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Several trials have shown that paclitaxel drug-coated balloons (DCBs) significantly reduce restenosis rates. However, some reports have shown distal embolisms occurring after DCBs. No study has analyzed the clinical outcomes of patients with DCB-induced distal embolism. This study aimed to investigate the clinical outcomes of DCB-induced distal embolism in patients with femoropopliteal artery disease. Between February 2018 and April 2019, consecutive patients ( n  = 32) who presented with de novo femoropopliteal artery disease and underwent endovascular therapy using DCB were retrospectively reviewed in a single-center study. Patients were divided into two groups based on whether distal embolism was detected using laser doppler flowmetry (DEL group) or not (non-DEL group). Baseline characteristics and 1-year clinical outcomes were compared between the groups. DEL was found in 44% of limbs (DEL group:  n  = 15, non-DEL group:  n  = 19). Below-the-knee arterial runoff ≤ 1 ( p  = 0.033), popliteal lesion ( p  = 0.044), ambulation difficulty ( p  = 0.021), and previous history of coronary artery disease ( p  = 0.013) were identified as predictive factors of DEL .  Procedural factors, reference vessel diameter, lesion length, and total drug amount were not predictive of DEL. The overall target lesion restenosis (TLR) rate was 17.4% ( n  = 5). The TLR rate was not significantly different between the DEL and non-DEL groups (13.3% vs. 15.8%,  p  = 0.55). Severe calcification was the only significant factor for TLR (4.2% vs. 40.0%,  p  = 0.02). Among patients with femoropopliteal disease, there was no difference in 1-year clinical outcome between patients who underwent DEL and those who did not.

cardiovascular intervention and therapeutics

Clinical outcome of the patients with femoropopliteal artery disease after endovascular therapy: focused on drug-coated-balloon-related distal embolism detected by laser doppler flowmetry