1Ameer E. Hassan, 2Johanna T. Fifi, 3Osama O. Zaidat
1University of Texas Rio Grande Valley, Texas, United States; 2Icahn School of Medicine At Mount Sinai, New York, United States; 3Mercy Health St. Vincent Medical Center, Ohio, United States
By reducing procedure times, devices with higher first pass effect (FPE: successful revascularization with a single pass) may improve outcomes. The purpose of this analysis is to evaluate the impact of FPE on 90-day outcomes.
Material(s) and Method(s):
COMPLETE was an international, multi-center, prospective, single-arm registry enrolling patients with intracranial large vessel occlusion and planned frontline thrombectomy with the Penumbra System. Primary endpoints included post-procedural revascularization success (mTICI ≥2b), good functional outcome (mRS 0-2), and all-cause mortality at 90 days. Angiographic revascularization scores were core-lab adjudicated and safety events reviewed by external medical reviewers.
This study enrolled 650 patients at 42 sites across the US and Europe. Occlusion locations in this study were 4.6% ICA, 12.8% Carotid-T, 55.2% M1, 17.4% M2, 1.4% M3, 0.2% M4, 0.6% ACA, and 7.8% posterior. The rate of FPE-TICI 3 was 31.8% (206/648), FPE-TICI 2c-3 was 41.5% (269/648), and FPE-TICI 2b-3 was 56.8% (368/648). In the FPE-TICI 3, FPE-TICI 2c-3, and FPE-TICI 2b-3 groups, the rate of mRS 0-2 at 90-days was 63.7% (123/193), 62.7% (158/252), and 61.2% (211/345) respectively (Table 1). These rates were significantly higher with FPE revascularization compared to non-FPE (p < 0.05).
Achieving revascularization to TICI 2b or greater with a single pass of the Penumbra System was associated with significantly higher rates of good clinical outcome.