May 29, 2007 — Medtronic Inc. has enrolled the first patient in the landmark PROTECT clinical study, the largest randomized trial focusing on the safety of drug-eluting stents (DES).
The 8,800-patient trial will compare the Medtronic Endeavor zotarolimus-eluting coronary stent system and the Johnson & Johnson Cypher sirolimus-eluting stent, using key safety endpoints and other clinically relevant outcomes. The first patient was implanted in Germany.
The primary endpoint for the PROTECT study will be overall stent thrombosis at three years, defined as definite and probable, according to the new Academic Research Consortium criteria. Secondary endpoints include a composite of death and non-fatal myocardial infarction, as well as numerous additional safety and clinical efficacy endpoints.
The study will enroll approximately 8,800 "real world" patients at 200 clinical centers worldwide. Real world refers to the general patient population typically seen by physicians in their everyday clinical practice, including a broad universe of patients with complex medical conditions.
"PROTECT is a very important clinical trial for the interventional industry, as it is well-designed and adequately powered to provide the type of long-term safety data physicians have been seeking," said Dr. William Wijns, co-director of the Cardiovascular Center, OLV Ziekenhuis, Aalst, Belgium and co-principal investigator of the PROTECT trial. "This trial should help offer greater clarity around the safety issues that have become part of the drug-eluting stent landscape. Patients and physicians are interested in the safety and efficacy performance of drug-eluting stents. This trial will provide the data which will be most relevant to daily clinical practice."
For more information visit www.medtronic.com.