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Changing the Rules of the Game: The Problem of Surrogate Angiographic Outcomes in the Evaluation of Aneurysm Treatments

Changing the Rules of the Game: The Problem of Surrogate Angiographic Outcomes in the Evaluation... EDITORIAL to that concern is that the clinical results are what count; they were Changing the Rules of the Game: The better with coiling in ISAT. In themeantime, becausecomplete Problem of Surrogate Angiographic occlusions were infrequent with coiling, we learned to accept a re- sidual neck as “acceptable” because rebleeding was rare compared Outcomes in the Evaluation of with patients with residual aneurysms. Aneurysm Treatments Now flow diverters are introduced; how can the case be made that they should be used instead of coiling? A randomized trial T.E. Darsaut, R. Chapot, and J. Raymond with a clinical outcome measure, say, to ensure the complication rate of flow diversion was not double that of coiling (ie, 5% to urrogate outcomes (indicators or signs used in place of the 10%), would require at least 865 patients. So, we use a surrogate Strue clinical outcome measure) are often used in the evalua- 1 angiographic outcome. But because we now consider residual tion of neurovascular treatments, but there are many pitfalls. necks as “satisfactory” and we can obtain this result in 80%–90% The various ways surrogate angiographic outcomes are handled of cases, even this strategy won’t work: a trial of 1000–1500 in our http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png American Journal of Neuroradiology American Journal of Neuroradiology

Changing the Rules of the Game: The Problem of Surrogate Angiographic Outcomes in the Evaluation of Aneurysm Treatments

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Publisher
American Journal of Neuroradiology
Copyright
© 2020 by American Journal of Neuroradiology
ISSN
0195-6108
eISSN
1936-959X
DOI
10.3174/ajnr.A6825
Publisher site
See Article on Publisher Site

Abstract

EDITORIAL to that concern is that the clinical results are what count; they were Changing the Rules of the Game: The better with coiling in ISAT. In themeantime, becausecomplete Problem of Surrogate Angiographic occlusions were infrequent with coiling, we learned to accept a re- sidual neck as “acceptable” because rebleeding was rare compared Outcomes in the Evaluation of with patients with residual aneurysms. Aneurysm Treatments Now flow diverters are introduced; how can the case be made that they should be used instead of coiling? A randomized trial T.E. Darsaut, R. Chapot, and J. Raymond with a clinical outcome measure, say, to ensure the complication rate of flow diversion was not double that of coiling (ie, 5% to urrogate outcomes (indicators or signs used in place of the 10%), would require at least 865 patients. So, we use a surrogate Strue clinical outcome measure) are often used in the evalua- 1 angiographic outcome. But because we now consider residual tion of neurovascular treatments, but there are many pitfalls. necks as “satisfactory” and we can obtain this result in 80%–90% The various ways surrogate angiographic outcomes are handled of cases, even this strategy won’t work: a trial of 1000–1500 in our

Journal

American Journal of Neuroradiology – American Journal of Neuroradiology

Published: Dec 1, 2020

References

  • Surrogate End Points in Clinical Trials: Are We Being Misled?
    TR. Fleming, DL. DeMets
  • Bioactive versus bare platinum coils in the treatment of intracranial aneurysms: the MAPS (Matrix and Platinum Science) trial
    CG. McDougall, SC. Johnston, A. Gholkar
  • Flow Diversion in Aneurysms Trial: The Design of the FIAT Study
    J. Raymond, TE. Darsaut, F. Guilbert
  • A Randomized Trial Comparing Platinum and Hydrogel-Coated Coils in Patients Prone to Recurrence after Endovascular Treatment (The PRET Trial)
    J. Raymond, D. Roy, PM. White
  • Hydrogel-coated coils versus bare platinum coils for the endovascular treatment of intracranial aneurysms (HELPS): a randomised controlled trial.
    PM. White, SC. Lewis, A. Gholkar
  • The cardiac arrhythmia suppression trial (CAST)
  • Clinical Epidemiology: How to Do Clinical Practice Research
  • International Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised trial.
  • Endovascular Treatment of Unruptured Aneurysms
    D. Roy, G. Milot, J. Raymond
  • Long-term angiographic recurrences after selective endovascular treatment of aneurysms with detachable coils
    J. Raymond, F. Guilbert, A. Weill
  • Pipeline for uncoilable or failed aneurysms: results from a multicenter clinical trial
    T. Becske, DF. Kallmes, I. Saatci
  • WEB-DL endovascular treatment of wide-neck bifurcation aneurysms: short- and midterm results in a European study
    B. Lubicz, J. Klisch, JY. Gauvrit
  • Aneurysm treatment with WEB in the cumulative population of two prospective, multicenter series: 3-year follow-up
    L. Pierot, I. Szikora, X. Barreau
  • A new aneurysm occlusion classification after the impact of flow modification
    HS. Cekirge, I. Saatci
  • Residual cerebral aneurysms after microsurgical clipping: a new scale, an agreement study, and a systematic review of the literature
    M. Kotowski, B. Farzin, R. Fahed
  • A Novel Grading Scale for the Angiographic Assessment of Intracranial Aneurysms Treated Using Flow Diverting Stents
    CJ. O'Kelly, T. Krings, D. Fiorella