Factors associated with recurrence after drug-coated balloon therapy for femoropopliteal in-stent restenosis.

Purpose: To evaluate the impact of intravascular ultrasound (IVUS)-evaluated tissue morphology on recurrence following drug-coated balloon (DCB) angioplasty for the treatment of femoropopliteal in-stent restenosis (FP-ISR).

Methods: This study was a single-center, retrospective, observational study. Study subjects were 65 FP-ISR lesions (mean lesion length: 165 ± 88 mm, occlusive restenosis: 25%) in 53 patients (age: 76 ± 8, diabetes mellitus: 66%) who underwent DCB angioplasty and whose IVUS data of tissue morphology were available. The morphology of ISR was determined by dominant tissue and classified into two group with and without fibrous tissue. Fibrous tissue was defined as the absence of calcification, equal to or more advanced than the echo luminance of the outer membrane, but without acoustic shadow. The outcome measure was recurrence-ISR, and cox proportional hazards models were used to explore factors associated with recurrence-ISR.

Results: During mean follow-up period of 16 ± 12 months, recurrence-ISR was found in 32% (n = 21). The tissue morphology of FP-ISR before DCB angioplasty was distributed with 68% (n = 44) in fibrous tissue group and with 33% (n = 21) in non-fibrous tissue group. Factors associated with recurrence-ISR were drug-eluting stent (DES)-ISR (hazard ratio [HR]: 4.329; 95% confidence interval [CI]: 1.572-11.918, P = 0.005) and non-fibrous tissue (HR: 4.595; 95% CI: 1.484-14.228, P = 0.008).

Conclusion: The current study revealed IVUS-evaluated tissue morphology and DES-ISR lesions were significantly associated with recurrence FP-ISR after DCB angioplasty.