A NOTE FROM THE EDITOR
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“Drug-Coated Stents May Not Significantly Raise Risk of Blood Clots” trumpeted a September 2 headline in the online edition of the Wall Street Journal. “International Study Shows Stent Risks” countered the Washington Post two days later. Both stories carried a Vienna dateline, which could only mean one thing: the annual European Society of Cardiology conference was in session, and the experts were once again debating the risks and benefits of drug-eluting stent (DES) technology.
One international study presented to conference attendees suggested that DES technology may expose certain patients to unnecessary risks. It showed that heart attack patients who received a DES in an emergency situation were five times more likely to die after two years than those who received a bare metal stent (BMS).
The research from Gabriel Steg, MD, professor of cardiology at Hôpital Bichat-Claude Bernard in Paris, showed that the risk of late stent thrombosis may be greater in the context of acute coronary syndromes than in other conditions. However, Steg told attendees, little information is available so far from rigorous randomized clinical trials comparing drug-eluting and bare metal stents in the context of acute coronary syndromes, particularly in the context of acute myocardial infarction.
The research presented by Steg is based on data from the Global Registry of Acute Coronary Syndromes, collected in 94 hospitals in 14 countries. While survival statistics were almost identical during the six months following treatment, mortality jumped among patients with a DES during the two-year study. Of the total 2298 patients, 1724 (75%) had a bare metal stent, while the remaining 574 patients had a DES. Twenty-seven patients from the first group ultimately died, whereas 49 patients from the second group perished, even though they made up only 25% of the cohort.
Based on these data, Steg recommends that “we perhaps need to take a step back from our use of drug-eluting stents.” If only it were that simple.
A second study, presenting follow-up data from the Swedish coronary angiography and angioplasty registry (SCAAR), showed no significant difference between patients with BMS or DES devices. In the opinion of Stefan James of the Uppsala Clinical Research (UCR) centre in Sweden and fellow UCR investigators, “drug-eluting stents are not dangerous.” They add, however, that the devices should be used selectively after careful consideration of individual risks of a renarrowing of the arteries. The patient’s ability to tolerate clot-inhibiting drugs for a long period of time as well as the increased cost associated with this treatment must also be part of the debate.
That debate is largely over, according to the National Institute for Health and Clinical Excellence (NICE). The health technology assessment body plans to issue guidance on the use of DES technology in January 2008; in all likelihood, it will state that DES devices are not a cost-effective use of the resources of the UK National Health Service.
Perhaps they should not be so hasty. DES technology has only been on the market since 2003. With each passing year, research findings take on greater depth, and sometimes contradict earlier conclusions. (It is somewhat ironic that SCAAR data presented in 2006 led James to conclude that patients with a DES had an 18% greater chance of dying compared with patients with a BMS. What a difference a year makes.)
The initial euphoria that greeted the drug-eluting stent and made it a blockbuster device in commercial terms was, certainly, overstated. In the United States, DES use peaked at more than 90% of eligible patients; it is down to 70% now because of the perceived risks. Should use decline further? Perhaps. A commonsense position, I believe, would be to methodically determine under which conditions a DES is the better alternative for a patient. It probably is not 90%, maybe not even 70%. But I would be surprised if it were 0.
