Atrial fibrillation: worldwide preliminary data of LINAC-based STAR prospective phase II trial
PO-1055
Abstract
Atrial fibrillation: worldwide preliminary data of LINAC-based STAR prospective phase II trial
Authors: Fabiana Gregucci1, Antonio Di Monaco2, Ilaria Bonaparte1, Alessia Surgo1, Federica Troisi2, Nicola Vitulano3, Federico Quadrini4, Domenico Di Molfetta5, Gaetano Martinelli5, Pietro Guida1, Roberta Carbonara1, Maria Paola Ciliberti1, Massimo Grimaldi2, Alba Fiorentino1
1Miulli General Regional Hospital, Radiation Oncology, Acquaviva delle Fonti - Bari, Italy; 2Miulli General Regional Hospital, Cardiology, Acquaviva delle Fonti - Bari, Italy; 3Miulli General Regional Hospital, Cardiology, Acquaviva delle Fonti -Bari, Italy; 4Miulli General Regional Hospital Acquaviva delle Fonti - Bari, Cardiology, Acquaviva delle Fonti - Bari, Italy; 5Miulli General Regional Hospital, Radiology, Acquaviva delle Fonti - Bari, Italy
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Purpose or Objective
In elderly,
paroxysmal atrial fibrillation (AF) is difficult to treat with
drugs and catheter
ablation due to the higher complication rate. Thus, non-invasive approaches
should be favorite. Stereotactic arrhythmia radioablation (STAR) was used for
ventricular tachycardia, but no data are available for LINear ACcelerator (Linac)-based STAR in AF patients. Based on this background, the aim of present study was to determine
whether Linac-based STAR is considered safe for AF elderly patients.
Material and Methods
The study was designed as a
prospective phase-II trial started in May 2021, conducted in a single, referral center (ClinicalTrials.gov:
NCT04575662). The inclusion criteria were: patients aged over 70
years, with symptomatic paroxysmal AF; intolerance or non-response to anti-arrhythmic (ATT) drugs. The primary study endpoint was the 1-month post-STAR safety, as complete STAR delivery and no acute
treatment-related adverse events more than G3, assessed according to the Common
Terminology Criteria for Adverse Events (version 5.0). Secondary endpoints were: reductions in
AF episodes and in AAT, overall survival.
The sample size planning is 20 cases based on 95%
success for the primary endpoint, with a significant level of 5% and a power of
90%. The date of the last follow-up was October 2021.
All patients underwent to LINAC-STAR for a treatment dose of 25 Gy in 1 fraction to the area of the pulmonary veins.
Results
Here, the data of the first 4 worldwide patients treated were presented.
All patients
completed STAR, with an overall treatment time of 3 minutes. No acute treatment-related adverse events (>G1) at
1-month from procedure were registered. For 3 patients, with a median follow-up
of 3 months, no acute side effects, no AF episodes and no AAT use, were
reported.
Conclusion
The LINAC-based STAR
could represent a valid alternative for elderly excluded from catheter ablation.