Adam de Havenon, MD

Pereira VM, Gralla J, Davalos A, Bonafé A, Castaño C, Chapot R, et al. Prospective, Multicenter, Single-Arm Study of Mechanical Thrombectomy Using Solitaire Flow Restoration in Acute Ischemic Stroke. Stroke. 2013

The field of endovascular treatment of acute ischemic stroke sustained a major blow on March 7th, 2013, when the New England Journal of Medicine published three prospective randomized negative studies (IMS-III, MR RESCUE, and SYNTHESIS) that showed endovascular therapy provided no benefit over intravenous t-PA or standard of care treatment. Many major stroke centers changed their practice based on these trials. However, most of that data is based on the use of the first-generation thrombectomy devices such as the Merci retriever and Penumbra System, while retrievable stents (“stentrievers”) are now preferred.

The STAR trial, by Vcitor Pereira et al., is a single arm intention-to-treat analysis using the Solitaire™ FR stentriever in 202 patients with angiographically-confirmed large vessel anterior circulation occlusions treated within 8 hours of symptom onset. Crucial exclusion criteria were modified Rankin scale (mRS) ≥2, ASPECT score ≤ 6 points on CT, or < 5 points on MRI. The median NIH stroke scale score was 17 and 59% of patients also received IV t-PA. The primary endpoint was revascularization, defined as ≥TICI 2b of the occluded vessel after a maximum of 3 passes, which was achieved in 79.2% of patients. The secondary endpoint was a good neurologic outcome defined as a mRS of 0-2 at 90 days, seen in 57.9% of patients.

Like other recently published data, the STAR trial suggests stentrievers result in higher rates of revascularization and lower rates of complications. The secondary outcome, a mRS of 0-2 at 90 days, of 58% is significantly higher than previously reported data. For comparison, the same result in SYNTHESIS, IMS-III, and SWIFT, which also used Solitaire, was 41%, 42%, and 37%. That’s what happens when you cherry-pick patients with small areas of infarct on imaging, premorbid mRS ≤2, and only anterior circulation occlusion. As a result, this trial does not change management, but it does wet my appetite for upcoming prospective randomized trials comparing second-generation stentrievers to IV t-PA.