Annals of vascular surgery · 2025
From Equipoise to Evidence: Pre-Trial Setup of the European Uncomplicated Type B Aortic Repair Clinical Trial.
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеНазвание и аннотация: Перевод в очереди
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Bashir Mohamad, Jubouri Matti, Surkhi Abdelaziz O, Jubouri Yousif, Abdelhaliem Amr, Tanyeli Ömer, Ugur Murat, Guagliano Alberto, D'Oria Mario, Bellosta Raffaello, Bertoglio Luca, Mazzaccaro Daniela, Nano Giovanni, Sirignano Pasqualino, Pratesi Giovanni, Bartoli Stefano, Alcaraz García Maria José, Perez-Andreu Joaquin, Hirnle Tomasz, Pfister Karin, Brandão Daniel, Hutchings Hayley A, Holland Gail, Hiles Stephen, Thielmann Matthias, Bailey Damian M, Williams Ian M, Piffaretti Gabriele
Аннотация
BACKGROUND: Optimal management of uncomplicated type B aortic dissection (uTBAD) remains debated. While thoracic endovascular aortic repair (TEVAR) promotes false lumen thrombosis (FLT) and remodeling, 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) program prospectively collated multicenter outcomes to evaluate real-world clinical outcomes of TEVAR for uTBAD across European centers, and to identify independent predictors of mortality, reintervention, and aortic remodeling to inform the design of a definitive randomized EU-TBAR trial.
METHODS: Multicenter observational cohort of consecutive patients undergoing TEVAR for uTBAD and related descending thoracic pathology across European centers. Standardized electronic case-report forms captured demographics, presentation, imaging, procedural details, and outcomes. Primary outcomes were in-hospital and follow-up mortality; secondary outcomes included complications, reintervention, and aortic remodeling. Multivariable logistic regression identified predictors of mortality, reintervention, and remodeling.
RESULTS: We analyzed 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 (odds ratio [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 hr (OR 2.69, P = 0.024). Higher hemoglobin (OR 0.74 per g/dL, P < 0.0001) and estimated glomerular filtration rate (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%. Remodeling 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., celiac 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).
CONCLUSION: 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 centers, with significant practice variation justifying a randomized 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.
METHODS: Multicenter observational cohort of consecutive patients undergoing TEVAR for uTBAD and related descending thoracic pathology across European centers. Standardized electronic case-report forms captured demographics, presentation, imaging, procedural details, and outcomes. Primary outcomes were in-hospital and follow-up mortality; secondary outcomes included complications, reintervention, and aortic remodeling. Multivariable logistic regression identified predictors of mortality, reintervention, and remodeling.
RESULTS: We analyzed 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 (odds ratio [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 hr (OR 2.69, P = 0.024). Higher hemoglobin (OR 0.74 per g/dL, P < 0.0001) and estimated glomerular filtration rate (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%. Remodeling 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., celiac 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).
CONCLUSION: 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 centers, with significant practice variation justifying a randomized 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.