Abstract Body (Do not enter title and authors here): Introduction:
Patients suffering from chronic limb-threatening ischemia (CLTI) are at a higher risk for amputation and a poor quality of life. Paclitaxel-drug eluting based stents (DEB) or drug-eluting balloons (DEB) treatments have shown lower restenosis rates than PTA, however, there’s scarcity of data on any reported improved clinical results such as lower amputation or death rates. We conducted a meta-analysis to compare the efficacy and safety performance of paclitaxel-DES/DEB with PTA in patients with CTLI.

Methods:
We searched articles in PubMed, Scopus, and Embase comparing paclitaxel-DES versus percutaneous transluminal angioplasty in infrapopliteal arteries in patients suffering from CTLI according to the PRISMA guidelines. Mantel-Hanezel method was used to determine the Risk Ratio (RR) at 95% confidence interval (CI) keeping the alpha criteria of 0.05 as significant. RevMan 5.4 was used to calculate random effect models.

Results:
Our analysis of 6 randomized controlled trials comparing Paclitaxel-DES/DEB with PTA did not show any significant difference between target lesion revascularization (RR 0.67; 95% CI 0.43-1.05; p=0.08), major amputation (RR 1.01; 95% CI 0.51-1.98; p=0.99), binary in-segment restenosis at a 1-year (RR 0.64; 95% CI 0.21-1.98; p=0.43), target vessel occlusion (RR 0.57; 95% CI 0.30-1.07; p=0.08), total deaths (RR 1.12; 95% CI 0.75-1.68; p=0.57), major adverse events (MAEs) (RR 0.82; 95% CI 0.47-1.43; p=0.48)

Conclusion:
Our analysis showed that there was no statistically significant difference between paclitaxel-DES and PTA when looking at the efficacy and safety which correlated with the SAVAL trial. Considering the impact of CTLI on quality of life, more studies are required to better understand the mechanism of paclitaxel-DEB/DES treatment in infrapopliteal lesions and to identify patient and lesion groups that may benefit from this treatment option.