First they were shown to restore blood flow during a heart attack. Then doctors used them to save the brain during a stroke. Now, physicians have shown that clot-busting drugs (thrombolytics) can save the legs, too, as effectively as invasive surgery. The study, the largest to compare a thrombolytic agent to surgery in patients with arterial blockages in the legs, is published in the April 16 issue of the New England Journal of Medicine.
In the study of 544 patients at 113 sites across North America and Europe, physicians compared patients who had immediate surgery to patients who were first given a clot- dissolving agent. The compound doctors used was an experimental form of recombinant urokinase made by Abbott Laboratories, which funded the study.
"This study shows conclusively that this drug minimizes the need for surgery," says first author Kenneth Ouriel, a University of Rochester vascular surgeon and a principal investigator of the study. "Lots of people, including many surgeons, still think that if you have a blocked artery in the leg, you need an operation. That's not necessarily true any longer."
Frank Veith of the Montefiore Medical Center/Albert Einstein College of Medicine in New York City, president of the Society of Vascular Surgery, was the co-principal investigator. Arthur Sasahara, formerly with Abbott Laboratories and now at Harvard, also helped to coordinate the study.
The team studied what doctors call acute ischemia of the legs: Just as in a heart attack or most strokes, it's caused when patients develop sudden arterial blockage that cuts off blood flow. The condition is very painful, and many patients end up having the leg amputated. Such patients are usually elderly and have another disease, such as heart disease, cancer, or diabetes; the condition occurs in more than 40,000 people in the U.S. each year.