Safety and efficacy of intensive blood pressure lowering after successful endovascular therapy in acute ischaemic stroke (BP-TARGET): a multicentre, open-label, randomised controlled trial

Mazighi, Mikaël; Richard, Sébastien; Lapergue, Bertrand; Sibon, Igor; Gory, Benjamin; Berge, Jérôme; Consoli, Arturo; Labreuche, Julien; Olivot, Jean‐Marc; Broderick, Joseph P.; Duhamel, Alain; Touzé, Emmanuel; Qureshi, Adnan I; Yavchitz, Amélie; Escalard, Simon; Desilles, Jean‐Philippe; Redjem, Hocine; Smajda, Stanislas; Fahed, Robert; Hébert, Solène; Maïer, Benjamin; Delvoye, François; Boursin, Perrine; Maacha, Malek Ben; Obadia, Michaël; Sabben, Candice; Blanc, Raphaël; Savatovsky, Julien; Piotin, Michel; Obadia, Alexandre; Raynouard, Igor; Morvan, Erwan; Wang, Adrien; Mione, Gioia; Humbertjean, Lisa; Bonnerot, Matthieu; Lacour, Jean‐Christophe; Anxionnat, René; Tonnelet, Romain; Bracard, Serge; Barreau, Xavier; Marnat, Gaultier; Lucas, Ludovic; Renou, Pauline; Debruxelles, Sabrina; Poli, Mathilde; Sagnier, Sharmila

doi:10.1016/s1474-4422(20)30483-x

Cited by 123 publications

(128 citation statements)

References 29 publications

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“…[109][110][111][112] The only completed RCT is the Blood Pressure Target in Acute Stroke to Reduce Haemorrhage After Endovascular Therapy (BP-TARGET) trial, a multicentre, prospective, randomised, controlled, open-label, blinded endpoint clinical trial conducted in France. 113,114 The study enrolled AIS patients with large vessel occlusion in the anterior circulation who had successful reperfusion (defined as modified Thrombolysis In Cerebral Infarction (mTICI) grades of 2 b or 3) following MT. The enrolled patients were randomly assigned, in a 1:1 ratio, to have intensive (systolic blood pressure target 100-129 mm Hg) or a conservative (systolic blood pressure target 130-185 mm Hg) blood pressure control in the following 24 hours, with the primary efficacy endpoint of radiographic intraparenchymal haemorrhage at 24-36 hours and the primary safety endpoint of hypotension occurrence.…”

Section: Analysis Of Current Evidencementioning

confidence: 99%

“…All secondary endpoints including three-month functional improvement (common OR for 1-point improvement across all mRS categories: 0.86; 95%CI: 0.57–1.28), three-month good functional outcome (mRS scores 0–2; 44% vs. 45%) and three-month mortality (19% vs. 14%) were similar in the two treatment groups. 113 The main methodological shortcoming of this RCT included: (i) modest systolic blood pressure difference (10 mm Hg) between the randomised groups; (ii) one third of the individuals in the conservative arm having systolic blood pressure measurements < 130 mm Hg; (iii) moderate sample size; (iv) primary endpoint being imaging, rather than clinical, (v) non-invasive modality of blood pressure assessment every 15 minutes for the first 2 hours, then every 30 minutes for 6 hours and every 1 hour for the remaining 16 hours.…”

Section: In Patients With Acute Ischaemic Stroke Caused By Large Vessel Occlusion and Undergoing Mechanical Thrombectomy (With Or Withoutmentioning

confidence: 99%

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European Stroke Organisation (ESO) guidelines on blood pressure management in acute ischaemic stroke and intracerebral haemorrhage

Sandset

Anderson

Bath

et al. 2021

European Stroke Journal

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The optimal blood pressure (BP) management in acute ischaemic stroke (AIS) and acute intracerebral haemorrhage (ICH) remains controversial. These European Stroke Organisation (ESO) guidelines provide evidence-based recommendations to assist physicians in their clinical decisions regarding BP management in acute stroke. The guidelines were developed according to the ESO standard operating procedure and Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology. The working group identified relevant clinical questions, performed systematic reviews and meta-analyses of the literature, assessed the quality of the available evidence, and made specific recommendations. Expert consensus statements were provided where insufficient evidence was available to provide recommendations based on the GRADE approach. Despite several large randomised-controlled clinical trials, quality of evidence is generally low due to inconsistent results of the effect of blood pressure lowering in AIS. We recommend early and modest blood pressure control (avoiding blood pressure levels >180/105 mm Hg) in AIS patients undergoing reperfusion therapies. There is more high-quality randomised evidence for BP lowering in acute ICH, where intensive blood pressure lowering is recommended rapidly after hospital presentation with the intent to improve recovery by reducing haematoma expansion. These guidelines provide further recommendations on blood pressure thresholds and for specific patient subgroups. There is ongoing uncertainty regarding the most appropriate blood pressure management in AIS and ICH. Future randomised-controlled clinical trials are needed to inform decision making on thresholds, timing and strategy of blood pressure lowering in different acute stroke patient subgroups.

