RevElution: First-in-Human Study of Drug-Filled Stent vs. DES in CAD
The polymer-free drug-filled stent was safe and effective compared to the Resolute zotarolimus-eluting stent, according to the results of the RevElution Trial presented Oct. 31 at TCT 2016 and simultaneously published in JACC: Cardiovascular Interventions.
In a first-in-human study, Stephen G. Worthley, MBBS, PhD, FACC, et al., enrolled 100 patients with de novo coronary lesions 2.25 – 3.50 mm in diameter and length ≤ 27 mm in two 50-patient cohorts for angiographic, intravascular ultrasound, and clinical assessment at nine 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 nine months compared with historical data from the Resolute stent as a control.
The results of the study showed that at nine-month assessment, the polymer-free drug-filled stent was non-inferior to the Resolute stent, with high rates of early strut coverage and non-inferior late lumen loss – 0.26±0.28 mm for the drug-filled stent and 0.36±0.52 mm for Resolute. Median stent strut coverage by OCT was 91.4 percent, 95.6 percent, and 99.1 percent at one, three, and nine months, respectively.
“This polymer-free stent may avoid polymer-associated adverse vascular responses potentially allowing for a shorter duration of dual antiplatelet therapy,” stated Worthley. “However, larger controlled studies with long-term follow-up are required to demonstrate whether the favorable properties of the drug-filled stent translate into improved event-free survival in patients with coronary artery disease.”
Keywords: Transcatheter Cardiovascular Therapeutics, Angiography, Drug-Eluting Stents, Polymers, Sirolimus, Coronary Artery Disease, Disease-Free Survival, Follow-Up Studies, Stents, Tomography, Optical Coherence
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