Aristeidis H. Katsanos, MD, PhD
Yoshimura S, Uchida K, Daimon T, Takashima R, Kimura K, Morimoto T, on behalf of ASSORT Trial Investigator. Randomized Controlled Trial of Early Versus Delayed Statin Therapy in Patients With Acute Ischemic Stroke ASSORT Trial (Administration of Statin on Acute Ischemic Stroke Patient). Stroke. 2017
Even though the role of statins in both primary and secondary stroke prevention has been well established, with a considerable number of acute ischemic stroke (AIS) patients receiving statin treatment during the first days of ictus, the usefulness of statin therapy in the acute phase of cerebral ischemia still remains debatable.
The Administration of Statin on Acute Ischemic Stroke Patient (ASSORT) Trial is a multicenter, Japanese, open-label, randomized clinical trial (RCT) with the aim to determine the efficacy of early (≤24 hours) versus delayed (7th day) statin initiation in AIS. After randomizing a total of 257 patients (early: 131, delayed: 126), authors concluded that there is no superiority of early statin administration for AIS, as no significant differences were found on the 3-month functional outcome, stroke recurrence or mortality between patients receiving early or delayed statin therapy. As highlighted by the authors, the low dose of statins that were administered in the current trial (atorvastatin 20mg/d, pitavastatin 4mg/d or rosuvastatin 5mg/d) could partially account for the aforementioned lack of efficacy, concluding that higher doses should be attested in future studies.
Although no significant differences on the effect of early statin treatment on the 3-month functional outcome was found in pre-specified subgroup analyses, a more pronounced effect — with a potential signal of efficacy (cOR=0.63, 95%CI: 0.31-1.27) — could be postulated in patients with atherothrombotic stroke when compared to other AIS subgroups. This finding is also supported by recent publications suggesting an ameliorative role of statin pretreatment in patients with large artery atherosclerotic stroke, presumably due to atheromatous plaque stabilization and collateral circulation-cerebral autoregulation enhancement through endothelium nitric oxide synthase activation.
Having ASSORT as their reference point, future trials need to investigate further the efficacy of high-dose statin administration in the acute phase of ischemic stroke due to large artery atherothrombosis.