Early Data Revealed From RevElution Trial of Medtronic's Drug-Filled Stent Trial

April 3, 2016—Medtronic plc announced new clinical data from one of the endpoints in the RevElution trial for its next-generation drug-filled stent (DFS). The data were revealed at ACC.16, the American College of Cardiology’s 65th annual scientific session held April 2–4 in Chicago, Illinois. 

According to Medtronic, the new data showed rapid vessel healing without inflammation in optical coherence tomography data of the complete 1-month follow-up patient cohort (N=15), with an average of approximately 90% full strut coverage and a low 1.5% rate of malapposed struts. The data also showed minimal neointimal hyperplasia formation. 

Additionally, the company advised that enrollment was recently completed in the 50-patient cohort of the RevElution Trial, which will be used to support European CE Mark approval. Medtronic’s DFS is available for investigational use only outside of the United States.

The company stated that the DFS features polymer-free stent design, which elutes sirolimus from the inside of the stent through laser-drilled abluminal holes, allowing for a controlled and sustained drug elution directly into the arterial wall. This may eliminate potential drawbacks experienced with bioabsorbable polymers and polymer-free technologies, such as inflammation due to polymer degradation and uncontrolled drug release in the absence of a polymer.

Ajay Kirtane, MD, who is member of the RevElution Trial Steering Committee, commented in the company’s press release, “The unique attribute of DFS technology is that it allows for controlled elution of drug directly from within a next-generation stent, obviating the need for a polymer. If the encouraging early data from the RevElution Trial continue to show promise with longer-term follow-up, they will set the stage for further pivotal investigations of the DFS. Furthermore, the ability to potentially reduce the mandatory duration of dual antiplatelet therapy following DFS implantation is vitally important for patients and treating physicians.” Dr. Kirtane is Director, New York-Presbyterian Hospital/Columbia University Cardiac Catheterization Laboratories, and Associate Professor of Medicine at Columbia University in New York, New York.