Medtronic completes enrollment in stent-safety comparison study

Protect is powered to detect a clinically significant difference in rates of stent thrombosis between the two devices. Protect’s primary endpoint is overall stent thrombosis at three years; secondary endpoints include death and non-fatal myocardial infarction (MI), target lesion revascularization and target vessel revascularization. The three-year data are expected to be available in 2012.

The trials that supported the regulatory approvals of the Endeavor drug-eluting stent have shown no increase in the rate of very late stent thrombosis compared with its bare-metal stent control and no new events after two years through four years of follow-up. These observations served as the rationale for Protect.

Sean Salmon, vice president and general manager of the coronary and peripheral business at Medtronic, said: “Given the consistency with which the Endeavor stent has performed in clinical studies and in clinical practice, we have every confidence that Protect will affirm the excellent clinical results that physicians have come to expect from a second-generation drug-eluting stent.

“We’re also confident this trial will deliver the incremental evidence that physicians need to make the best treatment decisions on behalf of their patients with coronary artery disease.”