Why is there some concern about using drug-eluting stents?
The Food and Drug Administration (FDA), which monitors the use of medical devices, considers both bare-metal and drug-eluting stents to be safe and effective in most people. But, all stents involve some risk. Sometimes the angioplasty procedure itself can cause complications such as a heart attack, blood clots, bleeding or injury to the blood vessels. Both bare-metal and drug-eluting stents have a risk of clotting both early and late after implantation. It appears that in some people who get drug-eluting stents, there’s a small increased risk of blood clots forming in the stent once the drug coating has been used up — sometimes a year or more after stent implantation. This risk is still quite low; about 0.5 percent or less when stents are used for FDA-approved reasons. The risk appears to be slightly higher when drug-eluting stents are used for off-label uses, ranging from about 0.4 to 1.6 percent.
