Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2023 Sep;8(3):647-654.
doi: 10.1177/23969873231173274. Epub 2023 May 11.

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  1 , Simone M Uniken Venema  2 , Natalie E LeCouffe  1 , Alida A Postma  3   4 , Geert J Lycklama À Nijeholt  5 , Leon A Rinkel  1 , Kilian M Treurniet  5   6 , Manon Kappelhof  6 , Agnetha E Bruggeman  6 , Katinka R van Kranendonk  6 , Charles Blm Majoie  6 , Diederik Wj Dippel  7 , H Bart van der Worp  2 , Jonathan M Coutinho  1 , Paul J Nederkoorn  1 , Yvo Bwem Roos  1
Affiliations
Randomized Controlled Trial

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 et al. Eur Stroke J. 2023 Sep.

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.

Keywords: Blood pressure; acute ischaemic stroke; alteplase; endovascular treatment; hypertension; intravenous thrombolysis; randomised controlled trial; thrombectomy.

PubMed Disclaimer

Conflict of interest statement

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: AP reports an institutional grant by Siemens Healthineers. CM reports funding from CVON/Dutch Heart Foundation and Stryker (related to this project) and funding from European Commission, Healthcare Evaluation Netherlands TWIN Foundation (unrelated to this project), all paid to institution, and is shareholder of Nicolab. DD reports funding from the Dutch Heart Foundation, Brain Foundation Netherlands, The Netherlands Organisation for Health Research and Development, Health Holland Top Sector Life Sciences & Health, and unrestricted grants from Penumbra Inc., Stryker, Medtronic, Thrombolytic Science, LLC and Cerenovus for research, all paid to institution. HW reports funding from Stryker, paid to the CONTRAST consortium, and consultation fees from Bayer and LivaNova, paid to his institution. JC reports funding from Boehringer Ingelheim, Bayer and Portola, all to fund medical research and paid to his institution. PN reports funding from Stryker, paid to the CONTRAST consortium. YR is minor shareholder of Nicolab. All other authors report no conflicting interests.

Figures

Figure 1.
Figure 1.
Flowchart of patient inclusion. INR: international normalised ratio; IVT: intravenous thrombolysis; EVT: endovascular treatment.
Figure 2.
Figure 2.
Admission systolic blood pressure and shift towards poorer functional outcome after EVT, with and without prior IVT. EVT: endovascular treatment; IVT: intravenous thrombolysis; mRS: modified Rankin Scale. The graph depicts the log odds for a shift towards poorer modified Rankin Scale (mRS) score with corresponding 95% CI, for admission systolic blood pressure (SBP) level, with practically parallel lines for prior intravenous thrombolysis (IVT) and no prior IVT (p-value for interaction: 0.94). Admission SBP ranged from 84 to 260 mmHg. In patients with BP exceeding 185/110 mmHg, SBP lowered to below this threshold before enrolment.
Figure 3.
Figure 3.
Functional outcome at 90 days after EVT according to received IVT and SBP groups. EVT: endovascular treatment; IVT: intravenous thrombolysis; mRS: modified Rankin Scale; SBP: systolic blood pressure.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Sandset EC, Anderson CS, Bath PM, et al.. European Stroke Organisation (ESO) guidelines on blood pressure management in acute ischaemic stroke and intracerebral haemorrhage. Eur Stroke J 2021; 6: II. - PMC - PubMed
    1. Bangalore S, Schwamm L, Smith EE, et al.. Blood pressure and in-hospital outcomes in patients presenting with ischaemic stroke. Eur Heart J 2017; 38: 2827–2835. - PMC - PubMed
    1. Vemmos KN, Tsivgoulis G, Spengos K, et al.. U-shaped relationship between mortality and admission blood pressure in patients with acute stroke. J Intern Med 2004; 255: 257–265. - PubMed
    1. Leonardi-Bee J, Bath PM, Phillips SJ, et al.. Blood pressure and clinical outcomes in the International Stroke Trial. Stroke 2002; 33: 1315–1320. - PubMed
    1. van den Berg SA, Uniken Venema SM, Mulder MJHL, et al.. Admission blood pressure in relation to clinical outcomes and successful reperfusion after endovascular stroke treatment. Stroke 2020; 51: 3205–3214. - PMC - PubMed

Publication types

Substances

Associated data