Cherry-picking the Wrong Patients has to be Avoided at all Cost!

Excerpt

We recently wrote about the influence of age and the Alberta Stroke Program Early CT Score (ASPECTS) on endovascular treatment (EVT) decisions in acute stroke, and hypothesized that by excluding old patients in low ASPECTS EVT trials, the overall treatment effect size of EVT will decrease, thereby possibly leading to a false negative trial outcome. In their response letter, the TENSION investigators argued that there is a possibility that while the overall outcomes are worse in older patients, the treatment effect might actually be preserved [1]. We agree with the TENSION investigators that there is a possibility that the EVT treatment effect is not influenced by patient age; however, a possible effect modification cannot be completely disregarded, since only few patients with ASPECTS <5 were included in past trials, and our knowledge about EVT benefit in this subgroup is limited by a very small sample size. Post-stroke outcomes in old patients are compromised by several factors, such as physical and cognitive comorbidities and lack of social support networks [2], which could negatively affect treatment effect size. Most importantly, we have to ask ourselves the question: what is a good outcome? It is known that older patients will suffer from worse outcomes compared to young patients, with and without EVT [1]. Let us assume that the treatment effect is preserved in older patients: EVT would then in many cases lead to a change in the 90-day modified Rankin score (mRS) from 4 to 3 or from 5 to 4. Although there clearly is a treatment effect, the question whether such a result is worth performing EVT remains unclear and depends on multiple factors including individual patient preferences and availability of support networks. It is definitely a question that needs to be answered. Thus, we completely agree with the TENSION investigators that the single most important thing to do now is to convince physicians to enroll as many eligible patients as possible across all age groups, in order to obtain a solid and valid trial result. …