Medtronic’s Resolute Onyx DES in ROLEX Study Shows Safety, Efficacy in Left Main PCI

May 19, 2022—Medtronic announced that Professor Giuseppe Tarantini, MD, Head of the Interventional Cardiology Unit at the University of Padua Medical School in Padua, Italy presented late-breaking clinical trial results from the ROLEX (Revascularization of Left Main With Resolute Onyx) registry, which is an investigator-initiated study funded by the company.

The large real-world, multicenter prospective ROLEX study on left main percutaneous coronary interventions (PCI) used Medtronic’s Resolute Onyx drug-eluting stent (DES), which has a dedicated DES platform for PCIs in the left main artery. Prof. Tarantini presented the findings at the EuroPCR 2022 conference held May 17-20 in Paris, France.

“Available data on left main PCI procedures have mostly been obtained in studies using DES platforms without large-vessel-dedicated devices and with limited expansion capability,” commented Prof. Tarantini in Medtronic’s press release. “The study was initiated with Resolute Onyx DES because of its 4.5- and 5-mm sizes, which can now expand to 6 mm. The data support 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.”

As summarized in the company’s press release, the ROLEX investigators at 26 centers enrolled 450 patients, which included complex patient populations often seen in real-world practice. Patients received a PCI procedure with Resolute Onyx DES; intravascular imaging guidance was used in 45% of patients. Medtronic stated that the 1-year results demonstrated strong safety and efficacy, including the following:

• 5.1% rate of target lesion failure (TLF); 2% ischemia-driven target lesion revascularization (ID-TLR); and 1.1% stent thrombosis (ST)
• Even lower rates were seen in procedures in which imaging guidance was employed (TLF, 2%; ID-TLR, 1%; and ST, 0.5%)

Additionally, the study also demonstrated a device success rate of 98.7% with the Resolute Onyx DES in a highly complex patient population that included patients with acute coronary syndrome (53.4%), multivessel disease (58.5%), and diabetes (30.4%).

Medtronic noted that left main PCI poses unique challenges because of the large vessel size, frequent involvement of the bifurcation with large and important branches, and the critical clinical impact of complications. The company stated that the Resolute Onyx DES is optimized for left main and bifurcation stenting and was the study device because of its diameter sizes and its single-wire design that enables conformability to achieve optimal strut apposition.

The Resolute Onyx DES received CE Mark approval in September 2014 with an increased maximum stent inner diameter in August 2020. It is indicated for use in bifurcation and left main lesions. The use of Resolute Onyx DES in left main and bifurcation lesions is not approved in the United States, advised Medtronic.