Response by Sex in Patient-Centered Outcomes With Baroreflex Activation Therapy in Systolic Heart Failure.

Response by Sex in Patient-Centered Outcomes With Baroreflex Activation Therapy in Systolic Heart Failure.
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DOI:
10.1016/j.jchf.2021.01.012
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发表时间:
2021-06
期刊:
JACC. Heart failure
影响因子:
--
通讯作者:
Zannad F
Zannad F
中科院分区:
其他
文献类型:
--
作者:
Lindenfeld J;Gupta R;Grazette L;Ruddy JM;Tsao L;Galle E;Rogers T;Sears S;Zannad F

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本研究的目的是评估BeAT-HF(压力反射激活疗法治疗心力衰竭)试验中压力反射激活疗法(BAT)的疗效和安全性的性别差异。将患者按1:1随机分为两组,对照组仅接受指南指导的药物治疗(GDMT),BAT加GDMT治疗。在男性与女性中进行预先规定的亚组分析,包括6分钟步行距离(6 MWD)从基线至6个月的变化、使用明尼苏达心力衰竭生活问卷(MLWHQ)评估的生活质量(QoL)、纽约心脏协会(NYHA)功能分级和N末端B型利钠肽前体(NT-proBNP)。对53名女性和211名男性进行了评估。与男性相比,女性的基线NT-proBNP水平、6 MWD和NYHA功能III级症状受试者百分比相似,但MLWHQ评分较差(平均值62 ± 22 vs. 50 ± 24; p = 0.01)。从基线到6个月,BAT + GDMT相对于GDMT单独治疗的女性MLWHQ评分有显著改善(分别为-34 ± 27 vs. -9 ± 23; p < 0.01),6 MWD(44 ± 45 m vs. -32 118 m; p < 0.01),NYHA心功能分级改善(70% vs. 27%; p < 0.01),与男性相似,安全性无显著差异。接受BAT加GDMT的女性NT-proBNP显著降低(-43% vs. 7%,单独使用GDMT;差异-48%; p < 0.01),而在男性中,这种降低分别为-15% vs. 2%(差异-17%; p = 0.08),相互作用p值为0.05。BeAT-HF组女性的基线QoL比男性差,但BAT组在6 MWD、QoL和NYHA心功能分级方面的改善相似。女性NT-proBNP有显著改善,而男性则没有。(心力衰竭的压力反射激活疗法[BeAT-HF]; NCT 02627196)(J Am科尔心脏病HF 2021;9:430-8)
The aim of this study was to assess sex differences in the efficacy and safety of baroreflex activation therapy (BAT) in the BeAT-HF (Baroreflex Activation Therapy for Heart Failure) trial. Patients were randomized 1:1 to receive guideline-directed medical therapy (GDMT) alone (control group) or BAT plus GDMT. Pre-specified subgroup analyses including change from baseline to 6 months in 6-min walk distance (6MWD), quality of life (QoL) assessed using the Minnesota Living With Heart Failure Questionnaire (MLWHQ), New York Heart Association (NYHA) functional class, and N-terminal pro–B-type natriuretic peptide (NT-proBNP) were conducted in men versus women. Fifty-three women and 211 men were evaluated. Women had similar baseline NT-proBNP levels, 6MWDs, and percentage of subjects with NYHA functional class III symptoms but poorer MLWHQ scores (mean 62 ± 22 vs. 50 ± 24; p = 0.01) compared with men. Women experienced significant improvement from baseline to 6 months with BAT plus GDMT relative to GDMT alone in MLWHQ score (—34 ± 27 vs. —9 ± 23, respectively; p < 0.01), 6MWD (44 ± 45 m vs. —32 118 m; p < 0.01), and improvement in NYHA functional class (70% vs. 27%; p < 0.01), similar to the responses seen in men, with no significant difference in safety. Women receiving BAT plus GDMT had a significant decrease in NT-proBNP (—43% vs. 7% with GDMT alone; difference —48%; p < 0.01), while in men this decrease was —15% versus 2%, respectively (difference —17%; p = 0.08), with an interaction p value of 0.05. Women in BeAT-HF had poorer baseline QoL than men but demonstrated similar improvements with BAT in 6MWD, QoL, and NYHA functional class. Women had a significant improvement in NT-proBNP, whereas men did not. (Baroreflex Activation Therapy for Heart Failure [BeAT-HF]; NCT02627196) (J Am Coll Cardiol HF 2021;9:430–8)
DOI: 10.1093/eurheartj/ehi446
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发表时间: 2013-03
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影响因子: --
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