Stenting versus aggressive medical therapy for intracranial arterial stenosis

Marc I. Chimowitz, Michael J. Lynn, Colin P. Derdeyn, Tanya N. Turan, David Fiorella, Bethany F. Lane, L. Scott Janis, Helmi L. Lutsep, Stanley L. Barnwell, Michael F. Waters, Brian L. Hoh, J. Maurice Hourihane, Elad I. Levy, Andrei Alexandrov, Mark R. Harrigan, David Chiu, Richard P. Klucznik, Joni M. Clark, Cameron G. McDougall, Mark D. Johnson & 5 others G. Lee Pride, Michel T. Torbey, Osama O. Zaidat, Zoran Rumboldt, Harry J. Cloft

Research output: Contribution to journalArticle

869 Citations (Scopus)

Abstract

BACKGROUND: Atherosclerotic intracranial arterial stenosis is an important cause of stroke that is increasingly being treated with percutaneous transluminal angioplasty and stenting (PTAS) to prevent recurrent stroke. However, PTAS has not been compared with medical management in a randomized trial. METHODS: We randomly assigned patients who had a recent transient ischemic attack or stroke attributed to stenosis of 70 to 99% of the diameter of a major intracranial artery to aggressive medical management alone or aggressive medical management plus PTAS with the use of the Wingspan stent system. The primary end point was stroke or death within 30 days after enrollment or after a revascularization procedure for the qualifying lesion during the follow-up period or stroke in the territory of the qualifying artery beyond 30 days. RESULTS: Enrollment was stopped after 451 patients underwent randomization, because the 30-day rate of stroke or death was 14.7% in the PTAS group (nonfatal stroke, 12.5%; fatal stroke, 2.2%) and 5.8% in the medical-management group (nonfatal stroke, 5.3%; non-stroke-related death, 0.4%) (P = 0.002). Beyond 30 days, stroke in the same territory occurred in 13 patients in each group. Currently, the mean duration of followup, which is ongoing, is 11.9 months. The probability of the occurrence of a primary end-point event over time differed significantly between the two treatment groups (P = 0.009), with 1-year rates of the primary end point of 20.0% in the PTAS group and 12.2% in the medical-management group. CONCLUSIONS: In patients with intracranial arterial stenosis, aggressive medical management was superior to PTAS with the use of the Wingspan stent system, both because the risk of early stroke after PTAS was high and because the risk of stroke with aggressive medical therapy alone was lower than expected. (Funded by the National Institute of Neurological Disorders and Stroke and others; SAMMPRIS ClinicalTrials.gov number, NCT00576693.)

Original languageEnglish (US)
Pages (from-to)993-1003
Number of pages11
JournalNew England Journal of Medicine
Volume365
Issue number11
DOIs
StatePublished - Sep 15 2011

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Pathologic Constriction
Stroke
Angioplasty
Therapeutics
Stents
Arteries
National Institute of Neurological Disorders and Stroke
Transient Ischemic Attack
Random Allocation

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Chimowitz, M. I., Lynn, M. J., Derdeyn, C. P., Turan, T. N., Fiorella, D., Lane, B. F., ... Cloft, H. J. (2011). Stenting versus aggressive medical therapy for intracranial arterial stenosis. New England Journal of Medicine, 365(11), 993-1003. https://doi.org/10.1056/NEJMoa1105335

Stenting versus aggressive medical therapy for intracranial arterial stenosis. / Chimowitz, Marc I.; Lynn, Michael J.; Derdeyn, Colin P.; Turan, Tanya N.; Fiorella, David; Lane, Bethany F.; Janis, L. Scott; Lutsep, Helmi L.; Barnwell, Stanley L.; Waters, Michael F.; Hoh, Brian L.; Hourihane, J. Maurice; Levy, Elad I.; Alexandrov, Andrei; Harrigan, Mark R.; Chiu, David; Klucznik, Richard P.; Clark, Joni M.; McDougall, Cameron G.; Johnson, Mark D.; Pride, G. Lee; Torbey, Michel T.; Zaidat, Osama O.; Rumboldt, Zoran; Cloft, Harry J.

In: New England Journal of Medicine, Vol. 365, No. 11, 15.09.2011, p. 993-1003.

