Patient Selection for Surgery vs Surveillance in Moderately Dilated Ascending Aorta: Insights From Treatment in Thoracic Aortic Aneurysm: Surgery versus Surveillance (TITAN:SvS), an International Prospective Trial.
Adham Makarem, Jehangir J Appoo, Munir Boodhwani, Ming Hao Guo, Sarah Brownlee, Philippe Demers, Himanshu J Patel, G Chad Hughes, Francois Dagenais, Michael W A Chu, Maral Ouzounian, Juan B Grau, John Bozinovski, Zlatko Pozeg, Elaine Tseng, Rony Atoui, Arminder S Jassar
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引用次数: 0
Abstract
Background: Guidelines for treating ascending thoracic aortic aneurysms (ATAA) are largely based on single-center studies. To understand factors influencing patient selection for surgery vs surveillance, patient and aneurysm characteristics were compared for patients in the randomized and registry arms of a large prospective, multicenter, multinational trial.
Methods: TITAN:SvS (Treatment in Thoracic Aortic aNeurysm: Surgery versus Surveillance) is a large prospective multicenter study of patients with ATAA between 5.0 and 5.4 cm, randomizing patients 1:1 to initial surgery vs surveillance. Nonrandomized patients are enrolled into a registry where results of operative or surveillance strategy can be monitored prospectively. Between 2018 and 2023, 615 patients were enrolled at 22 sites in the United States and Canada. Demographic and aneurysm characteristics were compared between randomized and registry arms.
Results: Compared with randomized and operative registry groups, patients in the surveillance registry were older with more comorbidities. No significant differences were observed in maximal ascending aortic diameter (5.1 cm [interquartile range, 5.0-5.2 cm] vs 5.1 cm [interquartile range, 4.9-5.2 cm] P = .2) or other aneurysm characteristics. Despite similar numbers of enrolling centers in the United States (n = 11) and Canada (n = 12), Canadian patients were more likely to be randomized (58% vs 7%, P < .01) and less likely to be enrolled in the operative (9% vs 42%, P < .01) or surveillance registry (34% vs 51%).
Conclusions: Enrollment data for TITAN:SvS suggest that patient and geographic characteristics, rather than aortic size, influence decision-making regarding the initial treatment strategy for ATAAs. These findings highlight the need for caution when generalizing outcomes from operative registries, because sicker patients may be excluded.
背景:胸升主动脉瘤(ATAA)的治疗指南主要基于单中心研究。为了了解影响患者选择手术还是监护的因素,我们比较了一项大型前瞻性、多中心、多国试验中随机分组和登记组受试者的患者和动脉瘤特征。方法:TITAN: SvS(胸主动脉瘤治疗:手术与监测)是针对5.0-5.4 cm ATAA患者的最大的前瞻性多中心研究,将患者1:1随机分配至初始手术与监测组。非随机患者入组到一个登记处,在那里可以前瞻性地跟踪手术或监测策略的结果。在2018年至2023年期间,在美国和加拿大的22个地点招募了615名患者。比较随机组和登记组的人口学和动脉瘤特征。结果:与随机和手术登记组相比,监测登记组的患者年龄更大,合并症更多。在最大升主动脉直径[(5.1 (5.0,5.2)vs 5.1 (4.9, 5.2) cm, p=0.2]或其他动脉瘤特征方面无显著差异。尽管美国(n=11)和加拿大(n=12)的入组中心数量相似,但加拿大患者更有可能被随机化(58% vs. 7%)。结论:入组数据TITAN:SvS表明,患者和地理特征,而不是主动脉尺寸,影响了ATAAs初始治疗策略的决策。这些发现强调了在推广手术登记结果时需要谨慎,因为病情较重的患者可能被排除在外。
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