Western Denmark Registry demonstrates lower risk of thrombosis for Cypher stent

C. Michael Gibson, M.S., M.D. October 2, 2007

WASHINGTON, D.C. Fifteen-month data from the Western Denmark Heart Registry demonstrates that treatment with the CYPHER® Sirolimus-eluting Coronary Stent was associated with a lower risk of stent thrombosis and target lesion revascularization than the Taxus Stent.

The Western Denmark Heart Registry is a multi-center, prospective, observational registry of all patients in western Denmark who underwent coronary interventions. Patients who received a drug-eluting stent between January 2002 through June 2005 were included in the registry. Patients who treated with a combination of drug-eluting and bare metal stents (BMS) were excluded. All patients were followed for 15 months.

The primary endpoints of the study were stent thrombosis, myocardial infarction and death. No significant differences were found in the clinical outcomes of myocardial infarction or death.

Stent thrombosis was defined according to the Academic Research Consortium (ARC) definitions for thrombosis: definite, which required confirmation of a clot by angiogram at follow-up; probable, which included a heart attack in the treated vessel in patients who did not have an angiographic confirmation of a thrombosis; and possible, which included sudden unexplained death.

Taxus Stent placement was associated with 55 percent relative increase in definite stent thrombosis compared with placement of the CYPHER® Stent [confidence interval (CI) 0.21-0.94]. In an expanded classification that includes definite/probable/possible stent thrombosis, Taxus Stent patients were 49 percent more likely to develop thrombosis than patients who received a CYPHER® Stent (CI 0.30-0.87). The CYPHER® stent was also associated with a 32% reduced risk of target lesion revascularization as well (CI 0.52-0.90).

“The study data show that the clinical outcomes following drug-eluting stent implantation may depend on the type of stent used to treat a patient with coronary artery disease,” said Professor Leif Thuesen, MD, DMSci, from Aarhus University Hospital in Denmark.