1Osama O. Zaidat, 2Johanna T. Fifi, 3Ameer E. Hassan
1Mercy Health St. Vincent Medical Center, Toledo, United States; 2Icahn School of Medicine At Mount Sinai, New York, United States; 3University of Texas Rio Grande Valley – Valley Baptist Medical Center, Harlingen, United States
The COMPLETE registry was done to evaluate the performance of a mechanical thrombectomy system in patients with large vessel occlusion acute ischemic stroke (LVO-AIS) in a real world setting.
Material(s) and Method(s):
The global prospective multicenter COMPLETE registry enrolled LVO-AIS patients aged ≥ 18 years with pre-stroke modified Rankin Scale (mRS) 0-1 who underwent mechanical thrombectomy using the Penumbra System with or without the 3D Revascularization Device (Penumbra, Inc). The primary safety endpoint was 90-day all-cause mortality. The primary efficacy endpoints were successful post-procedure angiographic revascularization (modified thrombolysis in cerebral infarction [mTICI] ≥ 2b) and 90-day functional outcome (mRS 0-2). Secondary endpoints included incidence of device- or procedure-related serious adverse events (SAEs), occurrence of embolization in previously uninvolved or new territories (ENT), and occurrence of symptomatic intracranial hemorrhage (sICH) at 24 hours.
Descriptive statistics were calculated for all subjects and for 3 cohorts: Anterior circulation LVO with ASPECTS ≥ 6, Anterior circulation LVO with ASPECTS < 6, and Posterior circulation LVO. A core lab evaluated imaging findings and independent medical reviewers reviewed and adjudicated clinical events related to the safety endpoints.
From July 2018 to October 2019, 650 patients were enrolled across 42 centers (29 in the US and 13 in Europe). Baseline characteristics and endpoints are available in the table.
Mechanical thrombectomy with the Penumbra System in anterior and posterior circulations appears to be safe and effective, resulting in high rates of successful revascularization across all 3 cohorts.