ImportanceHistorically, women with aortic stenosis have experienced worse outcomes and inadequate recognition compared to men, being both underdiagnosed and undertreated, while also facing underrepresentation in clinical trials.ObjectiveTo determine whether women with small aortic annuli undergoing transcatheter aortic valve replacement have better clinical and hemodynamic outcomes with a self-expanding valve (SEV) or balloon-expandable valve (BEV).Design, Setting, ParticipantsThe Small Annuli Randomized to Evolut or SAPIEN Trial (SMART) was a large-scale randomized clinical trial focusing on patients with small aortic annuli undergoing transcatheter aortic valve replacement, randomized to receive SEVs or BEVs and included 716 patients treated at 83 centers in Canada, Europe, Israel, and the US from April 2021 to October 2022. This prespecified secondary analysis reports clinical and hemodynamic findings for all 621 women enrolled in SMART. Data for this report were analyzed from February to April 2024.InterventionsTranscatheter aortic valve replacement with an SEV or a BEV.Main Outcomes and MeasuresThe composite coprimary clinical end point comprised death, disabling stroke, or heart failure–related rehospitalization. The coprimary valve function end point was the incidence of bioprosthetic valve dysfunction, both assessed through 12 months. Secondary end points included the incidence of moderate or severe prosthesis-patient mismatch.ResultsA total of 621 women (mean [SD] age, 80.2 [6.2] years; 312 randomized to the SEV group and 309 to the BEV group) were included in the present analysis. At 12 months, there were no significant differences in the coprimary clinical end point between the SEV and BEV groups (9.4% vs 11.8%, absolute risk difference −2.3%; 95% CI −7.2 to 2.5, P = .35). However, SEV implantation was associated with less bioprosthetic valve dysfunction (8.4% vs 41.8%; absolute risk difference, −33.4%; 95% CI, −40.4 to −26.4; P < .001). SEV implantation resulted in lower aortic valve gradients and larger effective orifice areas at 30 days and 12 months and less mild or greater aortic regurgitation at 12 months compared to BEV implantation. Prosthesis-patient mismatch was significantly lower with SEVs, regardless of the definition used and adjustment for body mass index. Use of SEVs was associated with better quality of life outcomes as assessed by the Valve Academic Research Consortium-3 ordinal quality of life measure.Conclusions and RelevanceAmong women with severe symptomatic aortic stenosis and small aortic annuli undergoing transcatheter aortic valve replacement, the use of SEVs, compared to BEVs, resulted in similar clinical outcomes and a markedly reduced incidence of bioprosthetic valve dysfunction through 12 months, including a lower risk of prosthesis-patient mismatch and better 12-month quality of life.Trial RegistrationClinicalTrials.gov Identifier: NCT04722250

中文翻译：

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按瓣膜类型划分的经导管主动脉瓣植入术用于小环女性


重要性从历史上看，与男性相比，患有主动脉瓣狭窄的女性预后更差且认识不足，既诊断不足，治疗不足，同时在临床试验中也面临代表性不足的问题。目的确定接受经导管主动脉瓣置换术的小主动脉环女性使用自膨式瓣膜 （SEV） 或球囊扩张瓣膜 （BEV） 是否具有更好的临床和血流动力学结局。设计、设置、参与者随机分配至进化组或 SAPIEN 试验 （SMART） 的小环是一项大规模随机临床试验，重点关注接受经导管主动脉瓣置换术的小主动脉环患者，随机接受 SEV 或 BEV，包括 2021 年 4 月至 2022 年 10 月在加拿大、欧洲、以色列和美国的 83 个中心接受治疗的 716 名患者。这项预先指定的二次分析报告了所有 621 名参加 SMART 的女性的临床和血流动力学结果。本报告的数据分析了 2024 年 2 月至 4 月。主要结局和测量复合共同原发性临床终点包括死亡、致残性卒中或心力衰竭相关再住院。共同主要瓣膜功能终点是生物人工瓣膜功能障碍的发生率，均通过 12 个月进行评估。次要终点包括中度或重度假体-患者错配的发生率。结果共有 621 名女性 （平均 [SD] 年龄，80.2 [6.2] 岁;312 名随机分配到 SEV 组，309 名随机分配到 BEV 组）。12 个月时，SEV 组和 BEV 组之间的共同主要临床终点没有显著差异 （9.4% vs 11.8%，绝对风险差 -2.3%;95% CI -7。2 到 2.5，P = .35）。然而，SEV 植入与较少的生物瓣膜功能障碍相关（8.4% 对 41.8%;绝对风险差，-33.4%;95% CI，-40.4 至 -26.4;P < .001）。与 BEV 植入相比，SEV 植入导致 30 天和 12 个月时主动脉瓣梯度降低，有效孔口面积更大，12 个月时轻度或重度主动脉瓣反流减少。无论使用的定义和体重指数的调整如何，SEV 的假体-患者错配率都显著降低。根据 Valve Academic Research Consortium-3 顺序生活质量测量评估，使用 SEV 与更好的生活质量结局相关。结论和相关性在接受经导管主动脉瓣置换术的严重症状性主动脉瓣狭窄和小主动脉环女性中，与 BEV 相比，使用 SEV 导致相似的临床结果，并且在 12 个月内生物瓣膜功能障碍的发生率显著降低，包括降低人工瓣膜-患者错配的风险和更好的 12 个月生活质量。试验注册临床试验。gov 标识符： NCT04722250