Carl M. Black, MD
Thousands of patients suffer from post-thrombotic syndrome (PTS) and in many patients its limited treatment options are ineffective in providing satisfactory relief from the long-term associated morbidity. PTS occurs as a complication of chronic lower extremity deep vein thrombosis in about 40% of cases (1). Although evolving endovascular techniques often allow for revascularization of chronically occluded deep veins and improvement in the condition of many patients, there is a limited amount of high-quality evidence in the peer-reviewed literature with regard to the degree of relief of PTS and the relative economic impact of endovascular therapies.
Suresh Vedantham, MD, FSIR (Mallinckrodt Institute of Radiology) and his co-investigators received funding from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) in 2018 to oversee a multicenter, randomized trial called Chronic Venous Thrombosis: Relief with Adjunctive Catheter-directed Therapy (C-TRACT) (2). C-TRACT is designed to evaluate the clinical effects of iliac vein stenting (with endovenous ablation as needed) on patients with moderate-to-severe PTS. The study is designed to determine if the use of endovascular therapy reduces the clinical severity of PTS and improves quality of life compared with standard PTS care without endovascular therapy. C-TRACT is also expected to characterize the risk benefit ratio and cost effectiveness of endovascular therapy (3,4). It is anticipated that 20 to 40 centers will participate with the objective of enrolling a total of 374 subjects.
The C-TRACT steering committee and investigators include experts in cardiology, hematology, interventional radiology, vascular medicine, and vascular surgery in addition to experts in biostatistics, economics, and epidemiology. The American Vein and Lymphatic Society (AVLS), along with the Society of Interventional Radiology Foundation, the North American Venous Thrombosis Forum, the National Blood Clot Association, the Society for Vascular Medicine, and the American Venous Forum have endorsed C-TRACT.
C-TRACT has already begun but is challenged by lower than anticipated patient enrollment. The AVLS and its membership are in a strong position to promote public, patient and provider awareness. Even if you are not at a participating institution, you can and should support C-TRACT by identifying potential study subjects and referring them to the study through the C-TRACT referral app, which is available for download at the Apple and Google app stores (‘C-TRACT’). Study recruitment to a participating facility can also be facilitated by calling 866-974-CLOT (2568) or by e-mailing CTRACT@wustl.edu.
Referring patients to the trial is vital to develop high quality evidence to better understand the role of these interventions in the management of this challenging population, even if we are capable of treating those patients ourselves outside the trial at our own institutions. Many of us have been critical of the restrictions placed on our care recommendations by health care insurers. The most common reason for the denial is the lack of high quality evidence. C-TRACT offers the venous community an opportunity to address this issue in patients with PTS. It is the responsibility of our community to support the patients we care for by collecting the data necessary to demonstrate the value of these treatments.
To conclude, the objectives of C-TRACT align closely with those of the AVLS for patient advocacy, promoting evidence-based practice standards, and impacting third-party payer policy. In the current economic climate, it is imperative for the future of venous care that we come together in a spirit of multidisciplinary collaboration to ensure C-TRACT is carried out as designed. To learn more, go to: https://bloodclotstudy.wustl.edu.
Investigators interested in participating in C-TRACT can contact Suresh Vedantham, MD at firstname.lastname@example.org. Interested investigators should be part of a multidisciplinary team with a strong technical ability to re-open chronically occluded veins, administer and manage anticoagulation, and provide compression therapy and compressive venous ulcer care. Participating institutions must also have institutional competency in participating in NIH-funded trials with FDA oversight and must be able to identify and enroll patients who qualify for this study.
- Baldwin MJ, Moore M, Rudarakanchana N, Gohel M, Davies AH. Post-thrombotic syndrome: a clinical review. J Thromb Haemost 2013; 11:795-805.
- Vedantham S, et al. Chronic venous thrombosis: relief with adjunctive catheter-directed therapy (C-TRACT) 2017 (study protocol).
- Kahn SR, Hirsch A, Shrier I. Effect of postthrombotic syndrome on health-related quality of life after deep venous thrombosis. Arch Intern Med 2002; 162:1144-1148.
- Phillips T, Stanton B, Provan A, Lew R. A study of the impact of leg ulcers on quality of life: financial, social, and psychologic implications. J Am Acad Dermatol 1994; 31:49-53.