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Research Article
Ling Tao
Xijing Hospital
Corresponding Author
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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 registration
URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02929030.
Keywords
real-world population, percutaneous coronary interventions, polymer-free drug-eluting stent, target lesion failure
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A new preprint design is coming!
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This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Research Article
Ling Tao
Xijing Hospital
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
History
CURRENT STATUS: Posted
View the published article at BMC Cardiovascular Disorders.
Version 1
Posted 10 Feb, 2021
No community comments so far
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Cardiac & Cardiovascular Systems
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at BMC Cardiovascular Disorders.
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 registration
URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02929030.
Figure 1
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