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REVEAL 风险评分计算器 2.0 在 PATENT 研究中的应用。

Application of the REVEAL risk score calculator 2.0 in the PATENT study.

机构信息

Department of Medicine, Ohio State University Wexner Medical Center, Columbus, OH, USA.

Pulmonary Hypertension Center, Boston University/Boston Medical Center, Boston, MA, USA.

出版信息

Int J Cardiol. 2021 Jun 1;332:189-192. doi: 10.1016/j.ijcard.2021.03.034. Epub 2021 Mar 17.

DOI:10.1016/j.ijcard.2021.03.034
PMID:33744348
Abstract

BACKGROUND

Regular risk assessment is recommended in pulmonary arterial hypertension (PAH) management to improve patient outcomes. The REVEAL risk score (RRS) predicts survival in patients with PAH, including those from the PATENT study, which assessed riociguat, a soluble guanylate cyclase stimulator approved for PAH treatment. An updated version, RRS 2.0, has been developed to further refine risk prediction.

METHODS

This post hoc analysis of PATENT-1 and its open-label extension PATENT-2 (n = 396) assessed RRS 2.0 score and risk stratum and their association with survival and clinical worsening-free survival (CWFS).

RESULTS

At PATENT-1 Week 12, riociguat improved RRS 2.0 versus placebo (least-squares mean difference versus placebo: -1.0 [95% confidence interval - 1.4 to -0.6; p < 0.0001]) and more patients improved risk stratum with riociguat (57%) versus placebo (42%). These improvements were maintained at PATENT-2 Week 12. RRS 2.0 score and risk strata at PATENT-1 baseline and Week 12 were significantly associated with survival and CWFS in PATENT-2 (p < 0.0001); change in RRS 2.0 score from PATENT-1 baseline to Week 12 was also significantly associated with outcomes.

CONCLUSIONS

These data suggest that RRS 2.0 has clinical utility in predicting long-term outcomes and monitoring treatment response in patients with PAH.

摘要

背景

在肺动脉高压(PAH)管理中推荐定期进行风险评估,以改善患者预后。REVEAL 风险评分(RRS)可预测 PAH 患者的生存率,包括评估可溶性鸟苷酸环化酶刺激剂 riociguat 的 PATENT 研究中的患者,riociguat 已被批准用于 PAH 治疗。已开发出更新的版本 RRS 2.0 以进一步完善风险预测。

方法

本研究是 PATENT-1 和其开放标签扩展 PATENT-2 的事后分析(n=396),评估了 RRS 2.0 评分和风险分层及其与生存率和临床无恶化生存(CWFS)的关系。

结果

在 PATENT-1 第 12 周,riociguat 改善了 RRS 2.0 评分(与安慰剂相比,最小二乘均数差值为-1.0[95%置信区间-1.4 至-0.6;p<0.0001]),与安慰剂相比,更多患者的风险分层得到改善(riociguat 组 57%,安慰剂组 42%)。在 PATENT-2 第 12 周时仍保持了这些改善。PATENT-2 基线和第 12 周时的 RRS 2.0 评分和风险分层与生存率和 CWFS 显著相关(p<0.0001);从 PATENT-1 基线到第 12 周时 RRS 2.0 评分的变化与结局也显著相关。

结论

这些数据表明 RRS 2.0 可用于预测 PAH 患者的长期结局,并监测治疗反应。

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