Why stents dont work

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Health Econ. Coey D. Quant Econ J. Esselstyn CB Jr. Am J Lifestyle Med. Devi S. US physicians urge end to unnecessary stent operations. The trial is also important for another big reason: It raises critical questions about the quality of evidence doctors rely on to make life-and-death decisions for their patients.

Over the years, studies have been piling up that suggest stenting stable angina patients may not actually be all that helpful. There was still a question about using stents in stable patients, whether the devices could relieve chest pain in the shorter term. Data from low-quality studies suggested this was possible.

But no one had ever done a double-blind sham-control study — the gold standard of evidence for medical device studies — on stents in stable chest pain patients, until this new Lancet paper. The authors of the Lancet paper enrolled patients with stable angina and at least one narrowed coronary vessel. For six weeks, they made sure the patients were getting the best medical treatment for angina, like beta blockers or long-acting nitroglycerine.

So after the six-week startup phase, where patients were stabilized with medications, of them were randomly assigned to get either a stent in their clogged artery or a sham stent procedure. The doctors then followed up with their patients after another six weeks. The main outcome they were interested in was how much time each group could spend exercising on a treadmill, since angina often acts up with exertion. They also looked at other secondary endpoints, such as changes in oxygen uptake and the severity of chest pain.

By the end of the study, the researchers found there were no clinically important differences between the real stent group and the sham stent group. In an editorial that accompanied the Lancet paper, Brown and Redberg wrote that medical guidelines need to change so that stenting for stable angina is only recommended as a last resort.

The study represents the best available evidence on the impact of stenting for pain in stable angina patients — and could eventually avert unnecessary, costly procedures in the future. But the study is also important for what it says about the quality of medical evidence doctors often rely on to make decisions. Right now, medical devices are less rigorously regulated than drugs: Only 1 percent of medical devices get FDA approval with high-quality clinical trials behind them.

Even in these cases, devices typically reach the market based on data from a single small, short-term trial, Redberg wrote in a editorial in the New England Journal of Medicine, where she called for a sham control study of stents.

Invasive procedures such as bypass surgery and stenting—commonly used to treat blocked arteries—are no better at reducing the risk for heart attack and death in patients with stable ischemic heart disease than medication and lifestyle changes alone. However, such procedures offer better symptom relief and quality of life for some patients with chest pain, according to two new, milestone studies.

The studies, designed to settle a decades-old controversy in cardiology, appear online March 30 in the New England Journal of Medicine. It compared an initial conservative treatment strategy to an invasive treatment strategy. The conservative treatment strategy involved medications to control blood pressure, cholesterol, and angina chest discomfort caused by inadequate blood to the heart , along with counseling about diet and exercise.

The invasive treatment strategy involved medications and counseling, as well as coronary procedures performed soon after patients recorded an abnormal stress test. The trial allowed tests that assess coronary blood flow restriction, called ischemia, to determine who could participate in the study.

He cautioned patients in the meantime to confer with their doctors to determine what strategies are best for them. Coronary artery disease, which is caused by narrowed arteries that reduce blood to the heart, is the most common type of heart disease. It affects about 18 million Americans and is the leading cause of death in the United States. Symptoms can vary, but some people do not have them at all and may not know they have heart disease until they experience chest pain, a heart attack, or sudden cardiac arrest.

To find out whether an invasive or conservative strategy would be more effective in reducing these kinds of events, researchers studied the impact of both on heart attack, hospitalization for unstable angina, heart failure, resuscitated cardiac arrest, and cardiovascular death.