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Original article
DOI: 10.1016/j.rec.2020.07.005
Available online 19 August 2020
Outcomes after complete dissolution of everolimus-eluting bioresorbable scaffolds implanted during routine practice
Evolución de pacientes tratados con armazones coronarios bioabsorbibles liberadores de everolimus tras su disolución completa
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Jens Wiebea,b,
Corresponding author
wiebe@dhm.mhn.de

Corresponding author: Deutsches Herzzentrum München, Lazarettstrasse, 36, Munich, Germany.
, Petra Hoppmannc, Salvatore Cassesea, Tobias Rheudea, Roisin Collerana, Constantin Kunaa, Himanshu Raia, Michael Valeskinia, Tareq Ibrahimc, Michael Jonera,b, Heribert Schunkerta,b, Karl-Ludwig Laugwitzb,c, Adnan Kastratia,b, Robert A. Byrned,e
a Deutsches Herzzentrum München, Department of Cardiology, Technische Universität München, Munich, Germany
b DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany
c 1. med. Klinik, Klinikum rechts der Isar, Technische Universität München, Munich, Germany
d Mater Private Hospital, Department of Cardiology, Dublin, Ireland
e Royal College of Surgeons, Dublin, Ireland
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Tables (4)
Table 1. Baseline characteristics
Table 2. Angiographic and procedural results
Table 3. Clinical outcomes until 5 years shown as Kaplan-Meier estimates
Table 4. Multivariate analysis of predictors of the composite primary endpoint and target lesion revascularization
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Abstract
Introduction and objectives

Long-term outcomes of unselected patients treated with bioresorbable vascular scaffold (BVS) implantation are lacking, especially for the period after complete dissolution of the BVS. This study sought to evaluate 5-year outcomes in patients treated with BVS in routine practice.

Methods

Consecutive patients who underwent implantation of everolimus-eluting BVS during routine clinical practice at 2 high-volume centres in Germany were studied. The patients were followed-up for up to 5 years. The primary endpoints of interest were the composite of death, myocardial infarction and target lesion revascularization, as well as definite scaffold thrombosis.

Results

A total of 419 patients (mean age 66.6 ± 10.9 years; 31.5% had diabetes) were included, of whom 38.9% presented with an acute coronary syndrome. Of the 527 lesions treated, 49.0% were classified as complex and 13.1% were bifurcation lesions. At 5 years, the composite clinical endpoint occurred in 33.1% of patients and definite scaffold thrombosis occurred in 4.7%. Most definite scaffold thrombosis occurred within 2 years after BVS implantation.

Conclusions

In patients treated with BVS implantation in routine clinical practice the rates of adverse clinical events at 5 years were high, including a considerable incidence of scaffold thrombosis.

Keywords:
Bioresorbable scaffolds
Acute coronary syndrome
ST-segment elevation acute coronary syndrome
Stable angina
Abbreviations:
BVS
DES
TLR
Resumen
Introducción y objetivos

Falta información acerca de los resultados a largo plazo de los pacientes no seleccionados tratados con implante de armazones vasculares bioabsorbibles (AVB), especialmente del periodo posterior a su disolución completa. Se analizaron los resultados a 5 años en pacientes tratados con AVB en la práctica habitual.

Métodos

Se estudió a los pacientes consecutivos tratados con implante de AVB liberadores de everolimus en la práctica clínica habitual de 2 centros de gran volumen en Alemania. El seguimiento clínico se realizó a 5 años. Los principales objetivos primarios de interés fueron el compuesto de muerte, infarto de miocardio y revascularización de la lesión diana, así como trombosis definitiva de los andamiajes.

Resultados

Se incluyó a un total de 419 pacientes (media de edad, 66,6 ± 10,9 años; el 31,5% diabéticos), el 38.9% de ellos con un síndrome coronario agudo. De las 527 lesiones tratadas, el 49,0% se clasificó como complejas y el 13,1% eran lesiones en bifurcación. A los 5 años, la variable clínica compuesta se produjo en el 33,1% de los pacientes y la trombosis definitiva del armazón, en el 4,7%. La mayoría de las trombosis definitivas de los armazones tuvieron lugar en los 2 años posteriores al implante del AVB.

Conclusiones

En los pacientes tratados con implantes de AVB en la práctica clínica habitual, las tasas de eventos adversos clínicos a los 5 años fueron altas e incluyeron una incidencia considerable de trombosis del armazón.

Palabras clave:
Armazón bioabsorbible
Síndrome coronario agudo
Síndrome coronario agudo sin elevación del segmento ST
Angina estable

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