Effectiveness of ACE68 and ACE64 Catheters in Anterior Circulation Large Vessel Occlusion: Promise Study Subgroup Analysis by Occlusion Location

Background: The PROMISE Study documented safety and efficacy of ACE68 and ACE64 Reperfusion Catheters in patients with acute ischemic stroke (AIS) from large vessel occlusion (LVO), treated with ADAPT (A Direct Aspiration First Pass Technique) as frontline treatment. This analysis examines the safety and efficacy by occlusion location. Method(s): PROMISE was a prospective, single-arm, multicenter study. Inclusion criteria were anterior circulation LVO within 6 hours of ictus; NIHSS ≥ 2; CT-ASPECTS ≥ 6; or MR-ASPECTS ≥ 5. Primary endpoints included successful angiographic revascularization (mTICI 2b-3), clinical independence (mRS 0-2) at 90 days. Secondary endpoints included safety events, functional improvement at 7-10 days. This subgroup analysis investigates these endpoints by occlusion location. Result(s): Across 20 European centers, 204 patients (median age 74 [IQR 65-80]) were enrolled. Primary occlusion locations were 21.1% (43/204) ICA/Carotid-T, 60.8% (124/204) M1, 18.1% (37/204) M2. Median baseline CT ASPECT score was 9 [IQR 8-10]. Median baseline NIHSS score was 16 [IQR 11-20]. Prior to procedure, 61.8% (126/204) patients had IV rtPA. Immediate post-procedural angiographic revascularization (mTICI 2b/3) rate was 93.1% (190/204), 90-day mRS 0-2 rate was 61.0% (122/200). Subgroup analysis by occlusion location: ICA/Carotid-T final revascularization (mTICI 2b/3) was 95.3% (41/43), 90-day mRS 0-2 was achieved in 64.3% (27/42); MCA M1 final revascularization was 92.7% (115/124) and 90-day mRS 0-2 rate was 57.0% (69/121); MCA M2 final revascularization was 91.9% (34/37) with 70.3% (26/37) having 90-day mRS 0-2. Safety rates were favorable (sICH=2.9%; ENT=1.5%); 90-day morbidity (mRS 3-5) was observed in 31.5% (63/200), and 90-day all cause-mortality was observed in 7.5% (15/200). Device and procedure-related SAEs at 30-days were reported in 2.0% (4/204) and 4.4% (9/204) of subjects, respectively. There was no significant difference in safety rates by treatment location. Conclusion(s): This subset analysis of the PROMISE study demonstrates the ACE68/64 Reperfusion Catheters are able to achieve high mTICI scores, with comparable safety profile and 3-month mRS in all studied locations for patients with LVO-AIS.

Publication History

Article published online:
11 May 2021