Daniel Clair, chairman, Department of Vascular Surgery, The Cleveland Clinic Foundation, presented at the TCT congress twelve-month clinical endpoint data from the ORION trial, which demonstrated robust safety and effectiveness outcomes for the Epic Self-Expanding Nitinol Stent System (Boston Scientific) in patients with iliac artery disease.
“Following the recent presentation of our nine-month data, the 12-month ORION data continue to show very strong clinical outcomes,” said Clair, principal investigator of the ORION trial. “The performance of the Epic stent in challenging iliac artery lesions and the long-term demonstration of both safety and efficacy of the Epic stent is another example of our ability to offer patients a durable treatment option for iliac artery disease.”
The prospective, single-arm ORION trial enrolled 125 patients at 28 sites in the United States. The trial previously met its primary endpoint of major adverse events (MAE) at nine months with a rate of 3.4% for the Epic stent compared to a pre-specified performance goal. Major adverse events are defined as death within 30 days, myocardial infarction occurring during hospitalisation, target vessel revascularisation (TVR) through nine months and amputation of the treated limb through nine months. The MAE rate at 12 months was 5.4%, with all MAEs related to TVR. No amputations were reported through the 12-month period.
Duplex ultrasound showed a primary patency of 94.4%, indicating the vast majority of treated lesions remained open through the 12-month follow-up period. Furthermore, outcomes for very complex (TASC C/D) lesions were similar to those reported for less complex (TASC A/B) lesions. Patients experienced significant clinical improvement from baseline to twelve months based on feedback from validated questionnaires evaluating walking distance, speed and stair climbing.
Epic stent and ORION trial
The Epic stent is a self-expanding nitinol stent designed to sustain vessel patency, while providing enhanced visibility and accuracy during placement. It employs an innovative Tandem Architecture, which is engineered to provide excellent stent flexibility while maintaining predictable radial force characteristics across a variety of stent sizes. This stent is compatible with 6F sheaths, and the stent delivery system is compatible with 0.035 inch guidewires.
The ORION clinical data was used to support application for US Food and Drug Administration approval of the Epic Stent System.
The Epic Nitinol Stent System received CE mark approval and was launched in Europe and other international markets in 2009. It was launched in the United States in May of 2012.