With Absorb Out, New Resorbable Scaffolds Have Come onto the Market

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.  

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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.

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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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