Prediction of Outcome and Endovascular Treatment Benefit Validation and Update of the MR PREDICTS Decision Tool

Esmee Venema; Bob Roozenbeek; Maxim J. H. L. Mulder; Scott Brown; Charles B. L. M. Majoie; Ewout W. Steyerberg; Andrew M. Demchuk; Keith W. Muir; Antoni Davalos; Peter J. Mitchell; Serge Bracard; Olvert A. Berkhemer; Geert J. Lycklama A. Nijeholt; Robert J. van Oostenbrugge; Yvo B. W. E. M. Roos; Wim H. van Zwam; Aad van Der Lugt; Michael D. Hill; Philip White; Bruce C. Campbell; Francis Guillemin; Jeffrey L. Saver; Tudor G. Jovin; Mayank Goyal; Diederik W. J. Dippel; Hester F. Lingsma; HERMES Collaboration; MR CLEAN Registry Investigators

doi:10.1161/STROKEAHA.120.032935

Prediction of Outcome and Endovascular Treatment Benefit Validation and Update of the MR PREDICTS Decision Tool

Esmee Venema^*, Bob Roozenbeek, Maxim J. H. L. Mulder, Scott Brown, Charles B. L. M. Majoie, Ewout W. Steyerberg, Andrew M. Demchuk, Keith W. Muir, Antoni Davalos, Peter J. Mitchell, Serge Bracard, Olvert A. Berkhemer, Geert J. Lycklama A. Nijeholt, Robert J. van Oostenbrugge, Yvo B. W. E. M. Roos, Wim H. van Zwam, Aad van Der Lugt, Michael D. Hill, Philip White, Bruce C. CampbellFrancis Guillemin, Jeffrey L. Saver, Tudor G. Jovin, Mayank Goyal, Diederik W. J. Dippel, Hester F. Lingsma, HERMES Collaboration, MR CLEAN Registry Investigators

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

BACKGROUND AND PURPOSE: Benefit of early endovascular treatment (EVT) for ischemic stroke varies considerably among patients. The MR PREDICTS decision tool, derived from MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands), predicts outcome and treatment benefit based on baseline characteristics. Our aim was to externally validate and update MR PREDICTS with data from international trials and daily clinical practice.

METHODS: We used individual patient data from 6 randomized controlled trials within the HERMES (Highly Effective Reperfusion Evaluated in Multiple Endovascular Stroke Trials) collaboration to validate the original model. Then, we updated the model and performed a second validation with data from the observational MR CLEAN Registry. Primary outcome was functional independence (defined as modified Rankin Scale score 0-2) 3 months after stroke. Treatment benefit was defined as the difference between the probability of functional independence with and without EVT. Discriminative performance was evaluated using a concordance (C) statistic.

RESULTS: We included 1242 patients from HERMES (633 assigned to EVT, 609 assigned to control) and 3156 patients from the MR CLEAN Registry (all of whom underwent EVT within 6.5 hours). The C-statistic for functional independence was 0.74 (95% CI, 0.72-0.77) in HERMES and, after model updating, 0.80 (0.78-0.82) in the Registry. Median predicted treatment benefit of routinely treated patients (Registry) was 10.3% (interquartile range, 5.8%-14.4%). Patients with low (

CONCLUSIONS: Because of the substantial treatment effect and small potential harm of EVT, most patients arriving within 6 hours at an endovascular-capable center should be treated regardless of their clinical characteristics. MR PREDICTS can be used to support clinical judgement when there is uncertainty about the treatment indication, when resources are limited, or before a patient is to be transferred to an endovascular-capable center.

Original language	English
Pages (from-to)	2764-2772
Number of pages	9
Journal	Stroke
Volume	52
Issue number	9
DOIs	https://doi.org/10.1161/STROKEAHA.120.032935
Publication status	Published - Sept 2021

Keywords

ischemic stroke
registry
reperfusion
thrombectomy
uncertainty
ACUTE ISCHEMIC-STROKE
MECHANICAL THROMBECTOMY
THERAPY
SELECTION
ANGIOGRAPHY
GUIDELINES

