At a glance


• Studies show that some changes of chronic deep venous obstructive disease resulting from iliac- obstructive PTS, such as illiac vein obstruction and saphenous reflux, can be favorably treated with endovascular therapy.11-14


• However, meta-analysis of studies shows patency of iliac vein stents have a primary patency of years, not decades. PTS impacts a wide cross- section of society, including younger


highlighted the lack of randomized trial data in support of endovascular therapy, as well as the significant potential risk for morbidity related to intervention. If this sentiment persists due to the lack of high-quality data, it is possible that payers will follow suit and will no longer support reimbursement of endovascular therapy for PTS.


Given that iliac-obstructive PTS can lead to severe disability, patients with this condition deserve high-quality data that accurately reflects the efficacy, safety and costs associated with a potentially corrective intervention. The current lack of consensus can best be addressed by a multicenter, randomized, controlled trial with systematic efforts to minimize bias. The Chronic Venous Thrombosis: Relief with Adjunctive Catheter-directed Therapy (C-TRACT) Trial, led by Suresh Vedantham, MD, FSIR, is an example of interventional radiology taking leadership in research efforts of the highest quality and integrity, aimed at answering critical clinical questions with broad implications. In this trial, patients with prior history of DVT and current moderate to severe PTS (utilizing a venous clinical severity score [VCSS] of 8 or greater, or Villalta score of 10 or greater) are enrolled and randomized to receive either the best supportive therapy, or endovascular therapy with stent placement and possible saphenous ablation. The trial has been carefully designed to accurately measure effects on PTS severity utilizing the VCSS, assess safety and cost metrics, and minimize bias via central randomization, blinded assessments and equal surveillance of both arms. SIR Foundation was among the first professional societies to support


patients. Frequent procedures to maintain stent patency may place undue burdens on patients.15


• These concerns have resulted in low confidence in the impact of intervention on treating iliac- obstructive PTS and could lead to lack of support for reimbursement of endovascular therapy for PTS.


• This highlights a need for randomized trial data in support


this critical research effort, leading the way for broad multisociety support.


The value of this trial to patients with iliac-obstructive PTS is enormous; the results have the potential to make a significant impact on the lives of patients with this debilitating condition. However, trials like this are a massive undertaking and require the broad support of the IR community; this includes referral of potential patients to trial sites or joining the trial as an investigator if PTS intervention represents a significant portion of your clinical practice. As members of SIR, support of this trial drives high-quality research and firmly demonstrates our commitment to delivering care backed by the highest quality of evidence.


Hear more about the C-TRACT Trial from Dr. Vedantham in episode 5 of The Kinked Wire podcast at bit.ly/3b3At1L. Learn more about this IRQ podcast at sirweb.org/ kinkedwire. Learn more about the trial at bloodclotstudy. wustl.edu/c-tract.


of its efficacy—such as the Chronic Venous Thrombosis: Relief with Adjunctive Catheter-directed Therapy (C-TRACT) Trial.


• The trial has been carefully designed to accurately measure effects on PTS severity utilizing the VCSS, assess safety and cost metrics, and minimize bias.


• To succeed, the trial needs support, collaboration and referrals.


4. Strandness DE, Jr., Langlois Y, Cramer M, Randlett A, Thiele BL. Long-term sequelae of acute venous thrombosis. JAMA. 1983;250(10):1289–1292.


5. Delis KT, Bountouroglou D, Mansfield AO. Venous claudication in iliofemoral thrombosis: long-term effects on venous hemodynamics, clinical status, and quality of life. Ann Surg. 2004;239(1):118–126.


6. 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(10):1144–1148.


7. Kahn SR, Shbaklo H, Lamping DL, et al. Determinants of health-related quality of life during the 2 years following deep vein thrombosis. J Thromb Haemost. 2008;6(7):1105–1112.


8. Kahn SR, Shapiro S, Wells PS, et al. Compression stockings to prevent post-thrombotic syndrome: A randomised placebo-controlled trial. Lancet. 2014;383(9920):880–888.


9. Cohen JM, Akl EA, Kahn SR. Pharmacologic and compression therapies for postthrombotic syndrome: A systematic review of randomized controlled trials. Chest. 2012;141(2):308–320.


10. Shull KC, Nicolaides AN, Fernandes e Fernandes J, et al. Significance of popliteal reflux in relation to ambulatory venous pressure and ulceration. Archives of surgery. 1979;114(11):1304–1306.


11. Neglen P, Hollis KC, Olivier J, Raju S. Stenting of the venous outflow in chronic venous disease: long-term stent-related outcome, clinical, and hemodynamic result. J Vasc Surg. 2007;46(5):979–990.


12. Delis KT, Bjarnason H, Wennberg PW, Rooke TW, Gloviczki P. Successful iliac vein and inferior vena cava stenting ameliorates venous claudication and improves venous outflow, calf muscle pump function, and clinical status in post-thrombotic syndrome. Ann Surg. 2007;245(1):130–139.


References


1. Vedantham S, Goldhaber SZ, Julian JA, et al. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. N Engl J Med. 2017;377(23):2240–2252.


2. Kahn SR, Shrier I, Julian JA, et al. Determinants and time course of the postthrombotic syndrome after acute deep venous thrombosis. Ann Intern Med. 2008;149(10):698–707.


3. Comerota AJ, Kearon C, Gu CS, et al. Endovascular thrombus removal for acute iliofemoral deep vein thrombosis. Circulation. 2019;139(9):1162–1173.


13. Nayak L, Hildebolt CF, Vedantham S. Postthrombotic syndrome: feasibility of a strategy of imaging-guided endovascular intervention. J Vasc Interv Radiol. 2012;23(9):1165–1173.


14. Neglen P, Hollis KC, Raju S. Combined saphenous ablation and iliac stent placement for complex severe chronic venous disease. J Vasc Surg. 2006;44(4):828–833.


15. Razavi MK, Jaff MR, Miller LE. Safety and effectiveness of stent placement for iliofemoral venous outflow obstruction: Systematic review and meta-analysis. Circ Cardiovasc Interv. 2015;8(10):e002772.


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