Evaluation of 24-Month Follow-up Outcomes of Patients Undergoing Combined Rotational Atherectomy and Drug-coated Balloon for Lower Extremity Peripheral Arterial Disease

The aim of this study was to evaluate 24-month outcomes of combined rotational atherectomy and drug-coated balloon therapy in patients with lower extremity peripheral arterial disease. This single-center case series analysis study looked at 84 people with peripheral arterial disease in their lower limbs who had both rotational atherectomy with the TemREN (R) atherectomy device and drug-coated balloon therapy with the Extender (R) drug-eluting balloon. We presented the clinical characteristics and follow-up data of the patients who had occlusion in the superficial femoral artery, popliteal artery, anterior tibial artery, and/or posterior tibial artery. The mean arterial stenosis percentages at pre-procedural, early post-procedural, and post-procedural 24-month follow-up periods were 87.5 SD8.3%, 8.6 SD6.7%, and 15.2 SD9.2% for the superficial femoral artery; 87.0 SD6.8%, 16.6 SD9.0%, and 31.1 SD18.7% for the popliteal artery; 88.5 SD7.0%, 12.8 SD7.6%, and 26.4 SD17.0% for the anterior tibial artery; and 89.8 SD7.3%, 13.5 SD7.8%, and 27.6 SD18.3% for the posterior tibial artery, respectively (p < 0.001). The mean preoperative ankle-brachial index of 0.6 SD0.1 improved to 1.0 SD0.1 at 24-month follow-up (p < 0.001). The improvement according to the Rutherford stage was also statistically significant, from 3.1 SD1.4 to 0.6 SD1.1 for the same period (p < 0.001). Seven (8%) patients underwent re-intervention in the early period. Two (2%) patients who had undergone superficial femoral artery intervention underwent an above-knee bypass. Minor amputation was required in five (6%) patients and major amputation in one (1%) patient. Our study revealed that a combined rotational atherectomy and drug-coated balloon therapy was effective and safe in the treatment of lower extremity peripheral arterial disease.