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Venema, E., Roozenbeek, B., Mulder, M. J. H. L., Brown, S., Majoie, C. B. L. M., Steyerberg, E. W., Demchuk, A. M., Muir, K. W., Davalos, A., Mitchell, P. J., Bracard, S., Berkhemer, O. A., Nijeholt, G. J. L. A., van Oostenbrugge, R. J., Roos, Y. B. W. E. M., van Zwam, W. H., van Der Lugt, A., Hill, M. D., White, P., ... MR CLEAN Registry Investigators (2021). Prediction of Outcome and Endovascular Treatment Benefit Validation and Update of the MR PREDICTS Decision Tool. Stroke, 52(9), 2764-2772. https://doi.org/10.1161/STROKEAHA.120.032935

@article{725f7b266c4848de93c689a36f22c87d,

title = "Prediction of Outcome and Endovascular Treatment Benefit Validation and Update of the MR PREDICTS Decision Tool",

abstract = "BACKGROUND AND PURPOSE: Benefit of early endovascular treatment (EVT) for ischemic stroke varies considerably among patients. The MR PREDICTS decision tool, derived from MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands), predicts outcome and treatment benefit based on baseline characteristics. Our aim was to externally validate and update MR PREDICTS with data from international trials and daily clinical practice.METHODS: We used individual patient data from 6 randomized controlled trials within the HERMES (Highly Effective Reperfusion Evaluated in Multiple Endovascular Stroke Trials) collaboration to validate the original model. Then, we updated the model and performed a second validation with data from the observational MR CLEAN Registry. Primary outcome was functional independence (defined as modified Rankin Scale score 0-2) 3 months after stroke. Treatment benefit was defined as the difference between the probability of functional independence with and without EVT. Discriminative performance was evaluated using a concordance (C) statistic.RESULTS: We included 1242 patients from HERMES (633 assigned to EVT, 609 assigned to control) and 3156 patients from the MR CLEAN Registry (all of whom underwent EVT within 6.5 hours). The C-statistic for functional independence was 0.74 (95% CI, 0.72-0.77) in HERMES and, after model updating, 0.80 (0.78-0.82) in the Registry. Median predicted treatment benefit of routinely treated patients (Registry) was 10.3% (interquartile range, 5.8%-14.4%). Patients with low (CONCLUSIONS: Because of the substantial treatment effect and small potential harm of EVT, most patients arriving within 6 hours at an endovascular-capable center should be treated regardless of their clinical characteristics. MR PREDICTS can be used to support clinical judgement when there is uncertainty about the treatment indication, when resources are limited, or before a patient is to be transferred to an endovascular-capable center.",

keywords = "ischemic stroke, registry, reperfusion, thrombectomy, uncertainty, ACUTE ISCHEMIC-STROKE, MECHANICAL THROMBECTOMY, THERAPY, SELECTION, ANGIOGRAPHY, GUIDELINES",

author = "Esmee Venema and Bob Roozenbeek and Mulder, {Maxim J. H. L.} and Scott Brown and Majoie, {Charles B. L. M.} and Steyerberg, {Ewout W.} and Demchuk, {Andrew M.} and Muir, {Keith W.} and Antoni Davalos and Mitchell, {Peter J.} and Serge Bracard and Berkhemer, {Olvert A.} and Nijeholt, {Geert J. Lycklama A.} and {van Oostenbrugge}, {Robert J.} and Roos, {Yvo B. W. E. M.} and {van Zwam}, {Wim H.} and {van Der Lugt}, Aad and Hill, {Michael D.} and Philip White and Campbell, {Bruce C.} and Francis Guillemin and Saver, {Jeffrey L.} and Jovin, {Tudor G.} and Mayank Goyal and Dippel, {Diederik W. J.} and Lingsma, {Hester F.} and {HERMES Collaboration} and {MR CLEAN Registry Investigators}",

