Messori Andrea, Trippoli Sabrina, Romeo Maria Rita, Fadda Valeria, Rivano Melania, Spazio Lorenzo Di
HTA Unit, Regione Toscana, Regional Health Service, 50139 Firenze, Italy.
Ospedale del Cuore, Fondazione Monasterio, Regional Health Service, 54100 Massa, Italy.
Rev Cardiovasc Med. 2024 Jun 20;25(6):223. doi: 10.31083/j.rcm2506223. eCollection 2024 Jun.
The reconstruction of individual patient data from published Kaplan-Meier survival curves is a new technique (often denoted as the IPDfromKM method) for studying efficacy in cases where multiple trials are available, and the endpoint is long-term mortality. In patients with tricuspid regurgitation, both valve repair and valve replacement have been proposed to improve prognosis; 6 controlled clinical trials (CTs) have been conducted to compare the two therapeutic options mentioned above. The objective of our analysis was to study these six trials through the application of the IPDfromKM method.
In the present report, we applied the IPDfromKM method to carry out a pooled analysis of these 6 CTs to investigate the effectiveness of valve repair vs valve replacement and to assess the between-study heterogeneity from this clinical material. After reconstructing individual patient data from these 6 trials, patients treated with valve repair were pooled together and their Kaplan-Meier curve was generated. Likewise, patients treated with valve replacement were pooled together and their Kaplan-Meier curve was generated. Finally, these two curves were compared by standard survival statistics. The hazard ratio (HR) was determined; death from any cause was the endpoint.
These 6 CTs included a total of 552 patients; in each of these CTs, the patient group treated with valve repair was compared with another group treated with valve replacement. Our statistical results showed a significantly better survival for valve repair compared with valve replacement (HR, 0.6098; 95% confidence intervals (CI), 0.445 to 0.835; = 0.002). Heterogeneity was found to be significant in the 6 patient arms undergoing replacement, but not in those undergoing valve repair. In valve replacement, the classification of patients in class III or IV of New York Heart Association (NYHA) was the main negative prognostic factor.
Our analysis confirmed the methodological advantages of the IPDfromKM method in the indirect comparative analysis of multiple trials. These advantages include appropriate analysis of censored patients, original assessment of heterogeneity, and graphical presentation of the results, wherein individual patients retain an important role.
从已发表的Kaplan-Meier生存曲线重建个体患者数据是一种新技术（通常称为IPDfromKM方法），用于在有多个试验且终点为长期死亡率的情况下研究疗效。对于三尖瓣反流患者，瓣膜修复和瓣膜置换均被认为可改善预后；已进行了6项对照临床试验（CT）来比较上述两种治疗选择。我们分析的目的是通过应用IPDfromKM方法来研究这6项试验。
在本报告中，我们应用IPDfromKM方法对这6项CT进行汇总分析，以研究瓣膜修复与瓣膜置换的有效性，并评估该临床资料中研究间的异质性。从这6项试验重建个体患者数据后，将接受瓣膜修复治疗的患者汇总在一起并生成其Kaplan-Meier曲线。同样，将接受瓣膜置换治疗的患者汇总在一起并生成其Kaplan-Meier曲线。最后，通过标准生存统计比较这两条曲线。确定风险比（HR）；任何原因导致的死亡作为终点。
这6项CT共纳入552例患者；在每项CT中，将接受瓣膜修复治疗的患者组与另一接受瓣膜置换治疗的组进行比较。我们的统计结果显示，与瓣膜置换相比，瓣膜修复的生存率显著更高（HR，0.6098；95%置信区间（CI），0.445至0.835；P = 0.002）。在接受置换的6组患者中发现异质性显著，但在接受瓣膜修复的患者中未发现。在瓣膜置换中，纽约心脏协会（NYHA）III级或IV级患者分类是主要的不良预后因素。
我们的分析证实了IPDfromKM方法在多项试验间接比较分析中的方法学优势。这些优势包括对删失患者的适当分析、对异质性的原始评估以及结果的图形呈现，其中个体患者起着重要作用。
