Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.
Department of Cardiology, University Hospital Rangueil, Toulouse, France.
Open Heart. 2019 Feb 28;6(1):e000941. doi: 10.1136/openhrt-2018-000941. eCollection 2019.
We aimed to evaluate the mechanical properties and healing patterns 6 and 9 months after implantation of the sirolimus-eluting Fantom bioresorbable scaffold (BRS).
The Fantom BRS (Reva Medical, San Diego, USA) has differentiating properties including radiopacity, strut thickness of 125 µm, high expansion capacity and has demonstrated favourable mid-term clinical and angiographic outcomes.
FANTOM II was a prospective, single arm study with implantation of the Fantom BRS in 240 patients with stable angina pectoris. Guidance by optical coherence tomography (OCT) was encouraged and was repeated at 6-month (cohort A) or 9-month follow-up (cohort B). Matched baseline and follow-up OCT recordings were available in 152 patients. In-scaffold mean lumen area in cohort A was 6.8±1.7 mm and 5.7±1.4 mm at baseline and follow-up (p<0.0001) and was 7.2±1.6 mm and 5.6±1.4 mm in cohort B (p<0.0001). Mean scaffold area remained stable from 7.1±1.5 mm at baseline to 7.2±1.4 mm at 6 months (p=0.12), and from 7.4±1.5 mm to 7.3±1.4 mm at 9 months. Strut malapposition was median 0.8 (IQR 0.0;3.5)% and 1.8 (IQR 0.3;6.0)% at baseline and was 0.0 (IQR 0.0;0.0)% in both groups at 6-month and 9-month follow-up. Strut tissue coverage was 98.1 (IQR 95.9;99.4)% at 6 months and 98.9 (IQR 98.3;100.0)% at 9 months.
The novel Fantom BRS had favourable healing patterns at 6-month and 9-month follow-up as malapposition was effectively resolved and strut coverage was almost complete. The scaffold remained stable through follow-up with no signs of systematic late recoil.
评估雷帕霉素洗脱 Fantom 生物可吸收支架（BRS）植入后 6 个月和 9 个月的机械性能和愈合模式。
Fantom BRS（Reva Medical，美国圣地亚哥）具有独特的性能，包括可透光性、125µm 的支架厚度、高扩张能力，并显示出有利的中期临床和血管造影结果。
Fantom II 是一项前瞻性、单臂研究，在 240 例稳定性心绞痛患者中植入 Fantom BRS。鼓励光学相干断层扫描（OCT）指导，并在 6 个月（队列 A）或 9 个月（队列 B）随访时重复进行。在 152 例患者中获得了匹配的基线和随访 OCT 记录。在队列 A 中，支架内平均管腔面积在基线和随访时分别为 6.8±1.7mm 和 5.7±1.4mm（p<0.0001），在队列 B 中分别为 7.2±1.6mm 和 5.6±1.4mm（p<0.0001）。从基线的 7.1±1.5mm 到 6 个月时的 7.2±1.4mm（p=0.12）和从 7.4±1.5mm 到 9 个月时的 7.3±1.4mm，支架面积保持稳定。支架贴壁不良中位数为 0.8（IQR 0.0；3.5）%和 1.8（IQR 0.3；6.0）%，在 6 个月和 9 个月随访时，两组均为 0.0（IQR 0.0；0.0）%。支架组织覆盖率在 6 个月时为 98.1（IQR 95.9；99.4）%，在 9 个月时为 98.9（IQR 98.3；100.0）%。
新型 Fantom BRS 在 6 个月和 9 个月随访时具有良好的愈合模式，因为贴壁不良得到有效解决，支架覆盖率几乎达到 100%。支架在随访过程中保持稳定，没有出现系统性晚期回缩的迹象。