note = "Funding Information: Dr Brown reports personal fees from University of Calgary during the conduct of the HERMES (Highly Effective Reperfusion Evaluated in Multiple Endovas-cular Stroke Trials) Collaboration, and personal fees from Medtronic outside the submitted work. Dr Majoie reports grants from CVON/Dutch Heart Foundation, European Commission, TWIN Foundation, and Stryker (all paid to his institution), outside the submitted work. He is a shareholder of Nico-lab, a company that focuses on the use of artificial intelligence for medical image analysis (modest). Dr Demchuk reports honoraria from Medtronic during the conduct of the HERMES Collaboration. Dr Muir reports reports personal fees and nonfinancial support from Boehringer Ingelheim, personal fees from Bayer, and personal fees from Daiichi-Sankyo, outside the submitted work. Dr D{\'a}valos reports consultancy and advisory board fees from Medtronic Neurovascular (Steering Committee STAR); and an unrestricted grant for the REVASCAT trial (Randomized Trial of Revascularization With Solitaire FR Device Versus Best Medical Therapy in the Treatment of Acute Stroke Due to Anterior Circulation Large Vessel Occlusion Presenting Within Eight Hours of Symptom Onset) from Medtronic (paid to his institution). Dr Mitchell reports speaking engagements from Stryker and Microvention and honoraria from Stryker, outside the submitted work. Dr Berkhemer has consulted for Stryker Neurovascular, and all funding was paid to his institution. Dr van Zwam reports personal fees from Stryker and Cerenovus, all paid to his institution, outside the submitted work. Dr Hill reports a research grant from Medtronic LCC paid to the University of Calgary for the HERMES Collaboration. Dr White reports grants from Microvention Terumo, Stryker, Medtronic, and Penumbra; and personal fees from Microvention Terumo, outside the submitted work. Dr Saver has acted as a scientific consultant regarding trial design and conduct for Medtronic, Stryker, Cerenovus, and Rapid Medical; reports that the University of California has patent rights in the retrieval devices for stroke. Dr Jovin has consulted for Cerenovus as DSMB/Steering Committee and Stryker Neurovascular as a principal investigator of the DAWN trial; received honoraria from Biogen as a consultant; holds stock or other ownership at Silk Road, Anaconda, Route 92, Corindus, Blockade Medical, and FreeOx Biotech. Dr Goyal reports an unrestricted research grant from Medtronic to the University of Calgary toward the HERMES collaboration; and personal fees from Medtronic, Stryker, Microvention, and Mentice, outside the submitted work. Dr van der Lugt and Dr Dippel report research grants from the Dutch Heart Foundation, the Dutch Brain Foundation, Top Sector Life Sciences & Health, the Netherlands Organisation for Health Research and Development, Stryker European Operations BV, Medtronic, Thrombolytic Science, LLC, and Cerenovus (all paid to institution), outside the submitted work. Funding Information: This validation study was funded by the Erasmus MC Cost-Effectiveness Research program. The HERMES (Highly Effective Reperfusion Evaluated in Multiple Endovascular Stroke Trials) collaboration was supported by an unrestricted grant from Medtronic to the University of Calgary. The MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands) Registry was partly funded by TWIN Foundation, Erasmus MC University Medical Center, Maastricht University Medical Center, and Amsterdam UMC, location AMC. Publisher Copyright: {\textcopyright} 2021 Lippincott Williams and Wilkins. All rights reserved.",

year = "2021",

month = sep,

doi = "10.1161/STROKEAHA.120.032935",

language = "English",

volume = "52",

pages = "2764--2772",

journal = "Stroke",

issn = "0039-2499",

publisher = "LIPPINCOTT WILLIAMS & WILKINS",

number = "9",

}

Venema, E, Roozenbeek, B, Mulder, MJHL, Brown, S, Majoie, CBLM, Steyerberg, EW, Demchuk, AM, Muir, KW, Davalos, A, Mitchell, PJ, Bracard, S, Berkhemer, OA, Nijeholt, GJLA, van Oostenbrugge, RJ, Roos, YBWEM, van Zwam, WH, van Der Lugt, A, Hill, MD, White, P, Campbell, BC, Guillemin, F, Saver, JL, Jovin, TG, Goyal, M, Dippel, DWJ, Lingsma, HF, HERMES Collaboration & MR CLEAN Registry Investigators 2021, 'Prediction of Outcome and Endovascular Treatment Benefit Validation and Update of the MR PREDICTS Decision Tool', Stroke, vol. 52, no. 9, pp. 2764-2772. https://doi.org/10.1161/STROKEAHA.120.032935

TY - JOUR

T1 - Prediction of Outcome and Endovascular Treatment Benefit Validation and Update of the MR PREDICTS Decision Tool

AU - Venema, Esmee

AU - Roozenbeek, Bob

AU - Mulder, Maxim J. H. L.

