Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice: early and midterm outcomes from the European multicentre GHOST-EU registry

Davide Capodanno, Tommaso Gori, Holger Nef, Azeem Latib, Julinda Mehilli, Maciej Lesiak, Giuseppe Caramanno, Christoph Naber, Carlo Di Mario, Antonio Colombo, Piera Capranzano, Jens Wiebe, Aleksander Araszkiewicz, Salvatore Geraci, Stelios Pyxaras, Alessio Mattesini, Toru Naganuma, Thomas Münzel, Corrado Tamburino

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)1144-1153
Number of pages10
JournalEuroIntervention
Volume10
Issue number10
DOIs
Publication statusPublished - Feb 1 2015

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Percutaneous Coronary Intervention
Blood Vessels
Registries
Thrombosis
Myocardial Infarction
Incidence
Everolimus
Diabetes Mellitus
Confidence Intervals

ASJC Scopus subject areas

  • Medicine(all)

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Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice : early and midterm outcomes from the European multicentre GHOST-EU registry. / Capodanno, Davide; Gori, Tommaso; Nef, Holger; Latib, Azeem; Mehilli, Julinda; Lesiak, Maciej; Caramanno, Giuseppe; Naber, Christoph; Di Mario, Carlo; Colombo, Antonio; Capranzano, Piera; Wiebe, Jens; Araszkiewicz, Aleksander; Geraci, Salvatore; Pyxaras, Stelios; Mattesini, Alessio; Naganuma, Toru; Münzel, Thomas; Tamburino, Corrado.

In: EuroIntervention, Vol. 10, No. 10, 01.02.2015, p. 1144-1153.

Research output: Contribution to journalArticle

Capodanno, D, Gori, T, Nef, H, Latib, A, Mehilli, J, Lesiak, M, Caramanno, G, Naber, C, Di Mario, C, Colombo, A, Capranzano, P, Wiebe, J, Araszkiewicz, A, Geraci, S, Pyxaras, S, Mattesini, A, Naganuma, T, Münzel, T & Tamburino, C 2015, 'Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice: early and midterm outcomes from the European multicentre GHOST-EU registry', EuroIntervention, vol. 10, no. 10, pp. 1144-1153. https://doi.org/10.4244/EIJY14M07_11
Capodanno, Davide ; Gori, Tommaso ; Nef, Holger ; Latib, Azeem ; Mehilli, Julinda ; Lesiak, Maciej ; Caramanno, Giuseppe ; Naber, Christoph ; Di Mario, Carlo ; Colombo, Antonio ; Capranzano, Piera ; Wiebe, Jens ; Araszkiewicz, Aleksander ; Geraci, Salvatore ; Pyxaras, Stelios ; Mattesini, Alessio ; Naganuma, Toru ; Münzel, Thomas ; Tamburino, Corrado. / Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice : early and midterm outcomes from the European multicentre GHOST-EU registry. In: EuroIntervention. 2015 ; Vol. 10, No. 10. pp. 1144-1153.
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abstract = "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.",
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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

PY - 2015/2/1

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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.

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