First-in-Human REVELUTION Data Presented for Medtronic's Drug-Filled Stent

October 31, 2016—The first-in-human REVELUTION study of Medtronic plc’s new polymer-free, drug-filled stent (DFS) indicated noninferior in-stent late lumen loss at 9-months compared with historical data of Medtronic’s Resolute zotarolimus-eluting stent (ZES). In addition, there was no binary restenosis, and a high degree of early stent strut coverage with minimal malapposition. The REVELUTION data were reported at TCT 2016, the 28th annual Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC, and simultaneously published online by Prof. Stephen G. Worthley, MBBS, et al in the Journal of American College of Cardiology (JACC): Cardiovascular Interventions.

As noted in the TCT announcement, a polymer-free metal surface stent that is capable of controlled antiproliferative drug elution may avoid the adverse effects of polymer-induced inflammation, thrombosis and nonuniformity, and could potentially allow for shorter durations of dual-antiplatelet therapy.

Medtronic’s polymer-free DFS evaluated in REVELUTION was designed to provide controlled and sustained drug elution from an internal stent lumen without a polymer coating. The DFS is made from a trilayered continuous wire with an outer cobalt chromium layer, a middle tantalum layer, and an inner lumen coated with sirolimus. Small laser-drilled holes on the abluminal stent surface control drug elution.

The study enrolled 100 patients with de novo coronary lesions 2.25–3.5 mm in diameter and length ≤ 27 mm in two 50-patient cohorts for angiographic, intravascular ultrasound, and clinical assessment at 9 or 24 months, with optical coherence tomography (OCT) performed in a subset of 30 patients at multiple time periods. The primary endpoint was angiographic in-stent late lumen loss at 9 months compared with historical data from the Resolute ZES as a control.

Fifty patients with 56 lesions were treated with DFS in the 9-month cohort. The investigators found in-stent late lumen loss was 0.26 ± 0.28 mm for DFS and 0.36 ± 0.52 mm for Resolute (P_{noninferiority} < .001). The binary angiographic restenosis rate was 0%. Median stent strut coverage by OCT was 91.4%, 95.6%, and 99.1% at 1, 3, and 9 months, respectively. One non–Q-wave myocardial infarction occurred, with a 9-month target lesion failure rate of 2.1%. No stent thrombosis occurred.

In the TCT announcement, Prof. Worthley commented, “At 9 months, the polymer-free DFS was safe and effective with high rates of early strut coverage and noninferior late lumen loss compared with historical Resolute data. This polymer-free stent may avoid polymer-associated adverse vascular responses potentially allowing for a shorter duration of dual antiplatelet therapy. However, larger controlled studies with long-term follow-up are required to demonstrate whether the favorable properties of DFS translate into improved event-free survival in patients with coronary artery disease.”