Clinical and Angiographic Outcomes With a Novel Radiopaque Sirolimus-Eluting Bioresorbable Vascular Scaffold

Abstract

Background: A novel bioresorbable scaffold, the sirolimus-eluting Fantom, incorporates a radiopaque polymer, struts with a thickness of 125 µm, and a crossing profile of 1.35 mm. The purpose of this study was to evaluate the 9-month angiographic and 12-month clinical outcomes of the FANTOM scaffold in a larger patient population. Methods and Results: The FANTOM II study (Safety & Performance Study of the Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold – First Report on Initial 24 Month Outcomes) was a prospective, multicenter trial which enrolled 240 patients with single de novo coronary stenosis with reference vessel diameter 2.5 to 3.5 mm diameter and lesion length ≤20 mm. Major adverse cardiac events through 12-month follow-up were assessed. Angiographic follow-up was performed in consecutive patient cohorts at 6 months (n=117) and 9 months (n=123). Acute delivery success, acute technical success, acute procedural success, and clinical procedural success rates as defined in the clinical protocol were 97.9% (235/240), 95.8% (230/240), 99.1% (228/230), and 99.6% (227/228), respectively. The mean in-stent late lumen loss at 6 months and 9 months were 0.25±0.40 mm and 0.33±0.36 mm, respectively, and in-segment binary restenosis occurred in 2.0% and 7.6% of patients, respectively. Major adverse cardiac events and target lesion failure through 12 months occurred in 4.2% of 240 patients; scaffold thrombosis developed in only one patient (0.4%). Conclusions: The Fantom sirolimus-eluting bioresorbable coronary scaffold demonstrated favorable safety and effectiveness performance at 12-month follow-up. Longer-term follow-up is ongoing to examine the late outcomes with this novel device. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02539966.

Clinical presentation does not affect acute mechanical performance of the Novolimus-eluting bioresorbable vascular scaffold as assessed by optical coherence tomography

“…New BVS platforms are being developed due to the lingering desire for BVS with transient vessel support. They are currently under clinical investigation [ 37 , 38 ]. The present study supports this development by contributing reasonable mechanical outcome data for patients presenting with acute and chronic coronary syndrome.…”

BIOSOLVE‐IV‐registry: Safety and performance of the Magmaris scaffold: 12‐month outcomes of the first cohort of 1,075 patients

“… 26 For the Fantom sirolimus‐eluting scaffold (REVA Medical, San Diego, California) no postmarket data are available, but the Fantom‐II premarket study reported a TLF‐rate of 4.2% and a scaffold thrombosis rate of 0.4% in 240 enrolled patients. 27 Further details are provided in Table S5 .…”

Tungsten disulfide nanotubes enhance flow-induced crystallization and radio-opacity of polylactide without adversely affecting in vitro toxicity

“…Further experiments are needed to establish the minimum quantity of WSNT to confer enough contrast to PLA when the scaffold is embedded in deep tissue. PLA-WSNT nanocomposites could be then a valid alternative to the Fantom BVS recently developed by REVA Medical which gains intrinsic radio-opacity from the iodinated diphenol in the Tyrocore TM polymer [82].…”