September 29, 2010 (Washington, DC) — Percutaneous interventions to remove thrombi in the popliteal, femoral, or iliac veins, when performed in conjunction with anticoagulant therapy, is better than anticoagulant therapy alone in preventing recurrent venous thromboembolism and a host of other end points in patients with symptomatic proximal deep vein thrombosis (DVT), according to the first randomized clinical trial to test the technique.
|Dr Mohsen Sharifi|
Dr Mohsen Sharifi (Arizona Cardiovascular Consultants, Mesa) presented mid-term results, at a mean of 30 months, from the Thrombus Obliteration by Rapid Percutaneous Endovenous Intervention (PEVI) in Deep Venous Occlusion (TORPEDO) at last week's TCT 2010 meeting. Six-month results from the study were published this summer in Catheterization and Cardiovascular Interventions .
As Sharifi noted in his presentation, roughly one in five patients with DVTs develop pulmonary emboli, even under adequate anticoagulation, and one in two develop long-term complications including pain, itching or tingling, varicose veins, swelling, and even ulcers--grouped under the term postthrombotic syndrome (PTS).
The study randomized 92 patients to anticoagulation alone (heparin or unfractionated heparin plus warfarin) and 91 patients to anticoagulation plus PEVI using a range of technologies and techniques: manual aspiration, thrombotic therapy via catheter, and the Angiojet aspiration system, among others, with all patients also getting retrievable inferior vena cava filters.
At a mean follow-up of 30 months, the number of total venous thromboembolisms (four vs 13, p=0.02) and total postthrombotic syndromes (six vs 24, p<0.001) was significantly lower in the PEVI group than in the control group. Patients in the PEVI group were also significantly more likely to have reductions in hospital length of stay, edema, skin induration, and duration of anticoagulant use; they also reported subjective improvements.
Following Sharifi's presentation, interventionalists on a discussion panel congratulated investigators for actually conducting a trial in this group of difficult-to-enroll patients, something "none of us have had the courage to do," one panel member noted.
|Dr Raghu Kolluri|
But Dr Raghu Kolluri (Prairie Vascular Institute, Springfield, IL) also raised some criticisms with the study, suggesting that the sample size may have been underpowered, and noting that the definition of PTS was somewhat different from that typically used in this area of research. Several physicians also expressed surprise at the fact that Sharifi and colleagues had used so many stents (a total of 47 stents in 27 patients, according to the published paper), including long stents in the infrainguinal artery, yet saw no stent fractures, something several panel members seemed uncomfortable with.
Speaking to heartwire after the presentation, Dr Deepak Bhatt (Brigham and Women's Hospital, Boston, MA), who moderated the session, said he thought cardiologists should be intrigued by these results. More and more interventional cardiologists are becoming interested in peripheral interventions with the rise of dedicated devices for these types of lesions. The National Institutes of Health is a cosponsor for the Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial, currently enrolling patients. "If that trial is positive, you'd see many interventional cardiologists moving into this field," Bhatt said. "But even short of that, I think there is interest in doing this, and that interest is growing."
Heartwire from Medscape © 2010 Medscape, LLC
Cite this: Shelley Wood. TORPEDO: Percutaneous Interventions Beat Anticoagulation for Proximal DVT - Medscape - Sep 29, 2010.