By restoring vascular physiology and eliminating the inflammatory focus and the chance of fracture and neo atherosclerosis inherent to DES, bioresorbable scaffolds offer the potential to improve long term outcomes.
A number of bioresorbable materials have been tested, mainly polylactic acid, with several limitations that have taken the Absorb bioresorbable scaffold out of the market.
Read also: “Endarterectomy vs. Stenting in Asymptomatic Carotid Artery Stenosis”.
In an attempt to overcome these limitations, the Fantom (REVA Medical, San Diego, California) sirolimus eluting scaffold was created; it has thin scaffolds struts (125 µm), a radiopaque material, and excellent scaffold strength comparable to that of current bare metal stents
Fantom’s 6-month outcomes were assessed in 117 patients with ≤20 mm de novo lesions in 2.5 – 3.5 mm lesions. Primary angiographic end point was late lumen loss assessed by quantitative angiography and primary clinical end point was a composite of death, infarction and clinically driven target vessel revascularization.
At 6 months, late lumen loss was 0.25±0.40mm in the 100 patients receiving quantitative angiography, with 2% binary restenosis.
Read also: “Frequency and Evolution of Cardiac Perforation in Patients with a History of MRS”.
There were clinical events in 3 patients (2.6%) with 2 infarctions and 2 revascularizations (1 patient presented both events). Thrombosis was 0.9%.
Conclusion
The study shows the new sirolimus eluting bioresorbable scaffold favorable outcomes at 6 months in simple coronary lesions.
Editorial Comment
The study has a modest number of patients, enough to give us an idea of angiographic performance at 6 months. Cohort B, programmed for angiographic follow up at 9 months, should confirm these results.
The longest follow up is in progress and should shed light on these outcomes once the scaffold is absorbed.
A comparative study vs. the best DES is out of the question.
Título original: 6-Month Clinical and Angiographic Outcomes of a Novel Radiopaque Sirolimus-Eluting Bioresorbable Vascular Scaffold. The FANTOM II Study.
Referencia: Alexandre Abizaid et al. J Am Coll Cardiol Intv 2017;10:1832–8.
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