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70. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie (DGNC)
Joint Meeting mit der Skandinavischen Gesellschaft für Neurochirurgie

Deutsche Gesellschaft für Neurochirurgie (DGNC) e. V.

12.05. - 15.05.2019, Würzburg

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Propective-Randomised Open-label Trial to Evaluate risk faCtor management in patients with Unruptured intracranial aneurysms – PROTECT-U

Propective-Randomised Open-label Trial to Evaluate risk faCtor Management in Patienten mit Unrupturierten intrakraniellen Aneurysmen – PROTECT-U

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  • presenting/speaker Nima Etminan - Universitätsmedizin Mannheim, Neurochirurgie, Mannheim, Deutschland
  • Katharina Hackenberg - Universitätsmedizin Mannheim, Neurochirurgie, Mannheim, Deutschland
  • Gabriel Rinkel - University Medical Centre Utrecht, Utrecht University, Brain Centre Rudolf Magnus, Department of Neurology and Neurosurgery, Julius Center for Health Sciences and Primary Care, Utrecht, Netherlands
  • Ale Algra - University Medical Centre Utrecht, Utrecht University, Brain Centre Rudolf Magnus, Department of Neurology and Neurosurgery, Julius Center for Health Sciences and Primary Care, Utrecht, Netherlands
  • Jens Fiehler - Universitätsklinikum Hamburg-Eppendorf, Neuroradiologie, Hamburg, Deutschland
  • Helmuth Steinmetz - Universitätsklinikum Frankfurt, Zentrum der Neurologie und Neurochirurgie, Frankfurt, Deutschland
  • Peter Vajkoczy - Charité – Universitätsmedizin Berlin, Neurochirurgie, Berlin, Deutschland
  • Daniel Hänggi - Universitätsmedizin Mannheim, Neurochirurgie, Mannheim, Deutschland
  • Mervyn Vergouwen - University Medical Centre Utrecht, Utrecht University, Brain Centre Rudolf Magnus, Department of Neurology and Neurosurgery, Julius Center for Health Sciences and Primary Care, Utrecht, Netherlands

Deutsche Gesellschaft für Neurochirurgie. 70. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie (DGNC), Joint Meeting mit der Skandinavischen Gesellschaft für Neurochirurgie. Würzburg, 12.-15.05.2019. Düsseldorf: German Medical Science GMS Publishing House; 2019. DocV119

doi: 10.3205/19dgnc125, urn:nbn:de:0183-19dgnc1251

Published: May 8, 2019

© 2019 Etminan et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/.

Outline

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Objective: Unruptured intracranial aneurysms (UIA) are currently left untreated, if the presumed complication risk of preventive endovascular or neurosurgical intervention is higher than the risk of rupture. Aneurysm wall inflammation and blood pressure are attractive modifiable risk factors of aneurysm rupture and growth. We aim to investigate in patients with an UIA who do not qualify for preventive endovascular or neurosurgical intervention whether a treatment strategy with acetylsalicylic acid (ASA) and intensive blood pressure (BP) reduction reduces the risk of aneurysm rupture or growth, compared to standard of care.

Methods: PROTECT-U is an international, multicentre, prospective, randomised, open-label phase III trial with blinded outcome assessment. Patients, 18 years or older, with an intradural, saccular UIA on MR or CT angiography are eligible, if it is decided to refrain from preventive endovascular or neurosurgical intervention, and to monitor the aneurysm on a regular basis for growth. We hypothesize that a treatment strategy consisting of ASA 100mg/day plus intensive BP treatment (targeted systolic BP<120mmHg, monitored with a home BP measuring device) reduces the risk of aneurysm rupture or growth compared with standard care (no ASA, targeted systolic BP<140mmHg, no home BP measuring device). The primary outcome is aneurysm rupture or growth (increase in any aneurysm diameter by ?≥1mm) on repeated MR or CT angiography within 36±6 months after randomization. We aim to randomize 776 patients 1:1 to the intervention arm or care as usual.

Results: The trial was initiated in 2017 and in November 29th, 2018, a total of 100 patients were included in Germany and The Netherlands. The aneurysm size distributions are: 9.1 mm=2. To date no severe adverse events related to the experimental treatment were detected.

Conclusion: The PROTECT-U trial is the first ever randomized Phase III trial to investigate whether a medical strategy reduces the risk of rupture or growth of intracranial aneurysms in patients not undergoing preventive endovascular or neurosurgical aneurysm treatment.