Endovascular brachytherapy after femoropopliteal balloon angioplasty fails to show robust clinical benefit over time

Purpose: To determine if the short-term efficacy of adjunctive endovascular brachytherapy (EVBT) is maintained over time in patients undergoing balloon angioplasty (BA) of femoropopliteal atherosclerotic lesions. Methods: To evaluate the long-term clinical and angiographic outcome of EVBT, 147 consecutive patients (82 men; mean age 70.8 +/- 8.5 years) with 147 treated limbs were randomized to BA with (n=72, 49%) or without (n=75, 51%) adjunctive EVBT (12 or 14-Gy from an Ir-192 source, no centering, a 5-mm reference depth). Sixty-eight (46%) limbs were treated for de novo and 79 (54%) for recurrent femoropopliteal lesions. Clinical follow-up at 1, 3, 6, and 12 months and annually thereafter included evaluation of symptoms, ankle-brachial index (ABI), and intra-arterial angiography for new/worsening symptoms or at follow-up between 2 and 5 years. Sustained clinical success was defined as improvement in ABI >= 0.1 and/or of symptoms without repeated target lesion revascularization. Angiographic restenosis was defined as >= 50% diameter reduction. Subgroup analysis was performed for de novo versus recurrent lesions. Results: Mean clinical follow-up was 32.3 +/- 21.5 months. Angiographic follow-up was available in 83 (56%) patients (41 BA and 42 BA+EVBT) at a mean 31.8 +/- 20.7 months. Cumulative sustained clinical success rates at 1, 2, and 3 years, respectively, were 84.3%, 82.1%, and 76.4% after BA versus 82.4%, 69.8%, and 67.5% after BA+EVBT (p=0.26 by log-rank). Although the proportion of patients undergoing follow-up angiography was moderate, the freedom from angiographic restenosis at 1, 2, and 3 years was 70.7%, 63.1%, and 47.1% after BA versus 82.7%, 64.3%, and 64.3% after BA+EVBT (p=0.16 by log-rank). No differences were found between BA and BA+EVBT outcomes in patients with de novo versus recurrent femoropopliteal lesions. Conclusion: The seemingly beneficial short-term effects of BA+EVBT are not sustained in the longer term, with no robust clinical improvement after angioplasty of atherosclerotic de novo or recurrent femoropopliteal lesions at up to 5 years.