The findings of a new study raise further questions about the benefits of heart stents, indicating that drug therapy and lifestyle changes may be just as effective at preventing heart problems.
Researchers with New York University School of Medicine found that patients who received drug therapy alone had improved heart conditions, without undergoing serious invasive procedures like bypass, stents, or angioplasty.
The findings were part of a study funded by the federal government, which was presented at the American Heart Association’s annual meeting in Philadelphia. The study is considered preliminary until published in a peer reviewed journal, but could help millions of individuals avoid the risk of complications associated with unnecessary, invasive procedures.
The study focused on patients with ischemic heart disease, which involves a build up of plaque in the coronary arteries that supply blood to the heart muscle, causing narrowing and making it more difficult to pump blood. Ischemic heart disease can cause chest pain and tightness, called angina. Some patients experience angina during exercise or emotional stress, but at rest the pain goes away. This is considered “stable angina,” which isn’t considered a medical emergency, but should be cared for by a doctor.
Traditional treatment includes invasive procedures, such as angioplasty to widen the artery with a balloon, stenting the artery with a metal tube, or even bypass surgery to redirect the flow of blood around the blocked artery. However, the new study suggests that the invasive procedures may not be necessary. Instead medication and lifestyle changes may be enough to alleviate symptoms and pain.
Researchers looked at data on more than 5,100 patients with ischemic heart disease in 37 countries. Patients were put on an intensive drug regimen that included aspirin and medications to lower levels of unhealthy LDL cholesterol, along with blood pressure drugs such as ACE inhibitors and beta blockers.
Patients were also encouraged to make lifestyle changes, such as losing weight if necessary, beginning exercise, cutting down on saturated fat in the diet, and quitting smoking.
Half of the patients maintained the drug and lifestyle approaches. The other half received the drug and lifestyle advice, but were then referred to a doctor for stent or bypass surgery.
After four years, the rates of heart attack and cardiovascular death were the same in both groups. Roughly 15% of the therapy group suffered a heart attack or died from cardiovascular related issues, compared to 13% of the invasive procedure group.
Researchers emphasized there was no added benefit for undergoing invasive procedures. Even those with severely blocked arteries had similar outcomes in both groups.
The only difference the study found was regarding chest pain. Patients in the invasive procedure group experienced more chest pain relief than those in the therapy group.
The drug therapy-only approach is also not for patients who have severe chest pain or pain at rest, researchers found. Those patients most often need invasive procedures.
Roughy 2.3 million office visits happen each year for stable angina. The new study indicates a conservative approach may be a better option for patients, giving them a chance to avoid invasive procedures with serious life-threatening side effects.
Stent Profits May Lead to Abuses
Concerns have emerged in recent years over the increase in use of coronary stents, with many reports suggesting that doctors and medical providers have been stretching the line for when to implant the devices, placing their own financial interests before the safety of patients when deciding whether to recommend heart stent placement.
According to a 2011 study published in the Journal of the American Heart Association (JAMA), it was estimated that 15% of all stent operations were likely unnecessary.
The coronary stent business rakes in big bucks. From 2002 to 2012, the 7 million coronary stent operations in the U.S. cost about $110 billion.
Some say that the lucrative money linked to coronary stents has also led to illegal activity. A number of hospitals and doctors have been investigated in recent years, and in some cases doctors have been fired or even jailed for implanting unnecessary stents in unsuspecting patients, who were lied to and told their lives were at risk.
In late 2009 and early 2010, Maryland’s St. Joseph Medical Center sent letters to more than 600 former patients of Dr. Mark Midei, informing them that a review of their medical records demonstrated that they may have received a stent that was unnecessary. Midei was stripped of his license to practice medicine in Maryland, fired from the hospital and faced hundreds of lawsuits over unnecessary stents.
Stent procedures, which are designed to prop open arteries that are significantly blocked, can cost $10,000 or more. Typically, most experts agree that a patient should have at least a 70% artery blockage for a stent implant to be necessary, and many patients have reported being told that they had blockages over that amount, but a subsequent review of records from the procedure found blockages that were well under 50%, which is generally considered “insignificant.”
Another Maryland doctor, John R. McLean, was ultimately sentenced to eight years in prison for unnecessary coronary stent procedures in a case where the judge said greed clearly played a factor. A Louisiana doctor got 10 years in 2009 in a similar case. During his trial, attorneys argued that his crimes were actually the industry standard.