Proximal versus distal embolic protection for carotid artery stenting: A national cardiovascular data registry analysis

Jay Giri, Sahil A. Parikh, Kevin F. Kennedy, Ido Weinberg, Cameron Donaldson, Beau M. Hawkins, Daniel J. McCormick, Benjamin Jackson, Ehrin J. Armstrong, Preethi Ramchand, Christopher J. White, Michael R. Jaff, Kenneth Rosenfield, Robert W. Yeh

Research output: Contribution to journalArticle

23 Citations (Scopus)

Abstract

Objectives The aim of this study was to compare the stroke/death rates between proximal embolic protection devices (P-EPDs) and distal filter embolic protection devices (F-EPDs) in elective carotid artery stenting (CAS). Background P-EPDs have theoretical advantages that may make them superior to F-EPDs for stroke prevention during CAS. Methods We examined 10,246 consecutive elective CAS procedures performed with embolic protection in the NCDR CARE registry between January 2009 and March 2013. We analyzed crude and propensity-matched rates of in-hospital combined death/stroke in patients treated with P-EPDs versus F-EPDs. Secondary analyses included 30-day adverse event rates and stroke rates by the involved cerebrovascular territory. Results P-EPDs were used in 590 of 10,246 cases (5.8%). Patients treated with P-EPDs had higher rates of symptomatic lesion status (46.8% vs. 39.7%, p < 0.001), atrial fibrillation/flutter (16.1% vs. 13.0%, p = 0.03), and history of a neurological event (51.2% vs. 46.6%, p = 0.03). In unadjusted and propensity-matched analyses, differences in in-hospital stroke/death between P-EPD and F-EPD cohorts were nonsignificant (1.5% vs. 2.4%, p = 0.16 and 1.6% vs. 2.0%, p = 0.56, respectively). For patients with available data (n = 7,693, 75.1%), 30-day adverse events rates were similar for P-EPDs and F-EPDs before (2.5% vs. 4.2%, p = 0.07) and after (2.7% vs. 4.0%, p = 0.22) propensity matching. Conclusions Use of a P-EPD during CAS was associated with low rates of in-hospital stroke/death similar to those with an F-EPD in the first comparative effectiveness study of the devices. An adequately powered randomized trial comparing clinical outcomes between these devices is unlikely to be feasible.

Original languageEnglish (US)
Pages (from-to)609-615
Number of pages7
JournalJACC: Cardiovascular Interventions
Volume8
Issue number4
DOIs
StatePublished - Apr 20 2015
Externally publishedYes

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Embolic Protection Devices
Carotid Arteries
Registries
Stroke

Keywords

  • Carotid artery stenosis
  • carotid artery stenting
  • embolic protection devices
  • stroke

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Proximal versus distal embolic protection for carotid artery stenting : A national cardiovascular data registry analysis. / Giri, Jay; Parikh, Sahil A.; Kennedy, Kevin F.; Weinberg, Ido; Donaldson, Cameron; Hawkins, Beau M.; McCormick, Daniel J.; Jackson, Benjamin; Armstrong, Ehrin J.; Ramchand, Preethi; White, Christopher J.; Jaff, Michael R.; Rosenfield, Kenneth; Yeh, Robert W.

In: JACC: Cardiovascular Interventions, Vol. 8, No. 4, 20.04.2015, p. 609-615.

Research output: Contribution to journalArticle

Giri, J, Parikh, SA, Kennedy, KF, Weinberg, I, Donaldson, C, Hawkins, BM, McCormick, DJ, Jackson, B, Armstrong, EJ, Ramchand, P, White, CJ, Jaff, MR, Rosenfield, K & Yeh, RW 2015, 'Proximal versus distal embolic protection for carotid artery stenting: A national cardiovascular data registry analysis', JACC: Cardiovascular Interventions, vol. 8, no. 4, pp. 609-615. https://doi.org/10.1016/j.jcin.2015.02.001
Giri, Jay ; Parikh, Sahil A. ; Kennedy, Kevin F. ; Weinberg, Ido ; Donaldson, Cameron ; Hawkins, Beau M. ; McCormick, Daniel J. ; Jackson, Benjamin ; Armstrong, Ehrin J. ; Ramchand, Preethi ; White, Christopher J. ; Jaff, Michael R. ; Rosenfield, Kenneth ; Yeh, Robert W. / Proximal versus distal embolic protection for carotid artery stenting : A national cardiovascular data registry analysis. In: JACC: Cardiovascular Interventions. 2015 ; Vol. 8, No. 4. pp. 609-615.
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title = "Proximal versus distal embolic protection for carotid artery stenting: A national cardiovascular data registry analysis",
abstract = "Objectives The aim of this study was to compare the stroke/death rates between proximal embolic protection devices (P-EPDs) and distal filter embolic protection devices (F-EPDs) in elective carotid artery stenting (CAS). Background P-EPDs have theoretical advantages that may make them superior to F-EPDs for stroke prevention during CAS. Methods We examined 10,246 consecutive elective CAS procedures performed with embolic protection in the NCDR CARE registry between January 2009 and March 2013. We analyzed crude and propensity-matched rates of in-hospital combined death/stroke in patients treated with P-EPDs versus F-EPDs. Secondary analyses included 30-day adverse event rates and stroke rates by the involved cerebrovascular territory. Results P-EPDs were used in 590 of 10,246 cases (5.8{\%}). Patients treated with P-EPDs had higher rates of symptomatic lesion status (46.8{\%} vs. 39.7{\%}, p < 0.001), atrial fibrillation/flutter (16.1{\%} vs. 13.0{\%}, p = 0.03), and history of a neurological event (51.2{\%} vs. 46.6{\%}, p = 0.03). In unadjusted and propensity-matched analyses, differences in in-hospital stroke/death between P-EPD and F-EPD cohorts were nonsignificant (1.5{\%} vs. 2.4{\%}, p = 0.16 and 1.6{\%} vs. 2.0{\%}, p = 0.56, respectively). For patients with available data (n = 7,693, 75.1{\%}), 30-day adverse events rates were similar for P-EPDs and F-EPDs before (2.5{\%} vs. 4.2{\%}, p = 0.07) and after (2.7{\%} vs. 4.0{\%}, p = 0.22) propensity matching. Conclusions Use of a P-EPD during CAS was associated with low rates of in-hospital stroke/death similar to those with an F-EPD in the first comparative effectiveness study of the devices. An adequately powered randomized trial comparing clinical outcomes between these devices is unlikely to be feasible.",
keywords = "Carotid artery stenosis, carotid artery stenting, embolic protection devices, stroke",
author = "Jay Giri and Parikh, {Sahil A.} and Kennedy, {Kevin F.} and Ido Weinberg and Cameron Donaldson and Hawkins, {Beau M.} and McCormick, {Daniel J.} and Benjamin Jackson and Armstrong, {Ehrin J.} and Preethi Ramchand and White, {Christopher J.} and Jaff, {Michael R.} and Kenneth Rosenfield and Yeh, {Robert W.}",
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T1 - Proximal versus distal embolic protection for carotid artery stenting

