Introduction
Drug-coated balloons (DCBs) have become the first line treatment option for endovascular revascularization in patients with peripheral arterial disease (PAD), aiming to improve patency and reduce reintervention rates compared with plain balloon angioplasty. Most available evidence is based on paclitaxel-coated balloons (PCBs), while data on sirolimus-coated balloons (SCBs) remain limited. Given the differences in pharmacologic mechanisms, coating technologies and safety profiles between paclitaxel and sirolimus, a direct comparison of clinical outcomes is crucial. The aim of this study was to compare short- and mid-term outcomes after endovascular interventions using SCBs versus PCBs in patients with PAD.
Methods
We performed a retrospective analysis of interventions for PAD from the multicenter, prospective RECCORD registry using either sirolimus- or paclitaxel-coated DCBs between 2022 and 2024. Propensity-score matching (1:1) was performed to adjust for baseline differences between groups using the following variables: age, sex, BMI, arterial hypertension, diabetes, hyperlipidemia, smoking, chronic kidney failure, chronic heart failure, coronary artery disease, cerebrovascular disease, polyneuropathy, previous revascularization, previous amputation, symptoms onset, Rutherford stage, lesion location, lesion length and endovascular therapy. After matching, each cohort included 85 patients with standardized mean differences (SMD) < 0.2 for all covariates. Primary endpoints were procedural complications and clinical outcomes at 12-month follow-up, including major adverse limb events.
Results
A total of 1728 endovascular interventions with DCBs were performed between 2022 and 2024, including 108 interventions with SCBs and 1630 with PCBs. After propensity-score matching, 85 patients remained in each group with well-balanced baseline characteristics. All matched interventions showed procedural success with comparable complication rates (4.7% vs. 8.2%, p = 0.35). During follow-up, both groups showed significant rises in ABI (0.1 ± 0.3 vs. 0.2 ± 0.4, p = 0.1) and Rutherford category improvements of at least 1 stage (47.1 % vs. 51.8%, p = 0.54). Regarding major adverse limb events, no differences were observed in terms of endovascular revascularization (0 % vs. 3.5 %, p = 0.08), surgical revascularization (1.2 % vs. 0 %, p = 0.32) and major amputation (1.2 % vs. 0 %, p = 0.32).
Conclusions
In this propensity-score matched analysis from the real-world RECCORD registry, the use of SCBs versus PCBs was associated with comparable procedural and one-year clinical outcomes in patients undergoing endovascular revascularization for PAD. The present findings suggest that both coating technologies offer similar safety and efficacy profiles in real-world practice. Larger, prospective studies with extended follow-up are needed to determine whether patient- or lesion-specific subgroups may benefit preferentially from one DCB type.
