Abstract

Introduction: Femoral artery is the most used access for mechanical thrombectomy (MT) in stroke patients with a large vessel occlusion. Routine radial access has been proposed as an alternative following cardiology guidelines although its safety and efficacy remain controversial. Hypothesis: Radial access for MT is non-inferior to femoral access in terms of final recanalization. Methods: The study was an investigator-initiated, single-center, evaluator-blinded randomized clinical trial. Stroke patients undergoing MT, with femoral artery patency and radial artery diameter ≥2.5mm were randomly assigned (1:1) to either radial (60 patients) or femoral access (60 patients). The primary binary outcome was successful recanalization (final eTICI score 2b-3) assigned by blinded evaluators. In the per protocol analysis, patients with allocated access failure were considered non-recanalized. We established a non-inferiority margin of -13.2%, considering an acceptable reduction of 15% in the expected recanalization rates. Results: From September 2021 to July 2023, 120 patients were randomly assigned and 114 (57 radial access, 57 femoral access) with confirmed intracranial occlusion on initial angiogram were included in the primary analysis. In the intention to treat analysis, successful recanalization was achieved in 48/57 (84.2%) patients assigned to femoral access and in 54/57(94.7%) patients assigned to radial (adjusted risk difference 3.36%, 95% CI –6.47% to 13%; p<0.001). The lower limit of one-sided 95% CI was –4.8%, which did not cross our predefined margin of -13.2%. Median time from angiography suite arrival to first pass (femoral: 30 (IQR 25-37) minutes versus radial: 41 (IQR 33-62) minutes, p<0.001) and from suite arrival to recanalization (femoral: 42 (IQR 28-74) versus radial: 59.5 (IQR 44-81) minutes, p<0.050) were longer after radial access. Both groups presented one severe access complication and there was no difference in the rate of allocated access failure: radial 6 (10.5%) radial Vs femoral 5 (8.8%) (p=0.751). Conclusion: Among patients who underwent MT, radial access was non-inferior to femoral access in terms of final recanalization. Procedural delays may favor femoral access as default first approach.

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