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Medtronic Announces Start of 8,800-Patient Clinical Trial Evaluating Drug-Eluting Stent Safety ET PROTECT Trial Will Compare Frequency of Stent Thrombosis Associated with Medtronic's Endeavor Stent and Johnson & Johnson's Cypher Stent in Large Randomized Trial |
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| May 21, 2007, Minneapolis --
Medtronic, Inc. 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., Hopital 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, Universitatsklinikum,
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.
About Medtronic
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. Caution: In the United States, the Endeavor drug-eluting Coronary Stent is an investigational device with an investigational drug (zotarolimus) and is exclusively used for clinical investigation. 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 28, 2006. Actual results may differ materially from anticipated results. Source: Medtronic, Inc. |
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