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ZES effective for treatment of CAD in small vessels at 1 year
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A zotarolimus-eluting stent designed to treat CAD in very small coronary vessels was effective at preventing target lesion failure at 1 year, according to findings presented at EuroPCR and published in JACC: Cardiovascular Interventions.
For the single-arm, open-label RESOLUTE ONYX 2.0 study, researchers evaluated the performance of the ZES (Resolute Onyx, Medtronic) in 104 lesions in 101 patients with CAD and vessel diameter < 2.25 mm by visual examination at 20 centers in the United States and Japan.
The performance goal was TLF < 19% at 1 year. TLF was defined as cardiac death, target-vessel MI or target lesion revascularization. Secondary endpoints included MACE, individual components of TLF and target vessel failure, stent thrombosis, late lumen loss, binary angiographic restenosis and percent diameter stenosis.
Presenter Matthew J. Price, MD, director of the cardiac catheterization laboratory at Scripps Clinic, La Jolla, California, and a member of the Cardiology Today’s Intervention Editorial Board, said in an interview that there had not previously been a prospective outcomes study of a drug-eluting stent in patients with vessels as small as 2 mm.
“There are not great options right now for these very small lesions, and [PCI may produce] bad outcomes because the vessel being so small may mean higher restenosis rates,” Price told Cardiology Today’s Intervention. “These vessels are often also too small for CABG, so then we have to try medical therapy or other options, which may not be optimal.”
At 1 year, the rate of TLF was 5% with an upper bound of the 95% CI of 10.2%, beating the performance goal of 19% (P ≤ .001), according to the researchers.
There were no cases of death or definite/probable stent thrombosis. Target-vessel MI occurred in 3% of patients, clinically driven TVR occurred in 2%, and TLF, TVF and MACE each occurred in 5%, Price said.
Late lumen loss was 0.26 mm in-stent and 0.25 mm in-segment, mean lumen diameter was 1.55 mm in-stent and 1.25 mm in-segment, reference vessel diameter was 2.02 mm, percent diameter stenosis was 22.49% in-stent and 37.92% in-segment, according to the researchers.
The in-stent binary angiographic restenosis rate was 12% and the in-segment binary angiographic restenosis rate was 20%.
“Considering that we enrolled lesions in extremely small vessels in this trial, the success rates were terrific,” Price told Cardiology Today’s Intervention. “This new stent really meets an unmet clinical need for operators and patients.”
The DES is not yet commercially available in the United States for treatment of small vessels, and the study will be used to support FDA approval, Price said. – by Erik Swain
References:
Price MJ, et al. PCI – Procedural techniques and clinical outcomes: Session comprising selected EuroPCR 2017 late-breaking trial submissions. Presented at: EuroPCR; May 16-19, 2017; Paris.
Price MJ, et al. JACC Cardiovasc Interv. 2017;doi:10.1016/j.jcin.2017.005.014.
Disclosure: The study was funded by Medtronic. Price reports receiving consultant fees from Boston Scientific and Medtronic and speaker fees from Abbott Vascular and Medtronic.
Perspective
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David J. Moliterno, MD, FACC
This is the smallest DES we have. What’s impressive about these results is that nearly half the population had diabetes, yet target lesion success at 12 months was 95% among patients with a 2-mm vessel. This is phenomenal.
We have 2.25-mm stents that we could use in these patients, but they’re less attractive because there is risk for damage to the artery.
As opposed to using balloon angioplasty, a bare-metal stent or — someday in the United States — a drug-eluting balloon, this DES allows us to treat the smallest vessels yet, particularly in higher-risk cohorts such as diabetics, with a very high success rate.
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