One-month, follow-up patient cohort data from the Revelution trial of Medtronic’s novel drug-filled stent indicate that device is associated with rapid vessel healing without inflammation, as assessed by optical coherence tomography (OCT). These data were presented at the 2016 American College of Cardiology meeting (ACC; 2–4 April; Chicago, USA) and, according to press release, follow the completion of enrolment of 50-patient trial.
The press release reports that the drug-filled stent is “an innovative, polymer-free stent design, which elutes the drug (sirolimus) from the inside of the stent through laser-drilled abluminal holes”. It explains that allows for a controlled and sustained drug elution directly into the arterial wall, which 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.
In the fully completed one-month cohort of patients (N=15) from the trial, which evaluated healing with OCT imaging, the drug-filled stent was associated with 90% full strut coverage (new cell growth over stent struts) and a low rate of malapposed struts (1.5%). Importantly, the data also showed minimal neointimal hyperplasia formation.
Study investigator Ajay Kirtane (New York-Presbyterian Hospital/Columbia University Cardiac Catheterization Laboratories, New York, USA), states: “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 drug-filled stent. Furthermore, the ability to potentially reduce the mandatory duration of dual antiplatelet therapy following drug-filled stent implantation is vitally important for patients and treating physicians.”