Admission blood pressure and clinical outcomes in patients with acute ischaemic stroke treated with intravenous alteplase and endovascular treatment versus endovascular treatment alone: A MR CLEAN-NO IV substudy

Sophie A. van den Berg; Simone M. Uniken Venema; Natalie E. LeCouffe; Alida A. Postma; Geert J. Lycklama à Nijeholt; Leon A. Rinkel; Kilian M. Treurniet; Manon Kappelhof; Agnetha E. Bruggeman; Katinka R. van Kranendonk; Charles B.L.M. Majoie; Diederik W.J. Dippel; H. Bart van der Worp; Jonathan M. Coutinho; Paul J. Nederkoorn; Yvo B.W.E.M. Roos

doi:10.1177/23969873231173274

Admission blood pressure and clinical outcomes in patients with acute ischaemic stroke treated with intravenous alteplase and endovascular treatment versus endovascular treatment alone: A MR CLEAN-NO IV substudy

Sophie A. van den Berg^*
, Simone M. Uniken Venema
, Natalie E. LeCouffe
, Alida A. Postma
, Geert J. Lycklama à Nijeholt
, Leon A. Rinkel
, Kilian M. Treurniet
, Manon Kappelhof
, Agnetha E. Bruggeman
, Katinka R. van Kranendonk
, Charles B.L.M. Majoie
, Diederik W.J. Dippel
, H. Bart van der Worp
, Jonathan M. Coutinho
, Paul J. Nederkoorn
, Yvo B.W.E.M. Roos

^*Corresponding author for this work

Neurology

Maastricht University
Haaglanden Medisch Centrum
University of Amsterdam
Utrecht University
Amsterdam UMC
University Medical Centre Utrecht

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

7 Citations (Scopus)

80 Downloads (Pure)

Abstract

Introduction: High systolic blood pressure (SBP) is associated with poor functional outcome. We analysed whether the association of SBP with outcomes after endovascular treatment (EVT) is modified by prior intravenous thrombolysis (IVT). Patients and methods: This was a post-hoc analysis of MR CLEAN-NO IV, a randomised trial of IVT with alteplase followed by EVT versus EVT alone, within 4.5 h from stroke onset. SBP was recorded on hospital admission. The primary outcome was 90-day modified Rankin Scale (mRS) score and secondary outcomes included symptomatic intracranial haemorrhage (sICH) and successful reperfusion (eTICI 2b-3), analysed with (ordinal) logistic regression. Estimates were calculated per 10 mmHg change in SBP. We assessed whether IVT modified the associations of SBP with these outcomes using multiplicative interaction terms. Results: Of 539 randomised patients, 266 received IVT. The association of SBP with mRS score was J-shaped, with an inflection point at 150 mmHg. Using 150 mmHg as a reference point, SBPs higher than 150 mmHg were associated with poor functional outcome (acOR: 1.23, 95% CI: 1.09–1.38), but lower SBPs were not (acOR: 1.14, 95% CI: 0.99–1.30). Higher SBP was not associated with the risk of sICH (aOR: 1.09, 95% CI: 0.93–1.27) nor with the probability of successful reperfusion (aOR: 1.00, 95% CI: 0.91–1.10). Our main result was that we found no effect modification by IVT (p-values for interaction, mRS = 0.94; sICH = 0.26; successful reperfusion = 0.58). Discussion and conclusion: There was no effect modification of IVT with SBP for any of the clinical outcomes. Therefore, the level of SBP (if ⩽185/110 mmHg) should not guide IVT decisions in patients otherwise eligible for both IVT and EVT within the 4.5-h time window. Trial registration: ISRCTN80619088, https://www.isrctn.com/ISRCTN80619088.

Original language	English
Pages (from-to)	647-654
Number of pages	8
Journal	European Stroke Journal
Volume	8
Issue number	3
Early online date	11 May 2023
DOIs	https://doi.org/10.1177/23969873231173274
Publication status	Published - Sept 2023

Bibliographical note

Funding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The trial was funded through the Collaboration for New TReatments of Acute Stroke (CONTRAST) Consortium. The CONTRAST consortium acknowledges the support from the Netherlands Cardiovascular Research Initiative, an initiative of the Dutch Heart Foundation (CVON2015-01: CONTRAST), and from the Brain Foundation Netherlands (HA2015.01.06). The collaboration project is additionally financed by the Ministry of Economic Affairs by means of the PPP Allowance made available by the Top Sector Life Sciences & Health to stimulate public-private partnerships (LSHM17016). This work was funded in part through unrestricted funding by Stryker, Medtronic and Cerenovus. The funding sources were not involved in study design, monitoring, data collection, statistical analyses, interpretation of results or manuscript writing.

