Abstract
Purpose
The efficacy and safety of drug-coated balloons (DCBs) for the treatment of short femoropopliteal arteries have been demonstrated. However, there are few studies on the prognosis of long lesions, especially long-term prognosis. The purpose of this study was to compare the long-term outcomes of DCB for long and short lesions and the risk factors associated with poor prognosis.
Methods
This real-world and single-center cohort study included 234 patients with de novo stenosis or restenosis of the femoropopliteal arteries (115 long lesions, 141 short lesions) who underwent successful DCB treatment from January 2019 to December 2021 at Peking Union Medical College Hospital. Stents were also used in 18 long lesions (15.7%) and 14 short lesions (9.9%). The primary safety endpoint was defined as freedom from major adverse events. Major adverse events were defined as death, target limb amputation or thrombosis. The primary efficacy endpoint was defined as primary patency and freedom from target lesion revascularization (TLR). The mean follow-up period was 2 years.
Results
Major adverse events at 2-year follow-up were reported in 12.4% of patients (29/234). The rate of primary patency and freedom from TLR by Kaplan-Meier estimation was 56.10 ± 3.28% and 85.71 ± 2.32% at 2 years, respectively. Significant difference in primary patency is shown in Rutherford Clinical Category (RCC) (p = 0.003), lesion length > 15cm versus ≤ 15cm (p = 0.005), target vessel = 1 versus target vessels = 2 (p = 0.018). Cox analysis suggested that Lesion length > 15 cm and RCC > 3 were associated with increased risk for primary patency loss at 2 years (p < 0.05). The change in RCC between baseline and 2-year follow-up was available in 199 patients with significant difference (p < 0.001).
Conclusion
DCB treatment is safe and effective at 2 years postoperatively. Patients with longer lesions, RCC > 3 had significantly lower rates of primary patency.