Heart Stents Failed To Relieve Stable Angina Symptoms: Study

The findings of new research suggests that heart stents often do not help alleviate the symptoms of stable angina, despite their widespread use for exactly that purpose. 

In a study published late last month in the Journal of the American Medical Association (JAMA), researchers indicate that a large placebo effect may be leading to the belief that percutaneous coronary intervention (PCI), or heart stents, lead to improvement of angina symptoms. The findings were first reported in The Lancet.

Researchers with the Imperial College of London, in the U.K. are running a clinical trial known as ORBITA, which is a blinded, multi-center randomized trial of heart stents versus placebo procedures for angina relieve. The study was conducted at five sites throughout the U.K. on 230 patients with severe single-vessel stenoses. Half of the patients were given heart stents while the other half underwent a placebo procedure after undergoing six weeks of medication.

The study looked at how long patients could exercise following the procedures. According to the findings, however, there was no statistically significant difference.

“In patients with medically treated angina and severe coronary stenosis, PCI did not increase exercise time by more than the effect of a placebo procedure,” the researchers concluded.

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 may be putting their own financial interests before the interests of patients when recommending 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 have also led to illegal activity. A number of hospitals and doctors have been investigated, and in some cases 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.”

The investigation into Midei’s activities revealed that Abbott Laboratories, the makers of the coronary stents he was using, lavished him with gifts, including holding a pig roast at his house. When the controversy over his procedures broke, the company spirited him away to Japan in the hopes that he could keep on promoting their coronary heart stents while the investigation continued.

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.