Detailed analysis of periprocedural strokes in patients undergoing intracranial stenting in stenting and aggressive medical management for preventing recurrent stroke in intracranial stenosis (SAMMPRIS)

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

Research output: Contribution to journalArticle

Abstract

BACKGROUND AND PURPOSE-: Enrollment in the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial was halted due to the high risk of stroke or death within 30 days of enrollment in the percutaneous transluminal angioplasty and stenting arm relative to the medical arm. This analysis focuses on the patient and procedural factors that may have been associated with periprocedural cerebrovascular events in the trial. METHODS-: Bivariate and multivariate analyses were performed to evaluate whether patient and procedural variables were associated with cerebral ischemic or hemorrhagic events occurring within 30 days of enrollment (termed periprocedural) in the percutaneous transluminal angioplasty and stenting arm. RESULTS-: Of 224 patients randomized to percutaneous transluminal angioplasty and stenting, 213 underwent angioplasty alone (n=5) or with stenting (n=208). Of these, 13 had hemorrhagic strokes (7 parenchymal, 6 subarachnoid), 19 had ischemic stroke, and 2 had cerebral infarcts with temporary signs within the periprocedural period. Ischemic events were categorized as perforator occlusions (13), embolic (4), mixed perforator and embolic (2), and delayed stent occlusion (2). Multivariate analyses showed that higher percent stenosis, lower modified Rankin score, and clopidogrel load associated with an activated clotting time above the target range were associated (P≤0.05) with hemorrhagic stroke. Nonsmoking, basilar artery stenosis, diabetes, and older age were associated (P≤0.05) with ischemic events. CONCLUSIONS-: Periprocedural strokes in SAMMPRIS had multiple causes with the most common being perforator occlusion. Although risk factors for periprocedural strokes could be identified, excluding patients with these features from undergoing percutaneous transluminal angioplasty and stenting to lower the procedural risk would limit percutaneous transluminal angioplasty and stenting to a small subset of patients. Moreover, given the small number of events, the present data should be used for hypothesis generation rather than to guide patient selection in clinical practice.

Original languageEnglish (US)
Pages (from-to)2682-2688
Number of pages7
JournalStroke
Volume43
Issue number10
DOIs
StatePublished - Oct 1 2012
Externally publishedYes

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Pathologic Constriction
Stroke
Angioplasty
clopidogrel
Multivariate Analysis
Vertebrobasilar Insufficiency
Patient Selection
Stents

Keywords

  • angioplasty and stenting
  • clinical trial
  • intracranial stenosis

ASJC Scopus subject areas

  • Clinical Neurology
  • Cardiology and Cardiovascular Medicine
  • Advanced and Specialized Nursing

Cite this

Detailed analysis of periprocedural strokes in patients undergoing intracranial stenting in stenting and aggressive medical management for preventing recurrent stroke in intracranial stenosis (SAMMPRIS). / Fiorella, David; Derdeyn, Colin P.; Lynn, Michael J.; Barnwell, Stanley L.; Hoh, Brian L.; Levy, Elad I.; Harrigan, Mark R.; Klucznik, Richard P.; McDougall, Cameron; Pride, G. Lee; Zaidat, Osama O.; Lutsep, Helmi L.; Waters, Michael F.; Hourihane, J. Maurice; Alexandrov, Andrei V.; Chiu, David; Clark, Joni M.; Johnson, Mark D.; Torbey, Michel T.; Rumboldt, Zoran; Cloft, Harry J.; Turan, Tanya N.; Lane, Bethany F.; Janis, L. Scott; Chimowitz, Marc I.

In: Stroke, Vol. 43, No. 10, 01.10.2012, p. 2682-2688.

