Mechanical performance and healing patterns of the novel sirolimus-eluting bioresorbable Fantom scaffold: 6-month and 9-month follow-up by optical coherence tomography in the FANTOM II study

Abstract

ObjectivesWe aimed to evaluate the mechanical properties and healing patterns 6 and 9 months after implantation of the sirolimus-eluting Fantom bioresorbable scaffold (BRS).BackgroundThe 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.Methods and resultsFANTOM 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 mm2 and 5.7±1.4 mm2 at baseline and follow-up (p<0.0001) and was 7.2±1.6 mm2 and 5.6±1.4 mm2 in cohort B (p<0.0001). Mean scaffold area remained stable from 7.1±1.5 mm2 at baseline to 7.2±1.4 mm2 at 6 months (p=0.12), and from 7.4±1.5 mm2 to 7.3±1.4 mm2 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.ConclusionsThe 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.

Bioresorbable magnesium scaffold in the treatment of simple coronary bifurcation lesions: The BIFSORB pilot II study

“…The use of BRS in bifurcations has been low as most clinical trials have excluded bifurcation lesions with an SB > 2.0 mm or SB > 50% diameter stenosis per protocol. 5,10,[18][19][20] Therefore, the experience with BRS in bifurcations is limited despite being theoretically promising. Only one case of bifurcation treatment with the Magmaris BRS has been published 16 but evaluation in bench tests and animal models were promising.…”

“…The use of BRS in bifurcations has been low as most clinical trials have excluded bifurcation lesions with an SB > 2.0 mm or SB > 50% diameter stenosis per protocol 5,10,18‐20 . Therefore, the experience with BRS in bifurcations is limited despite being theoretically promising.…”

Bioresorbable Scaffolds: Contemporary Status and Future Directions

“…The risk of MACE within 6 months occurred in 2.6% of patients; by contrast, other CE-marked BRSs have higher MACE risks, ranging from 3.0 to 5.0% ( 18 ). OCT analysis revealed a favorable healing pattern of the Fantom scaffolds at 6 and 9 months, during which the mean and minimal scaffold areas maintained stability and acute malapposition was effectively resolved, with no late vessel wall detachment ( 19 ).…”

Optimal lesion preparation before implantation of a Magmaris bioresorbable scaffold in patients with coronary artery stenosis: Rationale, design and methodology of the OPTIMIS study

“…However, degradation of the BRS over time makes conventional stent analysis less feasible as the majority of struts are often vanished at follow-up [ 15 ]. In previous BRS studies, OCT has been used to investigate the vascular healing of the BRS, but optimal consensus is not yet obtained [ 6 , 7 , [16] , [17] , [18] , [19] , [20] ].…”