Reteplase
| Evidence Level: L4 | Predicted Indications: 10 |
Table of Contents
- Reteplase
- Reteplase: From Acute Myocardial Infarction (STEMI) to Posterolateral Myocardial Infarction
Reteplase: From Acute Myocardial Infarction (STEMI) to Posterolateral Myocardial Infarction
One-Sentence Summary
Reteplase is a recombinant tissue plasminogen activator (tPA) approved for thrombolytic therapy in acute ST-elevation myocardial infarction (STEMI). The TxGNN model predicts it may also be effective for Posterolateral Myocardial Infarction, a specific anatomical MI subtype, but this direction is currently supported by only 1 case report and no dedicated clinical trials.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Acute ST-elevation myocardial infarction (STEMI) — thrombolytic therapy (per mechanistic rationale; no formal EU indication text on file) |
| Predicted New Indication | Posterolateral Myocardial Infarction |
| TxGNN Prediction Score | 99.90% |
| Evidence Level | L4 |
| EU Market Status | ✗ Not Marketed |
| Number of Authorizations | 0 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action (MOA) data is not available in this evidence pack. Based on the known pharmacology captured in the repurposing rationale, Reteplase is a recombinant tPA whose efficacy in acute STEMI thrombolysis is well established. Posterolateral myocardial infarction is not a distinct disease but an anatomical subtype of MI (typically related to circumflex or right coronary artery territory involvement), so mechanistically the drug’s thrombolytic action would be expected to apply equally well to this subtype as to MI in general.
However, the model’s high prediction score (99.90%) mainly reflects this general MOA-indication overlap rather than subtype-specific evidence. The single supporting publication is a case report describing intracoronary reteplase used to facilitate PCI in a patient with posterolateral AMI and unprotected left main disease — informative, but not generalizable proof of efficacy for this subtype specifically.
Clinical Trial Evidence
Currently no related clinical trials registered
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 21351226 | 2011 | Case report | Catheterization and Cardiovascular Interventions | Single case of primary PCI on an unprotected left main lesion, facilitated by intracoronary reteplase, in a patient presenting with posterolateral acute MI and reduced LVEF (30%) |
EU Market Information
Reteplase currently holds no marketing authorization in the EU market (0 authorizations on file).
Safety Considerations
Please refer to the SmPC for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests on a single case report with no dedicated clinical trials for the posterolateral MI subtype specifically; despite a high TxGNN score, the evidence level (L4) is too weak to justify moving forward at this time.
To proceed, the following is needed:
- TFDA/EMA label warnings and contraindications (currently blocking — flagged as DG001, severity Blocking)
- Detailed mechanism of action (MOA) data from DrugBank (flagged as DG002)
- Subtype-specific clinical evidence (RCT or larger cohort) for posterolateral MI, beyond the existing single case report
- Consider re-prioritizing evaluation toward septal myocardial infarction (rank 3 in this pack), which carries stronger evidence (L2, Phase 3 RCT NCT00046228, n=2,461, “Proceed with Guardrails”) and may represent a more defensible near-term repurposing candidate than posterolateral MI
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.