SAFESTEREO: phase II randomized trial to compare stereotactic radiosurgery with fractionated stereotactic radiosurgery for brain metastases.

BACKGROUND: Stereotactic radiosurgery (SRS) is a frequently chosen treatment for patients with brain metastases and the number of long-term survivors is increasing. Brain necrosis (e.g. radionecrosis) is the most important long-term side effect of the treatment. Retrospective studies show a lower risk of radionecrosis and local tumor recurrence after fractionated stereotactic radiosurgery (fSRS, e.g. five fractions) compared with stereotactic radiosurgery in one or three fractions. This is especially true for patients with large brain metastases. As such, the 2022 ASTRO guideline of radiotherapy for brain metastases recommends more research to fSRS to reduce the risk of radionecrosis. This multicenter prospective randomized study aims to determine whether the incidence of adverse local events (either local failure or radionecrosis) can be reduced using fSRS versus SRS in one or three fractions in patients with brain metastases. METHODS: Patients are eligible with one or more brain metastases from a solid primary tumor, age of 18 years or older, and a Karnofsky Performance Status ≥ 70. Exclusion criteria include patients with small cell lung cancer, germinoma or lymphoma, leptomeningeal metastases, a contraindication for MRI, prior inclusion in this study, prior surgery for brain metastases, prior radiotherapy for the same brain metastases (in-field re-irradiation). Participants will be randomized between SRS with a dose of 15-24 Gy in 1 or 3 fractions (standard arm) or fSRS 35 Gy in five fractions (experimental arm). The primary endpoint is the incidence of a local adverse event (local tumor failure or radionecrosis identified on MRI scans) at two years after treatment. Secondary endpoints are salvage treatment and the use of corticosteroids, bevacizumab, or antiepileptic drugs, survival, distant brain recurrences, toxicity, and quality of life. DISCUSSION: Currently, limiting the risk of adverse events such as radionecrosis is a major challenge in the treatment of brain metastases. fSRS potentially reduces this risk of radionecrosis and local tumor failure. TRIAL REGISTRATION: ClincalTrials.gov, trial registration number: NCT05346367 , trial registration date: 26 April 2022.

[Complications within 30 days following placement of a carotid stent with cerebral protection in patients with considerable symptomatic carotid stenosis; Erasmus MC, Rotterdam, 1999-2004]. / Complicaties in de eerste 30 dagen na plaatsing van een carotisstent met cerebrale bescherming bij pati nten met een aanzienlijke, symptomatische carotisstenose; Erasmus MC, Rotterdam, 1999-2004.

OBJECTIVE: To describe the complications that occur within 30 days following the placement of a stent in the carotid artery in patients with considerable symptomatic carotid stenosis. DESIGN: Retrospective. METHOD: Data were collected on 98 patients who received a carotid stent due to symptomatic carotid stenosis of > or = 70% of the lumen at the Erasmus MC, Rotterdam, the Netherlands, in the years 1999-2004. A filter, distal occlusion balloon or the Parodi anti-embolism system was used to prevent cerebral embolism. Outcome measures were complications within 30 days following intervention. RESULTS: Four patients were excluded in the period between diagnosis and stenting. Major complications occurred in 3 patients: 1 died due to cerebral haemorrhage and 2 experienced cerebral infarction. Transient neurological complications occurred in 4 patients who recovered completely. Dissection of the renal artery occurred in 1 patient, which necessitated a stent. Vascular damage of the internal carotid artery was not observed in any patient. The 3 major adverse events and 3 of the 4 minor adverse events occurred in the first 47 patients treated. None of the last 47 patients treated developed major adverse events.

Cerebral protection during percutaneous carotid intervention: wich device should be used ?

Embolic complications remain the major and unpredictable clinical event during carotid angioplasty and stenting. Cerebral protection devices could play an important role in the prevention of such emboli. Protection devices such as occlusion balloons, filters and reversed flow devices are currently undergoing clinical evaluation and appear to be promising in reducing the incidence of embolic events. This article provides an overview of the three different types of embolic protection devices.