Medtronic’s drug-filled stent as good as Resolute
The drug-filled stent developed by Medtronic proved to be as good as its Resolute drug-eluting stent at 9 months, according to the 100-patient RevElution study presented yesterday in D.C.
The DFS is made from a tri-layered 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, also published in JACC: Cardiovascular Interventions, had a primary endpoint of angiographic in-stent late lumen loss compared with historical data from the zotarolimus-eluting Resolute stent. In-stent late lumen loss was 0.26±0.28mm for the DFS arm and 0.36±0.52mm for the Resolute arm. The binary angiographic restenosis rate was 0%; median stent strut coverage measured 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.
“At 9 months, the polymer-free drug-filled stent was safe and effective with high rates of early strut coverage and non-inferior late lumen loss compared with historical Resolute data,” Dr. Stephen Worthley, of GenesisCare in Alexandria, Australia, said in prepared remarks. “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.”
“Today marks a notable milestone in working with interventional cardiologists across the globe to realize the potential of this breakthrough technology, which has the ability to help address unmet clinical needs if the clinical data continues to be positive,” added Medtronic vice president Jason Weidman. “Now with the initial clinical outcomes in hand, we look forward to beginning the path toward commercialization for the drug-filled stent to further advance our innovative coronary portfolio.”
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