Abstract Number: PB2205
Meeting: ISTH 2020 Congress
Theme: Venous Thromboembolism and Cardioembolism » Post-thrombotic Syndrome
Background: Patients with common femoral or iliac deep-vein thrombosis (DVT) are at very high risk of developing post-thrombotic syndrome (PTS, ≈50%) including moderate to severe PTS (≈28%). Inflammation during the acute phase of DVT plays an important role in the pathophysiology of PTS. Low molecular weight heparins (LMWHs) have anti-inflammatory properties that may hasten acute symptom resolution after DVT and prevent the development of PTS.
Aims: To determine whether an initial 3-week lead-in course of tinzaparin, a LMWH, followed by rivaroxaban, a direct oral anticoagulant (DOAC), is superior to rivaroxaban alone in resolving acute symptoms and preventing PTS in high-risk DVT patients (symptomatic iliac or common femoral DVT).
Methods: A multicenter open-label assessor-blinded pilot randomized controlled trial (RCT) will be conducted 1) to assess study feasibility; and 2) to estimate the magnitude of difference in effectiveness between tinzaparin followed by rivaroxaban vs. rivaroxaban alone to determine the required sample size for a future large, definitive, multicenter RCT. Pilot study design, eligibility criteria and outcomes are shown in Figure 1. For the pilot, 60 patients will be recruited over 18 months at 4 Canadian centres.
Results: The pilot study will be considered successful if >50% of eligible patients agree to participate, and compliance with tinzaparin is >80%. For the definitive RCT, sample size will be based on the pilot study’s results and the primary outcome will be the proportion of patients with PTS at 2 years.
Conclusions: The results of our pilot study will directly inform the feasibility and size of our definitive RCT. Given the health burden, economic burden, and impaired QOL caused by PTS, a non-invasive, safe and time-limited treatment to decrease the risk of PTS and accelerate early symptom resolution is desirable and may be cost-effective and even cost-saving.
[Figure 1: The pilot study design]
To cite this abstract in AMA style:
Galanaud JP, Abdulrehman J, Delluc A, Schulman S, Kahn S. Tinzaparin Lead-In to Prevent the Post-Thrombotic Syndrome (The TILE Pilot Study): Rationale and Study Protocol [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/tinzaparin-lead-in-to-prevent-the-post-thrombotic-syndrome-the-tile-pilot-study-rationale-and-study-protocol/. Accessed January 21, 2022.« Back to ISTH 2020 Congress
ISTH Congress Abstracts - https://abstracts.isth.org/abstract/tinzaparin-lead-in-to-prevent-the-post-thrombotic-syndrome-the-tile-pilot-study-rationale-and-study-protocol/