Revascularization Results in the Interventional Management of Stroke II Trial

Our aim was to detail revascularization results, including impact on outcome and mortality, in the Interventional Management of Stroke (IMS) II trial. IMS II was designed to obtain estimates of the efficacy and safety of reduced-dose intravenous recombinant tissue plasminogen activator (rtPA) followed by additional intra-arterial rtPA and low-energy sonography via the EKOS Primo Micro-Infusion Catheter at the occlusion in selected patients with ischemic stroke treated within 3 hours of onset. Revascularization outcomes were detailed and compared with modified Rankin Scale scores 0-2, mortality outcomes, and results from IMS I. Complete recanalization at 60 minutes occurred in 12 of 29 (41.4%) sonography microcatheter-treated occlusions. Complete recanalization was achieved at 2 hours or procedure end in 20/29 (68.9%) in the ultrasound catheter-treated group, and final thrombolysis in cerebral infarction (TICI) 2/3 reperfusion was achieved in 18/29 (62.0%) ultrasound-treated subjects. Fifteen-minute angiograms demonstrated some recanalization in 69/145 (46.7%) sonography microcatheter treatment intervals, compared with 39/111 (35.1%) in IMS I treatments in 23 subjects with reliable 15-minute angiograms (P = .046). Pooled IMS I-II data demonstrated that partial or complete recanalization occurred in 56/75 (74.6%) and good reperfusion (TICI 2/3) occurred in 46/75 (61.3%) of internal carotid artery T and M1 occlusions. Revascularization correlated with good outcome for TICI 2/3 reperfusion (P = .0004), TICI 2B/3 reperfusion (P = .0002), and arterial occlusive lesion 2/3 recanalization (P = .03). IMS II provides evidence that the EKOS Primo sonography microcatheter exhibits a trend toward improved recanalization of the occlusion compared with a standard microcatheter and again confirms the correlation between recanalization and reperfusion with good clinical outcome and reduced mortality.