Background: Treatment with IV tPA in acute stroke has restricted applicability due to its many contraindications. Indeed, the recent AHA guidelines provide only limited support to endovascular therapy (ET) in non IV-tPA patients as only few of these patients were included in the recent randomized ET trials. Our study aims to access the safety and efficacy of ET within 6 hours of stroke onset in patients ineligible to IV-tPA.
Methods: Retrospective analysis of a prospectively collected ET database between September/2010-April/2015 for patients presenting within 6 hours of symptom onset. Patients who underwent ET alone due to IV-tPA ineligibility were compared to those who underwent IV-tPA + ET. Primary and secondary efficacy outcome included the rates of good outcome (90-day mRS 0-2) and successful reperfusion (mTICI 2b-3), respectively. Safety outcome was accessed by rates of any parenchymal hematoma (PH-1 and PH-2) and 90-day mortality.
Results: 422 patients were included in the analysis, 253 received combined IV-tPA + ET (59% overall cohort) and 169 were treated with ET alone (41%). Patients in the ET alone group were slightly older (65±16 vs. 68±15 years-old, p=0.05) and more frequently had basilar occlusions (3% vs. 8%, p=0.02) but the remaining baseline characteristics were otherwise well balanced including NIHSS (19±5 vs. 18±6, p=0.85), ASPECTS (7.7±1.6 vs. 7.9±1.5, p=0.24), time stroke onset to puncture (235±70 vs. 240±81 min, p=0.27), and glucose levels (135±50 vs. 143±60 mg/dL, p=0.13). There were no differences in the rates of 90-day mRS≤2 (45% vs. 38%, p=0.21), mTICI 2b-3 (83% vs. 80%, p=0.52), or any PH (3% vs. 5%, p=0.21) across the combined therapy and ET alone groups. The 90-day mortality was higher in patients in the ET alone (e.g. IV t-PA ineligible) patients (21% vs. 34%, p<0.01). However, after multivariate analysis adjustments the use of IV-tPA was not associated with any significant differences in the rates of good outcome, successful reperfusion, any PH, or 90-day mortality.
Conclusion: Our data supports aggressive treatment with ET in IV tPA ineligible patients within 6 hours of stroke onset as these patients appear to have similar outcomes to IV tPA eligible patients and are known to have a poor natural history in the absence of reperfusion.