ARISE II Demonstrates Improved Reperfusion With EmboTrap in Ischemic Stroke
The majority of patients included in the ARISE II study achieved the primary efficacy endpoint of mTICI ≥2b within 3 passes.
Findings published in Stroke demonstrate that the EmboTrap dual-layer stent-retriever mechanical thrombectomy device, which traps and removes clots to restore blood flow, results in high reperfusion rates among patients with acute ischemic stroke associated with large-vessel occlusions. In addition, use of the EmboTrap is associated with high rates of functional independence in this patient population.
In the single-group, prospective ARISE II (Analysis of Revascularization in Ischemic Stroke With EmboTrap) study, a total of 227 patients with large-vessel occlusions and moderate to severe neurological deficits within an 8-hour period of symptom onset were recruited and treated with the EmboTrap device. Investigators assessed efficacy of device treatment, defined as a modified Thrombolysis in Cerebral Ischemia (mTICI) reperfusion score of ≥2b within a total of 3 device passes. In addition, investigators assessed safety as a composite of serious adverse effects and symptomatic intracerebral hemorrhage.
The majority of patients included in the ARISE II study achieved the primary efficacy endpoint of mTICI ≥2b within 3 passes (80.2%; 95% CI, 74%-85% vs 56% performance goal criterion; P <.0001). Use of rescue therapies, including intra-arterial thrombolysis, other thrombectomy devices, and pump aspiration, occurred in 19.4% of included patients. After all interventions, approximately 76% of patients achieved mTICI 2c/3, 92.5% achieved an mTICI of ≥2b, 75.8% achieved an mTICI of ≥2c, and 52.0% achieved an mTICI of 3. The composite rate of postprocedural symptomatic intracerebral hemorrhage or serious adverse effects was low (5.3%; 95% CI, 3%-9%). In addition, a majority of patients achieved functional independence at 90 days (67.3%; 95% CI, 61%-73%).
The lack of a comparator group as well as the relatively small patient sample represent the potential limitations of this study.
According to the investigators, factors "such as patient selection, good ASPECT score, and speed of treatment may potentially have contributed to the high rate of good long-term clinical outcomes" in this study.
Zaidat OO, Bozorgchami H, Ribó M, et al. Primary results of the multicenter ARISE II study (Analysis of Revascularization in Ischemic Stroke With EmboTrap). Stroke. 2018;49(5):1107-1115.