Perioperative Inflammatory Status Predicts Mid-Term Outcomes in Patients Undergoing Femoropopliteal Paclitaxel-Coated Balloon Angioplasty.

BACKGROUND:To evaluate the association of perioperative inflammatory status, as determined using the neutrophil-to-lymphocyte ratio (NLR) and high-sensitivity C-reactive protein (hs-CRP) level, with the efficacy of femoropopliteal paclitaxel-coated balloon (PCB) angioplasty. METHODS:The data of 122 patients (138 limbs) were retrospectively analyzed (median follow-up time, 21 months). The pre- and postoperative NLRs and hs-CRP levels were evaluated to determine their predictive value for mid-term primary patency and clinically driven target lesion revascularization (CD-TLR) during follow-up. Cox regression and Kaplan-Meier survival analyses were performed to investigate the predictive value of the inflammatory parameters and clinical risk factors. RESULTS:The study population had a median age of 67.2 ± 9.2 years, and 85.2 ± 3% of them were men. Approximately, 18.0 ± 3% of the cases were classified under Rutherford grade II; 52.5 ± 4%, grade III; 24.6 ± 3%, grade IV; 4.1 ± 1%, grade V; and 0.8 ± 0.7%, grade VI. The 12- and 24-month cumulative patency rates were 81.2 ± 27.0% and 60.4 ± 30.1%, respectively, and the freedom from CD-TLR rates were 90.8 ± 19.1% and 82.5 ± 28.3%, respectively. Severe lesion calcification was identified as an independent risk factor for CD-TLR (hazard ratio [HR] = 1.51, 95% confidence interval [CI] = 1.05-3.01), while hypertension was found as a protective factor for primary patency (HR = 0.54, 95% CI = 0.30-0.93). The patients with Trans-Atlantic Inter-Society Consensus (TASC) C/D lesions had more than a 2-fold increased adjusted risk of both primary patency loss and CD-TLR compared with those with TASC A/B lesions (HR = 2.44 for primary patency loss; HR = 2.51 for CD-TLR). The perioperative NLRs and hs-CRP levels were stratified into three grades. The patients with a higher preoperative hs-CRP level (>9.2 vs. 0.6-9.2 vs. <0.6 mg/L by each tertile) had a 2.4-fold increased adjusted risk of primary patency loss compared with those with a lower preoperative hs-CRP level. The patients with a higher hs-CRP level on the first postoperative day (>13.0 vs. 7.7-13.0 vs. <7.7 mg/L by each tertile) had a 1.8-fold increased adjusted risk of primary patency loss compared with those with a lower hs-CRP level. In contrast, the patients with a higher NLR at 4-6 hr postoperatively (>3.6 vs. 2.5-3.6 vs. <2.5 by each tertile) showed better primary patency (adjusted HR = 0.57) than did those with a lower NLR. A higher hs-CRP level on the first postoperative day was the only inflammatory marker associated with a high risk of CD-TLR (adjusted HR = 2.37). CONCLUSIONS:Perioperative inflammatory status serves as a valuable prognostic parameter for assessing the potential risk stratification of outcomes after paclitaxel-coated balloon (PCB) angioplasty.