Background: Outcomes comparing drug-coated balloons (DCB) versus drug-eluting stents (DES) have not been sufficiently studied in femoropopliteal peripheral arterial disease (PAD).
Aims: This meta-analysis aims to compare outcomes of DES versus DCBs in femoropopliteal PAD and uses regression to rule out effect modifiers.
Methods: An online literature search was conducted using the Preferred Reporting Items for Systematic Review and Meta-Analysis search strategy from inception till November 2022. STATA v.17 was used for statistical analysis to calculate odds ratios and for univariate meta-regression to rule out effect modifiers, including baseline characteristics and comorbidities.
Results: A total of eight studies with 1261 patients underwent femoropopliteal peripheral arterial intervention (DCB, n = 670; DES, n = 591). There was no difference in the primary outcome of all-cause mortality and primary patency at 1 year and 2 years between DCB and DES. One-year clinically-driven target lesion revascularization (CD-TLR) was significantly lower in the DCB group (OR: 0.68; 95% CI = 0.47-0.98; p = 0.04); however, no significant difference was found in 2-year CD-TLR. Regarding secondary outcomes' analysis, major amputation, procedural success, and post-procedure ankle-brachial index (ABI) failed to reach statistical significance. Univariate meta-regression results showed no effect modification based on demographics, comorbidities, and lesion characteristics (p > 0.05) for all outcomes except 1-year CD-TLR and major amputation.
Conclusion: There was no significant difference in all-cause mortality and primary patency between DCB and DES for up to 2 years. DCB was associated with lower CD-TLR at 1 year, which was lost at 2 years of follow-up.
Keywords: drug‐coated balloon; drug‐eluting stent; endovascular intervention; femoropopliteal disease; peripheral artery disease; peripheral intervention.
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