A Medical Device Daily

Cordis (Miami Lakes, Florida) reported that two independent studies published this week in the Journal of the American College of Cardiology showed that the Cypher stent outperformed the Taxus stent in small coronary vessels and everyday medical practice. The results of one of the studies were reviewed in an accompanying editorial.

A German study involving more than 2,000 patients fromDeutsches Herzzentrum and First Medizinische Klinik rechts der Isar, followed for nine months, found the Cypher drug-eluting stent (DES) more effective at preventing repeat procedures (target lesion revascularization or TLR) in small coronary vessels measuring less than 2.41 mm in diameter. Specifically, the Cypher had a TLR rate of 8.6% in such vessels; the TLR rate of the Taxus in the same type of vessels was 16%. The difference was statistically significant (p=0.002).

"The sheer size of the trial and high angiographic follow-up rates provide compelling evidence" supporting the use of the Cypher stent in small vessels, wrote Bradley Strauss, MD, PhD, from the University of Toronto , in an accompanying editorial.

The second study analyzed one-year results of the multi-center Registro regionale AngiopLastiche dell'Emilia-Romagna (REAL) registry in Italy and concluded that the Cypher reduced the incidence of major adverse cardiac events (MACE), by decreasing the need for repeat procedures compared to Taxus. In analysis of 1,676 patients, the rates of MACE – defined to include all death, heart attack (myocardial infarction) and TVR – were 9.2% for the Cypher, 14.1% for the Taxus (p=0.007). In addition, the TVR rate of the Taxus (10%) was twice as much as the TVR rate of the Cypher (5%), and statistically significant (p=0.0008).

The authors said the major study finding "is that in a real-world complex population, [the Cypher] is associated with a lower risk of reinterventions compared to the [Taxus]. This result deserves some attention, because a very intense debate is ongoing about the relative performance of these two drug-eluting stents in clinical practice."

As a caveat, the German study found no significant differences between the TLR rates of the Cypher and the Taxus in large vessels. And no statistical differences were found between the death and myocardial infarction rates of the two stents in the Italian registry.