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Novolimus-eluting stent superior to zotarolimus-eluting stent at 5 years
A novolimus-eluting stent yielded better outcomes than a zotarolimus-eluting stent in clinical efficacy and safety during long-term follow-up, according to data from the EXCELLA II trial.
At 5 years, the novolimus-eluting stent (NES; DESyne, Elixir Medical), as compared with the zotarolimus-eluting stent (ZES; Endeavor, Medtronic), was associated with a lower incidence of the patient-oriented composite endpoint, which included all death, all MI and all revascularization (HR = 0.53; 95% CI, 0.32-0.87). The same was true for the device-oriented composite endpoint, which included cardiac death, MI not clearly attributable to a non-intervened vessel and clinically indicated target lesion revascularization (HR = 0.38; 95% CI, 0.17-0.83), according to the results.
The researchers also noted no difference in cardiac death and definite or probable stent thrombosis between the NES and ZES groups. However, the NES was associated with a trend toward reduction in MI and repeat revascularization at 5 years.
Previously reported data demonstrated both noninferiority and superiority of the NES vs. the ZES for in-stent lumen loss — the primary endpoint — and superiority for IVUS-derived neointimal volume at 9 months.
EXCELLA II was a prospective, single blind, multicenter trial in which 210 patients were randomly assigned in a 2:1 ratio to the NES (n = 139) or the ZES (n = 71). All patients (mean age, 64 years; 66% men; 24% with diabetes) had at most two de novo lesions in two different epicardial vessels.
“Selection of a [drug-eluting stent] to implant in a patient undergoing PCI remains a subjective choice of individual operators, as trials comparing various newer-generation stents have not shown definite superiority of one over the others,” the researchers wrote.
“Further trials, powered for clinical outcomes, are warranted before a change in clinical practice can be recommended,” they wrote. – by Melissa Foster
Disclosure: EXCELLA II was funded by Elixir Medical; two researchers are full-time employees of Elixir Medical; and the guest editor reports receiving institutional research grants to the Cardiovascular Center Aalst from Medtronic.