3 Committee considerations
3.1 To inform the committee, NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 8 sources, which was discussed by the committee. The evidence included 1 systematic review, 2 randomised controlled trials (1 of which also reported a case series), 3 further case series (1 of which was also in the systematic review), 1 non-randomised comparative study and 1 registry report. It is presented in table 2 of the interventional procedures overview. Other relevant literature is in the appendix of the overview.
3.2 The specialist advisers and the committee considered the key efficacy outcomes to be: quality of life, relapse rates, and measures of disability and disease progression.
3.3 The specialist advisers and the committee considered the key safety outcomes to be: vascular rupture or dissection, venous thrombosis or occlusion, neurological damage including stroke, cardiac arrhythmia and stent fracture (if a stent is inserted after venoplasty).
3.4 Submissions were received from 2 patient organisations, which were discussed by the committee.