MedicalResearch.com Interview with:
Suresh Vedantham, M.D.
Principal Investigator, ATTRACT Trial
Professor of Radiology & Surgery
Mallinckrodt Institute of Radiology
Washington University School of Medicine
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: About 300,000 Americans each year are diagnosed with a blood clot (deep vein thrombosis, DVT) for the first time. In total, about 600,000 Americans have a DVT each year, as noted in the 2008 Surgeon General’s Call to Action.
Despite the use of standard treatment (blood thinning drugs and compression stockings), about 40% of DVT patients develop a long-term complication called post-thrombotic syndrome (PTS). PTS impairs patients’ quality of life and typically causes chronic pain and swelling of the leg that occur on a daily basis. In many patients, this leads to major disability the prevents them from walking, working, or conducting normal daily activities. Some patients develop painful open sores on the leg called “venous ulcers”, that are difficult to heal.
Pharmacomechanical catheter-directed thrombolysis (“PCDT”) is a minimally-invasive treatment that removes blood clots through a tiny (2-3 mm) incision using the clot-busting drug tissue plasminogen activator (TPA) along with catheter-based devices that can chew up the clots. The benefits and risks of PCDT have not before been evaluated for DVT treatment in a rigorous study.
The final results of the ATTRACT Trial, which was primarily sponsored by the National Heart Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH), are being published in The New England Journal of Medicine. ATTRACT, the most rigorous study to date of clot-busting treatment for DVT, was a multicenter randomized controlled trial comparing PCDT and standard therapy versus standard therapy alone in 692 patients with above-knee DVT. This landmark study, conducted in 56 U.S. hospitals, was led by Principal Investigator Dr. Suresh Vedantham, Professor of Radiology & Surgery at the Mallinckrodt Institute of Radiology at Washington University in St. Louis, along with outstanding DVT researchers at McMaster University (Hamilton, Ontario [Canada]), the Massachusetts General Hospital (Boston, MA), and the Mid America Heart Institute (Kansas City, MO).
The primary study result is that for most patients with DVT, the addition of PCDT to standard therapy does not prevent the development of PTS. Because the use of PCDT involves a small but significant increase in major bleeding complications, it should not be routinely used as first-line DVT treatment. However, PCDT did reduce the severity of PTS and appeared likely to provide better relief of DVT-related leg pain and swelling. Further analyses will determine which DVT patients are most likely to experience these benefits.
MedicalResearch.com: What should clinicians and patients take away from your report?
Response: ATTRACT has advanced patient care by providing high-quality evidence that:
(A) enables most DVT patients to avoid an unnecessary medical procedure; but
(B) suggests that patient comfort during initial DVT care may be improved, and late disability reduced, through more targeted use of clot-busting treatments to specific patients.
This concrete data on the benefits and risks of clot-busting treatment will enable DVT patients to make better choices for their own care, and will catalyze future research to improve patient outcomes.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: The study suggests that some patients may have experienced benefit from PCDT in reducing symptom severity. Additional analysis of the ATTRACT data is ongoing to determine which patients are most likely to benefit. In addition, further studies of the biology of PTS and the appropriate use of methods to open the veins are desired.
Disclosures: In addition to NIH, the study was supported by Boston Scientific, Covidien (now Medtronic), BSN Medical, and Genentech (A Roche Company). The Society of Interventional Foundation played a pivotal role in the development of the study.
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Suresh Vedantham, M.D., Samuel Z. Goldhaber, M.D., Jim A. Julian, M.Math., Susan R. Kahn, M.D., Michael R. Jaff, D.O., David J. Cohen, M.D., Elizabeth Magnuson, Sc.D., Mahmood K. Razavi, M.D., Anthony J. Comerota, M.D., Heather L. Gornik, M.D., Timothy P. Murphy, M.D., Lawrence Lewis, M.D., James R. Duncan, M.D., Ph.D., Patricia Nieters, B.S.N., Mary C. Derfler, M.S.N., Marc Filion, M.Sc., Chu-Shu Gu, Ph.D., Stephen Kee, M.D., Joseph Schneider, M.D., Ph.D., Nael Saad, M.D., Morey Blinder, M.D., Stephan Moll, M.D., David Sacks, M.D., Judith Lin, M.D., John Rundback, M.D., Mark Garcia, M.D., Rahul Razdan, M.D., Eric VanderWoude, M.D., Vasco Marques, M.D., and Clive Kearon, M.B., Ph.D., for the ATTRACT Trial Investigators*
N Engl J Med 2017; 377:2240-2252 December 7, 2017
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