Effect of Dapagliflozin on Quality of Life of Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation.

Dapagliflozin has been shown to reduce death and heart failure (HF) in these patients.

达格列净已被证明可以降低这些患者的死亡率和心力衰竭（HF）风险。

However, the impact of dapagliflozin on improving health status after TAVI is unknown.

然而，达格列净对改善经导管主动脉瓣植入术（TAVI）后健康状况的影响尚不明确。

In this prespecified analysis of the DapaTAVI (Dapagliflozin After Transcatheter Aortic Valve Implantation) trial, we examined the effects of dapagliflozin on health status by using the Kansas City Cardiomyopathy Questionnaire (KCCQ).

在这项DapaTAVI（达格列净在经导管主动脉瓣植入术后使用）试验的预先设定分析中，我们通过使用堪萨斯城心肌病问卷（KCCQ）来检查达格列净对健康状况的影响。

Methods

The DapaTAVI trial randomized patients undergoing TAVI to receive or not receive dapagliflozin.

DapaTAVI试验将接受TAVI治疗的患者随机分为接受或不接受达格列净治疗的组别。

We assessed the change in KCCQ score from baseline to 3 and 12 months by using an ordinal logistic regression model.

我们使用序数逻辑回归模型评估了从基线到3个月和12个月KCCQ评分的变化。

Additionally, we analyzed the effect of dapagliflozin on the composite of death or worsening HF by baseline KCCQ score.

此外，我们分析了达格列净对基线KCCQ评分患者死亡或心力衰竭恶化复合终点的影响。

Results

A total of 964 patients had baseline KCCQ scores (mean 39.5 ± 22.2).

共有964名患者有基线KCCQ评分（平均39.5 ± 22.2）。

Patients in both arms of the study exhibited improvements in KCCQ score, without significant differences between groups in the change in KCCQ score at 3 or 12 months (3-month OR for improvement: 0.96; 95% CI: 0.72-1.26; P = 0.745; 12-month OR: 1.03; 95% CI: 0.83-1.27; P = 0.819).

研究中两组患者均显示出KCCQ评分的改善，但在3个月或12个月时两组间KCCQ评分变化无显著差异（3个月改善的比值比为0.96；95%置信区间：0.72-1.26；P = 0.745；12个月比值比为1.03；95%置信区间：0.83-1.27；P = 0.819）。

At 12 months, similar proportions of patients in the dapagliflozin and control groups showed clinically meaningful improvements, with 43.4% vs 45.4%, respectively, improving by >50 points.

在12个月时，达格列净组和对照组中分别有43.4%和45.4%的患者显示出具有临床意义的改善，改善幅度超过50分。

The clinical benefits of dapagliflozin after TAVI appeared to be similar across the full range of baseline KCCQ scores.

在经导管主动脉瓣置换术（TAVI）后，达格列净的临床益处似乎在基线KCCQ评分的全范围内相似。

Conclusions

TAVI was associated with a substantial improvement in KCCQ scores.

经导管主动脉瓣置换术（TAVI）与KCCQ评分的显著改善相关。

However, the addition of dapagliflozin following the procedure did not confer an additional benefit in health status compared with standard care.

然而，在手术后添加达格列净并没有比标准治疗带来额外的健康状况益处。

(Dapagliflozin After Transcatheter Aortic Valve Implantation [DapaTAVI]; NCT04696185).

(经导管主动脉瓣植入术后使用达格列净 [DapaTAVI]; NCT04696185)。