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Randomized Controlled Trial
. 2022 Jul 26;23(1):598.
doi: 10.1186/s13063-022-06538-9.

Effect of an individualized versus standard blood pressure management during mechanical thrombectomy for anterior ischemic stroke: the DETERMINE randomized controlled trial

Benjamin Maïer  1   2 , Benjamin Gory  3 , Russell Chabanne  4 , Benoît Tavernier  5   6 , Baptiste Balanca  7   8 , Gérard Audibert  9 , Laurie-Anne Thion  10 , Morgan Le Guen  11 , Thomas Geeraerts  12 , Lionel Calviere  13 , Vincent Degos  14   15 , Bertrand Lapergue  16 , Sebastien Richard  17 , Azeddine Djarallah  18 , Ornellia Mophawe  18 , Perrine Boursin  19 , Chloé Le Cossec  18 , Raphael Blanc  19 , Michel Piotin  19 , Mikael Mazighi #  19   20 , Etienne Gayat #  20   21 ; DETERMINE Investigators
Collaborators, Affiliations
Randomized Controlled Trial

Effect of an individualized versus standard blood pressure management during mechanical thrombectomy for anterior ischemic stroke: the DETERMINE randomized controlled trial

Benjamin Maïer et al. Trials. .

Abstract

Background: Hypotension and blood pressure (BP) variability during endovascular therapy (EVT) for acute ischemic stroke (AIS) due to an anterior large vessel occlusion (LVO) is associated with worse outcomes. However, the optimal BP threshold during EVT is still unknown given the lack of randomized controlled evidence. We designed the DETERMINE trial to assess whether an individualized BP management during EVT could achieve better functional outcomes compared to a standard BP management.

Methods: The DETERMINE trial is a multicenter, prospective, randomized, controlled, open-label, blinded endpoint clinical trial (PROBE design). AIS patients with a proximal anterior LVO are randomly assigned, in a 1:1 ratio, to an experimental arm in which mean arterial pressure (MAP) is maintained within 10% of the first MAP measured before EVT, or a control arm in which systolic BP (SBP) is maintained within 140-180 mm Hg until reperfusion is achieved or artery closure in case of EVT failure. The primary outcome is the rate of favorable functional outcomes, defined by a modified Rankin Scale (mRS) between 0 and 2 at 90 days. Secondary outcomes include excellent outcome and ordinal analysis of the mRS at 90 days, early neurological improvement at 24 h (National Institutes of Health Stroke Scale), final infarct volume, symptomatic intracranial hemorrhage rates, and all-cause mortality at 90 days. Overall, 432 patients will be included.

Discussion: DETERMINE will assess the clinical relevance of an individualized BP management before reperfusion compared to the one size fits all approach currently recommended by international guidelines.

Trial registration: ClinicalTrials.gov , NCT04352296. Registered on 20th April 2020.

Keywords: Blood pressure; Circulation; Disability; Mean arterial pressure; Randomized controlled trial; Stroke; Thrombectomy.

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Conflict of interest statement

BM reports travel fees from Medtronic. MM reports personal fees from Boerhinger Ingelheim, Air Liquide, Acticor Biotech, Amgen, outside the submitted work. LC reports speaker fees and travel fees from Pfizer and BMS.

Figures

Fig. 1
Fig. 1
DETERMINE
Fig. 2
Fig. 2
Hemodynamic protocol
Fig. 3
Fig. 3
Overview of the DETERMINE trial
Fig. 4
Fig. 4
Overview of the DETERMINE trial
See this image and copyright information in PMC

References

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    1. Maïer B, Fahed R, Khoury N, Guenego A, Labreuche J, Taylor G, et al. Association of blood pressure during thrombectomy for acute ischemic stroke with functional outcome a systematic review. Stroke. 2019;50(10):2805–2812. doi: 10.1161/STROKEAHA.119.024915. - DOI - PubMed

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