpose: To evaluate the feasibility of stenting and cerebral protection in patients with carotid bifurcation disease. Methods: Carotid stenting with self-expanding nitinol stents was evaluated in 261 patients (157 men; mean age 70.9±9.7 years, range 41-90) treated at 33 clinical sites. Among these patients, 141 (54.3{\%}) were symptomatic, and 71 (27.2{\%}) had postendarterectomy restenotic lesions. An embolus protection device became available in the latter third of the study. The primary endpoint of the study was the 30-day composite occurrence of major adverse clinical events (all deaths, strokes, or myocardial infarctions [MI]). At 1 year, the endpoint included all deaths, strokes, or MIs at 30 days, plus all deaths or ipsilateral strokes between 31 days and 1 year. Results: SMART stents were placed in 147 (56{\%}) patients and Precise stents in 107 (41{\%}); 7 (3{\%}) patients were treated with non-study stents. Lesion success, defined as <30{\%} postprocedural residual stenosis, was achieved in 249 (95{\%}). An AngioGuard filter was used in 85 patients; of 90 filters employed, 78 (87{\%}) were successfully deployed and retrieved. Visible material was noted in 42 (54{\%}) retrieved filters. One (0.4{\%}) stent thrombosis occurred at <30 days, and no restenotic lesions >80{\%} were noted in up to 1 year of follow-up. At 30 days, stroke occurred in 16 (6.1{\%}) patients, MI in 1 (0.4{\%}), and 2 (0.8{\%}) patients died. The 30-day rate of stroke, MI, or death was 6.9{\%}. Major ipsilateral stroke occurred in 4 (1.5{\%}) patients between 0 and 30 days; no new major ipsilateral strokes were noted up to 1 year. By Kaplan-Meier analysis, the 1-year risk of stroke, MI, or death was 10.9{\%}±2.0{\%}. The 1-year risk of major ipsilateral stroke was significantly lower in patients treated with embolus protection devices (0.0{\%} versus 2.3{\%}, p=0.05). Conclusions: The use of nitinol self-expanding stents in the carotid position appears to be a safe and efficacious alternative for the treatment of carotid bifurcation disease. The addition of embolus protection devices may diminish the risk of postprocedural major ipsilateral strokes.",
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AU - Wholey, Mark H.

AU - Fayad, Pierre

AU - Katzen, Barry T.

AU - Whitlow, Patrick

AU - Frentzko, Michael

AU - Kuntz, Richard E.

AU - Wechsler, Lawrence

AU - Hopkins, Nelson

AU - Satler, Lowell

AU - Mishkel, Greg

AU - Yadav, Jay S.

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N2 - Purpose: To evaluate the feasibility of stenting and cerebral protection in patients with carotid bifurcation disease. Methods: Carotid stenting with self-expanding nitinol stents was evaluated in 261 patients (157 men; mean age 70.9±9.7 years, range 41-90) treated at 33 clinical sites. Among these patients, 141 (54.3%) were symptomatic, and 71 (27.2%) had postendarterectomy restenotic lesions. An embolus protection device became available in the latter third of the study. The primary endpoint of the study was the 30-day composite occurrence of major adverse clinical events (all deaths, strokes, or myocardial infarctions [MI]). At 1 year, the endpoint included all deaths, strokes, or MIs at 30 days, plus all deaths or ipsilateral strokes between 31 days and 1 year. Results: SMART stents were placed in 147 (56%) patients and Precise stents in 107 (41%); 7 (3%) patients were treated with non-study stents. Lesion success, defined as <30% postprocedural residual stenosis, was achieved in 249 (95%). An AngioGuard filter was used in 85 patients; of 90 filters employed, 78 (87%) were successfully deployed and retrieved. Visible material was noted in 42 (54%) retrieved filters. One (0.4%) stent thrombosis occurred at <30 days, and no restenotic lesions >80% were noted in up to 1 year of follow-up. At 30 days, stroke occurred in 16 (6.1%) patients, MI in 1 (0.4%), and 2 (0.8%) patients died. The 30-day rate of stroke, MI, or death was 6.9%. Major ipsilateral stroke occurred in 4 (1.5%) patients between 0 and 30 days; no new major ipsilateral strokes were noted up to 1 year. By Kaplan-Meier analysis, the 1-year risk of stroke, MI, or death was 10.9%±2.0%. The 1-year risk of major ipsilateral stroke was significantly lower in patients treated with embolus protection devices (0.0% versus 2.3%, p=0.05). Conclusions: The use of nitinol self-expanding stents in the carotid position appears to be a safe and efficacious alternative for the treatment of carotid bifurcation disease. The addition of embolus protection devices may diminish the risk of postprocedural major ipsilateral strokes.

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KW - Carotid artery

KW - Embolus protection device

KW - Nitinol stent

KW - Occlusive disease

KW - Outcome analysis

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