Research output: Contribution to journalArticle

Chimowitz, MI, Lynn, MJ, Derdeyn, CP, Turan, TN, Fiorella, D, Lane, BF, Janis, LS, Lutsep, HL, Barnwell, SL, Waters, MF, Hoh, BL, Hourihane, JM, Levy, EI, Alexandrov, A, Harrigan, MR, Chiu, D, Klucznik, RP, Clark, JM, McDougall, CG, Johnson, MD, Pride, GL, Torbey, MT, Zaidat, OO, Rumboldt, Z & Cloft, HJ 2011, 'Stenting versus aggressive medical therapy for intracranial arterial stenosis', New England Journal of Medicine, vol. 365, no. 11, pp. 993-1003. https://doi.org/10.1056/NEJMoa1105335
Chimowitz MI, Lynn MJ, Derdeyn CP, Turan TN, Fiorella D, Lane BF et al. Stenting versus aggressive medical therapy for intracranial arterial stenosis. New England Journal of Medicine. 2011 Sep 15;365(11):993-1003. https://doi.org/10.1056/NEJMoa1105335
Chimowitz, Marc I. ; Lynn, Michael J. ; Derdeyn, Colin P. ; Turan, Tanya N. ; Fiorella, David ; Lane, Bethany F. ; Janis, L. Scott ; Lutsep, Helmi L. ; Barnwell, Stanley L. ; Waters, Michael F. ; Hoh, Brian L. ; Hourihane, J. Maurice ; Levy, Elad I. ; Alexandrov, Andrei ; Harrigan, Mark R. ; Chiu, David ; Klucznik, Richard P. ; Clark, Joni M. ; McDougall, Cameron G. ; Johnson, Mark D. ; Pride, G. Lee ; Torbey, Michel T. ; Zaidat, Osama O. ; Rumboldt, Zoran ; Cloft, Harry J. / Stenting versus aggressive medical therapy for intracranial arterial stenosis. In: New England Journal of Medicine. 2011 ; Vol. 365, No. 11. pp. 993-1003.
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abstract = "BACKGROUND: Atherosclerotic intracranial arterial stenosis is an important cause of stroke that is increasingly being treated with percutaneous transluminal angioplasty and stenting (PTAS) to prevent recurrent stroke. However, PTAS has not been compared with medical management in a randomized trial. METHODS: We randomly assigned patients who had a recent transient ischemic attack or stroke attributed to stenosis of 70 to 99{\%} of the diameter of a major intracranial artery to aggressive medical management alone or aggressive medical management plus PTAS with the use of the Wingspan stent system. The primary end point was stroke or death within 30 days after enrollment or after a revascularization procedure for the qualifying lesion during the follow-up period or stroke in the territory of the qualifying artery beyond 30 days. RESULTS: Enrollment was stopped after 451 patients underwent randomization, because the 30-day rate of stroke or death was 14.7{\%} in the PTAS group (nonfatal stroke, 12.5{\%}; fatal stroke, 2.2{\%}) and 5.8{\%} in the medical-management group (nonfatal stroke, 5.3{\%}; non-stroke-related death, 0.4{\%}) (P = 0.002). Beyond 30 days, stroke in the same territory occurred in 13 patients in each group. Currently, the mean duration of followup, which is ongoing, is 11.9 months. The probability of the occurrence of a primary end-point event over time differed significantly between the two treatment groups (P = 0.009), with 1-year rates of the primary end point of 20.0{\%} in the PTAS group and 12.2{\%} in the medical-management group. CONCLUSIONS: In patients with intracranial arterial stenosis, aggressive medical management was superior to PTAS with the use of the Wingspan stent system, both because the risk of early stroke after PTAS was high and because the risk of stroke with aggressive medical therapy alone was lower than expected. (Funded by the National Institute of Neurological Disorders and Stroke and others; SAMMPRIS ClinicalTrials.gov number, NCT00576693.)",
author = "Chimowitz, {Marc I.} and Lynn, {Michael J.} and Derdeyn, {Colin P.} and Turan, {Tanya N.} and David Fiorella and Lane, {Bethany F.} and Janis, {L. Scott} and Lutsep, {Helmi L.} and Barnwell, {Stanley L.} and Waters, {Michael F.} and Hoh, {Brian L.} and Hourihane, {J. Maurice} and Levy, {Elad I.} and Andrei Alexandrov and Harrigan, {Mark R.} and David Chiu and Klucznik, {Richard P.} and Clark, {Joni M.} and McDougall, {Cameron G.} and Johnson, {Mark D.} and Pride, {G. Lee} and Torbey, {Michel T.} and Zaidat, {Osama O.} and Zoran Rumboldt and Cloft, {Harry J.}",
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T1 - Stenting versus aggressive medical therapy for intracranial arterial stenosis

AU - Chimowitz, Marc I.

