Department of Internal Medicine, Cardiovascular Sciences and Immunology, Federico II University, Via Pansini 5, Naples, Italy.
J Am Coll Cardiol. 2012 Sep 25;60(13):1192-201. doi: 10.1016/j.jacc.2012.01.083.
The objectives of this study were to verify whether improvement in 6-min walk distance (6MWD) is associated with clinical outcome in pulmonary arterial hypertension (PAH).
6MWD is used as an endpoint to assess the benefit of therapies in PAH. However, whether changes in 6MWD correlate with clinical outcome is unknown.
Randomized trials assessing 6MWD in patients with PAH and reporting clinical endpoints were included in a meta-analysis. The meta-analysis was performed to assess the influence of treatment on outcomes. Meta-regression analysis was performed to test the relationship between 6MWD changes and outcomes.
Twenty-two trials enrolling 3,112 participants were included. Active treatments led to significant reduction of all-cause death (odds ratio [OR]: 0.429; 95% confidence interval [CI]: 0.277 to 0.664; p < 0.01), hospitalization for PAH, and/or lung or heart-lung transplantation (OR: 0.442; 95% CI: 0.309 to 0.632; p < 0.01), initiation of PAH rescue therapy (OR: 0.555; 95% CI: 0.347 to 0.889; p = 0.01), and composite outcome (OR: 0.400; 95% CI: 0.313 to 0.510; p < 0.01). No relationship between 6MWD changes and outcomes was detected.
In patients with PAH, improvement in 6MWD does not reflect benefit in clinical outcomes.
本研究旨在验证 6 分钟步行距离（6MWD）的改善是否与肺动脉高压（PAH）的临床结局相关。
6MWD 被用作评估 PAH 治疗获益的终点。然而，6MWD 的变化是否与临床结局相关尚不清楚。
纳入评估 PAH 患者 6MWD 并报告临床终点的随机试验进行荟萃分析。进行荟萃分析以评估治疗对结局的影响。进行荟萃回归分析以检验 6MWD 变化与结局之间的关系。
共纳入 22 项纳入 3112 名参与者的试验。积极治疗可显著降低全因死亡率（比值比 [OR]：0.429；95%置信区间 [CI]：0.277 至 0.664；p < 0.01）、PAH 住院和/或肺或心肺移植（OR：0.442；95%CI：0.309 至 0.632；p < 0.01）、PAH 抢救治疗的启动（OR：0.555；95%CI：0.347 至 0.889；p = 0.01）和复合结局（OR：0.400；95%CI：0.313 至 0.510；p < 0.01）。6MWD 变化与结局之间未检测到相关性。
在 PAH 患者中，6MWD 的改善并不能反映临床结局的获益。
