Just as a quick background for the DETERMINE trial, we got very interested in BP management during thrombectomy back in 2016 because we showed that hypertension and BP variability during thrombectomy are associated with worse outcomes. So we’re trying to find some ways to improve functional outcome by controlling BP during a thrombectomy before a perfusion. And we got interested in the individualized BP management because we showed that the impact of hypotension or BP variability differed according to different parameters such as the anatomy of the circle of Willis or the collateral status...
Just as a quick background for the DETERMINE trial, we got very interested in BP management during thrombectomy back in 2016 because we showed that hypertension and BP variability during thrombectomy are associated with worse outcomes. So we’re trying to find some ways to improve functional outcome by controlling BP during a thrombectomy before a perfusion. And we got interested in the individualized BP management because we showed that the impact of hypotension or BP variability differed according to different parameters such as the anatomy of the circle of Willis or the collateral status. And that in major surgeries, in novelties such as major surgeries, the individualized approach was shown to be superior versus the standard approach in improving several organ dysfunction. So that’s why we tested this individualized approach versus the standard approach. So the individualized approach regarding BP management is to stabilize BP using MAP, mean arterial pressure, within 10% of the first MAP measured before a thrombectomy. And to stabilize it within 10%. And we compare it to the standard approach where BP systolic blood pressure was stabilized within 140 to 180 mm. And we use this strategy in a very pragmatic way in basically every eligible thrombectomy patients in the anterior large visceral occlusion circulation. We excluded posterior large vessel occlusion strokes and we also excluded intra-hospital strokes and patients with a pre-existing disability. So in the data mine we randomized 433 patients. I think it’s 214 in the standard group and 218 in the experimental group. And when the patient entered the angiographic suits we measured his blood pressure and used diluted norepinephrine to stabilize BP. And we did that until reperfusion or femoral artery closure in case of thrombectomy failure. Our primary endpoint was clinical it was a variable endpoint favorable outcome at 90 days. And we had also several typical secondary endpoints such as excellent outcome or mortality or symptomatic ICH at 24 hours. So the results of the DETERMINE trial we showed that there was no superiority of the individualized approach versus the standard approach. We had I think 44% favorable outcome in the individualized blood pressure management group versus 48 in the standard group. So no superiority of such individualized MAP targeted approach versus the standard approach. And we had similar findings for the secondary endpoints. Safety outcomes were not statistically different between the two groups, no difference in symptomatic ICH or mortality at 90 days also. But the individual blood pressure management was not superior to the standard approach. Before DETERMINE I was a strong believer of intense BP management before reperfusion during thrombectomy. So I was a really strong believer of targeting narrow BP targets and to stabilize BP until reperfusion. But now with the results and with the results of the standard blood pressure management with a fully 8.8% of good outcome, my approach is more to target the standard approach, meaning an SBP systolic blood pressure between 140 to 180. I think we need other trials to describe blood pressure management and to be sure what’s the best, what’s the optimal strategy during thrombectomy. And I think future trials will be needed to test the standard approach, 140 to 180 versus nothing. Because in lots of parts of the world, there is no BP control during thrombectomy. And they are very pragmatic and to be honest the proportion of patients with a favorable outcome in these studies is also the same as in our study. So for the time being it’s between 140 and 180 but I think future trials will be needed to test with nothing, no BP control.
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