Efficacy of Cerebrolysin Treatment as an Add-On Therapy to Mechanical Thrombectomy in Patients With Acute Ischemic Stroke Due to Large Vessel Occlusion in Anterior Circulation: Results of a three-month follow-up of a Prospective, Open Label, Single-Center Study
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Background and Aims
This study hypothesized that Cerebrolysin, a multimodal neuroprotective agent, enhances the efficacy and safety of mechanical thrombectomy (MT) in both acute ischemic stroke (AIS) and recovery stroke phases in selected patients with good collateral status (CTA-CS 2-3) and effective recanalization (mTICI 2b-3).
Methods
A single-center, prospective, open-label, single-arm study with blinded outcome assessment of 50 consecutive patients with moderate-to-severe AIS treated with MT ≤6 hours of stroke onset followed by Cerebrolysin (30 ml iv within 8 hours of onset and continued to day 21, first cycle) and in a recovery phase (between 69-90 days, second cycle) compared to 50 historical controls matched by propensity scores. Key outcomes included functional independence (mRS 0–2 at 90 days), safety endpoints, and neurological recovery (NIHSS at 24h and 7 day post MT).
Results
Patients receiving Cerebrolysin achieved higher rates of mRS 0–2 at 90 days (68% vs. 44%, p=0.016, OR 2.7, 95%CI 1.2 - 6.1; NNT: 4.2), had reduced risk of secondary ICH (14% vs. 40%, p=0.02; RR 0.37, 95%CI 0.14-0.95), and had lower NIHSS on Day 7 (median [IQR]: 3 [4] vs. 6 [9], p=0.01). There was a significant difference in Barthel Index scores between the Cerebrolysin group and the control group at 30 days (median [IQR]: 77 [32] vs. 63 [50], p=0.03) and at 3 months (86 [22] vs. 75 [29], p=0.01) primarily driven by the increase in the mobility and transfer components. Multivariate analysis identified Cerebrolysin as an independent predictor of favorable outcomes at 3 months (OR 7.5, 95% CI 1.8–30.9), particularly in patients with diabetes (interaction OR 9.6, 95% CI 1.01–92). The overall mortality rates at 30- and 90-days were similar in both groups (2% vs 6% and 8% vs 12%, p>0.1).
Conclusion
Cerebrolysin improved functional outcomes at 90 days, accelerated neurological recovery, and reduced complications post-MT in patients with small ischemic core, good collateral circulation and effective recanalization at baseline. These findings warrant further randomized trials to validate its efficacy and explore its long-term benefits.
Registration: URL: https://www.clinicaltrials.gov ; unique identifier: NCT04904341
