Early Results Presented from RevElution Trial of Medtronic's Drug-Filled Stent

October 12, 2015—Medtronic plc announced new data from the first implants of its drug-filled stent (DFS) at TCT 2015, the Transcatheter Cardiovascular Therapeutics scientific symposium, which is being held October 11–15 in San Francisco, California. The company advised that early results from an initial subset of patients in the Medtronic RevElution Trial show that the DFS achieved rapid and well-controlled stent coverage. The data were presented by the trial’s coprincipal investigator, Stephen Worthley, MD, professor at the Royal Adelaide Hospital in Adelaide, Australia, who performed the first implants in the study.

The global DFS study is underway at multiple sites in countries including Australia and Brazil. The study will enroll 100 patients and will evaluate late lumen loss as measured by quantitative coronary angiography. 

Medtronic’s DFS is designed to eliminate potential drawbacks experienced with bioabsorbable polymers and polymer-free technologies, such as inflammation caused by polymer degradation, and uncontrolled drug release in the absence of a polymer. The device is available for investigational use only outside of the United States, advised the company.

According to the company, optical coherence tomography data from the trial demonstrate an early healing profile with an average of 90% strut coverage at 1 month, with a 2% rate of malapposed struts across the six patients analyzed. The rate of malapposed struts dropped by 50% within 1 month postprocedure, further demonstrating the stent's ability to allow for rapid healing within the vessel. Importantly, the data also showed minimal neointimal hyperplasia formation.

In Medtronic’s press release, Dr. Worthley commented, “The novel DFS truly represents an innovative stent platform with advanced stent manufacturing to optimize clinical performance without the need of a polymer. These patients implanted with the DFS have shown very promising early outcomes of strut coverage and healing that indicate the new platform may provide many clinical benefits, including shorter dual-antiplatelet therapy duration, and we look forward to evaluating how well the stent continues to perform throughout the trial.”

The DFS is built on the proven platform of Medtronic’s Resolute Integrity drug-eluting stent (DES) with continuous sinusoid technology, which is the company’s method of stent manufacturing that forms one single strand of wire into a sinusoidal wave, enabling a continuous range of motion. The device also is built upon the next-generation Resolute Onyx DES with CoreWire technology that allows it to have a denser core metal surrounded by a cobalt alloy outer layer for thinner struts with enhanced radiopacity.

Medtronic further stated that the new DFS features a trilayer wire design that allows the inner sacrificial layer to become a lumen continuously coated with drug. Sirolimus (the drug) is contained on the inside of the stent and is released from a single continuous inner lumen through multiple laser-drilled holes on the abluminal side of the stent. This allows for a controlled and sustained polymer-free drug elution over a desired period of time directly into the arterial wall, potentially avoiding chronic inflammation and adverse vascular responses. In patients with complex lesions, containing the drug on the inside of the stent protects the coating to reduce concerns related to coating durability during tracking, stated the company.