Medtronic’s Resolute Onyx Drug-Eluting Stent Shows Success for Left Main PCI

University of Padua Medical School Head of Interventional Cardiology Giuseppe Tarantini shared late-breaking clinical trial results for the ROLEX (Revascularization Of LEft Main With Resolute onyX) registry, an investigator-initiated, Medtronic-funded study at EuroPCR 2022.
 
The ROLEX study used Medtronic’s Resolute Onyx drug-eluting stent (DES), a dedicated platform for left main artery percutaneous interventions (PCIs).
 
“Available data on left main PCI procedures have mostly been obtained in studies using drug eluting stent (DES) platforms without large-vessel-dedicated devices and with limited expansion capability,” Prof. Tarantini told the press. “The study was initiated with Resolute Onyx DES because of its 4.5 and 5.0 mm sizes, which can now expand to 6.0 mm. The data supports the use of the Resolute Onyx DES in left main stenting, as well as the benefits of image guided procedures in combination with a conformable DES platform to help reduce adverse events.”
 
The trial included 450 patients. Patients received a PCI procedure with Resolute Onyx DES and 45% of them were given intravascular guidance.
 
According to the data, low 5.1% rate of target lesion failure (TLF), 2% ischemia driven target lesion revascularization (ID-TLR), and 1.1% stent thrombosis were observed. A lower rate of 2% TLF, 1% ID-TLR, and 0.5% ST was observed in procedures with imaging guidance.
 
98.7% device success was demonstrated, including 53.4% with ACS, 58.5% with multivessel disease, and 30.4% with diabetes.
 
Resolute Onyx DES was chosen as the study stent because of its 4.5- and 5.0-mm diameter sizes, which now expand to 6.0 mm, and its single-wire design that enables conformability to achieve optimal strut 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,” said Jason Weidman, SVP and president of Medtronic’s Coronary & Renal Denervation Operating Unit. “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.”

This news comes just days after Medtronic received FDA approval for its Onyx Frontier drug-eluting stent.