Table 3.
Expert panel recommendations for post-thrombotic syndrome (PTS) clinical trial.
Item | Recommendation |
---|---|
1 | Perform multicenter RCT to assess EVT for iliac-obstructive PTS |
2 | Include patients with advanced PTS on Villalta or VCSS scales |
3 | Open-label study with blinded assessors and adjudicators |
4 | Primary outcome: change in VEINES-QOL measure at 6 months |
5 | Utilize run-in period to boost adherence, discourage crossover |
6 | Engage patient advocacy and health professional organizations |
7 | Encourage physical activity and risk factor modification |
8 | Non-proscriptive approach to medical PTS therapy |
9 | All patients use compression therapy (mainly graduated stockings) |
10 | Patients with active ulcer to be managed in specialized clinic |
11 | EVT = iliac vein stent placement followed by ablation of saphenous reflux |
12 | Early engagement of FDA around off-label use of stents |
RCT, randomized controlled trial; EVT, endovascular therapy; VCSS, Venous Clinical Severity Score; VEINES-QOL, venous insufficiency epidemiological and economic study quality of life; FDA, Food and Drug Administration.