Tonelli Adriano R, Sahay Sandeep, Gordon Kathryn W, Edwards Lisa D, Allmon Andrew G, Broderick Meredith, Nelsen Andrew C
Department of Pulmonary, Allergy and Critical Care Medicine, Respiratory Institute, Cleveland Clinic, OH, USA.
Weill Cornell Medical College, Institute of Academic Medicine, Houston Methodist Lung Center, Houston Methodist Hospital, Houston, TX, USA.
Pulm Circ. 2020 Dec 14;10(4):2045894020977025. doi: 10.1177/2045894020977025. eCollection 2020 Oct-Dec.
The 2015 European Society of Cardiology/European Respiratory Society treatment guidelines recommend frequent risk assessment in pulmonary arterial hypertension utilizing risk variables. Our objectives were: (1) to investigate the impact of inhaled treprostinil on risk stratification using the French noninvasive approach and REVEAL 2.0, and (2) to analyze the prognostic utility of both risk stratification methods in the predominantly New York Heart Association/World Health Organization functional class III/IV cohorts of TRIUMPH and BEAT. A post hoc analysis was performed to assess risk at baseline and follow-up at Week 12 in the TRIUMPH cohort ( = 148) and at Week 16, 21, and 30 in the inhaled treprostinil naïve placebo BEAT cohort ( = 73). Overall survival, clinical worsening-free survival, and pulmonary arterial hypertension-related hospitalization-free survival were all assessed in the pooled TRIUMPH and inhaled treprostinil naïve placebo BEAT cohorts based on risk group/strata at Week 12/16 follow-up. Inhaled treprostinil improved REVEAL 2.0 risk stratum (OR: 2.38, 95% CI: 1.09-5.19, = 0.0298) and REVEAL 2.0 score ( = 0.0008) compared to placebo in the TRIUMPH cohort at Week 12. REVEAL 2.0 risk stratum and the number of low-risk criteria by the French approach improved at Weeks 16, 21, and 30 in the inhaled treprostinil naïve placebo BEAT cohort. Combining cohorts, REVEAL 2.0 risk stratification at follow-up was prognostic for clinical worsening-free, pulmonary arterial hypertension hospitalization-free, and overall survival, whereas the number of low-risk criteria was not. These post-hoc pooled analyses suggest inhaled treprostinil improves risk status and indicates that the REVEAL 2.0 calculator may be more suitable than the French noninvasive method for evaluating short-term clinical change in the New York Heart Association/World Health Organization functional class III/IV population.
2015年欧洲心脏病学会/欧洲呼吸学会治疗指南建议，利用风险变量对肺动脉高压患者进行频繁的风险评估。我们的目标是：（1）采用法国非侵入性方法和REVEAL 2.0，研究吸入性曲前列尼尔对风险分层的影响；（2）分析两种风险分层方法在TRIUMPH和BEAT研究中以纽约心脏协会/世界卫生组织功能分级III/IV级为主的队列中的预后效用。对TRIUMPH队列（n = 148）第12周以及初治吸入性曲前列尼尔的安慰剂BEAT队列（n = 73）第16、21和30周的基线和随访风险进行事后分析。基于第12/16周随访时的风险组/分层，在合并的TRIUMPH队列和初治吸入性曲前列尼尔的安慰剂BEAT队列中评估总生存期、无临床恶化生存期和无肺动脉高压相关住院生存期。在TRIUMPH队列第12周时，与安慰剂相比，吸入性曲前列尼尔改善了REVEAL 2.0风险分层（OR：2.38，95%CI：1.09 - 5.19，P = 0.0298）和REVEAL 2.0评分（P = 0.0008）。在初治吸入性曲前列尼尔的安慰剂BEAT队列中，第16、21和30周时，REVEAL 2.0风险分层以及法国方法的低风险标准数量均得到改善。合并队列后，随访时的REVEAL 2.0风险分层对无临床恶化、无肺动脉高压住院和总生存期具有预后意义，而低风险标准数量则不然。这些事后合并分析表明，吸入性曲前列尼尔可改善风险状态，并表明对于评估纽约心脏协会/世界卫生组织功能分级III/IV级人群的短期临床变化，REVEAL 2.0计算器可能比法国非侵入性方法更合适。
