Author + information
- Joost Daemen1,
- Laurens van Zandvoort1,
- Dariusz Dudek2,
- Joachim Weber - Alders3,
- Evald Christiansen4,
- David Muller5,
- Janusz Kochman6,
- Jens Flensted Lassen7,
- Roman Wojdyla8,
- Joanna Wykrzykowska9 and
- Alexandre Abizaid10
- 1Erasmus MC - Thoraxcenter, Rotterdam, Netherlands
- 2Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland
- 3St.-Johannes-Hospital, Dortmund, Germany
- 4Aarhus University Hospital, Aarhus, Denmark
- 5St. Vincent's Hospital, Syndey, Australia
- 6Medical University of Warsaw, Warsaw, Poland
- 7Rigshospitalet, University, Copenhagen, Denmark
- 8Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakow, Krakow, Poland
- 9Department of cardiology, AMC, Amsterdam, Netherlands
- 10Instituto de Cardiologia Dante Pazzanese, São Paolo, Brazil
FANTOM II is a prospective multicenter study designed to assess the safety and efficacy of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold (BRS) in patients with stable coronary artery disease. The present substudy focuses on the performance of the device as assessed by IVUS.
A total of 240 patients with de novo coronary artery lesions presenting with stable or unstable disease were included in 2 cohorts. In cohort A (n=117), angiographic follow-up was performed at 6 months. IVUS data was available in 35 paired cases. In cohort B 23, angiographic follow-up was performed at 9 months, with IVUS available in 26 paired cases. IVUS was performed at 40MHz with a pullback speed of 0.5mm/sec. Analyses were performed by an independent corelab (Cardialysis BV, Rotterdam, the Netherlands). The region of interest beginning 5 mm distal to and extending 5 mm proximal to the treated segment was examined and analyzed.
Mean age was 62.7 years, 70.4% were male. Diabetes was present in 23.8% of the patients. Post procedure mean scaffold area was 6.09±1.08mm in cohort A and 6.46±1.11mm in cohort B. diameter was 2.94±0.16 mm. Average scaffold length was 18.59±1.80 mm. Post dilatation was performed in 80.4% of the cases (77.9% in cohort A and 86.1% in cohort B). In cohort A, mean and minimum scaffold area (SA) slightly decreased at 6 months (from 6.09±1.08mm2 to 5.88±1.07mm2, p=0.009 and 5.27±0.99mm2 to 5.05±0.99mm2, p=0.01 respectively). Neointimal hyperplasia area at 6 months was 0.11±0.12 and in-scaffold obstruction volume was 1.94±2.25%. In cohort B, the struts were still visually recognizable on IVUS as high echogenic structures. No significant change in mean scaffold and minimum scaffold area was observed at 9 months (6.46±1.11mm2 to 6.38±0.96mm2; p=0.35 and 5.45±1.00mm2 to 5.36±0.86mm2; p=0.32 respectively). Neointimal hyperplasia area at 9 months was 0.20±0.21 and in-scaffold obstruction volume was 3.40±4.11%.
The use of the FANTOM BRS in stable coronary artery disease was safe and effective with low rates of neointimal hyperplasia volume and in-scaffold volume obstruction at both 6 and 9 months.