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期刊来源：N Engl J Med

原文链接：https://doi.org/10.1056/NEJMoa2312573

摘要内容如下：

背景

严重主动脉瓣狭窄和主动脉瓣环小的患者在经导管主动脉瓣置换术（TAVR）后存在瓣膜血流动力学性能受损和相关不良心血管临床结果的风险。

方法

我们将有症状的重度主动脉瓣狭窄且主动脉瓣环面积为430 mm2或更小的患者以1:1的比例随机分配接受TAVR，使用自膨式环上瓣膜或球囊扩张式瓣膜。在12个月内评估的共同主要终点是死亡、致残性卒中或因心力衰竭再住院（非劣效性测试）和测量生物瓣膜功能障碍的复合终点（优效性测试）。

结果

共有716名患者在13个国家的83个地点接受了治疗（平均年龄80岁；87%为女性；胸外科医师协会预测的平均死亡风险为3.3%）。Kaplan-Meier估计的12个月内死亡、发生致残性卒中或因心力衰竭再次住院的患者百分比为：自膨式瓣膜9.4%，球囊扩张式瓣膜10.6%（差异为-1.2个百分点；90%置信区间[CI]，-4.9至2.5；非劣效性P<0.001）。根据卡普兰-迈耶（Kaplan-Meier）估计，12个月内生物瓣膜功能障碍患者的百分比为9.4%（自膨式瓣膜）和41.6%（球囊扩张式瓣膜）（差异为-32.2个百分点；95%置信区间，-38.7至-25.6；优势P<0.001）。12个月时，自膨式瓣膜的主动脉瓣平均压差为7.7 mm Hg，球囊扩张式瓣膜的主动脉瓣平均压差为15.7 mm Hg，12个月时其他次要终点的相应值如下：平均有效瓣口面积，1.99 cm2和1.50 cm2；血流动力学结构性瓣膜功能障碍的比例分别为3.5%和32.8%；患有生物瓣膜功能障碍的女性比例分别为10.2%和43.3%（均P<0.001）。30天时，11.2%的自膨式瓣膜组患者和35.3%的球囊扩张式瓣膜组患者出现中度或重度瓣膜-患者不匹配（P<0.001）。两组的主要安全性终点似乎相似。

结论

在接受TAVR的严重主动脉瓣狭窄和主动脉瓣环较小的患者中，在12个月的临床结果方面，自膨式环上瓣膜不劣于球囊扩张式瓣膜，并且在生物瓣膜功能障碍方面优于球囊扩张式瓣膜。（由美敦力公司资助；Smart ClinicalTrials.gov编号，NCT04722250。）

英文原文如下：

Abstracts

BACKGROUND  Patients with severe aortic stenosis and a small aortic annulus are at risk for impaired valvular hemodynamic performance and associated adverse cardiovascular clinical outcomes after transcatheter aortic-valve replacement (TAVR).

METHODS  We randomly assigned patients with symptomatic severe aortic stenosis and an aortic-valve annulus area of 430 mm2 or less in a 1:1 ratio to undergo TAVR with either a self-expanding supraannular valve or a balloon-expandable valve. The coprimary end points, each assessed through 12 months, were a composite of death, disabling stroke, or rehospitalization for heart failure (tested for noninferiority) and a composite end point measuring bioprosthetic-valve dysfunction (tested for superiority).

RESULTS  A total of 716 patients were treated at 83 sites in 13 countries (mean age, 80 years; 87% women; mean Society of Thoracic Surgeons Predicted Risk of Mortality, 3.3%). The Kaplan-Meier estimate of the percentage of patients who died, had a disabling stroke, or were rehospitalized for heart failure through 12 months was 9.4% with the self-expanding valve and 10.6% with the balloon-expandable valve (difference, -1.2 percentage points; 90% confidence interval [CI], -4.9 to 2.5; P<0.001 for noninferiority). The Kaplan-Meier estimate of the percentage of patients with bioprosthetic-valve dysfunction through 12 months was 9.4% with the self-expanding valve and 41.6% with the balloon-expandable valve (difference, -32.2 percentage points; 95% CI, -38.7 to -25.6; P<0.001 for superiority). The aortic-valve mean gradient at 12 months was 7.7 mm Hg with the self-expanding valve and 15.7 mm Hg with the balloon-expandable valve, and the corresponding values for additional secondary end points through 12 months were as follows: mean effective orifice area, 1.99 cm2 and 1.50 cm2; percentage of patients with hemodynamic structural valve dysfunction, 3.5% and 32.8%; and percentage of women with bioprosthetic-valve dysfunction, 10.2% and 43.3% (all P<0.001). Moderate or severe prosthesis-patient mismatch at 30 days was found in 11.2% of the patients in the self-expanding valve group and 35.3% of those in the balloon-expandable valve group (P<0.001). Major safety end points appeared to be similar in the two groups.

CONCLUSIONS  Among patients with severe aortic stenosis and a small aortic annulus who underwent TAVR, a self-expanding supraannular valve was noninferior to a balloon-expandable valve with respect to clinical outcomes and was superior with respect to bioprosthetic-valve dysfunction through 12 months. (Funded by Medtronic; SMART ClinicalTrials.gov number, NCT04722250.).

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