Sirolimus- vs. paclitaxel-coated balloons in peripheral arterial disease: a propensity score matched analysis from the real-world RECCORD registry
D Pinsdorf, D Messiha, O Petrikhovich, J Lortz, N Malyar, M Czihal, G Korosoglou, W Ito, J Stausberg, R Langhoff, T Rassaf, C RammosAbstract
Background
Drug-coated balloons (DCBs) are first-line devices for endovascular revascularization in peripheral arterial disease (PAD), improving patency and reducing reinterventions compared with plain balloon angioplasty. Evidence is largely 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, this study compared short- and mid-term outcomes of SCBs versus PCBs in patients with PAD.
Methods
We retrospectively analyzed endovascular PAD interventions from the multicenter, prospective RECCORD registry using either SCBs or PCBs between 2022 and 2024. Propensity score matching (1:1) was performed to adjust for baseline differences between groups using demographic variables, cardiovascular risk factors, comorbidities, lesion characteristics and procedural details. After matching, each cohort included 85 patients with standardized mean differences (SMD) < 0.2 for all covariates. Primary endpoints were procedural complications and 12-month clinical outcomes, including major adverse cardiovascular events (MACE), major adverse limb events (MALE) and functional outcomes.
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 between the groups. In the follow-up, there were no statistically significant differences between SCBs and PCBs regarding MACE, MALE and functional outcomes.
Conclusion
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 regarding MACE, MALE and functional outcomes. 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.