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Heart Disease Blog

By Richard N. Fogoros, M.D., About.com Guide to Heart Disease since 2000

Drug-Eluting Stents - How Long on Plavix?

Thursday April 17, 2008
The importance of taking Plavix (clopidogrel - a drug that helps prevent blood clotting) after receiving drug-eluting stents (DES) has received a lot of attention over the past few years. Not long after DES came into common usage, reports surfaced indicating that there is a long-term risk of sudden occlusion of the coronary artery with these stents, produced by the sudden formation of blood clots at the site of the stent. Sudden blockage of a coronary artery, of course, can have catastrophic results including heart attack and sudden death. The long-term use of Plavix is thought to substantially decrease this risk.

Unfortunately, long-term Plavix therapy is not benign. Indeed, trauma or surgery while on Plavix can have devastating consequences. Some cardiologists refuse to allow their DES patients to stop Plavix even long enough to have elective surgery - placing the patient in an untenable position. So a major remaining question with the use of DES is: How long should Plavix therapy be maintained?

In an extraordinary hearing of the FDA in late 2006, the recommendation was to continue Plavix therapy for at least 12 months after DES. But recognizing that there was little data on which to base this recommendation, a strong plea was made to conduct a randomized clinical trial as rapidly as possible to answer the Plavix question once and for all.

Unfortunately, as reported by Shelley Wood for theHeart.org, nearly a year and a half after this FDA hearing that study is not even close to getting off the ground, let alone yielding useful results. (Wood's report is linked here, but registration is required.) Wood describes continued difficult "negotiations" (some might call it squabbling) between researchers at the Cardiovascular Safety and Research Consortium (located at Duke University), various government agencies, and manufacturers of DES, over the goals, design, size and duration of the proposed study. From the sounds of it, the study that everybody's waiting for won't be providing anything like definitive answers, for many years to come, on how long DES patients need to remain on Plavix.

This means that if your doctor is recommending DES, for the foreseeable future you're still going to need a long talk with your doctor about Plavix - specifically, how long will the doctor want you to take it, and what is to be done if it turns out you need surgery 8 months from now? Unfortunately, it appears the Plavix question will be looming over the use of DES for a long time to come.

Comments

April 18, 2008 at 1:11 pm
(1) Garry Newman says:

Thanks for the update. But, you left out the two real reasons why this study has not begun 1)Money - who will pay for it and more Plavix will be sold if there no endpoint recommended and 2)Liability - The drug companies are afraid that the long term effects of Plavix may be negative.

April 19, 2008 at 11:37 pm
(2) Surefire Guy says:

I’m wondering if Plavix can cause major side-effects… My neighbor started taking it and now has blood on the surface of both sides of his face. The dr. says there’s no correlation, but I wonder…

April 21, 2008 at 9:15 am
(3) Chuck says:

I was on Plavix do to DES. Had an minor accident with major, major hematoma in three locations. Normally wouldn’t have even bruised. If I had hit my head, I’d be dead!! Pharmaceuticals are for their own interests; “bottom line $$$”. Took four months for the Plavix to leave my body!!!

April 21, 2008 at 9:24 am
(4) Stan Abrams says:

I just completed one year of using Plavix for DES with no side effects at all. I was also on Coumadin and aspirin for my Atrial Fibrillation.

April 21, 2008 at 11:27 am
(5) Richard says:

This concerns me greatly. I have been on Plavix since 1999. I have had numberous heart attacks and just had stents 8 through 15 installed in November and January. My cardiologists just say there is no answer to how long and, since I have had no side effects that can be attributed to Plavix, we will continue till we know different. I just have to be careful since I understand that any scratches etc will bleed for a while.

April 21, 2008 at 11:46 am
(6) Art in Boston says:

As the proud owner of 12 (yes, twelve) drug-eluting stents, I have not been on plavix for four years, and will continue to be on it indefinately…. I could be my own study! So far so good….

Art

April 21, 2008 at 12:49 pm
(7) Julie says:

I have been on Plavix nearly a year following a sudden cardiac death last June and installation of three DES. My doc says I should be fine, but I am still tired and short of breath. Any thoughts on this? I was down for 20 minutes before I came back.

April 21, 2008 at 4:38 pm
(8) Jeff says:

My first heart attack was in October 2006 and have been on Plavix and Asprin since … with no ill effects or further problems .. yet! I can only brag of one single drug releasing Stent .. so I suppose I am lucky?

April 22, 2008 at 11:58 am
(9) William Moskowitz says:

It is important to recognize that there are new modified stents that behave differently than the existing one. I refer you to inquire at the lab in Sarasota, Florida of Animal replacement Technologies: www.c.sakezles@anireptec.com

April 23, 2008 at 11:09 am
(10) karla says:

can it be cured or treaded

April 28, 2008 at 8:51 am
(11) len ball says:

have been on Plavix and asprin since its intoduction,have 14 stents most all due to scaring,no ill effects,seems like every 2years,wish they would do more with the stent coating for people like myself,body just doesnt like stents,coated or otherwise….len

April 28, 2008 at 6:23 pm
(12) frank says:

I had a heart attack june 2007 (my 4th), rec’d non des stent & was was prescribed Plavix which I stopped taking after a couple of months. I then had another heart attack which turned out, the stent from 8/07 was clogged. I went to a different cardiologist who went in and unclogged the stent of 8/07 but while he was cleanig it out, he stated that it had not been opened enough and he expanded it and demanded that I keep taking Plavix!!!

April 29, 2008 at 11:53 pm
(13) Anne says:

My goodness, I did not know that many stents could be placed. I thought I had too many at 3. After 3 I went on to bypass.

I decided to make some lifestyle changes. Sad to say my first change was the recommended low fat AHA diet On that diet, I gained weight, was short of breath, extremely fatigued and having pitting edema in my legs. I then discovered I have non-celiac gluten sensitivity. All these symptoms disappeared after I went on a diet free from wheat, barley and rye.

I was never diagnosed with DM although I had a positive GTT many years ago. I am now learning to keep my blood sugar from spiking over 140 by limiting my carbs.

I have seen my hs-CRP drop to 3 from a high of >13. My triglycerides use to be almost 300 on the AHA diet and now they are close to 100. I am trying very hard never to see the inside of a cath lab again. The idea of taking Plavix forever is rather frightening. Five years out from bypass and now feeling great.

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