Meta-Analysis-Derived Benchmarks of Patency and Target Lesion Revascularization of Percutaneous Balloon Angioplasty from Prospective Clinical Trials of Symptomatic Femoropopliteal In-Stent Restenosis.

PURPOSE: To establish historic benchmarks of patency and target lesion revascularization (TLR) in a study-level meta-analysis of prospective studies of balloon angioplasty in treating femoropopliteal in-stent restenosis (ISR).

MATERIALS AND

METHODS

Data from the balloon angioplasty control arms of 4 randomized multicenter trials (1 Food and Drug Administration-approved study in the United States and 3 conducted in Europe) and 1 European prospective registry were included. Trials included patients with Rutherford stage 1-5 disease or Fontaine ischemia classification states IIb, III, IV and femoropopliteal ISR lesion lengths of 4-27 cm. A two-stage meta-analysis was conducted with study-specific estimates obtained from the randomized trials at the first stage and an analysis that pooled all study-specific estimates at the second stage. The Breslow-Day test of homogeneity was performed on patency and TLR at 6 months and 1 year.

RESULTS

Analysis of the balloon-angioplasty control arms of the 5 prospective trials identified 303 patients (mean lesion length, 144.5 mm ± 88.0; vessel diameter, 4.9 mm ± 0.7). Six- and 12-month duplex ultrasound patency rates were 60.7% and 33%, respectively. Six- and 12-month TLR rates with and without "bailout" stent placement considered as TLR were 37.9% and 55.4% and 27.0% and 42.6%, respectively.

CONCLUSIONS

It is feasible to derive 6-month and 1-year patency and TLR benchmark data from existing prospective trials of balloon angioplasty in femoropopliteal ISR. However, the study is limited by the lack of data from larger prospective trials with longer-term follow-up.