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

Background: 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.

Methods: 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.

Results: 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).

Conclusion: 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.