From equipoise to evidence: pre-trial setup of the European Uncomplicated Type B Aortic Repair (EU-TBAR) Clinical Trial.

Background: Optimal management of uncomplicated type B aortic dissection (uTBAD) remains debated. While thoracic endovascular aortic repair (TEVAR) promotes false lumen thrombosis (FLT) and remodelling, the early clinical profile and long-term benefits in routine practice need further investigation. The pre-trial setup of the European Uncomplicated Type B Aortic Repair (EU-TBAR) programme prospectively collated multicentre outcomes to evaluate real-world clinical outcomes of TEVAR for uTBAD across European centres, and to identify independent predictors of mortality, reintervention, and aortic remodelling to inform the design of a definitive randomised EU-TBAR trial. Methods: Multicentre observational cohort of consecutive patients undergoing TEVAR for uTBAD and related descending thoracic pathology across European centres. Standardised eCRFs captured demographics, presentation, imaging, procedural details, and outcomes. Primary outcomes were in-hospital and follow-up mortality; secondary outcomes included complications, reintervention, and aortic remodelling. Multivariable logistic regression identified predictors of mortality, reintervention, and remodelling. Results: We analysed 263 patients (mean age 61.4±13.4 years; 79.5% male) from six countries. In-hospital mortality was 9.9%, and mortality during follow-up was 14.1% (median follow-up time ≈ 1 year). Postoperative acute kidney injury (AKI) was the strongest independent predictor of death (OR 9.93, p < 0.0001); additional predictors included AKI at presentation (OR 4.24, p = 0.012), syncope (OR 3.15, p < 0.0001), and ventilation for >48 hours (OR 2.69, p = 0.024). Higher haemoglobin (OR 0.74 per g/dL, p<0.0001) and eGFR (OR 0.79 per 10 units, p<0.0001) were protective; reintervention was associated with lower mortality (OR 0.26, p=0.013). Reintervention occurred in 18.3% at a median of 168 days; discharge endoleak (present in 18.3%) tripled reintervention odds (OR 3.08, p=0.003). Imaging at discharge and follow-up was performed in 70.7% and 63.9%, respectively. At follow-up, FLT was complete in 42.1% and partial in 39.3%. Remodelling was associated with beta-blockers (descending aorta OR 3.58, p=0.009), prior thoracic surgery (suprarenal OR 5.47; infrarenal OR 8.33; both p=0.008), and targeted branch stenting (e.g., coeliac OR 31.0, p=0.016). Female sex independently predicted FLT (OR 11.53, p=0.022). Survival was lower for emergent cases (65% vs 79-78%; p=0.039) and in patients with postoperative AKI (36% vs 86%; p<0.001). Conclusions: This pre-trial setup and analysis successfully confirm the feasibility and methodological foundation for the definitive EU-TBAR trial. There is a clinical equipoise across European centres, with significant practice variation justifying a randomised trial comparing pre-emptive TEVAR versus medical management for uTBAD. Key mortality predictors provide objective criteria for patient selection, while the reintervention rate establishes important trial endpoints.

Citation

Bashir M, Jubouri M, Surkhi AO, Jubouri Y, Abdelhaliem A, Tanyeli Ö, Ugur M, Guagliano A, D'Oria M, Bellosta R, Bertoglio L, Mazzaccaro D, Sirignano P, Pratesi G, Bartoli S, Alcaraz García MJ, Perez-Andreu J, Hirnle T, Pfister K, Brandão D, Hutchings HA, Holland G, Hiles S, Thielmann M, Bailey DM, Williams IM, Piffaretti G. From Equipoise to Evidence: Pre-Trial Setup of the European Uncomplicated Type B Aortic Repair (EU-TBAR) Clinical Trial. Ann Vasc Surg. 2025 Dec 18:S0890-5096(25)00888-X. doi: 10.1016/j.avsg.2025.12.007.

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Article