Efficacy of Rotational Atherectomy Followed by Drug-coated Balloon Angioplasty for the Treatment of Femoropopliteal Lesions-Comparison with Sole Drug-coated Balloon Revascularization: Two-year Outcomes.

ABSTRACT

BACKGROUND: We aimed to evaluate the results of the combined use of rotational atherectomy (RA) followed by drug-coated balloon (DCB) treatment against DCB angioplasty alone in patients who had significantly calcified and symptomatic femoropopliteal peripheral arterial disease. METHODS: Patients presented to the clinic with symptoms of chronic limb ischemia of femoropopliteal segment such as moderate or severe claudication and rest pain, who received endovascular therapy between January 2016 and January 2018 in our hospital comprised the study cohort and investigated, retrospectively. Patients with minor or major tissue loss were excluded from the study. We evaluated the effect of RA system followed by DCB with DCB alone in 121 patients and a total of 226 significantly calcified and symptomatic femoropopliteal lesions. Fifty-eight patients and 112 (49.5%) lesions were treated with RA + DCB, whereas 63 patients and 114 (50.5%) lesions were treated with DCB only. The mean age was 61.2 ± 9.7 years. Primary patency is evaluated with duplex ultrasound/angiography at 6, 12, and 24 months and with angiography on 12 and 24 months. Patients were followed up for 24 months to assign clinically driven target lesion revascularization (TLR). Overall survival rates were 96.5% (56/58) in RA + DCB group and 93.6% (59/63) in DCB alone group both at one-year and two-year follow-up. Amputation-free survival rates of RA + DCB and DCB-only groups are 96.5% (56/58) to 87.3% (55/63) at one year, and 94.8% (55/58) to 82.5% (52/63) at two years, respectively. RESULTS: Baseline characteristics of groups were similar. The lesions were longer in the RA + DCB group than the DCB alone group (14.4 ± 5.2 cm vs. 10.2 ± 3.1 cm; P = 0.05). The technical success rate in the RA + DCB group was superior to that of DCB-only group (95.4% vs. 84.8%, P = 0.006). The 12-month and 24-month patency rates with angiography in the RA-DCB group were similar to those in the DCB-only group (85.7% vs. 74.6% and 73.2% vs. 62.7%, respectively). The rates of bailout stenting were significantly lower among patients treated with RA + DCB (n = 3; 5.1% vs. n = 13; 20.6%, P < 0.001). The rates of flow-limiting dissections and vessel recoils after procedures were significantly in RA + DCB group (n = 2; 3.4% vs. n = 8; 12.6%, P < 0.001) than DCB only (n = 1; 1.7% vs. n = 4; 6.3%, P < 0.002). The freedom from TLR rate was significantly increased in the RA + DCB group at 12 months (95.2% vs. 76.3%, P = 0.002) and 24 months (93.4% vs. 63.7%, P = 0.002). The mean ankle brachial index at discharge in the RA-DCB group improved by 0.35 ± 0.24, and in the DCB-only group, it was 0.30 ± 0.23 (P = 0.683). CONCLUSIONS: Combined use of RA and DCB treatment is an effective, safe, and durable method for the treatment of the complex femoropopliteal lesions. Combination of RA and DCB angioplasty reveals increased technical success, fewer flow-limiting dissections, significantly reduced TLR, and bailout stenting rates compared with sole DCB angioplasty.