As we move forward in the field of acute ischemic stroke, after the publication of 3 negative trials last year, it is critical that we have a better understanding of patient selection. This will not only help in the conduct and design of the newer trials, it will allow for more appropriate utilization of resources. As one of the PIs of 2 ongoing international multicenter trials (ESCAPE and SWIFT PRIME), I have spent a lot of time thinking about these issues.
I feel that patient selection is going to be dependent on a combination of factors including age, premorbid status, and clinical severity of stroke. There are also going to be factors on the imaging side, such as the size of the core and the degree of the collaterals. There may be factors related to the procedure itself, such as tortuosity, access issues, and length and composition of clot.
In this study, we set out to explore the clinical factors looking at 2 very simple criteria: age and NIHSS score. It has been shown previously that patients with a score lower than 100 are unlikely to do well with IV thrombolysis. We wanted to explore whether these patients would do well with mechanical thrombectomy. As such, we decided to explore this question within the STAR study. The STAR study was a single-arm study in very experienced centers using the Solitaire device for mechanical thrombectomy. The workflow within these centers was excellent. The results of the workflow within the study have been recently published in Stroke.1 Overall, the workflow within the STAR study was excellent and showed dramatic improvement in time from imaging to recanalization, as the quality of recanalization (based on the TICI score) was compared with IMS III. As such, we felt it was the correct dataset to explore the SPAN-100 question.
In this study, we have shown that in patients with a sum of age and NIHSS score greater than 100, the likelihood of a good outcome is very low. I feel that these data will be quite useful in patient selection in ongoing studies.