Trial DesignCatheter-directed Venous Thrombolysis in acute iliofemoral vein thrombosis-the CaVenT Study: Rationale and design of a multicenter, randomized, controlled, clinical trial (NCT00251771)
Section snippets
Study objectives
The primary objectives of the CaVenT study is to investigate whether adjunctive CDT for first-time acute iliofemoral DVT increases patency rate at 6 months and/or reduces the incidence of PTS at 2 years. Our secondary objectives are to describe frequency of clinically relevant bleeding related to the procedure, effects on health-related quality of life (QOL), cost-effectiveness, procedural success, markers of importance for successful thrombolysis, patency at 2 years, PTS at 6 and 60 months,
Sample size
Quite diverse prevalence of PTS has been reported. In a recent meta-analysis including 2 studies evaluating thrombolysis versus AC for acute DVT, PTS was reported in 65% (26/49) of the controls and 48% (29/61) in the intervention group.7 A review of 4 studies evaluating the systematic use of elastic compression stockings showed a reduction in prevalence of PTS from 54% to 25%.20 Accordingly, we assume that the prevalence of PTS after 2 years will be at least 25% in those allocated conventional
Trial organization and funding
The study is an investigator-initiated study running independently of the pharmaceutical industry, and it is a major collaborative effort among most hospitals of the Southern and Eastern Norway Regional Health Authority (Helse Sør and Øst RHF). The study is financially supported by grants from the Eastern Norway Health Authority (doctoral fellow, Helse Øst grant 2005-090) and the Norwegian Research Council (project no. ES376301). Approvals have been obtained by Regional Ethics Committee East
Discussion
To our knowledge, the CaVenT study is the first implemented randomized controlled trial designed to evaluate the long-term clinically relevant efficacy of adjunctive CDT in patients with iliofemoral DVT, and our study protocol is in line with recently published reporting standards.23 Current status of the trial (86 patients recruited during the first 17 months) supports our appraisal that it is possible to obtain the necessary number of patients (n = 200) within a reasonable period.
The inherent
Conclusion
Clinical experience with CDT over the last years has lead to the development of a safe and improved procedure. However, venous CDT is still regarded as an experimental adjunctive therapy. Implementation of the CaVenT study will be an important contribution toward evidence-based medicine in the treatment of acute proximal DVT of the leg. Any documentation of improved functional outcome will most likely have a significant impact on clinical practice for this patient group and may lead to a
References (26)
- et al.
Randomised trial of effect of compression stockings in patients with symptomatic proximal-vein thrombosis
Lancet
(1997) - et al.
Thrombolysis for lower extremity deep venous thrombosis
Tech Vasc Interv Radiol
(2004) - et al.
Iliofemoral deep venous thrombosis: safety and efficacy outcome during 5 years of catheter-directed thrombolytic therapy
J Vasc Interv Radiol
(1997) - et al.
Catheter directed thrombolysis for treatment of ilio-femoral deep venous thrombosis is durable, preserves venous valve function and may prevent chronic venous insufficiency
Eur J Vasc Endovasc Surg
(2005) - et al.
Early results of thrombolysis vs anticoagulation in iliofemoral venous thrombosis. A randomised clinical trial
Eur J Vasc Endovasc Surg
(2002) Society of Interventional Radiology Position Statement: treatment of acute iliofemoral deep vein thrombosis with use of adjunctive catheter-directed intrathrombus thrombolysis
J Vasc Interv Radiol
(2006)- et al.
Revision of the CEAP classification for chronic venous disorders: consensus statement
J Vasc Surg
(2004) EuroQol: the current state of play
Health Policy
(1996)Reporting standards for endovascular treatment of lower extremity deep vein thrombosis
J Vasc Interv Radiol
(2006)- et al.
Definition of the post-thrombotic syndrome, differences between existing classifications
Eur J Vasc Endovasc Surg
(2005)
Comparison of the Villalta and Ginsberg clinical scales to diagnose the post-thrombotic syndrome: correlation with patient-reported disease burden and venous valvular reflux
J Thromb Haemost
Allocation concealment in randomised trials: defending against deciphering
The Lancet
The epidemiology of venous thromboembolism
Circulation
Cited by (97)
Treatment Strategies for Proximal Deep Vein Thrombosis: A Network Meta-analysis of Randomised Controlled Trials
2022, European Journal of Vascular and Endovascular SurgeryCitation Excerpt :These articles were assessed for eligibility and 755 articles were excluded as they were deemed not relevant to the review. Full texts were obtained for the remaining 43 articles and further evaluation narrowed the research results to seven studies (16 articles).2,12–14,27–37 These were incorporated in this study.
Limitations of the Villalta scale in diagnosing post-thrombotic syndrome
2019, Thrombosis ResearchCitation Excerpt :The present study aimed to examine the accuracy of the Villalta scale using four predefined clinical criteria in line with clinical practice as a reference standard in patients with a history of upper femoral and/or iliac DVT. In 2017 we invited the 170 patients still alive who were included in 2006–09 for a randomized clinical study that compared additional catheter-directed thrombolysis (CDT) for high proximal DVT to conventional anticoagulant treatment, the catheter-directed venous thrombolysis (CaVenT)study [12,22,23] to participate in a one time visit, cross-sectional follow-up study. The southeastern Norway Regional Committee for Medical and Health Research Ethics (REK) approved the study (no. 2015/1567), and written informed consent was obtained from all participants.
Posterior tibial vein approach to catheter-directed thrombolysis for iliofemoral deep venous thrombosis
2019, Journal of Vascular Surgery: Venous and Lymphatic DisordersA high Gas6 level in plasma predicts venous thromboembolism recurrence, major bleeding and mortality in the elderly: a prospective multicenter cohort study
2019, Journal of Thrombosis and HaemostasisRisk of Acute Kidney Injury after Percutaneous Pharmacomechanical Thrombectomy Using AngioJet in Venous and Arterial Thrombosis
2017, Annals of Vascular Surgery