Comparison of Drug-Coated Balloon Angioplasty Alone and Directional Atherectomy Combined with Drug-Coated Balloon Angioplasty in Patients with Lower Extremity Peripheral Arterial Disease with Claudication.

ABSTRACT

BACKGROUND: The objective of the study was to compare drug-coated balloon (DCB) angioplasty alone and directional atherectomy (DA) combined with DCB angioplasty in patients with lower extremity peripheral arterial disease (LE-PAD). METHODS: Subjects treated with DCB angioplasty alone (group A) and DA combined with DCB angioplasty (group B) were enrolled in the study. A retrospective chart review was performed between the 4 years. Subjects with severe and occluded LE-PAD were included. Demographic data, atherosclerotic vessel properties, and procedural data were recorded. For both groups, success rates (technical, procedural, and clinical) were presented. RESULTS: In total, 226 patients were evaluated. For baseline characteristics, only tobacco use and hyperlipidemia were higher in group B (P = 0.001 and P = 0.010, respectively). For the ankle-brachial index, no significant difference existed at the first, third, sixth, 12th or 24th month follow-ups. No significant difference existed for the Rutherford class at the first, third, sixth, or 12th months according to the groups. A significant difference was found at 24-month Rutherford levels. The incidence of severe claudication in group A was significantly higher than that in group B (13 [12.4%] for group A and 3 [2.8%] for group B, P = 0.035). The stenosis rate after predilatation in group B was significantly higher than that in group A (54.56 ± 5.36 for group A and 59.20 ± 6.21 for group B, P = 0.012). The distribution of full patency in the 12th month in group B was significantly higher than that in group A. The rate of 70-100% stenosis in the 12th month was significantly higher in group A than in group B. According to the groups, the distribution of the patients who were lost to follow-up and died during the follow-up and secondary results, primary patency rates, and 2-year disease-free survival rates were also similar. CONCLUSIONS: Atherectomy combined with DCB is superior for the long-term treatment of LE-PAD.