Background: The ultrathin-strut, polymer-free sirolimus- and probucol-eluting stent (PF-SES; Coroflex ISAR NEO; B. Braun, Melsungen, Germany) was developed to promote rapid arterial healing compared with durable-polymer drug-eluting stents (DESs). However, its long-term clinical performance remains unclear. This study aimed to evaluate the 2-year clinical outcomes following percutaneous coronary intervention (PCI) with PF-SES versus a durable-polymer everolimus-eluting stent (DP-EES; Xience).

Methods and Results: This single-center, retrospective observational study included 2916 lesions from 2090 patients with coronary artery disease who underwent successful PCI with either PF-SES (472 lesions, 333 patients) or DP-EES (2444 lesions, 1757 patients) between July 2011 and December 2022. Two-year outcomes, including major adverse cardiac events (MACEs; composite of cardiac death, myocardial infarction, or target vessel revascularization) and target lesion revascularization (TLR), were compared. Multivariate Cox proportional hazards model and inverse probability weighting (IPW) analyses were used to evaluate the impact of the PF-SES on outcomes. The 2-year cumulative incidences of MACE (PF-SES: 9.4% vs. DP-EES: 11.7%, P = 0.28) and TLR (PF-SES: 4.6% vs. DP-EES: 5.0%, P = 0.76) were comparable. Multivariate and IPW analyses confirmed no significant association between PF-SES use and MACE (P = 0.88 and P = 0.87) or TLR (P = 0.78 and P = 0.95). The interaction analysis showed that the effect of PF-SES on the risk of TLR did not differ significantly across subgroups.

Conclusion: PF-SES implantation was associated with comparable 2-year safety and efficacy outcomes to DP-EES.