Clinical Outcomes in 2481 Unselected Real-World Patients Treated With a Polymer-Free Sirolimus-Eluting Stent: 3 Years Results From the NANO Multicenter Registry

The long-term clinical data evaluating the safety and efficacy of the novel polymer-free sirolimus-eluting Nano plus stent (Lepu Medical, Beijing, China) is limited. We evaluated the 3-year clinical outcomes of a polymer-free sirolimus-eluting, Nano plus stent for the treatment of coronary artery disease in the NANO multicenter Registry. The NANO all-comers Registry trial was a prospective, multicenter clinical registry conducted in 26 centers between August 2016 and January 2017. A total of 2481 consecutive patients were exclusively treated with the Nano plus stent. The main clinical endpoint, target lesion failure (TLF, defined as cardiac death, target vessel nonfatal myocardial infarction, and clinically driven target lesion revascularization [CD-TLR]), was analyzed at 3 years. The incidence of TLF was 6.8% (168/2481). The rates of its individual components were as follows: cardiac death 3.8% (94/2481), target vessel nonfatal myocardial infarction 0.7% (18/2481), and CD-TLR 2.9% (68/2481). The rate of definite/probable stent thrombosis was 0.5% (13/2481). Diabetes mellitus, acute myocardial infarction, age, chronic renal failure, in-stent restenosis, chronic total occlusion and left ventricular ejection fraction <40% were the independent predictors of 3-year TLF. The TLF was relatively low in patients treated with polymer-free Nano plus stent at 3 years. The polymer-free Nano plus stent showed a favorable safety and efficacy profile in the real-world patients.Clinical trial registrationURL: https://www.clinicaltrials.gov/. Unique identifier: NCT02929030.