Clinical trial studies alternative treatment for coronary artery disease
11/14/2006 - For Stan Kopecky, mowing the lawn is more than a weekend chore. The 63-year-old Prospect Heights resident sees it as a treasured rite of summer. It usually takes Kopecky, a packaging development consultant, several hours to complete the job with his self-propelled mower, but early last summer, Kopecky noticed it was taking much longer because he had to keep stopping to rest. “I was becoming short of breath after only a few swipes,” he recalled.
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Drs. Ted Feldman (l.) and Alan Kogan used stents instead of surgery to open Stan Kopecky's blocked arteries.
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By fall, Kopecky’s breathing difficulties were so bad his wife insisted he visit his doctor, Alan Kogan, MD, an NorthShore University HealthSystem-affiliated cardiologist whose practice has offices in Evanston, Winnetka and Arlington Heights. Dr. Kogan diagnosed angina, or chest discomfort caused by restricted blood flow to the heart, and suggested Kopecky undergo further testing. A few weeks later, Kopecky was shocked to learn that he had life threatening coronary artery disease and required immediate treatment.
In the past, Kopecky’s only treatment option would have been open-heart bypass surgery. But, thanks to a groundbreaking clinical research study at Evanston Hospital, Kopecky was able to undergo percutaneous coronary intervention (PCI) with drug-eluting stents—a non-surgical procedure previously not available to patients with advanced coronary disease—and was out of the hospital the very next day.
Today, Kopecky feels better than ever and is a born-again health nut. “I’ve lost 25 pounds, dropped my cholesterol 100 points and work out five times a week,” he enthused. And he credits NorthShore University HealthSystem and its comprehensive cardiac care—from diagnosis through rehabilitation—for his new lease on life. “I feel very fortunate and lucky. If I had been at another hospital, I would have had open-heart surgery.”
Leading-edge research
The study that Kopecky participated in is known as the SYNTAX trial and is designed to determine the best treatment for people with complex coronary artery disease, explains Ted Feldman, MD, principal investigator for the study and director of cardiac catheterization at NorthShore University HealthSystem. Evanston Hospital is one of only 12 hospitals in the country and the only hospital in Illinois participating in the study.
“There are always going to be some cases where bypass surgery is the most appropriate treatment option,” Dr. Feldman said. “But the number of bypass surgeries is definitely diminishing, and the degree to which that continues will be determined in large part by this study.”
To date, bypass surgery has been the standard—and only—treatment for people with complex coronary disease, known as three-vessel and left main disease. People with less severe coronary disease, on the other hand, are usually treated with percutaneous coronary intervention (PCI). During this procedure, doctors thread a catheter with a balloon on the tip through a blood vessel (usually in the patient’s arm or groin) up to the point of the blockage. The balloon is inflated, opening the artery and allowing blood to flow through. Often, a tiny and flexible mesh tube called a stent is inserted to prevent the artery from narrowing again. Drug eluting stents are coated with a medication that slowly dissolves and helps prevent future blockages.
Until recently, doctors were reluctant to perform PCI on patients with complex coronary disease because the risk of re-blockage—caused either by new plaque or the body’s own scar tissue—in this critical blood-flow area was too high. But all that changed with the advent of drug-eluting stents, said Dr. Kogan. “The rate of repeat stent procedures in the non-coated era was 15 to 20 percent,” he explained. “Now, it’s down to 3 to 5 percent.” And that, he added, is good news for patients like Kopecky. “It allows us to treat a life threatening disease in a simple, relatively low-risk manner.”
Sophisticated diagnostic tools
Kopecky knew nothing of the trial when he first sought help from Dr. Kogan. He did, however, know that Evanston Hospital has some of the most advanced diagnostic tools and imaging equipment in the area, and if he needed a cardiologist, he wanted one with access to those tools. In fact, after Kopecky failed a stress test, an exercise test that helps doctors determine if the heart is getting enough blood, Dr. Kogan recommended he undergo a coronary CT scan. This sophisticated scanner produces 3-D images of the heart and coronary arteries with extraordinary clarity and speed, and Evanston Hospital is one of only a few facilities in the Chicago metro area to offer it.
Kopecky’s scan showed blockages, but Dr. Kogan knew the only way to determine the extent of the blockage was to perform an angiogram, an imaging test that allows doctors to see inside a person’s blood vessels. In late-October, an angiogram at the Evanston Hospital cardiac catheterization lab revealed that Kopecky had significant blockage (as much as 95 percent) in four major arteries.
At nearly every other hospital in the country, Kopecky would have been immediately referred for bypass surgery, but because he had the procedure at Evanston Hospital, Dr. Kogan informed him of the SYNTAX trial and the possibility of another treatment option. Kopecky jumped at the chance to participate.
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left main and three vessel coronary disease
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vessels are enlarged allowing more blood flow throughout the heart after stents have been placed
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An alternative treatment option
All patients with three-vessel or left main disease are informed of the SYNTAX study, explains research nurse Dale Seifert, RN. If they agree to participate, they must first fill out a lengthy patient questionnaire and meet certain eligibility requirements. For example, they must have never had a previous stent or balloon angioplasty procedure, or heart-bypass surgery. Next, a cardiothoracic surgeon and an interventional cardiologist (doctors who perform angioplasty procedures) evaluate the patient and explain the pros and cons of both treatments. If the doctors determine that a patient is suitable for either treatment, a computer will randomly assign them to one of the treatments.
“With SYNTAX, we’re offering patients a 50-50 chance of having a stent procedure instead of bypass surgery,” Seifert said “Most jump at the chance if they think they can avoid bypass surgery.”
Kopecky was one of those patients. “I figured I had nothing to lose,” he recalled. “Even if I didn’t get picked for the stent procedure, then I could still have open-heart surgery.”
A speedy recovery
Kopecky first learned of the trial on a Thursday. On Friday, he was sent home with strict instructions from Drs. Kogan and Feldman to take it easy—his heart health was simply too fragile. By Monday, he was back at Evanston Hospital for his stent procedure. It took Drs. Kogan and Feldman just two hours to complete the procedure, during which they inserted five stents to open Kopecky’s blocked arteries.
Kopecky spent just one night in the hospital and was back at work the following week. This rapid recovery is common, and one of the primary advantages of PCI, Dr. Feldman said. “After open-heart surgery, patients spend a week in the hospital, then often six to eight weeks recovering,” he explained. “Whereas with angioplasty and stent therapy, there’s a small groin puncture and people are back to full activity in less than a week.”
Now, as part of the study, the NorthShore University HealthSystem team will follow Kopecky’s health and progress for five years. This ongoing monitoring is important to the study’s long-term results, and an attractive selling point to patients, Seifert says. “Patients like [the fact] that they have a whole separate cardiology study team following them for five years. That team will keep patients up to date on current treatments, and can act as another set of eyes and ears to their heart health.”
Rehabilitation:The final piece
Also keeping close tabs on patients like Kopecky is the NorthShore University HealthSystem cardiac rehabilitation team. After his procedure, Kopecky was referred to one of ENH’s three rehabilitation programs. He signed up for the 12-week program at Highland Park Hospital and quickly became a devotee, attending sessions three times a week.
To contact our Cardiovascular Care Center and to learn more about our services, please visit our Contact Us page.
To contact Dr. Feldman, please visit his profile on our Find a Doctor page.
To contact Dr. Kogan, please visit his profile on our Find a Doctor page.