The Restricted Mean Survival Time as a Tool for Ranking Comparative Outcomes in a Narrative Review that Evaluates a Netw
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ORIGINAL RESEARCH ARTICLE
The Restricted Mean Survival Time as a Tool for Ranking Comparative Outcomes in a Narrative Review that Evaluates a Network of Randomized Trials: An Example Based on PCSK9 Inhibitors Andrea Messori1 · Laura Bartoli1 · Marco Chiumente2 · Daniele Mengato2 · Sabrina Trippoli1 Accepted: 22 September 2020 © Springer Nature Switzerland AG 2020
Abstract Introduction On the basis of two randomized trials, evolocumab and alirocumab have been approved in patients with cardiovascular disease. The evidence on these two agents has been studied through different methods of analysis that span from narrative approaches to network meta-analysis. In the present study, we assessed the performance of a narrative approach combined with the application of the restricted mean survival time (RMST). Methods We studied the two pivotal placebo-controlled trials focused on evolocumab and alirocumab. Our original framework of comparative assessment employed the RMST. Our objective was to show that in the context of a narrative review, the RMST can be an efficient although simple tool to make indirect comparisons. The endpoint was event-free survival, expressed in months. Results For each cohort of patients (13,784 patients administered evolocumab, 9462 patients administered alirocumab, 23,242 controls), we determined the RMST values with 95% confidence intervals (CI) [evolocumab: 33.60 months, 95% CI 33.46–33.74; alirocumab: 34.07 months, 95% CI 33.92–34.22]. These results, along with those of the control groups, were analyzed and interpreted narratively. Univariate statistics were conducted, but no network meta-analysis was performed. Conclusion The experience presented herein indicates that a framework of evidence assessment focused on the RMST is a worthwhile option. Our study is in line with the growing literature that has recently emphasized the methodological advantages of the RMST. Key Points The restricted mean survival time (RMST) is increasingly being used in the analysis of clinical studies as opposed to the hazard ratio. In the present paper, we applied the RMST to the analysis of the two pivotal trials published on the effectiveness of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors. Our paper confirms the methodological advantages of the RMST.
* Andrea Messori [email protected] 1
HTA Unit, Toscana Region Health Service, Toscana Region, Via Alderotti 46, 50135 Florence, Italy
Italian Society for Clinical Pharmacy and Therapeutics, Milan, Italy
2
1 Introduction The restricted mean survival time (RMST) is a relatively new parameter proposed to improve the analysis of survival curves [1–4]. In comparison with traditional analyses based on the hazard ratio (HR) and medians, the RMST has the advantage of capturing the overall shape of the survival curve, including the so-called ‘right tail’ of longterm survivors. Furthermore, the RMST is applicable even when the assumption of proportional hazards is violated. In recent times, a wide range of literature [5, 6] has
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