Dec. 22, 2003 -- A landmark clinical study shows that drug-eluting stents really work.
That's great news for patients who have recently had -- or who will have -- surgery to re-open blocked blood vessels. The success of this operation depends on stents: Flexible, little wire-mesh tubes that prop the blood vessel open.
But stents have a problem. Blockage from new growth in the blood vessel often means yet another operation. Recently, scientists invented new kinds of stents. These so-called drug-eluting stents slowly give off drugs that prevent re-growth in the blood vessel.
Doctors love them. They love them so much that they are using them in all types of patients. The only problem is that the devices had only been tested in those patients most likely to do well.
Now there's a real-world stent study. Led by Patrick W. Serruys, MD, PhD, of Erasmus Medical Center, Rotterdam, Netherlands, the study looks at all kinds of patients -- most of whom had conditions too severe to allow them to take part in earlier clinical trials.
The bottom line: Drug-eluting stents work better than bare-metal stents. The findings, released early by the American Heart Association, will appear in the Jan. 20, 2004 issue of Circulation.
"The treatment effects -- particularly the reduction of [new surgeries] -- were similar across very different subgroups of patients," Serruys says in a news release.
Serruys says the drug-eluting stent is one of the greatest breakthroughs in the surgical treatment of heart disease, ranking alongside the invention of balloon angioplasty and the original invention of the stent.
The study included 508 consecutive patients needing new surgery for blocked arteries. There were compared with the last 450 patients who received bare-metal stents just before the new stents became available.
Re-narrowing of the treated blood vessel happened to only 3.7% of those treated with drug-eluting stents, compared with 10.9% of those treated with bare stents.
Moreover, major heart problems developed in only 9.7% of those getting drug-eluting stents, while this happened to 14.8% of those getting bare stents.
In a Circulation editorial, David P. Faxon, MD, chief of cardiology at the University of Chicago, praises the Serruys study.
"The report ... goes a long way in reassuring the practitioner that drug-eluting stents are in fact safe and effective in a wide variety of patients undergoing 'real-world' angioplasty," he writes.
Faxon calls for the National Institutes of Health to establish a registry of all patients treated with drug-eluting stents. This, he says, would quickly allow doctors to find out who should and should not get the new stents.