Research output: Contribution to journalArticle

Fiorella, D, Derdeyn, CP, Lynn, MJ, Barnwell, SL, Hoh, BL, Levy, EI, Harrigan, MR, Klucznik, RP, McDougall, C, Pride, GL, Zaidat, OO, Lutsep, HL, Waters, MF, Hourihane, JM, Alexandrov, AV, Chiu, D, Clark, JM, Johnson, MD, Torbey, MT, Rumboldt, Z, Cloft, HJ, Turan, TN, Lane, BF, Janis, LS & Chimowitz, MI 2012, 'Detailed analysis of periprocedural strokes in patients undergoing intracranial stenting in stenting and aggressive medical management for preventing recurrent stroke in intracranial stenosis (SAMMPRIS)', Stroke, vol. 43, no. 10, pp. 2682-2688. https://doi.org/10.1161/STROKEAHA.112.661173
Fiorella, David ; Derdeyn, Colin P. ; Lynn, Michael J. ; Barnwell, Stanley L. ; Hoh, Brian L. ; Levy, Elad I. ; Harrigan, Mark R. ; Klucznik, Richard P. ; McDougall, Cameron ; Pride, G. Lee ; Zaidat, Osama O. ; Lutsep, Helmi L. ; Waters, Michael F. ; Hourihane, J. Maurice ; Alexandrov, Andrei V. ; Chiu, David ; Clark, Joni M. ; Johnson, Mark D. ; Torbey, Michel T. ; Rumboldt, Zoran ; Cloft, Harry J. ; Turan, Tanya N. ; Lane, Bethany F. ; Janis, L. Scott ; Chimowitz, Marc I. / Detailed analysis of periprocedural strokes in patients undergoing intracranial stenting in stenting and aggressive medical management for preventing recurrent stroke in intracranial stenosis (SAMMPRIS). In: Stroke. 2012 ; Vol. 43, No. 10. pp. 2682-2688.
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abstract = "BACKGROUND AND PURPOSE-: Enrollment in the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial was halted due to the high risk of stroke or death within 30 days of enrollment in the percutaneous transluminal angioplasty and stenting arm relative to the medical arm. This analysis focuses on the patient and procedural factors that may have been associated with periprocedural cerebrovascular events in the trial. METHODS-: Bivariate and multivariate analyses were performed to evaluate whether patient and procedural variables were associated with cerebral ischemic or hemorrhagic events occurring within 30 days of enrollment (termed periprocedural) in the percutaneous transluminal angioplasty and stenting arm. RESULTS-: Of 224 patients randomized to percutaneous transluminal angioplasty and stenting, 213 underwent angioplasty alone (n=5) or with stenting (n=208). Of these, 13 had hemorrhagic strokes (7 parenchymal, 6 subarachnoid), 19 had ischemic stroke, and 2 had cerebral infarcts with temporary signs within the periprocedural period. Ischemic events were categorized as perforator occlusions (13), embolic (4), mixed perforator and embolic (2), and delayed stent occlusion (2). Multivariate analyses showed that higher percent stenosis, lower modified Rankin score, and clopidogrel load associated with an activated clotting time above the target range were associated (P≤0.05) with hemorrhagic stroke. Nonsmoking, basilar artery stenosis, diabetes, and older age were associated (P≤0.05) with ischemic events. CONCLUSIONS-: Periprocedural strokes in SAMMPRIS had multiple causes with the most common being perforator occlusion. Although risk factors for periprocedural strokes could be identified, excluding patients with these features from undergoing percutaneous transluminal angioplasty and stenting to lower the procedural risk would limit percutaneous transluminal angioplasty and stenting to a small subset of patients. Moreover, given the small number of events, the present data should be used for hypothesis generation rather than to guide patient selection in clinical practice.",
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T1 - Detailed analysis of periprocedural strokes in patients undergoing intracranial stenting in stenting and aggressive medical management for preventing recurrent stroke in intracranial stenosis (SAMMPRIS)

AU - Fiorella, David

AU - Derdeyn, Colin P.

AU - Lynn, Michael J.

AU - Barnwell, Stanley L.

AU - Hoh, Brian L.

AU - Levy, Elad I.

AU - Harrigan, Mark R.

AU - Klucznik, Richard P.

AU - McDougall, Cameron

AU - Pride, G. Lee

AU - Zaidat, Osama O.

AU - Lutsep, Helmi L.

AU - Waters, Michael F.

AU - Hourihane, J. Maurice

AU - Alexandrov, Andrei V.

AU - Chiu, David

AU - Clark, Joni M.