Publisher Copyright:
© European Stroke Organisation 2023.

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van den Berg, S. A., Uniken Venema, S. M., LeCouffe, N. E., Postma, A. A., Lycklama à Nijeholt, G. J., Rinkel, L. A., Treurniet, K. M., Kappelhof, M., Bruggeman, A. E., van Kranendonk, K. R., Majoie, C. B. L. M., Dippel, D. W. J., van der Worp, H. B., Coutinho, J. M., Nederkoorn, P. J., & Roos, Y. B. W. E. M. (2023). Admission blood pressure and clinical outcomes in patients with acute ischaemic stroke treated with intravenous alteplase and endovascular treatment versus endovascular treatment alone: A MR CLEAN-NO IV substudy. European Stroke Journal, 8(3), 647-654. https://doi.org/10.1177/23969873231173274

@article{26402fa09a0b49859eabf6ec06ed907d,

title = "Admission blood pressure and clinical outcomes in patients with acute ischaemic stroke treated with intravenous alteplase and endovascular treatment versus endovascular treatment alone: A MR CLEAN-NO IV substudy",

abstract = "Introduction: High systolic blood pressure (SBP) is associated with poor functional outcome. We analysed whether the association of SBP with outcomes after endovascular treatment (EVT) is modified by prior intravenous thrombolysis (IVT). Patients and methods: This was a post-hoc analysis of MR CLEAN-NO IV, a randomised trial of IVT with alteplase followed by EVT versus EVT alone, within 4.5 h from stroke onset. SBP was recorded on hospital admission. The primary outcome was 90-day modified Rankin Scale (mRS) score and secondary outcomes included symptomatic intracranial haemorrhage (sICH) and successful reperfusion (eTICI 2b-3), analysed with (ordinal) logistic regression. Estimates were calculated per 10 mmHg change in SBP. We assessed whether IVT modified the associations of SBP with these outcomes using multiplicative interaction terms. Results: Of 539 randomised patients, 266 received IVT. The association of SBP with mRS score was J-shaped, with an inflection point at 150 mmHg. Using 150 mmHg as a reference point, SBPs higher than 150 mmHg were associated with poor functional outcome (acOR: 1.23, 95\% CI: 1.09{\textendash}1.38), but lower SBPs were not (acOR: 1.14, 95\% CI: 0.99{\textendash}1.30). Higher SBP was not associated with the risk of sICH (aOR: 1.09, 95\% CI: 0.93{\textendash}1.27) nor with the probability of successful reperfusion (aOR: 1.00, 95\% CI: 0.91{\textendash}1.10). Our main result was that we found no effect modification by IVT (p-values for interaction, mRS = 0.94; sICH = 0.26; successful reperfusion = 0.58). Discussion and conclusion: There was no effect modification of IVT with SBP for any of the clinical outcomes. Therefore, the level of SBP (if ⩽185/110 mmHg) should not guide IVT decisions in patients otherwise eligible for both IVT and EVT within the 4.5-h time window. Trial registration: ISRCTN80619088, https://www.isrctn.com/ISRCTN80619088.",

author = "\{van den Berg\}, \{Sophie A.\} and \{Uniken Venema\}, \{Simone M.\} and LeCouffe, \{Natalie E.\} and Postma, \{Alida A.\} and \{Lycklama {\`a} Nijeholt\}, \{Geert J.\} and Rinkel, \{Leon A.\} and Treurniet, \{Kilian M.\} and Manon Kappelhof and Bruggeman, \{Agnetha E.\} and \{van Kranendonk\}, \{Katinka R.\} and Majoie, \{Charles B.L.M.\} and Dippel, \{Diederik W.J.\} and \{van der Worp\}, \{H. Bart\} and Coutinho, \{Jonathan M.\} and Nederkoorn, \{Paul J.\} and Roos, \{Yvo B.W.E.M.\}",

