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Author Notes:

Corresponding author: Colin P Derdeyn MD, Mallinckrodt Institute of Radiology and the Departments of Neurology and Neurosurgery, Washington University School of Medicine, St Louis MO; derdeync@mir.wustl.edu

Colin Derdeyn MD serves on the Executive Committee of the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial which is funded by the National Institute of Neurological Disorders and Stroke (grant number: U01 NS058728). He is a Co-PI on the SAMMPRIS trial and receives salary support from the SAMMPRIS grant. Dr. Derdeyn also receives other grant support from the NINDS (P50 55977; R01 NS051631). He is also on the Scientific Advisory Board for W.L Gore and Associates and is the Chair of the Scientific Advisory Board for Pulse Therapeutics.

David Fiorella MD, PhD serves on the Executive Committee of the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial which is funded by the National Institute of Neurological Disorders and Stroke (grant number: U01 NS058728). He is a Co-PI on the SAMMPRIS trial and receives salary support from the SAMMPRIS grant. Dr. Fiorella has received institutional research support from Seimens Medical and Microvention, consulting fees from Micrus - Johnson and Johnson, EV3/Covidian, Vascular Simulators, NFocus, W.L. Gore and Associates, and Microvention, and royalties from Micrus - Johnson and Johnson.

Michael J. Lynn, MS serves on the Executive Committee of the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial which is funded by the National Institute of Neurological Disorders and Stroke (grant number: U01 NS058728). He is PI of the SAMMPRIS Statistical Coordinating Center and receives salary support from the SAMMPRIS grant. Mr. Lynn receives grant support from the National Eye Institute. He is the principal investigator of the Coordinating Center for Infant Aphakia Treatment Study (EY013287) and a co-investigator on the Core Grant for Vision Research (EY006360).

Stanley L. Barnwell, MD, PhD was an Interventionalist on the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial which is funded by the National Institute of Neurological Disorders and Stroke (grant number: U01 NS058728). Dr. Barnwell has also been a consultant for Stryker Corporation.

Osama O. Zaidat, MD, MS was an Interventionalist on the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial which is funded by the National Institute of Neurological Disorders and Stroke (grant number: U01 NS058728). He has also acted as a consultant for EV3, Codman Neurovascular, Stryker Corporation and Microvention.

Philip Meyers, MD, FAHA was an Interventionalist on the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial which is funded by the National Institute of Neurological Disorders and Stroke (grant number: U01 NS058728).

Y. Pierre Gobin, MD was an Interventionalist on the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial which is funded by the National Institute of Neurological Disorders and Stroke (grant number: U01 NS058728).

Jacques Dion, MD, FRCP was an Interventionalist on the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial which is funded by the National Institute of Neurological Disorders and Stroke (grant number: U01 NS058728).

Bethany F. Lane RN serves on the Executive Committee of the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial which is funded by the National Institute of Neurological Disorders and Stroke (grant number: U01 NS058728). Ms. Lane is the SAMMPRIS Project Manager and receives salary support from the grant. She has received consulting fees from Microvention Terumo.

Tanya N. Turan, MD serves on the Executive Committee of the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial which is funded by the National Institute of Neurological Disorders and Stroke (grant number: U01 NS058728). She is a Co-I on the SAMMPRIS trial. Dr. Turan is a past recipient of funding from the American Academy of Neurology (AAN) Foundation Clinical Research Training Fellowship and is the current recipient of a K23 grant from NIH/NINDS (1 K23 NS069668-01A1).

Scott Janis PhD is a program director at the National Institute of Neurological Disorders and Stroke.

Marc Chimowitz, MBChB is the grant recipient (U01 NS058728) for the NINDS funded clinical trial described in this paper. He has also received research grants from NINDS to fund the WASID trial (1 R01 NS36643) and to fund other research on intracranial stenosis (1 K24 NS050307 and 1 R01 NS051688). He currently serves on the stroke adjudication committee of an industry funded osteoporosis drug trial (Merck and Co., Inc.) and on the DSMB of another industry funded patent foramen ovale closure trial (W.L Gore and Associates) and is compensated for those activities.

Subjects:

Research Funding:

The SAMMPRIS trial was funded by a research grant (U01 NS058728) from the US Public Health Service National Institute of Neurological Disorders and Stroke (NINDS).

In addition, the following Clinical and Translational Science Awards, funded by the National Institutes of Health, provided local support for the evaluation of patients in the trial: Medical University of South Carolina (UL1RR029882), University of Florida (UL1RR029889), University of Cincinnati (UL1RR029890), and University of California, San Francisco (UL1RR024131).

Stryker Neurovascular (formerly Boston Scientific Neurovascular) provided study devices and supplemental funding for third party device distribution, site monitoring and study auditing.

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Neuroimaging
  • Surgery
  • Neurosciences & Neurology
  • Stroke
  • Stent
  • Angioplasty
  • INTRACRANIAL ARTERIAL-STENOSIS
  • AGGRESSIVE MEDICAL-MANAGEMENT
  • PREVENTING RECURRENT STROKE
  • ATHEROSCLEROTIC-DISEASE
  • WINGSPAN STENT
  • THERAPY
  • DESIGN
  • Intracranial stenosis
  • Angioplasty and stenting
  • Clinical trial

Impact of operator and site experience on outcomes after angioplasty and stenting in the SAMMPRIS trial

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Journal Title:

Journal of NeuroInterventional Surgery

Volume:

Volume 5, Number 6

Publisher:

, Pages 528-533

Type of Work:

Article | Post-print: After Peer Review

Abstract:

Background and purpose To investigate the relationship between physician and site experience and the risk of 30 day hemorrhagic and ischemic strokes in the stenting arm of the Stenting and Aggressive Medical Management for the Prevention of Recurrent Ischemic Stroke (SAMMPRIS) trial. Methods Study records and an investigator survey were examined for physician and site related factors, including: number of Wingspan and aneurysm stents submitted for credentialing, number of study procedures performed in SAMMPRIS, years in practice after training, primary specialty, and site enrollment. Bivariate and multivariate analyses were performed to determine if these factors were associated with the 30 day rate of cerebrovascular events after angioplasty and stenting. Results 213 patients underwent angioplasty alone (n=5) or angioplasty and stenting (n=208) with study devices by 63 interventionists at 48 sites. For credentialing, the median number of Wingspan and similar aneurysm stent cases submitted by study interventionists were 10 and 6, respectively. Interventionists with higher numbers ( > 10) of Wingspan cases submitted for credentialing tended to have higher rates of 30 day events (19.0% vs 9.9%) than those with < 10 cases. High enrolling sites in the trial tended to have lower rates of hemorrhagic stroke (9.8% at sites enrolling < 12 patients vs 2.7% at sites enrolling > 12 patients). Conclusions Interventionists credentialed with less Wingspan experience were not responsible for the high rate of periprocedural stroke in SAMMPRIS. Hemorrhagic stroke may be related to low enrollment in the trial but not previous Wingspan experience.

Copyright information:

Published by the BMJ Publishing Group Limited.

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