Post market surveillance registry (PIONEER) of the Yukon Choice PC-Elite Coronary Stent System for percutaneous coronary intervention in Indian acute coronary syndrome population.
Indian Heart J
; 75(1): 25-30, 2023.
Article
em En
| MEDLINE
| ID: mdl-36567065
ABSTRACT
AIM:
The aim of this study was to assess the safety and efficacy profile of a newer generation biodegradable DES, the Yukon Choice PC Elite with a temperature controlling mechanism, in patients with acute coronary syndrome (ACS).METHODS:
This prospective multi-center study (PIONEER Registry) was conducted in an Indian ACS population, therefore providing data in real world clinical practice. Patients with ACS underwent DES implantation in de novo native-vessel coronary lesions with the Yukon Choice PC Elite biodegradable polymer DES and were followed up for a year.RESULTS:
A total 999 patients were evaluated. The majority of patients were male (79.2%). A total of 6.7% of the patients had a history of prior myocardial infarction (MI) and 2.7% of patients had a history of previous coronary artery bypass graft. The clinical presentations of the patients included unstable angina pectoris (UA) (46.4%), ST-segment elevation MI (STEMI) (38.1%), and Non-ST-segment elevation MI (NSTEMI) (15.4%). Implantation of the device was successful in 99.9% of cases. The median stent length and stent size were 21.0 mm (Range 8.0-40.0 mm) and 2.8 mm (Range 2.0-4.0 mm), respectively. Through to one-year clinical follow-up after percutaneous coronary intervention, all-cause death occurred in 4 of 999 patients (Crude Percentage 0.4%). Cardiac death, MI, TLR, and stent thrombosis were occurred in 1 (0.1%), 8 (0.8%), 12 (1.2%) and 1 (0.1%) patients, respectively.CONCLUSION:
The results of this post marketing surveillance registry suggest favorable safety and efficacy outcomes associated with the Yukon Choice PC Elite biodegradable DES in a real world Indian ACS population.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Síndrome Coronariana Aguda
/
Stents Farmacológicos
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Intervenção Coronária Percutânea
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Infarto do Miocárdio sem Supradesnível do Segmento ST
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Infarto do Miocárdio com Supradesnível do Segmento ST
Tipo de estudo:
Clinical_trials
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Screening_studies
Limite:
Female
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Humans
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Male
País como assunto:
America do norte
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article