Abstract W P3: Clinical Outcomes and Safety of Endovascular Therapy for IV tpa Ineligible Patients Who Present Within the IV tpa Time Window
Background and Purpose: Outcomes in patients treated with endovascular therapy who present within the time window for IV tPA, but do not receive IV tPA, are poorly characterized. This information may be necessary in the planning of randomized trials. Methods: A retrospective analysis of a prospectively collected endovascular stroke database was performed to identify all patients who arrived within the time window for IV tPA (≤4.5 hours) who had significant neurologic deficits, but were not treated with IV tPA due to contraindications. Procedural, safety and clinical outcomes were assessed by determining rates of recanalization, hemorrhagic transformation and 90-day independent outcome (mRS 0-2). Results: Out of 961 patients entered in our endovascular stroke database, we identified 163 {mean age 69±1 years; median baseline NIH Stroke Scale 17 IQR 14-21; occlusion site: MCA-M1 82 (50%); MCA-M2 18 (11 %), ICA-T 33 (20 %), Basilar artery 15 (9 %), ACA-A1 2 (1%), ICA-intracranial 8 (5%)}. The main contraindications to IV tPA were elevated INR or PTT (25%), recent surgeries (34%), previous intracerebral hemorrhage (4%), recent stroke (7%), recent bleeding (5%) and others (25%). Following endovascular treatment, the symptomatic hemorrhage (sICH) rate was 11% and recanalization rates (TICI 2b or 3) was 74.7% (56/75). The rate of good functional outcomes at 90 days (mRS 0-2) was 40% (59/149). The 90-day mortality rate was 34.2% (51/149). There was no significant difference for 90-day good outcome, mortality or sICH with respect to the specific contraindication for IV tPA, but there was trend toward worse outcome and higher mortality rate for patients with elevated INR or PTT compared to other groups (good outcome: 29% vs. 38%, p=0.32, mortality rate: 44% vs. 33%, p=0.24) . Conclusion: This dataset provides an estimate of outcomes obtained with intra-arterial therapy in IV tPA ineligible patients over a 12 year period and may serve as preliminary data that can be used for sample size estimation in planned randomized trials. Our outcomes are comparable to patients treated with IV tPA in the IMS III trial and are superior to the natural history of this disease.