Last week
The Annals of Internal Medicine roiled the medical world by publishing a study suggesting that the drug-coated stents produced by companies like Boston Scientific and J&J may not be quite as miraculous as first advertised.Following a two-year study, researchers at the Cedars-Sinai Medical Center in Los Angeles are now suggesting that the “putative superiority” of drug-coated stents "is founded on questionable premises. Or as
The Wall Street Journal put it, the clinical trials of drug-coated stents (mostly funded by manufacturers), may “have exaggerated their real-life advantage.
Stents, you may remember, are those tiny metal scaffolds that cardiologists use to prop arteries open after they have been cleared of fatty deposits. Since they were approved in the early 1990s, manufacturers have made a fortune peddling the devices which, they say, can prevent a future heart attack while avoiding riskier and more invasive bypass surgery Today, stents are used in 85% of all coronary interventions in the United States.
Before turning to the new Cedars Sinai study, it should be said that THCB has long harbored doubts as to whether these cunning devices represented the best solution for quite so many patients. Back in 2003, THCB quoted a Stanford study which suggested that, over the long term, patients with multi-vessel disease would achieve better outcomes, at a lower cost, if they opted for the bypass.In 2005 THCB questioned the cost-effectiveness of the new, improved “drug-coated” stents that are designed to prevent the growth of scar tissue inside the artery. Granted, the drug coating has a real advantage: without it, scar tissue can cause the artery to narrow again. And while there is no proof that the coated stent improves survival (the scaring rarely leads to deaths from heart attack), scarring can affect a patient’s quality of life by causing chest pain. And ultimately, he or she may need to have the area opened up again.
Thus, drug-coated stents have become wildly popular, thanks in part to what The Annals of Internal Medicine describes as “aggressive marketing” and the unbridled expectations of patients Wall Street likes them too. At $2300 a pop (vs. a mere $700 for the uncoated, bare-metal variety), the newer stents are far more profitable. Despite the hoopla, nine months ago THCB was once again forced to ask “Are Stents A Waste of Money?” after reading about a study of 826 patients, published in Lancet, which suggested that the drug-coated stents made by J&J and Boston Scientific aren’t cost-effective for all patients and should be restricted to those at highest risk for heart attack.
A second 2005 study, published in The New England Journal of Medicine, added to the uncertainty about the widespread use of stents by reporting that patients suffering minor heart attacks do equally well with drug therapy. "In a study colliding with established practice, recovery from small heart attacks went just as well when doctors gave cardiac drugs time to work as when they favored quick, vessel-clearing procedures,” the NEJM reported. "The surprising Dutch finding raises questions over how to handle the estimated 1.5 million Americans annually who have small heart attacks – the most common kind. Most previous studies support the aggressive, surgical approach. ‘I think both strategies are more or less equivalent. I think it is more a matter of patient preference, doctor preference, logistics and, in the long run, it could be a matter of cost,’ said the Dutch study’s lead researcher, Dr. Robbert J. de Winter of the University Amsterdam."
Against that background, it should come as no surprise that the newest study published in the Annals last week is making hospitals think twice about using coated stents.