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Section: Analysis Of Current Evidencementioning

confidence: 99%

Section: In Patients With Acute Ischaemic Stroke Caused By Large Vessel Occlusion and Undergoing Mechanical Thrombectomy (With Or Withoutmentioning

confidence: 99%

European Stroke Organisation (ESO) guidelines on blood pressure management in acute ischaemic stroke and intracerebral haemorrhage

Sandset

Anderson

Bath

et al. 2021

European Stroke Journal

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“…In einer randomisierten kontrollierten Studie mit der markanten Bezeichnung BP-TARGET, untersuchten Mazighi et al. [ 17 ] nun den Effekt einer strikten Blutdruckkontrolle (systolisch 100–129 mm Hg) gegenüber der Standardbehandlung (systolisch 130–185 mm Hg), wobei die Zielbereiche innerhalb 1 h nach der Randomisierung erreicht und für 24 h aufrechterhalten werden mussten. Zwischen 2017 und 2019 wurden in 4 Zentren in Frankreich insgesamt 324 Patienten mit einem Verschluss der A. cerebri media im M1-Segment oder der A. carotis interna im distalen Abschnitt eingeschlossen.…”

Section: Blutdruckmanagement Während Und Nach Der Mechanischen Thrombektomieunclassified

“…Die Studie von Mazighi et al. [ 17 ] liefert damit auf den ersten Blick keinen Vorteil einer strikten Blutdruckkontrolle innerhalb der ersten 24 h nach einer mechanischen Rekanalisation. Die Vorteile der Studie liegen in dem randomisierten Design und der Auswahl funktionell relevanter Endpunkte (Blutungen als primärer Endpunkt, funktionelles Behandlungsergebnis als sekundärer Endpunkt).…”

Section: Blutdruckmanagement Während Und Nach Der Mechanischen Thrombektomieunclassified

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Fokus neurologische Intensivmedizin. Intensive Care Studies from 2020/2021

et al. 2021

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Blood Pressure Management After Endovascular Therapy for Acute Ischemic Stroke

Mistry,

Hart,

Davis

et al. 2023

JAMA

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ImportanceThe effects of moderate systolic blood pressure (SBP) lowering after successful recanalization with endovascular therapy for acute ischemic stroke are uncertain.ObjectiveTo determine the futility of lower SBP targets after endovascular therapy (&lt;140 mm Hg or 160 mm Hg) compared with a higher target (≤180 mm Hg).Design, Setting, and ParticipantsRandomized, open-label, blinded end point, phase 2, futility clinical trial that enrolled 120 patients with acute ischemic stroke who had undergone successful endovascular therapy at 3 US comprehensive stroke centers from January 2020 to March 2022 (final follow-up, June 2022).InterventionAfter undergoing endovascular therapy, participants were randomized to 1 of 3 SBP targets: 40 to less than 140 mm Hg, 40 to less than 160 mm Hg, and 40 to 180 mm Hg or less (guideline recommended) group, initiated within 60 minutes of recanalization and maintained for 24 hours.Main Outcomes and MeasuresPrespecified multiple primary outcomes for the primary futility analysis were follow-up infarct volume measured at 36 (±12) hours and utility-weighted modified Rankin Scale (mRS) score (range, 0 [worst] to 1 [best]) at 90 (±14) days. Linear regression models were used to test the harm-futility boundaries of a 10-mL increase (slope of 0.5) in the follow-up infarct volume or a 0.10 decrease (slope of −0.005) in the utility-weighted mRS score with each 20-mm Hg SBP target reduction after endovascular therapy (1-sided α = .05). Additional prespecified futility criterion was a less than 25% predicted probability of success for a future 2-group, superiority trial comparing SBP targets of the low- and mid-thresholds with the high-threshold (maximum sample size, 1500 with respect to the utility-weighted mRS score outcome).ResultsAmong 120 patients randomized (mean [SD] age, 69.6 [14.5] years; 69 females [58%]), 113 (94.2%) completed the trial. The mean follow-up infarct volume was 32.4 mL (95% CI, 18.0 to 46.7 mL) for the less than 140–mm Hg group, 50.7 mL (95% CI, 33.7 to 67.7 mL), for the less than 160–mm Hg group, and 46.4 mL (95% CI, 24.5 to 68.2 mL) for the 180–mm Hg or less group. The mean utility-weighted mRS score was 0.51 (95% CI, 0.38 to 0.63) for the less than 140–mm Hg group, 0.47 (95% CI, 0.35 to 0.60) for the less than 160–mm Hg group, and 0.58 (95% CI, 0.46 to 0.71) for the high-target group. The slope of the follow-up infarct volume for each mm Hg decrease in the SBP target, adjusted for the baseline Alberta Stroke Program Early CT score, was −0.29 (95% CI, −0.81 to ∞; futility P = .99). The slope of the utility-weighted mRS score for each mm Hg decrease in the SBP target after endovascular therapy, adjusted for baseline utility-weighted mRS score, was −0.0019 (95% CI, −∞ to 0.0017; futility P = .93). Comparing the high-target SBP group with the lower-target groups, the predicted probability of success for a future trial was 25% for the less than 140–mm Hg group and 14% for the 160–mm Hg group.Conclusions and RelevanceAmong patients with acute ischemic stroke, lower SBP targets less than either 140 mm Hg or 160 mm Hg after successful endovascular therapy did not meet prespecified criteria for futility compared with an SBP target of 180 mm Hg or less. However, the findings suggested a low probability of benefit from lower SBP targets after endovascular therapy if tested in a future larger trial.Trial RegistrationClinicalTrials.gov Identifier: NCT04116112

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Safety and efficacy of intensive blood pressure lowering after successful endovascular therapy in acute ischaemic stroke (BP-TARGET): a multicentre, open-label, randomised controlled trial

Cited by 123 publications

References 29 publications

European Stroke Organisation (ESO) guidelines on blood pressure management in acute ischaemic stroke and intracerebral haemorrhage

European Stroke Organisation (ESO) guidelines on blood pressure management in acute ischaemic stroke and intracerebral haemorrhage

Fokus neurologische Intensivmedizin. Intensive Care Studies from 2020/2021

Blood Pressure Management After Endovascular Therapy for Acute Ischemic Stroke

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