Best Endovenous treatment, including STenting, versus best non-endovenous treatment in chronic proximal deep venous disease – the BEST multi-centre randomised controlled trial

Background: Chronic obstruction of the iliac veins or inferior vena cava can occur as a result of deep vein thrombosis (DVT), or due to extrinsic compression in non-thrombotic iliac vein lesions (NIVLs). This obstruction can manifest as post-thrombotic syndrome (PTS) after DVT or as chronic venous disease (CVD) in NIVL.

Despite sparse evidence, rates of venous stenting for PTS and NIVLs are increasing.

Methods: A pragmatic, observer-blind, multi-centre, randomised-controlled trial for adults with CVD secondary to either PTS or NIVLs randomised to either best endovenous therapy (including venoplasty and deep venous stenting) or standard therapy (compression +/- anticoagulation).

Included participants will have chronic venous disease (CEAP classification 3 – 6) secondary to proximal deep venous disease.

The primary outcome is severity of venous disease at 6 months as ascertained by the Venous Clinical Severity Score (VCSS). Secondary outcomes include mean change in Villalta score, VEINES-QoL, stent patency and cost-effectiveness.

The study will have a vanguard phase in which we will (a) assess the feasibility of recruitment and (b) check the assumptions behind the sample size, in particular the assumed standard deviation and aggregated mean score for primary outcome of change over baseline VCSS at 6 months.