News | February 03, 2009

Medtronic Completes Study Enrollment to Compare Stent Safety

February 3, 2009 – Medtronic has completed enrollment in PROTECT, the company’s global study comparing its Endeavor drug-eluting stent (DES) to Johnson & Johnson’s Cypher DES.

Said to be the first and largest randomized controlled trial (RCT) of its kind, PROTECT is powered to detect a clinically significant difference in rates of stent thrombosis between the two devices. Stent thrombosis is a rare but serious adverse event in which a blood clot forms inside the stent, with the potential to cause heart attack or death. Occurrences after one year post-implant are called very late stent thrombosis (VLST) and a subject of significant concern.

“The scale and scope of this trial will make the results applicable to a wide spectrum of practices worldwide. PROTECT will yield contemporary data on stent thrombosis rates and other clinically relevant endpoints for these two drug-eluting stents, including the role of antiplatelet therapy after their implantation. Thanks to the efforts of our fellow investigators and their teams, PROTECT successfully randomized 8,800 patients in 18 months,” said William Wijns, M.D., of the Cardiovascular Center in Aalst, Belgium; Prof. Philippe Gabriel Steg of Hôpital Bichat-Claude Bernard in Paris, France; and Edoardo Camenzind, M.D., of University Hospital Geneva in Switzerland, the investigators representing the trial’s steering committee.

“With the Endeavor DES, the rate of VLST appears to be remarkably and sustainably low – a reassuring record,” said steering committee member William O’Neill, M.D., of the University of Miami School of Medicine in Florida. “While the Endeavor DES has demonstrated durable efficacy to four years of patient follow-up in comparison to other DES, its long-term safety profile resembles that of a bare-metal stent (BMS), the benchmark for stent safety. PROTECT puts this contention to the test in a large RCT.”

The trials that supported the regulatory approvals of the Endeavor DES have shown no increase in the rate of VLST compared with its BMS control and no new events after two years through four years of follow-up. These observations served as the rationale for PROTECT.

PROTECT’s primary endpoint is overall stent thrombosis at three years; secondary endpoints include death and non-fatal myocardial infarction (MI), target lesion revascularization (TLR) and target vessel revascularization (TVR). Three-year data are expected to be available in 2012.

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