note = "Funding Information: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The trial was funded through the Collaboration for New TReatments of Acute Stroke (CONTRAST) Consortium. The CONTRAST consortium acknowledges the support from the Netherlands Cardiovascular Research Initiative, an initiative of the Dutch Heart Foundation (CVON2015-01: CONTRAST), and from the Brain Foundation Netherlands (HA2015.01.06). The collaboration project is additionally financed by the Ministry of Economic Affairs by means of the PPP Allowance made available by the Top Sector Life Sciences \& Health to stimulate public-private partnerships (LSHM17016). This work was funded in part through unrestricted funding by Stryker, Medtronic and Cerenovus. The funding sources were not involved in study design, monitoring, data collection, statistical analyses, interpretation of results or manuscript writing. Publisher Copyright: {\textcopyright} European Stroke Organisation 2023.",

year = "2023",

month = sep,

doi = "10.1177/23969873231173274",

language = "English",

volume = "8",

pages = "647--654",

journal = "European Stroke Journal",

issn = "2396-9873",

publisher = "Oxford University Press",

number = "3",

}

van den Berg, SA, Uniken Venema, SM, LeCouffe, NE, Postma, AA, Lycklama à Nijeholt, GJ, Rinkel, LA, Treurniet, KM, Kappelhof, M, Bruggeman, AE, van Kranendonk, KR, Majoie, CBLM, Dippel, DWJ, van der Worp, HB, Coutinho, JM, Nederkoorn, PJ & Roos, YBWEM 2023, 'Admission blood pressure and clinical outcomes in patients with acute ischaemic stroke treated with intravenous alteplase and endovascular treatment versus endovascular treatment alone: A MR CLEAN-NO IV substudy', European Stroke Journal, vol. 8, no. 3, pp. 647-654. https://doi.org/10.1177/23969873231173274

Admission blood pressure and clinical outcomes in patients with acute ischaemic stroke treated with intravenous alteplase and endovascular treatment versus endovascular treatment alone: A MR CLEAN-NO IV substudy. / van den Berg, Sophie A.; Uniken Venema, Simone M.; LeCouffe, Natalie E. et al.
In: European Stroke Journal, Vol. 8, No. 3, 09.2023, p. 647-654.

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

TY - JOUR

T1 - Admission blood pressure and clinical outcomes in patients with acute ischaemic stroke treated with intravenous alteplase and endovascular treatment versus endovascular treatment alone

T2 - A MR CLEAN-NO IV substudy

AU - van den Berg, Sophie A.

AU - Uniken Venema, Simone M.

AU - LeCouffe, Natalie E.

AU - Postma, Alida A.

AU - Lycklama à Nijeholt, Geert J.

AU - Rinkel, Leon A.

AU - Treurniet, Kilian M.

AU - Kappelhof, Manon

AU - Bruggeman, Agnetha E.

AU - van Kranendonk, Katinka R.

AU - Majoie, Charles B.L.M.

AU - Dippel, Diederik W.J.

AU - van der Worp, H. Bart

AU - Coutinho, Jonathan M.

AU - Nederkoorn, Paul J.

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

N1 - Funding Information: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The trial was funded through the Collaboration for New TReatments of Acute Stroke (CONTRAST) Consortium. The CONTRAST consortium acknowledges the support from the Netherlands Cardiovascular Research Initiative, an initiative of the Dutch Heart Foundation (CVON2015-01: CONTRAST), and from the Brain Foundation Netherlands (HA2015.01.06). The collaboration project is additionally financed by the Ministry of Economic Affairs by means of the PPP Allowance made available by the Top Sector Life Sciences & Health to stimulate public-private partnerships (LSHM17016). This work was funded in part through unrestricted funding by Stryker, Medtronic and Cerenovus. The funding sources were not involved in study design, monitoring, data collection, statistical analyses, interpretation of results or manuscript writing. Publisher Copyright: © European Stroke Organisation 2023.

