Is There Increased Risk of a Heart Attack with the New Medicated Stents?
Metal stents, devices placed into an artery to keep the vessel open, have been used in lieu of balloon angioplasty to treat patients with coronary artery disease (CAD) for about 15 years, due to their better long term patency. Nonetheless, with conventional ("bare metal") stents , there may be a disease recurrence rate of at least 20-30% due to scar tissue formation within the stent. Much research has been done to try to prevent this scar tissue formation. In the last 3-4 years newer metal stents coated with medication to prevent scar tissue formation have become widely available. These stents have reduced the recurrence ("restenosis") rate of coronary artery disease to well under 10%.
A major concern with use of stents is that the stainless steel they are composed of may promote the formation of blood clots, which may occlude the stent and result in heart attack or even death. When a stent is placed in a coronary artery, the body naturally coats the stent with a protective lining called "endothelium", which serves as a barrier that prevents blood clotting. This process generally is complete within three weeks, so patients generally take an anti-blood clotting regimen of aspirin and Plavix (clopidogrel) for four weeks, until the protective lining is in place.
With the new medicated stents, there has been concern that the medication which prevents scar tissue formation may also delay the formation of the protective endothelial lining as well. For this reason, patients initially receiving medicated stents were advised to take aspirin and Plavix for 3-6 months. In the initial period of medicated stent usage, there were occasional, but infrequent cases when patients would form clots in their stents and have a heart attack soon after stopping the anti-clotting medications. For that reason, cardiologists have generally recommended continuing aspirin and Plavix for 12 months after receiving a medicated stent.
In recent months, there has been much publicity that heart attacks or death due to clot formation in medicated stents may develop more than a year after implantation, after discontinuing anti-clotting medication. While this is a significant concern, the number of patients in whom this has occurred is extraordinarily small compared to the large numbers of patients who have received these stents. Furthermore, at this time, there is no conclusive research-based evidence that these new stents do in fact have an increased clotting risk after one year. It is also important to remember that, since the availability of these new stents, due to the very low disease recurrence risk with the medicated stents, many thousands of patients have been spared the need for coronary artery bypass surgery and its attendant risks.
At the present time, the soundest recommendations for patients who receive medicated stents would be to remain on aspirin and Plavix for at least 12 months. After 12 months, if the medications are well tolerated, it would probably be prudent to continue with them until ongoing research and scientific investigation can accurately assess if there is in fact an increased risk for blood clots after one year, and if taking aspirin and Plavix over he long-term can prevent that. After 12 months, however, if there is a need to go off aspirin and/or Plavix for a short time(3-7 days) due to bleeding or the need for a surgical procedure, the risk of a blood clot within the stent is likely quite small.
It is imperative to never stop taking aspirin or Plavix after receiving a stent without checking with your cardiologist first. If you have received a medicated stent in the past, were on aspirin and Plavix for the prescribed duration, and then it has been stopped for some time, it is probably not necessary to resume the regimen until more information is available, but you should discuss your concerns about the need for medication with your cardiologist. Hopefully within the immediate future, the true long term "risk" of the new medicated stents, if any, will be scientifically clarified. |
