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March 13, 2006

Plavix and Aspirin -- Stent Patients, Don't Stop Taking Your Meds
So you've just had a stent put in and your cardiologist has prescribed aspirin and Plavix (clopidogrel) for a year. And you're watching KARE11-TV in Minneapolis and see a news story, titled "Plavix and Aspirin a Dangerous Combination". This combination doubles the risk of death, says the reporter.

You might try calling your cardiologist to find out why you were given such a dangerous drug combination, but most likely the line is busy because all his/her other patients are calling about the same thing. (We're getting questions as well in our Forum topic on the subject.)

No doubt today doctors across the country are fielding questions from patients -- and the genesis for these reports is the CHARISMA study, presented yesterday at the annual meeting of the American College of Cardiology -- or rather the relatively misleading headlines about that study (some of the articles themselves are a bit clearer, but editors tend to go for attention-grabbing headlines; I call them dreadlines.)

So, first off and most important: if you have a stent, a recent angioplasty, heart attack, been diagnosed with acute coronary syndrome, etc. don't stop taking your Plavix/aspirin combo without discussing it with your doctor!

What has been left out of the scores of news articles I've read this morning is that nothing in this study changes the current indications for patients with Acute Coronary Syndrome, recent heart attack or coronary intervention with balloon or stent. And more importantly, if you have had a stent placed, stopping Plavix and aspirin could be very dangerous!

The combination of Plavix and aspirin has been shown in many studies to be a definite benefit to patients with confirmed vascular disease and premature withdrawal of Plavix, especially for patients with drug-eluting stents, can increase the incidence of stent thrombosis (blood clotting inside the stent). This has been the subject of other studies and a topic I have discussed before.

So the bottom line: the misleading media reports about this study are confusing and could be dangerous to heart patients.

For more on what the study really showed, read on.

CHARISMA (Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization Management and Avoidance) was a study funded by sanofi-aventis and Bristol-Myers Squibb Company, the people who make Plavix. The study was designed to determine if clopidogrel (Plavix) and aspirin together were of benefit as a preventative therapy. The company obviously hoped that the results would be positive -- there's a lot of money to be made if the drug was shown to prevent coronary events. They were disappointed, to say the least.

The patient population was made up of two groups: symptomatic patients with established atherothrombotic disease (80%) and asymptomatic patients -- those with multiple risk factors (high blood pressure, etc.) for atherothrombotic events (20%) but who had not yet experienced the symptoms of vascular disease. The results did show a little benefit (about 1%) in the symptomatic patients, but not enough to warrant prescribing the combination therapy.

The surprise to researchers was that the asymptomatic group (those without actual disease) showed a higher rate of death from cardiovascular causes, from 2.2% in the aspirin only to 3.9% in the combination of aspirin plus Plavix. It is this subset of patients that has generated the headlines. One of the primary investigators for the CHARISMA study, Dr. Deepak Bhatt of the Cleveland Clinic, stated that the results mean that "dual antiplatelet therapy should not be used in patients without a history of established vascular disease. "

So the CHARISMA study is very important. It cautions against prescribing Plavix (clopidogrel) as a preventative therapy, especially when simple aspirin works as well or better. But for patients who already have more advanced disease, to the point where angioplasty has been performed, the dual antiplatelet combination of aspirin and Plavix is a life-saver.

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