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

Latest on Drug-Coated Stents

Wednesday November 14, 2007
At the recent American Heart Association Scientific Sessions in Orlando, investigators from Massachusetts presented evidence from a large registry trial suggesting that, after a two-year follow-up, drug-coated stents (or drug-eluting stents, DES) may yield a somewhat lower overall risk of mortality than bare metal stents.

This report offered much-desired good news for proponents of DES, who had heard pretty much nothing but bad news for a couple of years. The question of the long-term safety of DES was first raised a few years ago with reports 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. Because of this now-widely acknowledged risk, many cardiologists are insisting that patients treated with DES remain on Plavix (clopidogrel) for at least a year, and possibly forever.

This new study offers substantial reassurance to proponents of DES. Even with only 6 months of Plavix therapy (which was standard during the time this registry study was performed), for at least two years there was no excess in mortality or heart attacks with DES, and the risk of requiring additional revascularization procedures (more stenting or bypass surgery) was reduced as compared to bare metal stents.

This is certainly encouraging. However, this new study (which must be considered a preliminary report, since it has not yet been published) does not give the complete "green light" to DES - if for no other reason than it was a 2-year study, and the risk of sudden clotting with DES (while statistically quite low) appears to extend well beyond 2 years.

So, despite this good news, and despite the fact that the New York Times reports that, based on this latest study, "many physicians say the medical community overreacted [about the dangers with DES] and should now reverse course," patients whose doctors wish to place a DES still need to ask two questions first.

First, "Do I really need a stent?" Recently, the COURAGE trial showed that for patients with stable angina, outcomes were similar in patients receiving either aggressive drug therapy or stents. Make sure the decision to place a stent is carefully considered.

And second, "If you give me a DES, how are we going to manage the Plavix?" The stent itself is only half of the question. Long-term Plavix therapy - now thought to be required whenever a DES is placed - 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 before agreeing to any therapy that requires long-term Plavix, discuss with your doctor what the plan will be if, in 18 months, you need gallbladder surgery or a breast biopsy. If he/she doesn't give you a straightforward answer, think long and hard before you let him/her place a DES.

The bottom line: this new study is certainly encouraging, but preliminary evidence that DES may modestly improve the risk of dying or of heart attacks does not entirely settle the question. In general, patients still need to ask some tough questions before agreeing to receive a DES.

Comments

November 19, 2007 at 9:37 am
(1) mike says:

I read your article about the drug eluded stents. I had two drug eluded stents put in 2 and a half years ago. I have been taking the plavix everyday since then because I am afraid to stop taking it because of the clotting problem. What would be wrong with taking fish oil instead which does the same thing as plavix and without the side effects of plavix. One needs to take fish oil anyway for good health and it is natural and cheap.

November 19, 2007 at 10:47 am
(2) Valentino Falcone says:

The Drug Company that was the Sponsor was who?
We must remind ourselves that there is a great deal of $$ at stake regarding the study and that the outcome usually benefits the involvment of those using the device( Surgeons,Cardiologists) being studied and the Manufacturer.

November 19, 2007 at 5:02 pm
(3) Rob says:

My family doctor wants me to get a colonastopy. They want me to go off of plaviv for 1 week before the test. My cardiologist said its ok. My last stent was 2 years ago. Are there any stats for clotting after going off of plavix after 2 years of treatment?

November 19, 2007 at 6:26 pm
(4) Patricia says:

There are financial incentives for a cardiologist to recommend a drug eluting stent vs. medication. There are financial incentives from sponsoring drug companies for primary investigators (physicians enlisting patients in a drug study)to “discover” findings favorable to the drug sponsor. I expect drug eluting stent companies to publish studies that are in direct conflict with this study as they will pay physician investigators to present data that says DES and Plavix long term survival data is preferable to medication. The findings are all about who is sponsoring the study and who has a financial incentive. There is no financial incentive for the average non-research oriented cardiologist to refer a patient for cardiac surgery, but that wasn’t part of the study. Patients have to look at what is being offered and not only ask themselves what is in his or her own best interest, but what is in the best interest of the doctor—and then ask what other options are available, even if they don’t benefit the doctor presenting the options. If patients don’t ask about ALL of their options (medications, uncoated stents, drug eluting stents, cardiac surgery), they wouldn’t know. Ask about what is best in the long term, out 15 years or so.

November 22, 2007 at 2:52 am
(5) Jack says:

I’m not sure anyone with any certainty can say which path is best. In the almost 2 years since I recieved my DES stent I have continued with Plavix/ASA therapy. I quit taking it twice for 6 days each time with no ill effects. Once at 6 months post stent for back surgery, without which my career would have been over. While I am not advocating anyone quit anti-coagulation therapy w/o consulting their MD, I believe research will show the risk of stent occlusion after 1 year is fairly low. As well the earliest case of stent occlusion I could find published, secondary to coagulation non-compliance, was 2 weeks after discontinuing Plavix/ASA. While the above commentary is correct re: financial incentives for MD’s, Drug Companies, etc is true, I still believe that having a stent was the correct treatment course for me. The only question I have would be DES vs Non DES.

July 7, 2008 at 10:23 pm
(6) Judy says:

I am needing to find out what is the most stents that can bein your heart,I heard it is 13 and I have already had 12 and my health has not improved,it has been 2 years and I am still having problems.

August 24, 2008 at 10:31 am
(7) bob says:

has any got the answer to the question does fish oil do the same thing as plavix??? and if fish oil does the same why take plavix at $300. per month????

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