In July of this year, FDA compelled Johnson & Johnson (makers of Cypher) to issue a "Dear Colleage" letter to US physicians describing what was feared to be an increased incidence of SAT with the Cypher stent. (You can read all about it here.) At the time, 47 instances of SAT had been reported, thus triggering the concern. But the number of Cypher stents implanted was not known in July - so the actual incidence of SAT, and even whether SAT actually occurred more often with the Cypher stent, could not be accurately estimated.
Since July, many more cases of SAT were reported (more than 300,) but now the number of Cypher stents implanted is known - it is approximately 570,000. Thus, the overall risk of SAT with Cypher is quite low; and is certainly no higher(and is perhaps lower) than is seen with any other stent. The new FDA notice confirms this fact, and goes on to say, "We want to be sure physicians and their patients understand that, based on the information currently available, we consider the Cypher stent a safe and effective product when used according to the labeling, particularly concerning patient selection and appropriate periprocedural medications."
In another update from the FDA, the agency says it now believes that hypersensitivity reactions previously thought to have been caused by the Cypher stent are instead apparently due to the drugs used along with stent placement. There does not appear to be an allergy concern with Cypher.
Regarding their attitude toward drug coated stents, patients and doctors may now feel free to whipsaw themselves away from unmitigated panic, and back toward unbridled enthusiasm, where they were a few months ago - at least for the time being. It's still possible there's another shoe to drop - but this wasn't it. Drug coated stents continue to look very useful for preventing restenosis.
