Tchetche Didier, Pibarot Philippe, Bax Jeroen J, Bonaros Nikolaos, Windecker Stephan, Dumonteil Nicolas, Nietlispach Fabian, Messika-Zeitoun David, Pocock Stuart J, Berthoumieu Pierre, Swaans Martin J, Timmers Leo, Rudolph Tanja Katharina, Bleiziffer Sabine, Leroux Lionel, Modine Thomas, van der Kley Frank, Auffret Vincent, Tomasi Jacques, Stastny Lukas, Hengstenberg Christian, Andreas Martin, Leclercq Florence, Gandet Thomas, Mascherbauer Julia, Trescher Karola, Prendergast Bernard, Vasa-Nicotera Mariuca, Chieffo Alaide, Mares Jan, Wesselink Wilbert, Rakova Radka, Kurucova Jana, Bramlage Peter, Eltchaninoff Helene
Groupe Cardiovasculaire Interventionnel, Clinique Pasteur, 45 avenue de Lombez, 31076 Toulouse Cedex 3, France.
Department of Cardiology, Quebec Heart & Lung Institute, Laval University, Quebec City, QC, Canada.
Eur Heart J. 2025 Jun 9;46(22):2079-2088. doi: 10.1093/eurheartj/ehaf133.
Although women with severe symptomatic aortic stenosis have more complications than men when undergoing surgical valve replacement, they are under-represented in clinical trials. The Randomized researcH in womEn all comers wIth Aortic stenosis (RHEIA) trial investigates the balance of benefits and risks of transcatheter aortic valve implantation (TAVI) vs. surgery in women.
Women were randomized 1:1 to transfemoral TAVI with a balloon-expandable valve or surgery. The primary composite endpoint was death, stroke, or (valve, procedure or heart failure related) rehospitalization at 1 year. Non-inferiority testing with a pre-specified 6% margin and superiority testing were performed in the as-treated population.
At 48 European centres, 443 women underwent randomization, and 420 were treated as randomized. Mean age was 73 years, and the mean estimated surgical risk of death was 2.1% (Society of Thoracic Surgeons risk score). Kaplan-Meier estimates of the primary endpoint event rates at 1 year were 8.9% in the TAVI and 15.6% in the surgery group. This difference of -6.8% with an upper 95% confidence limit of -1.5% demonstrated the non-inferiority of TAVI (P < .001). The two-sided 95% confidence interval of -13.0% to -.5% further resulted in superiority (P = .034). The 1-year incidence of the primary endpoint components was: .9% with TAVI vs. 2.0% with surgery for death from any cause, 3.3% vs. 3.0% for stroke, and 5.8% vs. 11.4% for rehospitalization.
Among women with severe aortic stenosis, the incidence of the composite of death, stroke, or rehospitalization at 1 year was lower with TAVI than with surgery.
CLINICALTRIALS.GOV NUMBER: NCT04160130.
尽管有严重症状性主动脉瓣狭窄的女性在接受外科瓣膜置换术时比男性有更多并发症，但她们在临床试验中的代表性不足。女性主动脉瓣狭窄全人群随机研究（RHEIA）试验调查了经导管主动脉瓣植入术（TAVI）与外科手术在女性中的获益与风险平衡。
女性按1:1随机分为接受球囊扩张瓣膜经股动脉TAVI组或外科手术组。主要复合终点为1年时的死亡、卒中或（瓣膜、手术或心力衰竭相关）再次住院。在接受治疗的人群中进行了预先设定6%界值的非劣效性检验和优效性检验。
在48个欧洲中心，443名女性接受了随机分组，420名按随机分组接受了治疗。平均年龄为73岁，平均估计手术死亡风险为2.1%（胸外科医师协会风险评分）。TAVI组1年时主要终点事件率的Kaplan-Meier估计值为8.9%，手术组为15.6%。-6.8%的差异，95%置信上限为-1.5%，证明了TAVI的非劣效性（P <.001）。-13.0%至-.5%的双侧95%置信区间进一步显示了优效性（P =.034）。主要终点各组成部分的1年发生率为：任何原因导致的死亡，TAVI组为.9%，手术组为2.0%；卒中，TAVI组为3.3%，手术组为3.0%；再次住院，TAVI组为5.8%，手术组为11.4%。
在有严重主动脉瓣狭窄的女性中，TAVI组1年时死亡、卒中或再次住院的复合发生率低于手术组。
NCT04160130。
