Abstract WMP10: Single-center Experience In The Off Label Use Of FDA Approved Drugs And Devices For Endovascular Treatment Of Cerebrovascular Diseases
Background: The off label use of FDA approved drugs and devices in neuroendovascular procedures is common. However, the frequency and characteristics of such use in the endovascular treatment of cerebrovascular diseases is not well defined.
Methods: We reviewed 100 consecutive endovascular procedures and ascertained off label use with either drugs or devices. The off label uses were categorized as I or II if the drug or device had been evaluated as primary or ancillary intervention in prospective trial/registry of neuro-endovascular procedures and III if evaluated in case series. Category IV use was based on evaluation as primary or ancillary intervention in prospective trial/registry of non neuro-endovascular procedures.
Results: Of the 100 consecutive endovascular procedures reviewed, all the procedures were performed under heparin infusion (category II off label use); intra-arterial (IA) nicardipine or verapamil (category III) in 31 cases; dual anti platelet therapy (category II) in 24 cases; IA thrombolytics (category I) in 13 cases; stent assisted embolization of intracranial aneurysms (category I) in 3 cases; stent placement of intracranial stenosis (category I) in 4 cases; angioplasty alone of intracranial stenosis (category III) in 3 cases; 5 cases had stent placement of carotid or vertebral dissections (category III); the intravascular ultrasound (IVUS) catheter system were used in 3 cases (category III); and PVA embolization of the internal maxillary artery (category III) in 2 cases.
Conclusions: The off label use of FDA approved drugs and devices for endovascular treatment of cerebrovascular diseases is highly prevalent. However, physicians have the responsibility to be well informed about the product, in order to base its use on firm scientific rationale and to maintain awareness of the product’s use and effects.
- © 2012 by American Heart Association, Inc.