Key result
IV thrombolysis after protamine heparin reversal achieves a ~37% median 24-hour NIHSS reduction vs conservative care.
Why the study?
Intravenous thrombolysis for acute ischemic stroke is contraindicated after PCI due to heparin, prompting assessment of its safety and efficacy following protamine sulfate heparin reversal.
Does heparin reversal by protamine sulfate followed by intravenous thrombolysis improve outcomes in patients with acute ischemic stroke after percutaneous coronary intervention?
RCT (n=42)
Single-blind
Random Integer Generator
No
Does heparin reversal by protamine sulfate followed by intravenous thrombolysis improve outcomes in patients with acute ischemic stroke after percutaneous coronary intervention?
Absolute Event Rate: 37% vs 11%
p-value: p=<0.0001
Heparin reversal with protamine sulfate to enable intravenous thrombolysis in patients with acute ischemic stroke post-PCI improves 3-month outcomes without increasing bleeding risk.
Supports protamine reversal to enable thrombolysis in post-PCI stroke; extends RCT evidence for this strategy.
Background Acute ischemic stroke (AIS) after percutaneous cardiac intervention (PCI) is an uncommon complication, ranging from 0.1% to 0.4% according to recent incident reports. It is associated with significantly increased risks of both in-hospital mortality and major adverse cardiovascular events. (MACEs). Although intravenous thrombolysis (IVT) is the recommended standard for the management of AIS in the first 4.5 h after stroke onset, it is contraindicated in this subgroup of AIS patients who receive heparin and usually have a partial thromboplastin time (PTT) of more than 40 s. Fortunately, protamine sulfate is an effective antidote that can counteract the anticoagulant effect of heparin within 5 min. This work aimed to assess the safety and efficacy of IVT in acute ischemic stroke patients after PCI and after the reversal of the heparin effect by protamine sulfate. The total number of patients who developed AIS after PCI was 42, all of whom received loading antiplatelet agents before PCI. The patients were randomly assigned to two groups: group I received heparin reversal via intravenous protamine sulfate, and group II was conservatively followed up. Results While group I showed significantly less stroke severity on discharge and better outcomes at 3 months, there was no significant difference between the groups in terms of mortality rates or bleeding events. Conclusion IVT after heparin reversal by protamine in appropriately selected AIS patients is thought to have a good outcome without increasing the risk of symptomatic ICH.
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Elmancy et al. (2025) conducted an RCT in Acute ischemic stroke after percutaneous coronary intervention (n=42). Heparin reversal with protamine sulfate followed by intravenous thrombolysis vs. Conservative management was evaluated on Percentage change in NIHSS score from baseline to 24 hours (p=<0.0001). Intravenous thrombolysis following heparin reversal with protamine sulfate significantly improved neurological recovery, achieving a 37% median reduction in NIHSS at 24 hours compared to 11% with conservative management.
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