AU - Johnson, Mark D.

AU - Torbey, Michel T.

AU - Rumboldt, Zoran

AU - Cloft, Harry J.

AU - Turan, Tanya N.

AU - Lane, Bethany F.

AU - Janis, L. Scott

AU - Chimowitz, Marc I.

PY - 2012/10/1

Y1 - 2012/10/1

N2 - BACKGROUND AND PURPOSE-: Enrollment in the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial was halted due to the high risk of stroke or death within 30 days of enrollment in the percutaneous transluminal angioplasty and stenting arm relative to the medical arm. This analysis focuses on the patient and procedural factors that may have been associated with periprocedural cerebrovascular events in the trial. METHODS-: Bivariate and multivariate analyses were performed to evaluate whether patient and procedural variables were associated with cerebral ischemic or hemorrhagic events occurring within 30 days of enrollment (termed periprocedural) in the percutaneous transluminal angioplasty and stenting arm. RESULTS-: Of 224 patients randomized to percutaneous transluminal angioplasty and stenting, 213 underwent angioplasty alone (n=5) or with stenting (n=208). Of these, 13 had hemorrhagic strokes (7 parenchymal, 6 subarachnoid), 19 had ischemic stroke, and 2 had cerebral infarcts with temporary signs within the periprocedural period. Ischemic events were categorized as perforator occlusions (13), embolic (4), mixed perforator and embolic (2), and delayed stent occlusion (2). Multivariate analyses showed that higher percent stenosis, lower modified Rankin score, and clopidogrel load associated with an activated clotting time above the target range were associated (P≤0.05) with hemorrhagic stroke. Nonsmoking, basilar artery stenosis, diabetes, and older age were associated (P≤0.05) with ischemic events. CONCLUSIONS-: Periprocedural strokes in SAMMPRIS had multiple causes with the most common being perforator occlusion. Although risk factors for periprocedural strokes could be identified, excluding patients with these features from undergoing percutaneous transluminal angioplasty and stenting to lower the procedural risk would limit percutaneous transluminal angioplasty and stenting to a small subset of patients. Moreover, given the small number of events, the present data should be used for hypothesis generation rather than to guide patient selection in clinical practice.

AB - BACKGROUND AND PURPOSE-: Enrollment in the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial was halted due to the high risk of stroke or death within 30 days of enrollment in the percutaneous transluminal angioplasty and stenting arm relative to the medical arm. This analysis focuses on the patient and procedural factors that may have been associated with periprocedural cerebrovascular events in the trial. METHODS-: Bivariate and multivariate analyses were performed to evaluate whether patient and procedural variables were associated with cerebral ischemic or hemorrhagic events occurring within 30 days of enrollment (termed periprocedural) in the percutaneous transluminal angioplasty and stenting arm. RESULTS-: Of 224 patients randomized to percutaneous transluminal angioplasty and stenting, 213 underwent angioplasty alone (n=5) or with stenting (n=208). Of these, 13 had hemorrhagic strokes (7 parenchymal, 6 subarachnoid), 19 had ischemic stroke, and 2 had cerebral infarcts with temporary signs within the periprocedural period. Ischemic events were categorized as perforator occlusions (13), embolic (4), mixed perforator and embolic (2), and delayed stent occlusion (2). Multivariate analyses showed that higher percent stenosis, lower modified Rankin score, and clopidogrel load associated with an activated clotting time above the target range were associated (P≤0.05) with hemorrhagic stroke. Nonsmoking, basilar artery stenosis, diabetes, and older age were associated (P≤0.05) with ischemic events. CONCLUSIONS-: Periprocedural strokes in SAMMPRIS had multiple causes with the most common being perforator occlusion. Although risk factors for periprocedural strokes could be identified, excluding patients with these features from undergoing percutaneous transluminal angioplasty and stenting to lower the procedural risk would limit percutaneous transluminal angioplasty and stenting to a small subset of patients. Moreover, given the small number of events, the present data should be used for hypothesis generation rather than to guide patient selection in clinical practice.

KW - angioplasty and stenting

KW - clinical trial

KW - intracranial stenosis

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