Need for and update on clinical trials for uncomplicated type B aortic dissection

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Abstract

The mainstay of management for uncomplicated type B aortic dissection is currently optimal medical therapy, targeting blood pressure and heart rate, along with serial imaging. There is a paucity of data that informs whether early intervention with thoracic endografting in this group of patients will promote aortic remodeling and better long-term outcomes. Investigations to date, including the Investigation of Stent Grafts in Aortic Dissection (INSTEAD), INSTEAD-XL, and Acute Dissection: Stent Graft or Best Medical Therapy (ADSORB) studies, have compared thoracic endovascular aortic repair (TEVAR) with optimal medical therapy in patients with uncomplicated type B aortic dissection but have not shown a benefit for TEVAR conclusively. We discuss three major new randomized trials, which will recruit concurrently in Scandinavia (the Scandinavian trial of uncomplicated aortic dissection therapy [SUNDAY] trial), in the United States (the IMPRoving outcomes in vascular DisEase - aortic dissection [IMPROVE-AD] trial) and the United Kingdom (the Early aortic repair in patients needing endovascular surgery for type B aortic dissection [EARNEST] trial), which promise to provide conclusive, level 1 evidence to decipher whether early TEVAR in this cohort of patients in beneficial.
无并发症 B 型主动脉夹层临床试验的必要性和最新进展
目前,治疗无并发症的 B 型主动脉夹层的主要方法是针对血压和心率的最佳药物治疗,以及连续成像。至于对这类患者进行胸腔内支架植入术的早期干预是否会促进主动脉重塑并改善长期预后,目前还缺乏相关数据。迄今为止,包括主动脉夹层中支架移植物的研究(INSTEAD)、INSTEAD-XL 和急性夹层在内的多项研究表明,主动脉夹层中支架移植物的治疗效果并不理想:支架移植物或最佳医疗疗法(ADSORB)研究)等研究对无并发症的 B 型主动脉夹层患者进行了胸腔内血管主动脉修复术(TEVAR)与最佳医疗疗法的比较,但并未明确显示 TEVAR 有益。我们将讨论三项新的重要随机试验,它们将同时在斯堪的纳维亚(斯堪的纳维亚无并发症主动脉夹层治疗试验 [SUNDAY] 试验)和美国(IMPR 试验)进行招募、这些试验有望提供确凿的 1 级证据,揭示早期 TEVAR 是否对这类患者有益。
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