TY - JOUR
T1 - Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice
T2 - Early and midterm outcomes from the European multicentre GHOST-EU registry
AU - Capodanno, Davide
AU - Gori, Tommaso
AU - Nef, Holger
AU - Latib, Azeem
AU - Mehilli, Julinda
AU - Lesiak, Maciej
AU - Caramanno, Giuseppe
AU - Naber, Christoph
AU - Di Mario, Carlo
AU - Colombo, Antonio
AU - Capranzano, Piera
AU - Wiebe, Jens
AU - Araszkiewicz, Aleksander
AU - Geraci, Salvatore
AU - Pyxaras, Stelios
AU - Mattesini, Alessio
AU - Naganuma, Toru
AU - Münzel, Thomas
AU - Tamburino, Corrado
N1 - Publisher Copyright:
© Europa Digital & Publishing 2015. All rights reserved.
PY - 2015/2/1
Y1 - 2015/2/1
N2 - Aims: Clinical data on the early and midterm outcomes of bioresorbable vascular scaffolds (BVS) in routine clinical practice are limited. To fill this gap, we report on the early and midterm clinical outcomes of PCI with everolimus-eluting BVS from the large multicentre GHOST-EU registry. Methods and results: Between November 2011 and January 2014, 1,189 patients underwent percutaneous coronary intervention with one or more BVS (Absorb BVS; Abbott Vascular, Santa Clara, CA, USA) at 10 European centres. The primary outcome of interest was target lesion failure (TLF), defined as the combination of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularisation (TLR). A total of 1,731 Absorb BVS were implanted at a mean of 12.3±3.4 atm. Technical success was achieved in 99.7% of cases. TLF was recorded in 67 of 1,189 patients at a median of 109 (interquartile range 8-227) days after implantation. The cumulative incidence of TLF was 2.2% at 30 days and 4.4% at six months. The annualised rate of TLF was 10.1%. At six months, the rate of cardiac death was 1.0%, target vessel myocardial infarction was 2.0%, TLR was 2.5%, and target vessel revascularisation was 4.0%. Diabetes mellitus was the only independent predictor of TLF (hazard ratio 2.41, 95% confidence interval: 1.28-4.53; p=0.006). The cumulative incidence of definite/probable scaffold thrombosis was 1.5% at 30 days and 2.1% at six months, with 16 of 23 cases occurring within 30 days. Conclusions: "Real-world" outcomes of BVS showed acceptable rates of TLF at six months, although the rates of early and midterm scaffold thrombosis, mostly clustered within 30 days, were not negligible.
AB - Aims: Clinical data on the early and midterm outcomes of bioresorbable vascular scaffolds (BVS) in routine clinical practice are limited. To fill this gap, we report on the early and midterm clinical outcomes of PCI with everolimus-eluting BVS from the large multicentre GHOST-EU registry. Methods and results: Between November 2011 and January 2014, 1,189 patients underwent percutaneous coronary intervention with one or more BVS (Absorb BVS; Abbott Vascular, Santa Clara, CA, USA) at 10 European centres. The primary outcome of interest was target lesion failure (TLF), defined as the combination of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularisation (TLR). A total of 1,731 Absorb BVS were implanted at a mean of 12.3±3.4 atm. Technical success was achieved in 99.7% of cases. TLF was recorded in 67 of 1,189 patients at a median of 109 (interquartile range 8-227) days after implantation. The cumulative incidence of TLF was 2.2% at 30 days and 4.4% at six months. The annualised rate of TLF was 10.1%. At six months, the rate of cardiac death was 1.0%, target vessel myocardial infarction was 2.0%, TLR was 2.5%, and target vessel revascularisation was 4.0%. Diabetes mellitus was the only independent predictor of TLF (hazard ratio 2.41, 95% confidence interval: 1.28-4.53; p=0.006). The cumulative incidence of definite/probable scaffold thrombosis was 1.5% at 30 days and 2.1% at six months, with 16 of 23 cases occurring within 30 days. Conclusions: "Real-world" outcomes of BVS showed acceptable rates of TLF at six months, although the rates of early and midterm scaffold thrombosis, mostly clustered within 30 days, were not negligible.
KW - Bioresorbable scaffolds
KW - Bioresorbable vascular scaffolds
KW - Clinical outcomes
KW - Percutaneous coronary intervention
UR - http://www.scopus.com/inward/record.url?scp=84923863711&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84923863711&partnerID=8YFLogxK
U2 - 10.4244/eijy14m07_11
DO - 10.4244/eijy14m07_11
M3 - Article
C2 - 25042421
AN - SCOPUS:84923863711
SN - 1774-024X
VL - 10
SP - 1144
EP - 1153
JO - EuroIntervention
JF - EuroIntervention
IS - 10
ER -