Five‐Year Clinical Outcomes of Biodegradable Versus Durable Polymer Drug‐Eluting Stents: A Propensity Score‐Matched Analysis of 4394 Patients
Yangyoun Lee, Hong‐Seok Lim, Kyoung‐Woo Seo, Hyoung‐Mo Yang, So‐Yeon Choi, Seung‐Jea Tahk, Myeong‐Ho YoonABSTRACT
Background
Biodegradable‐polymer (BP) drug‐eluting stents (DES) were developed to mitigate potential late adverse events related to persistent durable polymers in durable‐polymer (DP) DES; however, contemporary long‐term real‐world comparative data remain limited.
Aims
We aimed to compare the 5‐year clinical outcomes of contemporary BP‐DES and DP‐DES in patients undergoing routine percutaneous coronary intervention (PCI).
Methods
We analyzed consecutive patients undergoing PCI with second‐generation or newer DES at a single institution (2010–2021). Propensity scores were estimated using prespecified clinical, angiographic, and procedural covariates, and 1:1 nearest‐neighbor matching was performed. The primary endpoint was 5‐year target lesion failure (TLF: cardiac death, target vessel myocardial infarction [TV‐MI], or clinically driven target lesion revascularization [TLR]). Key secondary endpoints were 1‐year TLF, all‐cause mortality, and ARC‐2 definite or probable stent thrombosis. A prespecified 1‐year landmark analysis evaluated outcomes from 0 to 1 and 1 to 5 years.
Results
After matching, 2197 pairs (4394 patients) were included. At 5 years, TLF occurred in 7.9% of BP‐DES and 7.9% of DP‐DES patients (HR 1.01, 95% CI 0.81–1.26; p = 0.936). No statistically significant differences were observed in secondary endpoints, including 1‐year TLF, individual TLF components, all‐cause mortality, or ARC‐2 definite or probable stent thrombosis. All‐cause mortality at 5 years was similar between groups (7.1% vs. 8.2%; HR 0.87, 95% CI 0.69–1.09; p = 0.213); however, in the 1–5‐year landmark period, mortality was numerically lower with BP‐DES (HR 0.73, 95% CI 0.53–1.00; nominal p = 0.047). No significant treatment‐by‐subgroup interactions were observed.
Conclusions
In routine PCI using second‐generation or newer DES, BP‐DES and DP‐DES demonstrated comparable 5‐year TLF. The potential late survival signal with BP‐DES is hypothesis‐generating and should be interpreted cautiously given the observational design.