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March 11, 2010 -- 10:10pm EST Three Months of Plavix After Stent: When Less
May Be More A little background: from 2003-2006 patients were given six months of Dual AntiPlatelet Therapy (DAPT, usually Plavix plus aspirin) after getting a drug-eluting stent to prevent blood clots (stent thrombosis) from forming inside the stent. It was assumed that after six months, the stent struts would be covered and thrombosis, would not be an issue. Then came "the firestorm" of the 2006 European Society of Cardiology meeting where papers were presented showing a risk of very late stent thrombosis six months, a year, two years after stenting. The interventional community was thrown into shock and this issue was debated in every meeting, culminating in a two-day FDA panel on stent safety. Following this meeting, new guidelines recommended 12 months minimum of DAPT and more, if patients were not experiencing any adverse effects (bleeding being the main one). But, as Dr. Eric Topol told me in his interview, this recommendation wasn't based on scientific data, because there wasn't any -- it was an intuitive decision that more DAPT would reduce this new found albeit infrequent problem of late stent thrombosis. So the idea of designing a 3,000-plus patient trial testing whether three months of DAPT is sufficient goes against this intuitive concept. Well, things are different. in 2006 there were only two DES: Taxus and Cypher. And Dr. Feres gives his patients 12 months of DAPT when he uses those, except that he rarely uses those. Mostly he is using the second-generation Endeavor stent from Medtronic which numerous imaging studies have shown to "heal" more quickly. OCT imaging has shown almost 100% strut coverage at 3-6 months, even better than bare metal stents. And Dr. Feres has been giving patients only three months of Plavix and aspirin with no problems so far. So the OPTIMIZE Trial, taking place in 30 centers in Brazil will see if there is any difference in three or twelve months. If three months turns out to be "as good", it will actually be "better" and here's why. Plavix costs $4/day. That's $1,100 per patient better. Plus, there are bleeding and other complications associated with Plavix and aspirin. It's estimated about 5%. Hospitalization, transfusions, not to mention poorer patient outcomes. Eliminating those -- that's also better. Finally, patients who get stents also often need other surgeries: dental surgery, knee replacements, biopsies, etc. and many of these procedures are difficult or impossible to do when the patient is on Plavix and aspirin. Reducing the DAPT period to three months reduces this problem as well. For more on the OPTIMIZE Trial, read my interview with Dr. Fausto Feres of Instituto Dante Pazzanese de Cardiologia in São Paulo, Brazil. |
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"All
stents are not the same," Dr. Fausto Feres told me in