Drug-Eluting Heart Stents No Better Than Bare Stents At Preventing Deaths: Study

Norwegian researchers indicated that popular drug-eluting heart stents do not appear to be any more effective at preventing the deaths of patients than stents made of nothing but bare metal, raising concerns about the drug-coated coronary implants. 

Researchers with the NORSTENT trial, a 9,000-patient coronary stent clinical trial, indicate that their findings found little difference in survivability if a patient with heart disease is given a drug-eluting stent or bare metal stent. In addition, there appeared to be no difference in quality of life as well. The findings were published on September 29 in the New England Journal of Medicine.

The study, begun in 2008, had more than 9,000 patients with stable or unstable heart disease undergo percutaneous coronary intervention (PCI), including implantation of either drug-eluted or bare metal stents. They looked at rates of heart attacks, death, the need for repeat vascularization, stent thrombosis and quality of life.

According to the findings, after six years, there was no significant difference in the rates of heart attacks or deaths, while repeat revascularization was needed in 16.5% of the group that received drug-coated stents, compared to 19.8% in the group with are metal stents. Stent thrombosis rates were 0.8% in the group receiving drug-eluted stents, compared to 1.2% in the bare metal stent group. There was no significant difference in quality of life.

“In patients undergoing PCI, there were no significant differences between those receiving drug-eluting stents and those receiving bare-metal stents in the composite outcome of death from any cause and nonfatal spontaneous myocardial infarction,” the researchers concluded. “Rates of repeat revascularization were lower in the group receiving drug-eluting stents.”

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 has 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. Another Louisiana doctor got 10 years in 2009 in a similar case. During his trial his attorneys argued that his crimes were actually the industry standard.