Reason for request

Inclusion on the list of medicines approved for use by hospitals in the extension of indication: “ANGIOX is indicated as an anticoagulant in adult patients undergoing percutaneous coronary intervention (PCI), including patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI”.

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Clinical Benefit

Substantial

The actual benefit of ANGIOX in this extension of the indication is substantial.


Clinical Added Value

no clinical added value

ANGIOX does not provide any improvement in actual benefit (IAB level V) in comparison with the usual therapeutic management when indicated as an anticoagulant therapy in STEMI patients reperfused with primary angioplasty, given the heterogeneous nature of practice and prehospital prescription practice in France. Bivalirudin (ANGIOX) is nevertheless considered a useful additional therapeutic tool.


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