Medtronic starts new arm of global stent study

Medtronic has announced the start of the next arm of its global study to compare the safety of the Endeavor and Cypher drug-eluting stents.

The next arm of the Protect study – the largest randomised controlled trial of its type – will take place in the US.

In total, 8,800 coronary artery disease patients will be enrolled to assess the difference in stent thrombosis and other specified endpoints.

Stent thrombosis occurs when a blood clot forms inside a stent and can potentially cause heart attack or death and is a rare but serious adverse event of stent implantation.

The first US patients in the Protect study were enrolled last week by Dr Carlos Mego and his patient care team situated at Doctors Hospital at Renaissance in Edinburg, Texas.

Dr William O’Neill, an interventional cardiologist and professor of medicine at the University of Miami School of Medicine in Florida, said: “Protect is the first large-scale, prospective, randomized controlled trial focused primarily on the safety of drug-eluting stents, which remains an important concern among patients and physicians alike.”

He added concerns over stent safety are mainly focused on stent thrombosis, with worries heightened especially a year after implantation.

Earlier this month, Medtronic finalised its deal to acquire Restore Medical.