PY - 2023/9

Y1 - 2023/9

N2 - Introduction: High systolic blood pressure (SBP) is associated with poor functional outcome. We analysed whether the association of SBP with outcomes after endovascular treatment (EVT) is modified by prior intravenous thrombolysis (IVT). Patients and methods: This was a post-hoc analysis of MR CLEAN-NO IV, a randomised trial of IVT with alteplase followed by EVT versus EVT alone, within 4.5 h from stroke onset. SBP was recorded on hospital admission. The primary outcome was 90-day modified Rankin Scale (mRS) score and secondary outcomes included symptomatic intracranial haemorrhage (sICH) and successful reperfusion (eTICI 2b-3), analysed with (ordinal) logistic regression. Estimates were calculated per 10 mmHg change in SBP. We assessed whether IVT modified the associations of SBP with these outcomes using multiplicative interaction terms. Results: Of 539 randomised patients, 266 received IVT. The association of SBP with mRS score was J-shaped, with an inflection point at 150 mmHg. Using 150 mmHg as a reference point, SBPs higher than 150 mmHg were associated with poor functional outcome (acOR: 1.23, 95% CI: 1.09–1.38), but lower SBPs were not (acOR: 1.14, 95% CI: 0.99–1.30). Higher SBP was not associated with the risk of sICH (aOR: 1.09, 95% CI: 0.93–1.27) nor with the probability of successful reperfusion (aOR: 1.00, 95% CI: 0.91–1.10). Our main result was that we found no effect modification by IVT (p-values for interaction, mRS = 0.94; sICH = 0.26; successful reperfusion = 0.58). Discussion and conclusion: There was no effect modification of IVT with SBP for any of the clinical outcomes. Therefore, the level of SBP (if ⩽185/110 mmHg) should not guide IVT decisions in patients otherwise eligible for both IVT and EVT within the 4.5-h time window. Trial registration: ISRCTN80619088, https://www.isrctn.com/ISRCTN80619088.

AB - Introduction: High systolic blood pressure (SBP) is associated with poor functional outcome. We analysed whether the association of SBP with outcomes after endovascular treatment (EVT) is modified by prior intravenous thrombolysis (IVT). Patients and methods: This was a post-hoc analysis of MR CLEAN-NO IV, a randomised trial of IVT with alteplase followed by EVT versus EVT alone, within 4.5 h from stroke onset. SBP was recorded on hospital admission. The primary outcome was 90-day modified Rankin Scale (mRS) score and secondary outcomes included symptomatic intracranial haemorrhage (sICH) and successful reperfusion (eTICI 2b-3), analysed with (ordinal) logistic regression. Estimates were calculated per 10 mmHg change in SBP. We assessed whether IVT modified the associations of SBP with these outcomes using multiplicative interaction terms. Results: Of 539 randomised patients, 266 received IVT. The association of SBP with mRS score was J-shaped, with an inflection point at 150 mmHg. Using 150 mmHg as a reference point, SBPs higher than 150 mmHg were associated with poor functional outcome (acOR: 1.23, 95% CI: 1.09–1.38), but lower SBPs were not (acOR: 1.14, 95% CI: 0.99–1.30). Higher SBP was not associated with the risk of sICH (aOR: 1.09, 95% CI: 0.93–1.27) nor with the probability of successful reperfusion (aOR: 1.00, 95% CI: 0.91–1.10). Our main result was that we found no effect modification by IVT (p-values for interaction, mRS = 0.94; sICH = 0.26; successful reperfusion = 0.58). Discussion and conclusion: There was no effect modification of IVT with SBP for any of the clinical outcomes. Therefore, the level of SBP (if ⩽185/110 mmHg) should not guide IVT decisions in patients otherwise eligible for both IVT and EVT within the 4.5-h time window. Trial registration: ISRCTN80619088, https://www.isrctn.com/ISRCTN80619088.

UR - https://www.scopus.com/pages/publications/85159098134

U2 - 10.1177/23969873231173274

DO - 10.1177/23969873231173274

M3 - Article

C2 - 37641554

AN - SCOPUS:85159098134

SN - 2396-9873

VL - 8

SP - 647

EP - 654

JO - European Stroke Journal

JF - European Stroke Journal

IS - 3

ER -

van den Berg SA, Uniken Venema SM, LeCouffe NE, Postma AA, Lycklama à Nijeholt GJ, Rinkel LA et al. Admission blood pressure and clinical outcomes in patients with acute ischaemic stroke treated with intravenous alteplase and endovascular treatment versus endovascular treatment alone: A MR CLEAN-NO IV substudy. European Stroke Journal. 2023 Sept;8(3):647-654. Epub 2023 May 11. doi: 10.1177/23969873231173274

Admission blood pressure and clinical outcomes in patients with acute ischaemic stroke treated with intravenous alteplase and endovascular treatment versus endovascular treatment alone: A MR CLEAN-NO IV substudy

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