Didier Tchétché, Roxana Mehran, Daniel J Blackman, Ramzi F Khalil, Helge Möllmann, Mohamed Abdel-Wahab, Walid Ben Ali, Paul D Mahoney, Hendrik Ruge, Sabine Bleiziffer, Lang Lin, Molly Szerlip, Kendra J Grubb, Isida Byku, Mayra Guerrero, Linda D Gillam, Anna Sonia Petronio, Guilherme F Attizzani, Wayne B Batchelor, Hemal Gada, Toby Rogers, Joshua D Rovin, Brian Whisenant, Stewart Benton, Blake Gardner, Ratnasari Padang, Andrew D Althouse, Howard C Herrmann
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引用次数: 0
摘要
重要性：从历史上看，女性主动脉瓣狭窄患者的治疗效果比男性差，而且没有得到足够的认可，既诊断不足又治疗不足，同时在临床试验中的代表性也不足：目的：确定患有小主动脉瓣环的女性接受经导管主动脉瓣置换术时，使用自膨胀瓣（SEV）或球囊扩张瓣（BEV）是否能获得更好的临床和血流动力学结果：小主动脉瓣环随机选择Evolut或SAPIEN试验（SMART）是一项大规模随机临床试验，主要针对接受经导管主动脉瓣置换术的小主动脉瓣环患者，随机选择接受SEV或BEV，共纳入716名患者，这些患者于2021年4月至2022年10月期间在加拿大、欧洲、以色列和美国的83个中心接受治疗。本预设二次分析报告了所有 621 名参加 SMART 的女性患者的临床和血液动力学结果。本报告的数据分析时间为 2024 年 2 月至 4 月：经导管主动脉瓣置换 SEV 或 BEV：复合主要临床终点包括死亡、致残性中风或心衰相关再住院。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，均在12个月内进行评估。次要终点包括中度或重度人工瓣膜与患者不匹配的发生率：本分析共纳入了 621 名女性（平均 [SD] 年龄为 80.2 [6.2] 岁；312 名随机分配到 SEV 组，309 名随机分配到 BEV 组）。12个月后，SEV组和BEV组的主要临床终点无显著差异（9.4% vs 11.8%，绝对风险差异-2.3%；95% CI -7.2 to 2.5，P = .35）。然而，SEV植入与较少的生物人工瓣膜功能障碍相关（8.4% vs 41.8%；绝对风险差异，-33.4%；95% CI，-40.4 至 -26.4；P 结论及意义：在接受经导管主动脉瓣置换术的重度症状性主动脉瓣狭窄和小主动脉瓣环的女性患者中，与BEV相比，使用SEV可获得相似的临床结果，12个月内生物假体瓣膜功能障碍的发生率明显降低，包括假体与患者不匹配的风险更低，12个月的生活质量更好：试验注册：ClinicalTrials.gov Identifier：试验注册：ClinicalTrials.gov Identifier：NCT04722250。
Transcatheter Aortic Valve Implantation by Valve Type in Women With Small Annuli: Results From the SMART Randomized Clinical Trial.
Importance: Historically, 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.
Objective: To 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, participants: The 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.
Interventions: Transcatheter aortic valve replacement with an SEV or a BEV.
Main outcomes and measures: The 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.
Results: A 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 relevance: Among 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.
JAMA cardiologyMedicine-Cardiology and Cardiovascular Medicine
CiteScore
45.80
自引率
1.70%
发文量
264
期刊介绍：
JAMA Cardiology, an international peer-reviewed journal, serves as the premier publication for clinical investigators, clinicians, and trainees in cardiovascular medicine worldwide. As a member of the JAMA Network, it aligns with a consortium of peer-reviewed general medical and specialty publications.
Published online weekly, every Wednesday, and in 12 print/online issues annually, JAMA Cardiology attracts over 4.3 million annual article views and downloads. Research articles become freely accessible online 12 months post-publication without any author fees. Moreover, the online version is readily accessible to institutions in developing countries through the World Health Organization's HINARI program.
Positioned at the intersection of clinical investigation, actionable clinical science, and clinical practice, JAMA Cardiology prioritizes traditional and evolving cardiovascular medicine, alongside evidence-based health policy. It places particular emphasis on health equity, especially when grounded in original science, as a top editorial priority.
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