Background/Purposes: Despite enhanced immediate technical success, neointimal hyperplasia, and restenosis remain the Achilles heel of endovascular interventions. Drug-coated balloons (DCBs) have shown promise in improving the outcomes for patients with peripheral arterial disease (PAD). Several trials have shown that drug coated balloon (DCB) angioplasty has superior anti-restenotic efficacy in the femoropopliteal artery (FPA) disease. This controlled, prospective, multicenter study was designed to establish the efficacy of DCB to improve angiographic outcomes and inhibit restenosis of the femoropopliteal arteries in an exclusive diabetic population in 12-month follow-up period. Patients and methods: Between January 2016 through December 2017, 84 consecutive adult diabetic patients with type 1 and 2 with oral euglycaemics or insulin injection had been enrolled. 42 treated with DCB angioplasty and 42 treated with plain old balloon angioplasty (POBA) in a 1:1 randomization pattern. The primary endpoint of the study was the primary patency, mean diameter restenosis and binary restenosis of the treated sites at 12 months without re- intervention in the interim.
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Results: The 12-month mean diameter restenosis was significantly lower in the DCB arm than in the POBA group (27.9±35.1% vs. 44.8±33.9%, P=0.034). Furthermore, analysis showed that the binary (≥50% diameter stenosis) restenosis rates was significantly lower in DCB patients as compared with the POBA’s (28% vs. 47%, P=0.029). The primary patency was significantly better in DCB group (71% vs. 49%, P=0.028). On the other hand, we noted that the rate of clinically-driven TLR was slightly higher in the POBA patients, however, not statistically significant as compared to the paclitaxel-coated balloon group (28% vs. 20%, P= 0.13). There were no procedure- or device-related deaths in either study arm. The 12-month adverse effects, in terms of all cause death (N.3= 7.1% POBA vs. N.2= 4.8% DCB), minor amputation (N.5=12% POBA vs. N.4=9.5% DCB), major amputation (0 % POBA vs. N.1= 2.4% DCB), and myocardial infarction (N.1= 2.4% POBA vs. 0% DCB) were equal in both groups (P=713). Causes of mortality included myocardial infarction, cerebral infarction & sudden death. Conclusions: The treatment of diabetic PAD of FPA disease with IN.PACT paclitaxel coated balloon angioplasty is associated with superior anti-restenotic efficacy that provides a better primary patency rate compared to plain old balloon angioplasty at 12 months. However, DCB showed no clinical benefit over POBA at this 12-month follow-up period. The number of major adverse clinical events was comparable between DCB and POBA groups of patients. |
