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Research and Clinical Trials

Return to Preventing Blood Clot Complications Overview

More on Preventing Blood Clot Complications

Preventing Blood Clot Complications

An Endovascular Approach With Targeted Medications and Mechanical Devices

NEW YORK (Sep 1, 2012)

Akhilesh K. Sista, M.D.
Akhilesh K. Sista, M.D.

When blood clots arise in the body, they most commonly develop in the deep veins of the legs – a condition called "deep vein thrombosis" (DVT). Patients with DVT are at risk for a potentially fatal complication called a pulmonary embolism, when part of the clot breaks off and travels to the heart, where it can lodge in the pulmonary artery and impede blood flow to the lungs.

But there is another complication of DVT that can lead to poor quality of life: the post-thrombotic syndrome. In patients with this condition, the clotted veins become permanently damaged and obstructed. Patients develop pain, swelling, sensitivity, shooting nerve pains, and, in some cases, skin ulcers in the affected leg. While for some it is a cosmetic problem, for others it is a source of lifelong pain and disability, often leading to missed work days.

What's alarming is that up to half of patients with DVT develop the post-thrombotic syndrome to some degree. With obesity, aging, and cancer as the major risk factors for DVT – risk factors that are increasing in the U.S. population – the incidence of DVT and its complications are expected to climb as well.

Standard therapy for DVT includes blood thinners such as heparin, enoxaparin, and/or coumadin, and patients wear elasticized compression stockings. But for many patients, this treatment does not prevent the post-thrombotic syndrome. Therefore, physicians have developed an endovascular approach in which a device is inserted through a catheter to "chew up" the clot and then remove it. "This approach combines pharmacological and mechanical means to break up the clot," explained Akhilesh K. Sista, M.D.

Akhilesh K. Sista, M.D., describes deep vein thrombosis (DVT), its dangers, and treatments.

The Procedure

During pharmacomechanical thrombolysis, the doctor inserts a catheter into a vein in the patient (most commonly into the popliteal vein behind the knee). A device is threaded through the catheter to the site of the clot. Tissue plasminogen activator (tPA), a drug commonly used to dissolve blood clots in victims of stroke, is applied directly to the clot while the device mechanically macerates it, after which the clot is removed. "With these means, we are able to remove a significant amount of the clot," said Dr. Sista.

Mechanical Device Options

There are different devices available to accomplish this task.

  • The AngioJet® System features a catheter with two holes at its tip. In the first step, tPA is infused into the clot through one of the holes. During the second step, a vortex is created between the two holes that actively breaks up the clot and sucks it out.
  • The Trellis® System has two balloons and a wire at its tip. The balloons are inflated to flank the clot while a rotating wire macerates it. Between the balloons is a hole through which tPA can be sprayed. The physician then attaches a syringe to the device to suck out the dissolved clot.
Outpatient or Overnight

The pharmacomechanical thrombolysis procedure takes about 30 minutes to complete. If the clot is not fully dissolved using this approach, the patient may stay in the hospital overnight to receive more direct tPA and then have the procedure repeated the next day. But for many patients, they can go home the same day as the procedure.

Traditional Measures Still Needed

Patients who undergo catheter-directed therapy must still take blood thinners and wear compression stockings. Dr. Sista noted that pharmacomechanical thrombolysis does not replace these approaches, but augments them. "I have personally seen dramatic changes in patients using this technique," he maintained. "The patient's leg goes from swollen and painful to normal."

Clinical Trial Research

The findings of a recent large clinical trial, the European CaVenT Study, along with other retrospective and single-center prospective studies, suggest that such catheter-directed "thrombolysis" therapy can reduce the incidence of the post-thrombotic syndrome following DVT. The federally funded ATTRACT (Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis) Study is now under way at multiple hospitals across the United States to determine if pharmacomechanical thrombolysis used in addition to standard therapy is more effective than standard therapy alone for preventing the post-thrombotic syndrome in patients with symptomatic DVT. Researchers will also determine if this approach improves quality of life and is safe and cost-effective. NewYork-Presbyterian has enrolled a significant number of patients into the ATTRACT trial, which has almost completed enrollment.

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