REMEDEE Postmarket Registry Begins Enrollment for OrbusNeich's Combo Dual-Therapy Stent

August 6, 2013—OrbusNeich (Fort Lauderdale, FL) announced that patient enrollment has been initiated in the postmarket REMEDEE registry for the Combo dual-therapy stent to evaluate the device's long-term safety and performance in routine clinical practice. On May 27, the company announced European CE Mark approval of the Combo dual-therapy stent for the treatment of coronary artery disease. The Combo stent is being introduced in Europe and selected markets in the Asia-Pacific and Middle East regions.

According to OrbusNeich, the all-comers REMEDEE postmarket registry is a multicenter, prospective evaluation of clinical outcomes after deployment of the Combo bioengineered abluminal sirolimus-eluting stent. It will enroll 1,000 patients at nine European sites. Study sites will consecutively enroll patients in whom Combo stent placement is attempted to treat a coronary lesion in the setting of routine clinical care.

The company advised that it will conduct flash-type patient recruitment that will include 100 to 150 patients at each of the participating nine high-volume percutaneous coronary intervention centers in France, Latvia, Luxembourg, The Netherlands, Northern Ireland, and Spain. Robbert de Winter, MD, of the Academic Medical Center in Amsterdam, the Netherlands, is principal investigator of the study.

“The Combo dual-therapy stent is a truly innovative device that addresses the challenge of delayed arterial healing caused by monotherapy drug-eluting stents by combining the antiproliferative property of a drug-eluting stent with a prohealing antibody coating technology,” commented Dr. de Winter in the OrbusNeich press release.

REMEDEE's primary endpoint is clinically driven target vessel failure at 1 year postprocedure, which includes cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization. Primary endpoint data are expected in the first quarter of 2015.

Secondary endpoints include device and procedural success and adjudicated target lesion failure at 30 and 180 days postprocedure. Additional secondary endpoints to be evaluated at 30, 180, and 365 days include the components of target vessel failure, defined as cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization; adjudicated major adverse cardiac events as a composite and as each of its components, defined as death, any myocardial infarction, and any revascularization; and adjudicated stent thrombosis. Clinical follow-up will be conducted each year up to 5 years, advised OrbusNeich.