AU - Brown, Scott

AU - Majoie, Charles B. L. M.

AU - Steyerberg, Ewout W.

AU - Demchuk, Andrew M.

AU - Muir, Keith W.

AU - Davalos, Antoni

AU - Mitchell, Peter J.

AU - Bracard, Serge

AU - Berkhemer, Olvert A.

AU - Nijeholt, Geert J. Lycklama A.

AU - van Oostenbrugge, Robert J.

AU - Roos, Yvo B. W. E. M.

AU - van Zwam, Wim H.

AU - van Der Lugt, Aad

AU - Hill, Michael D.

AU - White, Philip

AU - Campbell, Bruce C.

AU - Guillemin, Francis

AU - Saver, Jeffrey L.

AU - Jovin, Tudor G.

AU - Goyal, Mayank

AU - Dippel, Diederik W. J.

AU - Lingsma, Hester F.

AU - HERMES Collaboration

AU - MR CLEAN Registry Investigators

N1 - Funding Information: Dr Brown reports personal fees from University of Calgary during the conduct of the HERMES (Highly Effective Reperfusion Evaluated in Multiple Endovas-cular Stroke Trials) Collaboration, and personal fees from Medtronic outside the submitted work. Dr Majoie reports grants from CVON/Dutch Heart Foundation, European Commission, TWIN Foundation, and Stryker (all paid to his institution), outside the submitted work. He is a shareholder of Nico-lab, a company that focuses on the use of artificial intelligence for medical image analysis (modest). Dr Demchuk reports honoraria from Medtronic during the conduct of the HERMES Collaboration. Dr Muir reports reports personal fees and nonfinancial support from Boehringer Ingelheim, personal fees from Bayer, and personal fees from Daiichi-Sankyo, outside the submitted work. Dr Dávalos reports consultancy and advisory board fees from Medtronic Neurovascular (Steering Committee STAR); and an unrestricted grant for the REVASCAT trial (Randomized Trial of Revascularization With Solitaire FR Device Versus Best Medical Therapy in the Treatment of Acute Stroke Due to Anterior Circulation Large Vessel Occlusion Presenting Within Eight Hours of Symptom Onset) from Medtronic (paid to his institution). Dr Mitchell reports speaking engagements from Stryker and Microvention and honoraria from Stryker, outside the submitted work. Dr Berkhemer has consulted for Stryker Neurovascular, and all funding was paid to his institution. Dr van Zwam reports personal fees from Stryker and Cerenovus, all paid to his institution, outside the submitted work. Dr Hill reports a research grant from Medtronic LCC paid to the University of Calgary for the HERMES Collaboration. Dr White reports grants from Microvention Terumo, Stryker, Medtronic, and Penumbra; and personal fees from Microvention Terumo, outside the submitted work. Dr Saver has acted as a scientific consultant regarding trial design and conduct for Medtronic, Stryker, Cerenovus, and Rapid Medical; reports that the University of California has patent rights in the retrieval devices for stroke. Dr Jovin has consulted for Cerenovus as DSMB/Steering Committee and Stryker Neurovascular as a principal investigator of the DAWN trial; received honoraria from Biogen as a consultant; holds stock or other ownership at Silk Road, Anaconda, Route 92, Corindus, Blockade Medical, and FreeOx Biotech. Dr Goyal reports an unrestricted research grant from Medtronic to the University of Calgary toward the HERMES collaboration; and personal fees from Medtronic, Stryker, Microvention, and Mentice, outside the submitted work. Dr van der Lugt and Dr Dippel report research grants from the Dutch Heart Foundation, the Dutch Brain Foundation, Top Sector Life Sciences & Health, the Netherlands Organisation for Health Research and Development, Stryker European Operations BV, Medtronic, Thrombolytic Science, LLC, and Cerenovus (all paid to institution), outside the submitted work. Funding Information: This validation study was funded by the Erasmus MC Cost-Effectiveness Research program. The HERMES (Highly Effective Reperfusion Evaluated in Multiple Endovascular Stroke Trials) collaboration was supported by an unrestricted grant from Medtronic to the University of Calgary. The MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands) Registry was partly funded by TWIN Foundation, Erasmus MC University Medical Center, Maastricht University Medical Center, and Amsterdam UMC, location AMC. Publisher Copyright: © 2021 Lippincott Williams and Wilkins. All rights reserved.

