One-year clinical outcome of biodegradable polymer sirolimus-eluting stent in patients needing short dual antiplatelet therapy. Insight from the ULISSE registry (ULtimaster Italian multicenter all comerS Stent rEgistry).
Int J Cardiol
; 290: 52-58, 2019 09 01.
Article
em En
| MEDLINE
| ID: mdl-30917900
ABSTRACT
BACKGROUND:
This study aimed to evaluate real-world clinical outcome of patients needing short dual antiplatelet therapy (S-DAPT) following PCI with Ultimaster® thin-strut, biodegradable polymer sirolimus-eluting stent (BP-SES), which was supposed to induce faster stent endothelialization and reduce device thrombogenicity.METHODS:
In this sub-group analysis of patients enrolled in the ULISSE registry, two groups were identified 1) patients discharged with S-DAPT (≤3-month) due to high bleeding risk or need for urgent major non-cardiac surgery and 2) patients discharged with recommended DAPT (R-DAPT) duration (≥6-month). The primary ischemic-safety and bleeding-safety endpoints were TLF (composite of cardiac-death, target vessel MI, and clinically driven target lesion revascularization), and BARC major bleedings (≥type-3a) at 1-year follow-up. To account for events occurring before DAPT discontinuation we performed 3-month landmark analysis.RESULTS:
82 patients (5%) were discharged with ≤3-month DAPT (57⯱â¯27â¯days), and 1558 patients (94%) were discharged with ≥6-month DAPT (318⯱â¯75â¯days). No significant differences between S-DAPT and R-DAPT group were observed in TLF at 1-year (7.9% vs. 4.6%). The rate of BARC major bleeding resulted significantly higher in S-DAPT group (3.9% vs. 0.3%; pâ¯=â¯0.001), with the majority of bleeding events occurring within 3â¯months. The landmark analysis showed no significant differences in BARC major bleedings between groups (1.4% vs. 0.3%; pâ¯=â¯0.142).CONCLUSIONS:
As compared to those treated with R-DAPT (≥6-month), patients needing -S-DAPT (≤3-month) after PCI with Ultimaster® BP-SES had similar rates of 1-year TLF and BARC major bleedings following early DAPT discontinuation.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Inibidores da Agregação Plaquetária
/
Sistema de Registros
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Sirolimo
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Implantes Absorvíveis
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Síndrome Coronariana Aguda
/
Stents Farmacológicos
Tipo de estudo:
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Aged
/
Aged80
/
Humans
/
Middle aged
País/Região como assunto:
Europa
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article