AU - Lynn, Michael J.

AU - Derdeyn, Colin P.

AU - Turan, Tanya N.

AU - Fiorella, David

AU - Lane, Bethany F.

AU - Janis, L. Scott

AU - Lutsep, Helmi L.

AU - Barnwell, Stanley L.

AU - Waters, Michael F.

AU - Hoh, Brian L.

AU - Hourihane, J. Maurice

AU - Levy, Elad I.

AU - Alexandrov, Andrei

AU - Harrigan, Mark R.

AU - Chiu, David

AU - Klucznik, Richard P.

AU - Clark, Joni M.

AU - McDougall, Cameron G.

AU - Johnson, Mark D.

AU - Pride, G. Lee

AU - Torbey, Michel T.

AU - Zaidat, Osama O.

AU - Rumboldt, Zoran

AU - Cloft, Harry J.

PY - 2011/9/15

Y1 - 2011/9/15

N2 - BACKGROUND: Atherosclerotic intracranial arterial stenosis is an important cause of stroke that is increasingly being treated with percutaneous transluminal angioplasty and stenting (PTAS) to prevent recurrent stroke. However, PTAS has not been compared with medical management in a randomized trial. METHODS: We randomly assigned patients who had a recent transient ischemic attack or stroke attributed to stenosis of 70 to 99% of the diameter of a major intracranial artery to aggressive medical management alone or aggressive medical management plus PTAS with the use of the Wingspan stent system. The primary end point was stroke or death within 30 days after enrollment or after a revascularization procedure for the qualifying lesion during the follow-up period or stroke in the territory of the qualifying artery beyond 30 days. RESULTS: Enrollment was stopped after 451 patients underwent randomization, because the 30-day rate of stroke or death was 14.7% in the PTAS group (nonfatal stroke, 12.5%; fatal stroke, 2.2%) and 5.8% in the medical-management group (nonfatal stroke, 5.3%; non-stroke-related death, 0.4%) (P = 0.002). Beyond 30 days, stroke in the same territory occurred in 13 patients in each group. Currently, the mean duration of followup, which is ongoing, is 11.9 months. The probability of the occurrence of a primary end-point event over time differed significantly between the two treatment groups (P = 0.009), with 1-year rates of the primary end point of 20.0% in the PTAS group and 12.2% in the medical-management group. CONCLUSIONS: In patients with intracranial arterial stenosis, aggressive medical management was superior to PTAS with the use of the Wingspan stent system, both because the risk of early stroke after PTAS was high and because the risk of stroke with aggressive medical therapy alone was lower than expected. (Funded by the National Institute of Neurological Disorders and Stroke and others; SAMMPRIS ClinicalTrials.gov number, NCT00576693.)

AB - BACKGROUND: Atherosclerotic intracranial arterial stenosis is an important cause of stroke that is increasingly being treated with percutaneous transluminal angioplasty and stenting (PTAS) to prevent recurrent stroke. However, PTAS has not been compared with medical management in a randomized trial. METHODS: We randomly assigned patients who had a recent transient ischemic attack or stroke attributed to stenosis of 70 to 99% of the diameter of a major intracranial artery to aggressive medical management alone or aggressive medical management plus PTAS with the use of the Wingspan stent system. The primary end point was stroke or death within 30 days after enrollment or after a revascularization procedure for the qualifying lesion during the follow-up period or stroke in the territory of the qualifying artery beyond 30 days. RESULTS: Enrollment was stopped after 451 patients underwent randomization, because the 30-day rate of stroke or death was 14.7% in the PTAS group (nonfatal stroke, 12.5%; fatal stroke, 2.2%) and 5.8% in the medical-management group (nonfatal stroke, 5.3%; non-stroke-related death, 0.4%) (P = 0.002). Beyond 30 days, stroke in the same territory occurred in 13 patients in each group. Currently, the mean duration of followup, which is ongoing, is 11.9 months. The probability of the occurrence of a primary end-point event over time differed significantly between the two treatment groups (P = 0.009), with 1-year rates of the primary end point of 20.0% in the PTAS group and 12.2% in the medical-management group. CONCLUSIONS: In patients with intracranial arterial stenosis, aggressive medical management was superior to PTAS with the use of the Wingspan stent system, both because the risk of early stroke after PTAS was high and because the risk of stroke with aggressive medical therapy alone was lower than expected. (Funded by the National Institute of Neurological Disorders and Stroke and others; SAMMPRIS ClinicalTrials.gov number, NCT00576693.)

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