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ESOC 2021 | Key data at ESOC 2021: ANNEXA-4, RESTART, SWIFT DIRECT and DECOMPRESS2

Ana Catarina Fonseca, MD, PhD, University of Lisbon, Lisbon, Portugal, discusses key trial data reported at the European Stroke Organisation Conference (ESOC), 2021. Prof. Fonseca highlights the final report of the ANNEXA-4 registration study (NCT02329327) evaluating andexanet in patients with acute major bleeding, for the reversal of FXa inhibition. The data shared showed that andexanet treatment reduced anti–FXa activity, supporting its use. Prof. Fonseca also discusses the RESTART trial of antiplatelet therapy after intracerebral hemorrhage. Extended follow-up data showed a trend towards benefit of restarting antiplatelet therapy. The SWIFT DIRECT trial (NCT03192332), assessing the use of mechanical thrombectomy alone versus mechanical thrombectomy combined with intravenous thrombolysis, and the DECOMPRESS2 study of decompressive neurosurgery for patients with severe cerebral venous thrombosis are also discussed. This interview took place at the European Stroke Organisation Conference (ESOC), 2021.

Transcript (edited for clarity)

Yes, there were some clinical trials and registries that were presented. There were the results of the ANNEXA-4 trial. So currently, when patients have bleeding and they are in the treatment with a direct inhibitor of the factor II thrombin, they can be treated with idarucizumab. And currently, there was few good data about reversal of agents that are direct inhibitors to factor 10a. And what they show was that andexanet alpha also has efficacy and is able to revert anticoagulation of these patients...

Yes, there were some clinical trials and registries that were presented. There were the results of the ANNEXA-4 trial. So currently, when patients have bleeding and they are in the treatment with a direct inhibitor of the factor II thrombin, they can be treated with idarucizumab. And currently, there was few good data about reversal of agents that are direct inhibitors to factor 10a. And what they show was that andexanet alpha also has efficacy and is able to revert anticoagulation of these patients. So probably you can also get an antidote, not only for direct inhibitors of thrombin, but also for direct inhibitors of the factor 10a.

There’s also another important trial that were presented. The continuation of the RESTART trial. And they showed that there was a trend towards benefits from patients that have had intercranial hemorrhage to reinitiate the antiplatelet therapy but the results need to be duplicated also in other trials. There was also the presentation of the SWIFT DIRECT trial, in which they studied the use of mechanical thrombectomy alone versus mechanical thrombectomy plus intravenous thrombolysis. And they weren’t able to show that just doing clinical thrombectomy was noninferior to using mechanical thrombectomy plus intravenous thrombolysis. And so consistent also inline to other clinical trials that have been published. So what this says to us, is that currently these patients should be treated with intravenous thrombolysis plus mechanical thrombectomy. It’s not considered as fair treatment to just treat these patients with mechanical thrombectomy, according to the current knowledge, we cannot think about currently not to do intravenous thrombolysis in these patients.

And there was also an important registery which was presented, the DECOMPRESS trial and it was a registry of patients that had cerebral venous thrombosis and they had to undergo micronectomy. And what it showed was that these patients overall they had a good prognosis. There was one third of patients ended up dying through, but a considerable fraction of patients were independent, more than two thirds of patients were independent at six months. So, in patients with cerebral venous thrombosis it seems that to offer a micronectomy is associated to a better outcome than in patients with ischemic stroke.

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Disclosures

Prof. Fonseca reports the following disclosures:
Speaker fees from Daiichi Sankyo