Drugs as good as stenting and bypass surgery in stable CAD: ISCHEMIA trial

USA: Taking medications and making lifestyle changes may suffice the need to undergo invasive stenting for patients with severe but stable heart disease, suggests a recent study presented at the American Heart Association (AHA) meeting in Philadelphia. Results, if adopted into practice could save hundreds of millions of dollars spend a year in healthcare costs. The trial, called ISCHEMIA, was led researchers at the Stanford School of Medicine and New York University's medical school.

According to the study, the invasive procedures to clear and prop open clogged arteries in heart patients is no good than taking medications such as aspirin, cholesterol-lowering drugs, and other measures. The trial did show, however, that among patients with coronary artery disease who also had symptoms of angina (chest pain), treatment with invasive procedures, such as stents or bypass surgery, was more effective at relieving symptoms and improving quality of life.

The results of this study do not apply to people with acute heart conditions, such as those having a heart attack, the researchers said. People experiencing acute heart events should immediately seek appropriate medical care.

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Coronary artery disease is characterized by narrowing of heart arteries by fatty deposits causing periodic angina, or chest pain, typically after exercising or emotional distress. Some 500,000 new patients a year are diagnosed with the disease. Current guidelines recommend patients with severe narrowing of their arteries have heart bypass surgery or a stent implanted to restore blood flow. Stents are tiny tubes that keep the artery open after blockage-clearing angioplasty.

Previous two studies have demonstrated that artery-cleaning bypass surgery or stenting in addition to medical treatment does not lower heart attack or death risk compared with the use of non-invasive medical approaches alone. But may cardiologists are still reluctant to adopt this practice the patients who get stents to keep their artery open feel better right away, according to experts.

The study by Judith Hochman, NYU Langone cardiologist, and colleagues is the largest yet to look at whether procedures to restore normal blood flow in patients with stable heart disease offers an added benefit over more conservative treatment with aspirin, cholesterol-lowering drugs, and other measures.

"For patients with severe but stable heart disease who don't want to undergo these invasive procedures, these results are very reassuring," said David Maron, MD, clinical professor of medicine and director of preventive cardiology at the Stanford School of Medicine. "The results don't suggest they should undergo procedures in order to prevent cardiac events," added Maron.

The study involved 5,179 participants at 320 sites in 37 countries. Patients were randomly divided into two groups. Both groups received medications and lifestyle advice, but only one of the groups underwent invasive procedures. The study followed patients between 1 ½ and seven years, keeping tabs on any cardiac events.

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Key findings include:

• Those who underwent an invasive procedure had roughly a 2% higher rate of heart events within the first year when compared with those on medical therapy alone. This was attributed to the additional risks that come with having invasive procedures.


• By the second year, no difference was shown.


• By the fourth year, the rate of events was 2% lower in patients treated with heart procedures than in those on medication and lifestyle advice alone. This trend resulted in no significant overall difference between the two treatment strategies.

"Based on our results, we recommend that all patients take medications proven to reduce risk of heart attack, be physically active, eat a healthy diet and quit smoking," Maron said. "Patients without angina will not see an improvement, but those with angina of any severity will tend to have a greater, lasting improvement in the quality of life if they have an invasive heart procedure. They should talk with their physicians to decide whether to undergo revascularization."

Investigators plan to continue to follow the study participants for another five years to determine whether the results change over a longer period of time.

"It will be important to follow up to see if, over time, there will be a difference. For the period that we followed participants, there was absolutely no survival benefit from the invasive strategy," Maron said. "I think these results should change clinical practice. A lot of procedures are performed on people who have no symptoms. It's hard to justify putting stents into patients who are stable and have no symptoms."

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