Clinical Trial Underway At Providence Holy Cross Medical Center
A cardiologist at Providence Holy Cross Medical Center has implanted in a patient a state-of-the-art heart stent that delivers medication directly to a diseased artery, part of a clinical trial on a device now being tested in the United States.
The metal alloy stent, about the size of a tiny spring, releases medication into the diseased segment of the artery to keep it open and allow continued flow of blood to the heart.
“It’s a next-generation stent,” said Susie Parker, the research nurse coordinating the trial at Providence Holy Cross. “We’re looking at the new coating which holds the drug and releases it over 90 days. We’re expecting to see less inflammation and other problems.”
What sets this stent apart from its predecessor is the polymer coating, said cardiologist Jack A. Patterson, M.D., who performed the procedure on a man, a patient in his late 40s.
“The polymer is more biocompatible,” said Dr. Patterson, the hospital’s associate medical director of cardiology. “It’s an inert substance; it’s better handled by the body.”
The medication applied to the stent is designed to delay the growth of new tissue. Compared to traditional metal stents that wedge open blocked arteries, these drug-eluting stents reduce the chance of renewed blockage, known as restenosis.
Stents are used to treat coronary artery disease, which affects an estimated 13 million people in the United States and remains the nation’s leading cause of death. Commonly implanted as part of a procedure called balloon angioplasty, stents prop open the artery after it is cleared of plaque to help maintain blood flow to the heart muscle.
Drug-eluting stents are designed to reduce the need to repeat the angioplasty.
Providence Holy Cross is the only Los Angeles-area hospital taking part in the trial of the device, Medtronic’s Endeavor Resolute zotarolimus-eluting coronary stent system. The clinical trial will enroll a total of 1,399 patients at up to 125 sites across the nation. Medtronic is seeking Food and Drug Administration approval of the stent, which is currently being used in more than 100 countries.
Parker said more patients are being evaluated to determine whether they qualify for the trial. The Providence Holy Cross patient who has been treated so far had a recent history of coronary disease and underwent the minimally invasive procedure March 17 to implant the stent. The surgery, Dr. Patterson said, was successful, and the patient is doing well.
Like other patients in the study, he will be prescribed an anti-platelet medication as well as daily aspirin for the next one to two years, a regimen that protects the arteries from restenosis once the medication embedded in the stent is used.
HealthGrades, the nation’s leading health care ratings service, ranks Providence Holy Cross among the nation’s top hospitals for cardiac care. The Mission Hills medical center also is a designated STEMI receiving center, which means ambulances carrying patients suffering the most severe types of heart attacks bypass other hospitals top get to Providence Holy Cross.