Medtronic Completes Enrollment in Global Head-to-Head Stent-Safety Study
8,800 Patients Enrolled in PROTECT, First and Largest Trial of Its Kind
MINNEAPOLIS – Medtronic, Inc. (NYSE: MDT), today announced the completion of enrollment in PROTECT,1 the company’s global study comparing its Endeavor drug-eluting stent (DES) to Johnson & Johnson’s Cypher® DES. A landmark study of groundbreaking devices used to treat coronary artery disease, PROTECT is the first and largest randomized controlled trial (RCT) of its kind.
“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 Dr. William Wijns of the Cardiovascular Center in Aalst, Belgium; Prof. Philippe Gabriel Steg of Hôpital Bichat-Claude Bernard in Paris, France; and Dr. Edoardo Camenzind of University Hospital Geneva in Switzerland, the investigators representing the trial’s steering committee.
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.
“With the Endeavor DES, the rate of VLST appears to be remarkably and sustainably low – a reassuring record,” said steering committee member Dr. William O’Neill 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.”
VLST emerged as a safety concern with the first generation of DES in 2006, when clinical trials conducted to support the regulatory approvals of these devices revealed a numerical increase in the rate of VLST compared to BMS controls.
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.
Involving more than 200 medical centers worldwide, PROTECT constitutes a large part of the ENDEAVOR clinical program, which has demonstrated that the Endeavor stent is associated with low rates of stent thrombosis, MI and cardiac death, as well as low rates of clinically-driven TLR and TVR, out to as long as five years of patient follow-up. The program has enrolled more than 21,000 subjects to date.
“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 DES,” said Sean Salmon, vice president and general manager of the Coronary and Peripheral business at Medtronic. “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.”
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 25, 2008. Actual results may differ materially from anticipated results.
1 Patient Related OuTcomes with Endeavor versus Cypher stenting Trial.
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