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Five-Year Clinical Outcomes of Biodegradable Versus Durable Polymer Drug-Eluting Stents: A Propensity Score-Matched
Yangyoun Lee1, Hong-Seok Lim1, Kyoung-Woo Seo1
1Department of Cardiology, Ajou University School of Medicine, Suwon, Republic of Korea.
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.