Research Update: Stents
Chester J. Zelasko, Ph.D. | April 24, 2007

Before beginning to write this Newsletter, I ran three miles. That fact is significant due to the subject of this Newsletter: an update on the latest research on percutaneous coronary intervention (PCI), more commonly known as stents.

Researchers recently published the results of a study comparing PCI along with medical therapy versus medical therapy alone. The results of that study and the implications for the treatment of coronary artery disease are the focus of this Better Life Newsletter. More about my run later.

Percutaneous coronary intervention
PCI is a process that opens coronary arteries and holds them open using a wire-mesh tube called a stent. You’ve probably heard that word before--it’s the name given to the wire-mesh tube itself but often is shorthand for the entire procedure. After a procedure called an angioplasty, stents keep open arteries that were blocked with plaque.

Here’s what happens in an angioplasty: A thin wire catheter is inserted into an artery in the groin and moved to the coronary arteries. Dye is injected so the cardiologist can see areas where blockages occur via x-ray. If the plaque is not long, the catheter with a balloon on the end of it is placed in the blockage. The balloon is inflated and while opening the artery, it also expands the stent and leaves it behind to hold the artery open. Blood flow is instantly restored to the affected cardiac tissue.

There are about 1.2 million stent procedures per year in the U.S. With a cost ranging from $25,000 to $40,000 per procedure, that’s a significant cost to our healthcare system. As a result of the expense involved, researchers were interested in seeing if there were any differences in mortality between a group of subjects with stable coronary artery disease treated with stents plus medication and a similar group treated with medication but not stents.

The Study
Researchers from the U.S. and Canada recruited over 35,000 subjects for a multi-center clinical trial to determine the difference in treatment regimens using stents (1). Of those, only 2,287 met the qualifications as to their state of coronary artery disease and numerous other conditions; the researchers wanted subjects with stable coronary disease to eliminate confounding factors.

Subjects were randomly assigned to one of two groups: optimal medical therapy with a stent or optimal medical therapy without a stent. In both groups, the medical therapy included aggressive treatment with pharmaceuticals for high total cholesterol, high LDL-cholesterol, and low HDL-cholesterol.

Subjects were followed for an average of 4.6 years. The primary outcome was mortality, and the secondary outcomes were heart attack and stroke. The findings of the study revealed that there were no differences in death rate, heart attack, or stroke between the groups. Without a doubt, this outcome was a surprise--researchers expected a reduction in mortality and morbidity in the stent group.

In an editorial in the same issue of the New England Journal of Medicine, two physicians interpreted the results of this study as a call to change the way stable heart disease is treated. Why? Because it will save money. In their opinion, if there’s no difference in negative outcomes such as death or heart attack, the pharmaceutical approach should be used to reduce cost.

Needless to say, every commentary in newspapers and on the web since the publication of this paper has called for the medical and insurance industry to re-evaluate the way heart disease is treated. “If there’s no difference in outcomes, why should we pay more?” is the mantra of the healthcare industry.

The Problem
There were two significant problems with the study. The first was the age of the subjects who died. While researchers said they accounted for age statistically, it would have been better to see the actual data. If the mortality rate was evenly distributed, that would be significant because that means that the death rate was the same for 50-year-olds and 70-year-olds. But because they accounted for it statistically, the death rate was distributed according to expectations: proportionally more people die in their 70s than in their 50s. That’s not surprising. But they didn’t let us see the data and that’s problematic. If more older patients die than young, it can mean is that it may make a difference in the way patients with coronary artery disease are treated based on age--perhaps the younger you are, the more you need a stent, or vice versa. We don’t know, because they generalized the results to all subjects regardless of age.

The real issue is something they didn’t report: how the different treatment regimens affected the subjects’ quality of life. I started this Newsletter by telling you I ran three miles today. Five years ago I had a 90% blockage in my right coronary artery. Based on the level of single-vessel disease and clinical manifestations, I would have qualified to be in the study. If I hadn’t had the stent, I would have been doomed to physical activity no more intense than walking. For me, that would have destroyed the quality of my life, both physically and mentally--I need to run. One week after my stent, I was running again with no symptoms.

Researchers stated that while they collected data on quality of life, they didn’t report it in this paper. That’s a real problem. There was no evidence that they reversed any arterial plaque with the medication-only program. Even though there was no difference in mortality, there may have been a tremendous difference in quality of life in the stent group, just like it was for me. We’ll have to wait to evaluate this until they finish analyzing the data.

Bottom Line
The bottom line comes down to money and education. As stated earlier, stent procedures cost $25,000 to $40,000. If the treatment norm becomes medication, $25,000 can buy a lot of medications for a lot of years. It’s tough not to be sympathetic to rising healthcare costs. Insurance companies would like to save money, and maybe they’d pass that on to all of us in lower health-insurance premiums.

The current healthcare system, especially specialists in cardiology, doesn’t do an adequate job of educating cardiac patients about how to change their lifestyle. What these researchers have really proven is that stents and drug therapy treat the symptoms equally, but they don’t treat the underlying disease. The disease can be changed only by a significant change in lifestyle. That means a better diet--high in vegetables, fruits, whole grains, and lean meat and fish, and low in fat and refined carbohydrates--along with normalization of body weight, cessation of smoking, and regular exercise including aerobic exercise, strength training, and stretching.

The solution to treating heart disease doesn’t lie in a scalpel or a pill. It never did. The solution lies in education. To that end, we at Better Life remain committed to helping people change their lifestyle to change their life.

References:
  1. Boden, WE. et al. Optimal Medical Therapy with or without PCI for Stable Coronary Disease. N Engl J Med 2007;356. (Published online 3-27-2007).
  2. Hochman JS and Steg PG. Does Preventive PCI Work? N Engl J Med 2007;356 (Published online 3-27-2007).
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