Comparing the efficacy and safety of the Skyflow device with those of the Solitaire FR stent in patients with acute ischemic stroke: a prospective, multicenter, randomized, non-inferiority clinical trial.

BACKGROUND: Mechanical thrombectomy is the standard treatment for acute ischemic stroke (AIS) with large vessel occlusion (LVO) in the anterior circulation. This trial aimed to indicate whether Skyflow, a new thrombectomy device, could achieve the same safety and efficacy as Solitaire FR in the treatment of AIS. METHODS: This study was a prospective, multicenter, randomized, single blind, parallel, positive controlled, non-inferiority clinical trial. Patients with intracranial anterior circulation LVO within 8 hours from onset were included to receive thrombectomy treatment with either the Skyflow or Solitaire FR stent retriever. The primary endpoint was the rate of successful reperfusion (modified Treatment In Cerebral Infarction (mTICI) ≥2b) after the operation. The safety endpoints were the rate of symptomatic intracranial hemorrhage (sICH) and subarachnoid hemorrhage (SAH) at 24 hours after operation. RESULTS: A total of 95 and 97 patients were involved in the Skyflow group and Solitaire FR group, respectively. A successful reperfusion (mTICI ≥2b) was finally achieved in 84 (88.4%) patients in the Skyflow group and 80 (82.5%) patients in the Solitaire FR group. Skyflow was non-inferior to Solitaire FR in regard to the primary outcome, with the criterion of a non-inferiority margin of 12.5% (p=0.0002) after being adjusted for the combined center effect and the National Institutes of Health Stroke Scale (NIHSS) score. The rate of periprocedural sICH and SAH did not differ significantly between the two groups. CONCLUSION: Endovascular thrombectomy with the Skyflow stent retriever was non-inferior to Solitaire FR with regard to successful reperfusion in AIS due to LVO (with a pre-specified non-inferiority margin of 12.5%).

Safety and efficacy of a new prophylactic tirofiban protocol without oral intraoperative antiplatelet therapy for endovascular treatment of ruptured intracranial aneurysms.

BACKGROUND: Coil embolization of intracranial aneurysms is being increasingly used; however, thromboembolic events have become a major periprocedural complication. OBJECTIVE: To determine the safety and efficacy of prophylactic tirofiban in patients with ruptured intracranial aneurysms. METHODS: Tirofiban was administered as an intravenous bolus (8.0 µg/kg over 3 min) followed by a maintenance infusion (0.10 µg/kg/min) before stent deployment or after completion of single coiling. Dual oral antiplatelet therapy (loading doses) was overlapped with half the tirofiban dose 2 h before cessation of the tirofiban infusion. Cases of intracranial hemorrhage or thromboembolism were recorded. RESULTS: Tirofiban was prophylactically used in 221 patients, including 175 (79.19%) who underwent stent-assisted coiling and 46 (20.81%) who underwent single coiling, all in the setting of aneurysmal subarachnoid hemorrhage. Six (2.71%) cases of intracranial hemorrhage occurred, including four (1.81%) tirofiban-related cases and two (0.90%) antiplatelet therapy-related cases. There were two (0.90%) cases of fatal hemorrhage, one related to tirofiban and the other related to dual antiplatelet therapy. Thromboembolic events occurred in seven (3.17%) patients (6 stent-assisted embolization, 1 single coiling), of which one (0.45%) event occurred during stenting and six (2.72%) occurred during intravenous tirofiban maintenance. No thromboembolic events related to dual antiplatelet therapy were found. CONCLUSIONS: Tirofiban bolus over 3 min followed by maintenance infusion appears to be a safe and efficient prophylactic protocol for the endovascular treatment of ruptured intracranial aneurysms and may be an alternative to intraoperative oral antiplatelet therapy, especially in the case of stent-assisted embolization.