Background: 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.
Materials and Methods: COMPLETE was an international, multicenter, prospective, single-arm registry enrolling
patients with intracranial large vessel occlusion and planned frontline thrombectomy
with the Penumbra system. Primary endpoints included postprocedural revascularization
success (mTICI ≥ 2b), good functional outcome (mRS: 0–2), and all-cause mortality
at 90 days. Angiographic revascularization scores were core-laboratory adjudicated
and safety events reviewed by external medical reviewers.
Results: This study enrolled 650 patients at 42 sites across the United States 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.
These rates were significantly higher with FPE revascularization compared with non-FPE
(p < 0.05).
Conclusion: Achieving revascularization, TICI 2b or greater with a single pass of the Penumbra
system was associated with significantly higher rates of good clinical outcome.
