经导管主动脉瓣置换术患者的临床表现和结局的性别差异：一项队列研究。

Sex-Specific Differences at Presentation and Outcomes Among Patients Undergoing Transcatheter Aortic Valve Replacement: A Cohort Study.

出版信息

Ann Intern Med. 2016 Mar 15;164(6):377-84. doi: 10.7326/M15-0121. Epub 2016 Feb 23.

Abstract

BACKGROUND

Female sex is associated with poorer outcomes after surgical aortic valve replacement (SAVR). Data on sex-specific differences after transcatheter aortic valve replacement (TAVR) are conflicting.

OBJECTIVE

To examine sex-specific differences in patients undergoing TAVR in the PARTNER (Placement of Aortic Transcatheter Valves) trial.

DESIGN

Secondary analysis of the randomized and nonrandomized portions of the PARTNER trial. (ClinicalTrials.gov: NCT00530894).

SETTING

25 hospitals in the United States, Canada, and Germany.

PATIENTS

High-risk and inoperable patients (1220 women and 1339 men).

INTERVENTION

TAVR.

MEASUREMENTS

Demographic characteristics, cardiac and noncardiac comorbidities, mortality, stroke, rehospitalization, vascular complications, bleeding complications, and echocardiographic valve parameters.

RESULTS

At baseline, women had lower rates of hyperlipidemia, diabetes, smoking, and renal disease but higher Society of Thoracic Surgeons Predicted Risk of Mortality scores (11.9% vs. 11.1%; P < 0.001). After TAVR, women had more vascular complications (17.3% vs. 10.0%; difference, 7.29 percentage points [95% CI, 4.63 to 9.95 percentage points]; P < 0.001) and major bleeding (10.5% vs. 7.7%; difference, 2.8 percentage points [CI, 0.57 to 5.04 percentage points]; P = 0.012) but less frequent moderate and severe paravalvular regurgitation (6.0% vs. 14.3%; difference, -8.3 percentage points [CI, -11.7 to -5.0 percentage points]; P < 0.001). At 30 days, the unadjusted all-cause mortality rate (6.5% vs. 5.9%; difference, 0.6 percentage point [CI, -1.29 to 2.45 percentage points]; P = 0.52) and stroke incidence (3.8% vs. 3.0%; difference, 0.8 percentage point [CI, -0.62 to 2.19 percentage points]; P = 0.28) were similar. At 1 year, all-cause mortality was significantly lower in women than in men (19.0% vs. 25.9%; hazard ratio, 0.72 [CI, 0.61 to 0.85]; P < 0.001).

LIMITATION

Secondary analysis that included nonrandomized trial data.

CONCLUSION

Despite a higher incidence of vascular and bleeding complications, women having TAVR had lower mortality than men at 1 year. Thus, sex-specific risk in TAVR is the opposite of that in SAVR, for which female sex has been shown to be independently associated with an adverse prognosis.

PRIMARY FUNDING SOURCE

Edwards Lifesciences.

摘要

背景

女性在接受主动脉瓣置换术（SAVR）后预后较差。经导管主动脉瓣置换术（TAVR）后性别差异的数据存在争议。

目的

检查 PARTNER 试验中接受 TAVR 的患者的性别差异。

设计

PARTNER 试验的随机和非随机部分的二次分析。（ClinicalTrials.gov：NCT00530894）。

地点

美国、加拿大和德国的 25 家医院。

患者

高危和手术禁忌患者（1220 名女性和 1339 名男性）。

干预

TAVR。

测量

人口统计学特征、心脏和非心脏合并症、死亡率、中风、再住院、血管并发症、出血并发症和超声心动图瓣膜参数。

结果

基线时，女性的高脂血症、糖尿病、吸烟和肾脏疾病发生率较低，但胸外科医师协会预测死亡率评分较高（11.9% vs. 11.1%；P<0.001）。TAVR 后，女性血管并发症更多（17.3% vs. 10.0%；差异 7.29 个百分点[95%CI，4.63 至 9.95 个百分点]；P<0.001）和大出血（10.5% vs. 7.7%；差异 2.8 个百分点[CI，0.57 至 5.04 个百分点]；P=0.012），但中度和重度瓣周漏较少（6.0% vs. 14.3%；差异 -8.3 个百分点[CI，-11.7 至-5.0 个百分点]；P<0.001）。30 天时，未调整的全因死亡率（6.5% vs. 5.9%；差异 0.6 个百分点[CI，-1.29 至 2.45 个百分点]；P=0.52）和中风发生率（3.8% vs. 3.0%；差异 0.8 个百分点[CI，-0.62 至 2.19 个百分点]；P=0.28）相似。1 年时，女性的全因死亡率明显低于男性（19.0% vs. 25.9%；风险比，0.72[CI，0.61 至 0.85]；P<0.001）。