Chemical Angioplasty Alone Versus Chemical and Mechanical Angioplasty for Cerebral Vasospasm after Aneurysmal Hemorrhage: A Pilot Randomized Controlled Study

BACKGROUND: Refractory cerebral vasospasm (CV) and delayed-cerebral-ischemia (DCI) following aneurysmal subarachnoid hemorrhage (aSAH) are associated with high morbidity and mortality; CV may recur despite intra-arterial chemical treatment, the role of mechanical angioplasty remains unclear. METHODS: In a prospective, monocentric, interventional trial, we randomly assigned patients with a refractory CV within the internal carotid arteries (ICAs) and an indication for endovascular management to undergo intra-arterial chemical angioplasty (control group) or chemical plus mechanical angioplasty (treatment group). The primary end point was the change of brain perfusion in the dedicated arterial territory measured by the Time to Drain (TTD) on CT perfusion, before and after treatment. RESULTS: A total of 12 patients underwent 44 ICA procedures: 23 were assigned to nimodipine and 21 to nimodipine plus angioplasty. The median percent change in TTD was -14% (interquartile range [IQR], -37 to 9) with nimodipine and -42% (IQR, -54 to -30) with nimodipine plus angioplasty (P=0.006). The percent change in arterial diameter was +30% (IQR, 17 to 40) and +91% (IQR, 68 to 130), respectively (P<0.001). Retreatment was required in 22 of 23 procedures (96%) in the nimodipine group and in 7 of 21 procedures (33%) in the angioplasty group (P<0.001). Complications occurred in 2 of 44 procedures (4.5%), both in the angioplasty group, with no disabling sequelae. CONCLUSIONS: In this pilot randomized study, the addition of mechanical angioplasty to intra-arterial nimodipine for refractory vasospasm after subarachnoid hemorrhage was associated with greater vessel dilation, improved perfusion, and fewer retreatments than nimodipine alone, with an acceptable safety profile. Larger, multicenter trials are warranted.