Cypher Coronary Stent Alert

Background: The Cypher Stent is an important device for treating coronary artery disease. It is a drug-eluting stent -- a tiny metal scaffold used to prop open a coronary artery that has been opened by balloon angioplasty and keep it open by eluting the drug sirolimus. Sirolimus reduces the chance of regrowth of normal tissue into the artery causing the artery to restenose (narrow again).

The FDA has advised physicians of "adverse events" associated with the Cypher Stent: (1) thrombosis (a blood clot) in close to 300 cases, over 60 of them fatal and (2) allergic reactions in more than 50 cases. "including some deaths."

Comments: The first reaction may be to say "Whoa, this is a dangerous device." But there are many questions that need to be answered. One is: What is the denominator here? How many Cypher Stents have been implanted? About 260,000 Cypher Stents have reportedly been distributed in the US and 180,000 abroad. Is that 60 deaths out of, let us say, 240,000 stents? That would be 1 death per 4,000 stents.

Did the blood clots occur despite the recommended routine or not? All patients should take an antiplatelet medication (a "bloodthinner") after receiving the stent. Cordis (the company that makes the stent) cautions that it is "very important that you take your medications exactly as prescribed" and "be sure not to miss any doses."

And were the proper precautions taken in regard to an allergy? Cordis cautions: "Persons allergic to 316L stainless steel, polymers (plastics) or sirolimus may suffer an allergic response to this implant. It is important to notify your physician if you have any known metal, plastic or drug allergies."