PY - 2021/9

Y1 - 2021/9

N2 - BACKGROUND AND PURPOSE: Benefit of early endovascular treatment (EVT) for ischemic stroke varies considerably among patients. The MR PREDICTS decision tool, derived from MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands), predicts outcome and treatment benefit based on baseline characteristics. Our aim was to externally validate and update MR PREDICTS with data from international trials and daily clinical practice.METHODS: We used individual patient data from 6 randomized controlled trials within the HERMES (Highly Effective Reperfusion Evaluated in Multiple Endovascular Stroke Trials) collaboration to validate the original model. Then, we updated the model and performed a second validation with data from the observational MR CLEAN Registry. Primary outcome was functional independence (defined as modified Rankin Scale score 0-2) 3 months after stroke. Treatment benefit was defined as the difference between the probability of functional independence with and without EVT. Discriminative performance was evaluated using a concordance (C) statistic.RESULTS: We included 1242 patients from HERMES (633 assigned to EVT, 609 assigned to control) and 3156 patients from the MR CLEAN Registry (all of whom underwent EVT within 6.5 hours). The C-statistic for functional independence was 0.74 (95% CI, 0.72-0.77) in HERMES and, after model updating, 0.80 (0.78-0.82) in the Registry. Median predicted treatment benefit of routinely treated patients (Registry) was 10.3% (interquartile range, 5.8%-14.4%). Patients with low (CONCLUSIONS: Because of the substantial treatment effect and small potential harm of EVT, most patients arriving within 6 hours at an endovascular-capable center should be treated regardless of their clinical characteristics. MR PREDICTS can be used to support clinical judgement when there is uncertainty about the treatment indication, when resources are limited, or before a patient is to be transferred to an endovascular-capable center.

AB - BACKGROUND AND PURPOSE: Benefit of early endovascular treatment (EVT) for ischemic stroke varies considerably among patients. The MR PREDICTS decision tool, derived from MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands), predicts outcome and treatment benefit based on baseline characteristics. Our aim was to externally validate and update MR PREDICTS with data from international trials and daily clinical practice.METHODS: We used individual patient data from 6 randomized controlled trials within the HERMES (Highly Effective Reperfusion Evaluated in Multiple Endovascular Stroke Trials) collaboration to validate the original model. Then, we updated the model and performed a second validation with data from the observational MR CLEAN Registry. Primary outcome was functional independence (defined as modified Rankin Scale score 0-2) 3 months after stroke. Treatment benefit was defined as the difference between the probability of functional independence with and without EVT. Discriminative performance was evaluated using a concordance (C) statistic.RESULTS: We included 1242 patients from HERMES (633 assigned to EVT, 609 assigned to control) and 3156 patients from the MR CLEAN Registry (all of whom underwent EVT within 6.5 hours). The C-statistic for functional independence was 0.74 (95% CI, 0.72-0.77) in HERMES and, after model updating, 0.80 (0.78-0.82) in the Registry. Median predicted treatment benefit of routinely treated patients (Registry) was 10.3% (interquartile range, 5.8%-14.4%). Patients with low (CONCLUSIONS: Because of the substantial treatment effect and small potential harm of EVT, most patients arriving within 6 hours at an endovascular-capable center should be treated regardless of their clinical characteristics. MR PREDICTS can be used to support clinical judgement when there is uncertainty about the treatment indication, when resources are limited, or before a patient is to be transferred to an endovascular-capable center.

KW - ischemic stroke

KW - registry

KW - reperfusion

KW - thrombectomy

KW - uncertainty

KW - ACUTE ISCHEMIC-STROKE

KW - MECHANICAL THROMBECTOMY

KW - THERAPY

KW - SELECTION

KW - ANGIOGRAPHY

KW - GUIDELINES

U2 - 10.1161/STROKEAHA.120.032935

DO - 10.1161/STROKEAHA.120.032935

M3 - Article

C2 - 34266308

SN - 0039-2499

VL - 52

SP - 2764

EP - 2772

JO - Stroke

JF - Stroke

IS - 9

ER -

Prediction of Outcome and Endovascular Treatment Benefit Validation and Update of the MR PREDICTS Decision Tool

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Keywords

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