Drug-coated balloon treatment of complex femoropopliteal disease yields favorable and durable outcomes at 5 years

Randomized clinical trials (RCTs) of drug-coated balloon (DCB) treatment of femoropopliteal (FP) disease compared to balloon angioplasty (PTA) have demonstrated superior outcomes. A meta- analysis of 13 RCTs and 9 registries demonstrated odds ratio of clinically driven target lesion revascularization (CD-TLR) of 0.29 [95% confidence interval (CI): 0.20–0.40] at 2 years.¹ CD-TLR and restenosis were also significantly less frequent with paclitaxel DCBs employing urea as the excipient such as the IN.PACT Admiral DCB. Similarly, a meta-analysis of six trials with 541 patients with FP in-stent restenosis demonstrated a relative risk of CD-TLR of 0.38 [95% CI: 0.27–0.54] at 1 year.² The DCB groups had greater symptomatic improvement than PTA as well.

Peripheral vascular disease patients treated in RCTs, however, generally have shorter, less complex disease with fewer chronic total occlusions (CTO) and adverse comorbidities than FP disease patients treated in routine practice. Durations of follow-up in RCTs also tend to be ≤3 years. Ko et al. report 5-year outcomes in 114 DCB treated Asian patients (Singapore, South Korea) in the multinational, multicenter IN.PACT Global Study of 1520 patients.³ The Asian subgroup had a similar mean age (68 years) and target vessel diameter (5.6 mm) as the overall cohort. But lesion length was longer at 17.4 ± 12.4 versus 12.1 ± 9.5 cm, a higher percentage of diabetics (54.4% vs. 39.9%), more CTOs (51.4% vs. 35.5%), more in-stent restenosis lesions (26.8% vs. 18%), and frequent significant below the knee vascular disease (39.5%). This Asian subgroup appears at higher baseline risk for CD-TLR than the overall study cohort. To prevent geographic miss, DCBs were to provide 10 mm of coverage proximal and distal to the lesion margins. Predilation was performed in 91.2% compared to 78% and provisional stenting was 16.7% versus 21.2% in the non-Asian study population.

Follow-up was detailed and complete with clinic visits through the first 3 years and telephone interviews in years 3–5 with vital status reports on those who withdrew or were lost to follow-up. An independent clinical events committee adjudicated CD-TLR through the 5-year follow-up. Freedom from CD-TLR was similar in the Asian subgroup 77.1% [95% CI: 67.0–84.5] compared to the non-Asian group 69.4% [95% CI: 66.1–72.5]. Freedom from all-cause mortality was 79.4% in the Asian versus 78.9% in the non-Asian subgroup. No major target limb amputations occurred through 5 years in the Asian subgroup, similar to the 1.7% occurrence in the non-Asians. Significant clinical symptomatic improvement persisted at 3 years follow-up with half of the patients remaining in Rutherford Class 0. Despite more diabetics, longer lesions, more total occlusions, and in- stent restenosis, the 5-year outcomes are statistically equivalent in the Asian and non-Asian subgroups.

While there were no appreciable racial differences in outcomes, this IN.PACT Global sub-study demonstrates treatment of relatively complex FP disease with the IN.PACT Admiral DCB had favorable and durable outcomes in real world patients at 5 years.

Key Points.

• Randomized clinical trials have previously demonstrated drug- coated balloon (DCB) treatment of femoropopliteal disease reduces the odds of clinically driven target lesion revascularization (CD-TLR) by 60%–70% at 2–3 years compared to balloon angioplasty alone.

• The single-arm IN.PACT Global Study demonstrates clinical outcomes observed at 2 years tend to remain durably stable through 5 years of follow-up.

• Approximately three-quarters of patients undergoing DCB treatment of relatively complex femoropopliteal disease had freedom from CD-TLR at 5 years.