Background: Endovascular thrombectomy trials established efficacy in acute ischemic stroke, yet real-world data on device effectiveness is warranted. Core lab adjudication of angiography is required to validate reperfusion, providing evidence and detailed data beyond randomized, controlled trials. We report the largest endovascular therapy registry data linking independent core lab data on reperfusion with clinical outcomes.
Methods: The Trevo Retriever Registry is a prospective, open-label, consecutive enrollment, multicenter, international registry with more than 65 enrolling sites worldwide. An independent Imaging Core Lab, blind to all other data, evaluates the angiography with a battery of various TICI scores (mTICI, oTICI, oTICI2C) to define reperfusion. Statistical analyses examined TICI reperfusion and association with clinical outcomes considering expansive data collected in the registry.
Results: 506 enrolled subjects (mean age 68.2 ± 14.2 yrs; 53% female) had core lab adjudicated angiography as of July 2016, including 21.5% > 80 years old. Baseline NIHSS was median 15.0 (9.0, 20.0) with time from onset to CT of median 4.0 (1.7, 9.7) hrs. Core lab adjudicated arterial occlusion sites were: 53% M1, 24% ICA, 16% M2, 4% Basilar and 2% other. Time to reperfusion (oTICI ≥ 2A) was median 30.0 (19.0, 42.0) min. Core lab adjudicated revascularization was mTICI ≥ 2B in 90.4% (95%CI 87.4, 92.9), oTICI ≥ 2B in 82.3% (95%CI 78.6, 85.6) and oTICI2C ≥ 2C in 45.0% (95%CI 40.5, 49.6). mRS of 0-2 at 90 days was achieved in 57.3% (95%CI 52.5, 62.1). Extensive clinical, laboratory and stroke workflow variables were considered, yet only male sex (OR 0.62 (95% CI 0.38, 0.99) was an independent predictor of successful reperfusion (oTICI ≥ 2B) while age (OR 0.96 (95% CI 0.94, 0.97), NIHSS (OR 0.91 (95% CI 0.88, 0.94) and diabetes (OR 0.54 (95% CI 0.33, 0.88) predicted mRS 0-2 at 90 days.
Conclusions: Proven reperfusion rates after endovascular stroke therapy excel in the real-world translation of thrombectomy devices around the globe, leading to good outcomes after stroke.