Comin’ down the wire, we get news that Metronic, Inc has enrolled its first patient in a clinical trial examining the safety of their Endeavor drug-eluting stent along with Johnson and Johnson’s Cypher DES….
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.
Given that the whole study is funded my Medtronic, and that DES-s represent a huge market, we wonder which of the two stents will be found to be safer…
Also, we wonder what PROTECT stands for. Oh, wait, found it: PROTECT = Patient Related OuTcomes with Endeavor versus Cypher stenting Trial. Way to go with that one, guys…
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