• A
  • A
  • A

Department of Surgery News


New Drug Therapy Improves Symptoms and Appearance of Visible Varicosities

Antonios P. Gasparis, MD
Dr. Antonios P. Gasparis

STONY BROOK, NY, May 7, 2014 — Varicose veins affect millions in the United States — over 20% of the adult population. They are superficial vessels that are abnormally lengthened, twisted, or dilated, and are seen most often on the legs and thighs. Women are twice as likely as men to develop varicosities.

Varicose veins bulge and rise above the skin’s surface. They may often be uncomfortable and result in swelling of the legs. If left untreated, varicose veins may lead to more serious medical problems, such as phlebitis, inflammation, or leg ulcers.

Now, to advance patient care, our vascular specialists are providing a non-surgical treatment that involves the injection of a foam drug; specifically, polidocanol endovenous microfoam (PEM; Varithena).

PEM injection requires no anesthesia or sedation, and is the most minimally invasive treatment option for varicose veins. The treatment only requires an ultrasound machine and standard medical supplies, in addition to the foam solution.

This advance in the treatment of varicose veins is the result of a successful research effort that involved multicenter clinical trials in which the principal investigator at Stony Brook Medicine was Antonios P. Gasparis, MD, professor of surgery (Vascular and Endovascular Surgery Division) and director of the Stony Brook Vein Center.

Varicose leg veins can be not simply a cosmetic problem but a medical condition for which treatment is covered by most insurance.

Results of the U.S. phase 3 trial of PEM in 2012 showed a high degree of statistical significance.

PEM is the first and only foam drug approved by the Food and Drug Administration (FDA) for the treatment of incompetent veins and visible varicosities of the great saphenous vein (GSV) system.

"Varithena sets a new standard for the treatment of both the symptoms and the appearance of varicose veins," says Dr. Gasparis. "It provides comprehensive therapy for the widest range of varicose veins — incompetent GSV, accessory saphenous veins, and visible varicosities of the GSV system both above and below the knee."

"Patients undergoing treatment with Varithena can return to normal activities and work following administration of the drug."

Patients are encouraged to walk/mobilize the same day with minimal restrictions. The only restrictions post-treatment are to wear compression stockings for two weeks and to avoid heavy exercise for one week and extended periods of inactivity for one month.

PEM is a sclerosant, that is, a chemical (drug) that causes veins to close. This sclerosant has been made into foam of very small bubbles to create microfoam.

Patients with varicose leg veins treated with Varithena can return to normal activities and work immediately following administration of the foam.

Leg of patient in the Varithena trial at the Stony Brook Vein Center, before (left) and after treatment.
Leg of patient in the Varithena trial
at the Stony Brook Vein Center,
before (left) and after treatment.
(Click on image to enlarge.)

PEM is intended to act as follows: (1) the foam displaces blood from the vein to be treated and (2) the polidocanol then scleroses the endothelium (inner lining of vein).

Varicose veins often require treatment for symptoms including leg pain, aching, heaviness, restless legs, cramps, throbbing, fatigue, itchiness, tingling, and edema.

These symptoms are frequently the cause of absenteeism from work, disability, and decreased quality of life.

Varicose veins are a clinical presentation of superficial venous insufficiency — a condition in which veins are inefficient in returning blood to the heart because of venous hypertension. One-way valves that normally direct blood towards the heart are damaged or missing, and instead, some blood refluxes (moves in the opposite direction) and often pools in the vein.

Current treatments for varicose veins include thermal ablation and surgery, both of which are excellent options with proven long term results.

PEM provides an effective alternative that should appeal to patients who are candidates. It was approved by the FDA in November 2013.

"Polidocanol endovenous microfoam [PEM] provided clinically meaningful benefit in treating symptoms and appearance in patients with varicose veins. Polidocanol endovenous microfoam was an effective and comprehensive minimally invasive treatment for patients with a broad spectrum of vein disease (clinical, etiology, anatomy, pathophysiology clinical class C2 to C6) and great saphenous vein diameters ranging from 3.1 to 19.4 mm. Treatment with polidocanol endovenous microfoam was associated with mild or moderate manageable side effects."

— "The VANISH-2 Study: A Randomized, Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Polidocanol Endovenous Microfoam 0.5% and 1.0% Compared with Placebo for the Treatment of Saphenofemoral Junction Incompetence." Phlebology (2014).

For an appointment with one of our vascular specialists to learn more about PEM (Varithena) and/or for a free varicose vein screening, please call 631-444-VEIN (8346).