PB0420 - Study protocol for the DISTINCT trial: inDividual, targeted thrombosIS prophylaxis versus the standard ‘one size fits all’ approach in patients undergoing Total hIp or total kNee replaCement.

Sunday, June 23, 2024

13:45 – 14:45 ICT

Room: Exhibition Hall

Presenting Author(s)

RK

Ruben Y. Kok, MD

MD, PhD Candidate
Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands
Leiden, Zuid-Holland, Netherlands

Co-Author(s)

Lv

Leti van Bodegom-Vos

dr. Assistant professor
Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands
Leiden, Zuid-Holland, Netherlands
HE

Harmen B. Ettema

dr. MD
Department of Orthopaedic surgery, Isala ziekenhuis, Zwolle, The Netherlands
Zwolle, Overijssel, Netherlands
RG

Rolf H.H. Groenwold

prof. dr
Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.
Leiden, Zuid-Holland, Netherlands
Wv

Wilbert B. van den Hout

PhD, prof
Department of Biomedical Data Science - Medical Decision Making, Leiden University Medical Center, Leiden, The Netherlands
Leiden, Zuid-Holland, Netherlands
MH

Menno V. Huisman

Professor of Medicine
Department of Medicine – Division of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands; Dutch Thrombosis Network, The Netherlands.
Leiden, Zuid-Holland, Netherlands
Erik Klok, MD, PhD, FESC

Leiden University Medical Center
RN

Rob G.H.H. Nelissen

prof. dr. Chairman department Orthopaedics
Department of Orthopaedic surgery, Leiden University Medical Center, Leiden, The Netherlands
Leiden, Zuid-Holland, Netherlands
Nienke van Rein

PhD
Leiden University Medical Center, department of Clinical Pharmacy and Toxicology and Clinical Epidemiology
Leiden, Zuid-Holland, Netherlands
Mv

Merel R. van Veen-Wagensveld

PhD
Vereniging Afwijkende Heupontwikkeling, Nijkerk, The Netherlands
Nijkerk, Gelderland, Netherlands
SV

Stephan Vehmeijer

MD, dr
Department of Orthopaedic surgery, Reinier Haga Orthopedisch centrum, Zoetermeer, The Netherlands
Zoetermeer, Zuid-Holland, Netherlands
JW

Jan Joost I. Wiegerinck

MD. dr
Department of Orthopaedic surgery, Bergman Clinics, Naarden, The Netherlands
Naarden, Noord-Holland, Netherlands
Suzanne C. Cannegieter

MD, PhD, prof
Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.
Leiden, Zuid-Holland, Netherlands
BN

Banne Nemeth

MD, PhD
Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands
Leiden, Zuid-Holland, Netherlands

Background: Patients undergoing total hip and knee arthroplasty (THA/TKA) have a symptomatic venous thromboembolism (VTE) risk of 1.5% despite thromboprophylaxis. Fast-track treatment protocols, including early mobilization, have substantially lowered VTE risk in most patients. Hence, the majority of patients may be unnecessarily exposed to the burden and risks of thromboprophylaxis. On the contrary, there are still patients with a high VTE risk who develop VTE despite thromboprophylaxis. Individualizing thromboprophylaxis treatment potentially reduces both VTE and bleeding risks.

Aims: To study whether individualized thromboprophylaxis reduces the occurrence of symptomatic VTE (primary outcome) and major bleeding (primary safety outcome) within 90 postoperative days in comparison with standard thromboprophylaxis in patients undergoing THA/TKA.

Methods: In this national, multicenter, randomized, multi-arm, open-label trial, patients with a low, intermediate or high predicted VTE risk (based on the TRiP(plasty) score) will be included in the DISTINCT 1,2 or 3 study, respectively (Figure 1). In the DISTINCT-1 non-inferiority trial 3478 patients will be randomly allocated to in-hospital thromboprophylaxis only versus standard prophylaxis. In the DISTINCT-2 observational study 2500 patients will receive standard prophylaxis. In the DISTINCT-3 superiority trial 4100 patients will be randomly allocated to 6-weeks of therapeutically dosed thromboprophylaxis versus standard prophylaxis. Standard prophylaxis is a low-dose of any approved thromboprophylaxis agent for 4-weeks. The study is funded by ZonMW. Approval of the medical ethics committee is pending.

Results: not applicable

Conclusion(s): We hypothesize that the efficacy of in-hospital only thromboprophylaxis is non-inferior and equally safe to standard prophylaxis in low VTE risk patients and that prolonged and therapeutically dosed thromboprophylaxis is superior as compared with the standard prophylaxis in high VTE risk patients. Ultimately this will lead to a reduced treatment burden and less thrombotic and bleeding complications in patients undergoing THA/TKA. At the ISTH meeting the rationale, design, and feasibility of the study will be presented.