Systematic Review and Meta-analysis of the Outcomes of Drug-Eluting Stent Versus Drug-Coated Balloon Angioplasty for Lower Extremity Peripheral Artery Diseases.

Background: Recent evidence raised the concern that paclitaxel-containing therapy was associated with an increased risk of mortality in patients with peripheral artery diseases (PADs). However, it is unclear whether drug-eluting stent (DES) versus drug-coated balloon (DCB) have a different effect on mortality of PAD patients. Our study aimed to systematically review current literature comparing clinical outcomes of patients treated with DES versus DCB for PAD.

Methods: MEDLINE and Embase were searched for eligible studies from January 2000 to December 31, 2020. Randomized controlled trials (RCTs) or cohort studies that reported outcomes of DES versus DCB were included in our study. The primary outcome was 12-month all-cause mortality. A random-effect model was used to pool the odds ratios (ORs) and related 95% confidence intervals (CIs).

Results: Our review included 7 studies, involving 2 RCTs and 5 cohort studies. A total of 4,237 patients with DES and 9,234 patients with DCB were analyzed. All included cohort studies were of high quality with Newcastle-Ottawa scores from 7 to 8. No significant difference in 12-month all-cause mortality was found between DES and DCB without significant heterogeneity (OR 1.02, 95% CI 0.91-1.14, I = 0%). As for primary patency, no significant difference between treatments was observed (OR 1.27, 95% CI 0.75-2.15, I = 55%). Similar results were observed for freedom from target lesion revascularization (OR 0.94, 95% CI 0.64-1.40, I = 0%).

Conclusions: This systematic review and meta-analysis suggest that no significant difference in 12-month all-cause mortality was found between DES and DCB. Primary patency and freedom from target lesion revascularization of lower extremity PAD were also comparable between the 2 groups.