Individualized blood pressure management during endovascular treatment of acute ischemic stroke under procedural sedation (INDIVIDUATE) – An explorative randomized controlled trial

 So still no protocol for blood pressure management. What we need is an EFFECTIVE STROKE LEADER THAT WILL SOLVE THIS PROBLEM. Alas we have none.

Individualized blood pressure management during endovascular treatment of acute ischemic stroke under procedural sedation (INDIVIDUATE) – An explorative randomized controlled trial

 

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Min Chen, Dorothea Kronsteiner, Markus A Möhlenbruch, ...

First Published March 4, 2021 Research Article 

https://doi.org/10.1177/23969873211000879

Article information

Abstract

Background

Optimal blood pressure is not well established(So your doctor is shooting in the dark! Good to know) during endovascular therapy of acute ischemic stroke. Applying standardized blood pressure target values for every stroke patient might be a suboptimal approach.

Aim

To assess whether an individualized intraprocedural blood pressure management with individualized blood pressure target ranges might pose a better strategy for the outcome of the patients than standardized blood pressure targets.

Sample size: Randomization of 250 patients 1:1 to receive either standard or individualized blood pressure management approach.

Methods and design

We conduct an explorative single-center randomized controlled trial with a PROBE (parallel-group, open-label randomized controlled trial with blinded endpoint evaluation) design. In the control group, intraprocedural systolic blood pressure target range is 140–180 mmHg. The intervention group is the individualized approach, which is maintaining the intraprocedural systolic blood pressure at the level on presentation (±10 mmHg).

Study outcomes: The primary endpoint is the modified Rankin scale assessed 90 days +/− 2 weeks after stroke onset, dichotomized by 0–2 (favorable outcome) to 3–6 (unfavorable outcome). Secondary endpoints include early neurological improvement, infarction size, and systemic physiology monitor parameters.

Discussion

An individualized approach for blood pressure management during thrombectomy could lead to a better outcome for stroke patients. The trial is registered at clinicaltrials.gov as ‘Individualized Blood Pressure Management During Endovascular Stroke Treatment (INDIVIDUATE)’ under NCT04578288.

Keywords Ischemic stroke, endovascular therapy, blood pressure

Introduction and rationale

Optimal blood pressure (BP) management during acute endovascular treatment (EVT) for acute ischemic stroke is not well established. Current international guidelines(NOT GOOD ENOUGH!, Protocols are needed.) recommend maintaining the systolic blood pressure (SBP) under 180–185 mmHg and over 140 mmHg, as well as avoiding excessive BP drops during thrombectomy with low to moderate level of evidence.^1–4 Extreme hypo- as well as hypertensive blood pressures during an acute ischemic stroke may have a harmful influence with a U-shaped relationship between blood pressure and functional outcome.^5–14

Substantial decreases of BP during the endovascular procedure are associated with worse functional outcome as a decrease in systemic blood pressure might lead to to larger final infarction sizes.^15–18

The Society for Neuroscience in Anesthesiology and Critical Care Expert recommend maintaining SBP >140 mmHg with moderate level of evidence during EVT, based on retrospective data.³ However, one study suggested that intraprocedural SBP between 100–140 mmHg was not resulting in different functional outcomes and only values <100 mmHg had fewer patients with good functional outcome.¹⁹ Additionally, a post-hoc analysis of the EVT trial (MR CLEAN) showed that 16.2% patients had an SBP of <120 mmHg on presentation and there was no significantly different functional outcome than those who had an SBP >120 mmHg.⁹

Current guidelines suggest, that in patients who are eligible for IV thrombolytic and endovascular therapy, BP should be lowered to <185/110 mmHg before treatment and to <180/105 mmHg after treatment with low to moderate evidence.²⁰ However, in patients with a BP of <220/110 mmHg who did not receive reperfusion therapy (i.e. IV fibrinolytic therapy and/or endovascular thrombectomy) initiating or reinitiating antihypertensive medication is not effective to prevent death or dependency with level A evidence.²⁰

In summary, there is evidence for association of worse functional outcome for extremes of blood pressure levels at presentation. For intraprocedural intra-individual blood pressure variation the evidence is largely limited for blood pressure drops, while some evidence^14,21 also showed negative effects of prolonged high blood pressures. As there are considerable inter-individual differences of necessary systemic blood pressure levels to maintain a sufficient penumbral perfusion, managing blood pressure via absolute targets independent of the individual needs might be a suboptimal approach. Lower BP than necessary might lead to reduced penumbral hypoperfusion and thus larger infarction, higher values might be associated with adverse effects like edema and hemorrhage. The admission blood pressure might represent the lowest necessary compensatory blood pressure to maintain penumbral perfusion. Thus, it could be reasonable to maintain intraprocedural systolic blood pressure before reperfusion at the presentation level, if higher and lower bounds for extreme values are established.