Long-Term serial functional evaluation after implantation of the fantom sirolimus-eluting bioresorbable coronary scaffold: the FANTOM II study

Saito, Yuichi; Bouras, Georgios; Abizaid, Alexandre; Lutz, Matthias; Carrié, Didier; Weber-Albers, Joachim; Anderson, Jeffrey; Lansky, Alexandra

BACKGROUND:

The Fantom sirolimus-eluting bioresorbable coronary scaffold (BRS) (REVA Medical, San Diego, California) was previously studied with angiographic late lumen loss at 6, 9, and 24 months with clinical events being followed through 36 months. However, a functional evaluation has not previously been performed. The aim of this study was to assess serial functional changes after percutaneous coronary intervention (PCI) with the Fantom BRS implantation.

METHODS:

The FANTOM II trial was a prospective, multicenter, single-arm study that enrolled 240 patients with stable coronary artery disease or unstable angina and single de novo native coronary lesions, of which 235 patients received the Fantom BRS and are included in the present analysis. Serial quantitative flow ratio (QFR) analysis was performed in an independent core laboratory at baseline, after PCI, and at 6- or 9-month and 24-month follow-up.

RESULTS:

QFR was analyzable in 178 patients at baseline, 185 post-PCI, 178 at 6- or 9-month follow-up, and 31 at 24-month follow-up. At baseline, 59 patients (33.1%) had QFR >0.80, whereas 12 (6.5%) at post-PCI, 13 (7.3%) at 6- or 9-month followup, and 3 (9.7%) at 24-month follow-up had QFR _0.80. In the paired analyses, QFR was significantly increased from baseline to post-PCI (0.73 _ 0.12 vs. 0.94 _ 0.07; p < 0.001), while it decreased from post-PCI to 6- or 9-month follow-up (0.94 _ 0.07 vs. 0.92 _ 0.08; p < 0.001) and from 6- or 9-month to 24-month follow-up (0.93 _ 0.07 vs. 0.91 _ 0.09; p » 0.03).

CONCLUSION:

Serial angiographic analysis showed significant increase in QFR values between baseline and post-PCI. A slight decrease was observed in QFR values with the Fantom BRS over 24 months. (AU)

Secretaria de Estado da Saúde - BVS

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