T2 - A national cardiovascular data registry analysis

AU - Giri, Jay

AU - Parikh, Sahil A.

AU - Kennedy, Kevin F.

AU - Weinberg, Ido

AU - Donaldson, Cameron

AU - Hawkins, Beau M.

AU - McCormick, Daniel J.

AU - Jackson, Benjamin

AU - Armstrong, Ehrin J.

AU - Ramchand, Preethi

AU - White, Christopher J.

AU - Jaff, Michael R.

AU - Rosenfield, Kenneth

AU - Yeh, Robert W.

PY - 2015/4/20

Y1 - 2015/4/20

N2 - Objectives The aim of this study was to compare the stroke/death rates between proximal embolic protection devices (P-EPDs) and distal filter embolic protection devices (F-EPDs) in elective carotid artery stenting (CAS). Background P-EPDs have theoretical advantages that may make them superior to F-EPDs for stroke prevention during CAS. Methods We examined 10,246 consecutive elective CAS procedures performed with embolic protection in the NCDR CARE registry between January 2009 and March 2013. We analyzed crude and propensity-matched rates of in-hospital combined death/stroke in patients treated with P-EPDs versus F-EPDs. Secondary analyses included 30-day adverse event rates and stroke rates by the involved cerebrovascular territory. Results P-EPDs were used in 590 of 10,246 cases (5.8%). Patients treated with P-EPDs had higher rates of symptomatic lesion status (46.8% vs. 39.7%, p < 0.001), atrial fibrillation/flutter (16.1% vs. 13.0%, p = 0.03), and history of a neurological event (51.2% vs. 46.6%, p = 0.03). In unadjusted and propensity-matched analyses, differences in in-hospital stroke/death between P-EPD and F-EPD cohorts were nonsignificant (1.5% vs. 2.4%, p = 0.16 and 1.6% vs. 2.0%, p = 0.56, respectively). For patients with available data (n = 7,693, 75.1%), 30-day adverse events rates were similar for P-EPDs and F-EPDs before (2.5% vs. 4.2%, p = 0.07) and after (2.7% vs. 4.0%, p = 0.22) propensity matching. Conclusions Use of a P-EPD during CAS was associated with low rates of in-hospital stroke/death similar to those with an F-EPD in the first comparative effectiveness study of the devices. An adequately powered randomized trial comparing clinical outcomes between these devices is unlikely to be feasible.

AB - Objectives The aim of this study was to compare the stroke/death rates between proximal embolic protection devices (P-EPDs) and distal filter embolic protection devices (F-EPDs) in elective carotid artery stenting (CAS). Background P-EPDs have theoretical advantages that may make them superior to F-EPDs for stroke prevention during CAS. Methods We examined 10,246 consecutive elective CAS procedures performed with embolic protection in the NCDR CARE registry between January 2009 and March 2013. We analyzed crude and propensity-matched rates of in-hospital combined death/stroke in patients treated with P-EPDs versus F-EPDs. Secondary analyses included 30-day adverse event rates and stroke rates by the involved cerebrovascular territory. Results P-EPDs were used in 590 of 10,246 cases (5.8%). Patients treated with P-EPDs had higher rates of symptomatic lesion status (46.8% vs. 39.7%, p < 0.001), atrial fibrillation/flutter (16.1% vs. 13.0%, p = 0.03), and history of a neurological event (51.2% vs. 46.6%, p = 0.03). In unadjusted and propensity-matched analyses, differences in in-hospital stroke/death between P-EPD and F-EPD cohorts were nonsignificant (1.5% vs. 2.4%, p = 0.16 and 1.6% vs. 2.0%, p = 0.56, respectively). For patients with available data (n = 7,693, 75.1%), 30-day adverse events rates were similar for P-EPDs and F-EPDs before (2.5% vs. 4.2%, p = 0.07) and after (2.7% vs. 4.0%, p = 0.22) propensity matching. Conclusions Use of a P-EPD during CAS was associated with low rates of in-hospital stroke/death similar to those with an F-EPD in the first comparative effectiveness study of the devices. An adequately powered randomized trial comparing clinical outcomes between these devices is unlikely to be feasible.

KW - Carotid artery stenosis

KW - carotid artery stenting

KW - embolic protection devices

KW - stroke

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