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

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: http://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.

October 2, 2008 at 5:45 am
(14) raghavan says:

Had a heart attack out of the blue in jan 2007.Have one DES and am on plavix and asprin since then. I get frequent stomach aches and am taking pantazol to manage this. Ok this far by God’s grace! Touch wood.

January 16, 2009 at 2:21 pm
(15) Shirley says:

Have been on Plavix and Simvastatin and 325mg.aspirin and metropolol since July, 2008, following angioplasty for clogged artery in which DES was inserted. Don’t like taking all this medicine, and would like to know long term effects on my liver and kidneys! So far, no problems.

January 18, 2009 at 4:04 pm
(16) vermin says:

I had minor exercise induced angina then an over zealous Cardiologist slapped a stent in me. He must have been falling behind on his payment on his condo in Boca Raton. Then I ran across http://www.heartattackproof.com with Dr. Esselstyn and got really pissed off at the AHA. Dr. Ornish and those guys appear to be correct. Essey shows pictures of arteries clogged up in the left frame and then in the right frame they are clear. In a nutshell, no fruit juices, no nuts, no dairy, no meat, statins = reversed CAD.

February 24, 2009 at 5:33 am
(17) Lynda says:

Had heart attack Oct 2003;Nov 2003 had carotid surgery to unclog artery; Feb 2004 swelling in ankles, shortness of breath when walking, and some discomfort in stomach, resulting in inserting medicated stent in a diff. artery in heart. Medications my Cardiologist put me on since then: Plavix,Atenolol,81 mg. aspirin, Zocor, Ramipril, Niaspan, 2,ooo mg daily of Fish Oil Softgels (was previously taking Xanax for panic attacks prescribed by my family dr. and still taking; also Darvocet). I recently had a physical and all results reported to me as normal except kidney, which they said was borderline-no further info was provided. I have many Q’s abt that, and all of these drugs, pros and cons, and plan to do a lot of research on my own. I have so many weird physical problems, some, diagnosed; others, drs. have no answers for my symptoms: I have degenerative C-spine problems, arthritis in lumbar, scoliosis, osteopenia in right hip; abnormal coldness in facial bones that feel as if penetrating deeply into the bones(cheeks,nose,ears,forehead)that is very painful & abt to drive me crazy (dread eating out due to EXTREMELY COLD temp’s that apparently effect only ME) temperature chgs (to cold) cause extreme pressure and pain in head, causing dizziness and, at times, feeling faint. The face and head problems occur daily and no one (dr’s, others in medical field, etc.) that I’ve talked to so far has an explanation. I’m desperate..has anyone ever experienced any of these systems? When the coldness and headaches kick in, it seems to start a chain reaction, and my neck pain increases tremendously! I have had a scalp irritation for abt. the past 4 yrs, and the dermatologist hasn’t found a cure for it yet. I am literally DIGGING the hair fm my head & have a huge bald spot on top. I’ve tried home remedies such as tea tree oil, Vitamin E oil, Aloe Vera, etc. w/neg. results. Any suggestions, or anyone with any of these systems, pls respond. I’ve reached the end of my rope but still hangin on! Pls forgive me for “dumping” my entire med. history on you, when the subj. was Plavix, but I thought, just maybe, some of these problems are related, or somebody out there just might have some advice, some of the same symptoms, some recommendations or referrals. For anyone who took time to read all of this, I truly thank you! L

February 24, 2009 at 2:50 pm
(18) heartdisease says:

I have no idea what might be causing your symptoms. You might do well to go to a good general internal medicine specialist for a full evaluation.

October 5, 2009 at 8:37 pm
(19) You mean 62 says:

Diagnosed with CAD at 26. The nurse though the age on my chart was flipped and should have been 62 until she walked in and met me. One DES inserted to open acute blockage. Been on Plavix and Asprin since 2006. November this year will be my third year on this drug. I am sure that I have the same usual issues with this as most of you. Bruses and a lot of bleeding when cut. After CAD event I started a vegitarian life style plus fish. Total cholesterol is 100 with LDL being 29. Doctor is still not sure what Caused my event. Just remember to eat healthy and excercise. Hope and wait for something to come along to help us.

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