Dados do Trabalho

Título

7 Years clinical events of a bioresorbable scaffold pilot study with total intravascular imaging use

Resumo

Background: The safety and performance of the absorb bioresorbable vascular scaffold (brs) (Abbott vascular, santa clara, ca) has been previously demonstrated with clinical data. However, these trials included patients with simple lesions. Absorb III, IV and AIDA trials demonstrated an excess of adverse events following brs implantation, though scarce was intravascular imaging use in these studies. Aiming to evaluate clinical outcomes, we analyzed 7 years clinical follow up of a pilot study from a single center, including real world patients treated with brs implantation using optimal technique and complete intravascular image guidance in all cases.
Methods: Observational prospective pilot study, including 100 patients treated with brs implantation from 12/2014 to 10/2016. Safety and efficacy outcomes were analyzed for in-hospital and 7 years follow-up .
Results: Mean age was 58.1 years; 88% were male, 31% had diabetes, and 28% presented with acute coronary syndromes. A total of 171 lesions in 141 vessels were treated with 190 brs (mean 1.9 scaffolds/patient). Further intervention following intravascular imaging to optimize brs implantation was required in 31% of patients. Procedure success was 100%. All patients completed a 7 year follow-up. Clinical events rate were: all cause mortality 2%, cardiac death 0%, MI 2%, target vessel myocardial infarction 0% ,tvr 16%, definite scaffold thrombosis 0%.
Conclusions: This real-world experience, using optimal technique and complete intravascular image guidance in all cases , showed at 7 years follow up high event-free survival rate with no scaffold thrombosis.

Palavras Chave

Absorbable stents; intravascular imaging; clinical follow up