Medtronic Announces Start of 8,800-Patient Clinical Trial Evaluating Drug-Eluting Stent Safety

PROTECT Trial Will Compare Frequency of Stent Thrombosis Associated with Medtronic’s Endeavor Stent and Johnson & Johnson’s Cypher Stent in Large Randomized Trial

Medtronic, Inc. (NYSE: MDT) said today that it 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.”

In addition to Dr. Wijns, the other co-principal investigators for PROTECT are: Prof. Patrick Serruys, Thoraxcenter, Erasmus University, Rotterdam, Netherlands; Prof. Philippe Gabriel Steg, M.D., Hôpital Bichat-Claude Bernad, Paris; and Dr. Edoardo Camenzind, Division of Cardiology, University Hospital Geneva. An independent Clinical Events Committee will be engaged for adjudication of events related to the primary endpoint and an independent statistical organization will be used for data analysis.

The first patient was enrolled by Prof. Dr. med. Johannes Brachmann, Klinikum Coburg, Coburg, Germany and Prof. Dr. med. Christoph Bode, Universitätsklinikum, Freiburg, Germany.

The Endeavor drug-eluting stent received CE Mark in 2005 and is available in more than 100 countries. It is under review by the U.S. Food and Drug Administration for approval in the United States.

Prior to the PROTECT trial, there have been no large, randomized clinical trials that have provided head-to-head analysis of two major stent platforms with safety as the primary endpoint and other clinically relevant outcomes as secondary endpoints. The PROTECT trial will do this, as well as assess the balance between safety and efficacy in DES and compare Endeavor and Cypher in several subgroups with specific patient demographics and vessel or lesion characteristics.

“We are encouraged by the safety results achieved with Endeavor in our clinical trials thus far,” said Sean Salmon, vice president and General Manager of Medtronic’s Coronary and Peripheral business in Santa Rosa, California. “We’ve consistently seen very low rates of repeat procedures and stent thrombosis in a large number of patients who have been monitored for at least two years and many for three years. Our observed rates of stent thrombosis are extremely low and this strong safety profile has come without a tradeoff in efficacy. This trial will generate valuable information for the industry and we have confidence that PROTECT will deliver the data physicians need to make the best possible decisions about treating their patients with coronary artery disease.”

Drug-eluting stents are tiny mesh devices that help prop open clogged arteries during angioplasty procedures. They were introduced in Europe in 2002 and have been considered a breakthrough in interventional cardiology because of their effectiveness in reducing restenosis, or the re-clogging of an artery following a stent implant. Large randomized studies have established that drug-eluting stents are more effective at preventing restenosis than their bare metal predecessors, which have no drug coating. Bare metal stents remain a valuable tool for physicians in the treatment of cardiovascular disease, especially for patients with specific medical conditions or for whom drug-eluting stents are not ideal due to medical procedures that require patients to discontinue anti-platelet therapy.