The Wall Street Journal reported today that a clinical trial known as Syntax had failed because it revealed that for a particular subset of cardiac patients, coronary artery bypass surgery was more effective than intracoronary stenting.
Syntax was not a failure. It just didn’t fulfill the aspirations of Boston Scientific, a sponsor of the study and a producer of Taxus, a high end, drug eluting stent that annually generates $1.8 billion in sales for Boston Scientific.
By design, all Syntax patients had severe or widespread blockages of their coronary arteries. Such patients represent only 5% of those receiving stents, but they generate large revenues for stent makers because they require multiple stents and repeat procedures.
Syntax investigators found that among those who received a stent, 17.8% either died or had a life-threatening event within a year following the procedure. Only 12.1% of bypass patients incurred such a fate. This difference was statistically significant.
The fallout from Syntax is that Boston Scientific and other stent makers won’t soon be gaining FDA approval to promote Taxus for use in the subset of patients involved in this study.
That may seem like a failure to the stent makers but from a patient perspective, Syntax is a success.