University of Padua Medical School Head of Interventional Cardiology Dr. Giuseppe Tarantini presented late-breaking clinical trial results from the investigator-initiated, Medtronic-funded ROLEX (Revascularization Of LEft Main With Resolute onyX) registry.
ROLEX, the largest real-world, multicenter prospective study, observed the Resolute Onyx drug-eluting stent (DES) in percutaneous coronary interventions (PCI) in the left main artery, according to a news release.
A total of 450 patients were enrolled across 26 centers, receiving a PCI procedure with Resolute Onyx. Intravascular imaging guidance was used in 45% of patients.
One-year data demonstrated strong safety and efficacy, with a low 5.1% rate of target lesion failure (TLF), 2% ischemia-driven target lesion revascularization (ID-TLR) and 1.1% stent thrombosis (ST). In procedures where imaging guidance was employed, those numbers were even lower, with 2% TLF, 1% ID-TLR and 0.5% ST.
The study also demonstrated 98.7% device success in a highly complex patient population, Medtronic said, with 53.4% of patients having acute coronary syndrome, 58.5% having multivessel disease and 30.4% having diabetes.
Resolute Onyx was selected for the study as it is optimized for left main and bifurcation stenting and has 4.5 mm and 5 mm diameter sizes that now expand to 6 mm, plus a single-wire design that enables conformability to achieve optimal strug apposition.
“The data from the ROLEX registry presented today at EuroPCR adds to the unmatched body of evidence supporting Resolute Onyx DES in left main PCI procedures,” Medtronic SVP and President of Coronary and Renal Denervation Jason Weidman said in the release. “We have prioritized investing in product innovation and meaningful evidence to support left main PCI. In addition to ROLEX, the EBC MAIN study showed the benefits of using Resolute Onyx DES to support provisional or two-stent strategies in true left main bifurcations and provided impactful additional data to support physician decision making.”
Strong study results for Resolute Onyx come on the back of last week’s FDA approval for the Onyx Frontier DES.
Onyx Frontier, the latest iteration of Medtronic’s Resolute DES family, was designed to leverage the same stent platform as Resolute with an enhanced delivery system for improving deliverability and increasing acute performance, even in the most challenging of cases.
