Instantaneous Wave-Free Ratio-Guided Paclitaxel-Coated Balloon Treatment for De Novo Coronary Lesions

Abstract

Paclitaxel-coated balloon (PCB) treatment guided by fractional flow reserve (FFR) is safe and effective for de novo coronary lesions. It is unknown whether the instantaneous wave-free ratio (iFR), an alternative measure that does not require the administration of adenosine, will offer benefits similar to those of FFR in de novo lesion treatment with PCB. Baseline, post-balloon and 9-month angiographical parameters were obtained from 116 lesions of 104 patients. The cutoff value of iFR after balloon angioplasty used to define functionally nonsignificant residual stenotic lesions was 0.86 and they were subdivided into PCB or Stent group according to the treated device. The primary endpoint was late lumen loss at 9 months and the secondary endpoint was target vessel failure (TVF) at 3 years. Fifty-eight lesions were treated with PCB only and 58 lesions were treated with metal stent implantation. There were no differences in iFR between PCB and Stent groups at baseline (0.76 ± 0.19 vs. 0.73 ± 0.23, p = 0.630) and after procedure (0.93 ± 0.04 vs. 0.94 ± 0.05, p = 0.574). At 9 months, late lumen loss was significantly lower in PCB group compared with Stent group (0.04 ± 0.32 mm vs. 0.59 ± 0.77 mm, p = 0.001). At 3-year follow-up, TVF were not different between the treatment groups (5.2% vs. 8.6%, p = 0.453). PCB treatment guided by iFR measured right after balloon angioplasty is safe and effective for de novo coronary lesions with good angiographic results at 9 months and similar clinical outcomes at 3 years compared to stent group.