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Intravascular ultrasound findings of the Fantom sirolimus-eluting bioresorbable scaffold at six- and nine-month follow-up: the FANTOM II study

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van Zandvoort, Laurens J C ; Dudek, Dariusz ; Weber-Albers, Joachim ; Abizaid, Alexandre ; Christiansen, Evald Høj ; Muller, David W M ; Kochman, Janusz ; Kołtowski, Łukasz ; Lassen, Jens Flensted ; Wojdyla, Roman ; Wykrzykowska, Joanna J ; Onuma, Yoshinobu ; Daemen, Joost. / Intravascular ultrasound findings of the Fantom sirolimus-eluting bioresorbable scaffold at six- and nine-month follow-up : the FANTOM II study. I: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2018 ; Bind 14, Nr. 11. s. e1215-e1223.

Bibtex

@article{c8c4e5457c88461596a3a77347862074,
title = "Intravascular ultrasound findings of the Fantom sirolimus-eluting bioresorbable scaffold at six- and nine-month follow-up: the FANTOM II study",
abstract = "AIMS: FANTOM II is a prospective multicentre trial assessing the safety and efficacy of the Fantom sirolimus-eluting bioresorbable coronary scaffold (BRS). The present substudy focuses on the six- and nine-month IVUS findings.METHODS AND RESULTS: A total of 240 patients with de novo coronary artery lesions presenting with stable or unstable disease were included in two sequential cohorts (cohort A [n=117] and cohort B [n=123]) in which angiographic follow-up was performed at either six or nine months, respectively. Matched IVUS data were available for 35 paired cases in cohort A and 26 paired cases in cohort B. At six months, mean and minimum scaffold area (SA) decreased from 6.09±1.08 mm2 to 5.88±1.07 mm2, p=0.009, and 5.27±0.99 mm2 to 5.05±0.99 mm2, p=0.01, respectively. At nine months, no significant change in mean scaffold and minimum scaffold area was observed (6.46±1.11 mm2 to 6.38±0.96 mm2; p=0.35, and 5.45±1.00 mm2 to 5.36±0.86 mm2; p=0.32, respectively). Neointimal hyperplasia area was low at both six (0.11±0.12 mm2) and nine months (0.20±0.21 mm2), as was in-scaffold obstruction volume (1.94±2.25{\%} at six months, and 3.40±4.11{\%} at nine months).CONCLUSIONS: The use of the Fantom BRS in stable coronary artery disease was associated with low rates of neointimal hyperplasia volume and in-scaffold volume obstruction at both six and nine months.",
author = "{van Zandvoort}, {Laurens J C} and Dariusz Dudek and Joachim Weber-Albers and Alexandre Abizaid and Christiansen, {Evald H{\o}j} and Muller, {David W M} and Janusz Kochman and Łukasz Kołtowski and Lassen, {Jens Flensted} and Roman Wojdyla and Wykrzykowska, {Joanna J} and Yoshinobu Onuma and Joost Daemen",
year = "2018",
month = "12",
day = "7",
doi = "10.4244/EIJ-D-18-00491",
language = "English",
volume = "14",
pages = "e1215--e1223",
journal = "EuroIntervention",
issn = "1774-024X",
publisher = "Europa Edition",
number = "11",

}

RIS

TY - JOUR

T1 - Intravascular ultrasound findings of the Fantom sirolimus-eluting bioresorbable scaffold at six- and nine-month follow-up

T2 - the FANTOM II study

AU - van Zandvoort, Laurens J C

AU - Dudek, Dariusz

AU - Weber-Albers, Joachim

AU - Abizaid, Alexandre

AU - Christiansen, Evald Høj

AU - Muller, David W M

AU - Kochman, Janusz

AU - Kołtowski, Łukasz

AU - Lassen, Jens Flensted

AU - Wojdyla, Roman

AU - Wykrzykowska, Joanna J

AU - Onuma, Yoshinobu

AU - Daemen, Joost

PY - 2018/12/7

Y1 - 2018/12/7

N2 - AIMS: FANTOM II is a prospective multicentre trial assessing the safety and efficacy of the Fantom sirolimus-eluting bioresorbable coronary scaffold (BRS). The present substudy focuses on the six- and nine-month IVUS findings.METHODS AND RESULTS: A total of 240 patients with de novo coronary artery lesions presenting with stable or unstable disease were included in two sequential cohorts (cohort A [n=117] and cohort B [n=123]) in which angiographic follow-up was performed at either six or nine months, respectively. Matched IVUS data were available for 35 paired cases in cohort A and 26 paired cases in cohort B. At six months, mean and minimum scaffold area (SA) decreased from 6.09±1.08 mm2 to 5.88±1.07 mm2, p=0.009, and 5.27±0.99 mm2 to 5.05±0.99 mm2, p=0.01, respectively. At nine months, no significant change in mean scaffold and minimum scaffold area was observed (6.46±1.11 mm2 to 6.38±0.96 mm2; p=0.35, and 5.45±1.00 mm2 to 5.36±0.86 mm2; p=0.32, respectively). Neointimal hyperplasia area was low at both six (0.11±0.12 mm2) and nine months (0.20±0.21 mm2), as was in-scaffold obstruction volume (1.94±2.25% at six months, and 3.40±4.11% at nine months).CONCLUSIONS: The use of the Fantom BRS in stable coronary artery disease was associated with low rates of neointimal hyperplasia volume and in-scaffold volume obstruction at both six and nine months.

AB - AIMS: FANTOM II is a prospective multicentre trial assessing the safety and efficacy of the Fantom sirolimus-eluting bioresorbable coronary scaffold (BRS). The present substudy focuses on the six- and nine-month IVUS findings.METHODS AND RESULTS: A total of 240 patients with de novo coronary artery lesions presenting with stable or unstable disease were included in two sequential cohorts (cohort A [n=117] and cohort B [n=123]) in which angiographic follow-up was performed at either six or nine months, respectively. Matched IVUS data were available for 35 paired cases in cohort A and 26 paired cases in cohort B. At six months, mean and minimum scaffold area (SA) decreased from 6.09±1.08 mm2 to 5.88±1.07 mm2, p=0.009, and 5.27±0.99 mm2 to 5.05±0.99 mm2, p=0.01, respectively. At nine months, no significant change in mean scaffold and minimum scaffold area was observed (6.46±1.11 mm2 to 6.38±0.96 mm2; p=0.35, and 5.45±1.00 mm2 to 5.36±0.86 mm2; p=0.32, respectively). Neointimal hyperplasia area was low at both six (0.11±0.12 mm2) and nine months (0.20±0.21 mm2), as was in-scaffold obstruction volume (1.94±2.25% at six months, and 3.40±4.11% at nine months).CONCLUSIONS: The use of the Fantom BRS in stable coronary artery disease was associated with low rates of neointimal hyperplasia volume and in-scaffold volume obstruction at both six and nine months.

U2 - 10.4244/EIJ-D-18-00491

DO - 10.4244/EIJ-D-18-00491

M3 - Journal article

VL - 14

SP - e1215-e1223

JO - EuroIntervention

JF - EuroIntervention

SN - 1774-024X

IS - 11

ER -

ID: 56521526