Scaffold Versus Repeat Drug‐Coated Balloon Therapy for Early and Late Drug‐Coated Balloon Restenosis in Femoropopliteal Arteries: Results of the RECURRENCE‐2 Study

The current study aimed to investigate whether scaffolds or repeat drug-coated balloons (DCBs) were more effective in preventing recurrent restenosis after repeat endovascular therapy (EVT) for early (within 12 months) and late (after 12 months) DCB restenosis. This study retrospectively analyzed 234 limbs from 213 consecutive patients who underwent repeat EVT using scaffold (n = 52) or DCB only (n = 182) for primary DCB restenosis in femoropopliteal lesions at eight cardiovascular centers across Japan. Repeat EVT for early and late DCB restenosis was performed in 123 and 111 limbs, respectively. Following repeat EVT, the freedom from recurrent restenosis rate was significantly higher with scaffolds than with DCBs for early DCB restenosis (81.6% vs. 62.3% at 12 months; p = 0.038), whereas no difference between treatment strategies was observed for late restenosis (80.0% vs. 85.9% at 12 months; p = 0.629). Among those who underwent repeat EVT for early restenosis, age ≤ 75 years (hazard ratio [HR], 2.05; 95% confidence interval [CI], 1.06-3.96; p = 0.031), male sex (HR, 2.12; 95% CI, 1.08-4.20; p = 0.029), and lesion length ≥ 150 mm (HR, 2.43; 95% CI, 1.31-4.52; p = 0.005) were significantly associated with recurrent restenosis, while scaffold use during repeat EVT was significantly associated with decreased recurrent restenosis (HR, 0.38; 95% CI, 0.17-0.81; p = 0.012). Given the decreased rates of recurrent restenosis, scaffold implantation for DCB restenosis might be an acceptable strategy, particularly for early DCB restenosis after initial DCB.