Objective Efficacy and safety data on biodegradable polymer-coated biolimus-eluting stent (BP-BES) are currently limited to 5 years. We evaluated longer term (8–10 years) clinical and angiographic outcomes after BP-BES implantation.
Methods Between 2005 and 2008, 243 patients (301 lesions) underwent BP-BES implantation. The primary clinical outcome measure was defined as any target lesion revascularisation (TLR). Absolute serial angiographic studies without any concomitant TLR within 2 years after the procedure were performed in 55 patients (65 lesions) at postprocedure, mid-term (within 1 year), late term (between 1 and 2 years) and very late term (beyond 2 years).
Results The median follow-up duration was 9.4 years (IQR 8.2–10.2 years). The 8-year cumulative incidence of any TLR was 20.3%. The increase rate was approximately 7% per year in the first 2 years, but decelerated to approximately 1.2% per year beyond 2 years after the procedure. The minimal lumen diameter significantly decreased from postprocedure (2.63±0.44 mm) to mid-term (2.43±0.59 mm, p=0.002) and from late term (2.27±0.63 mm) to very late term (1.98±0.73 mm, p=0.002). The 8-year cumulative incidences of definite or probable stent thrombosis (ST) and major bleeding (Bleeding Academic Research Consortium (BARC) ≥3) were 0.5% and 12.0%, respectively. Definite ST was none within 10 years in the entire cohort.
Conclusions The long-term clinical outcomes after BP-BES implantation were favourable, although angiographic late progression of luminal narrowing did not reach a plateau. The incidence of ST remained notably low, whereas that of major bleeding gradually increased.
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Contributors MO, SK, KK: conception and design as well as analysis and interpretation of data and final approval of the manuscript submitted. MO: drafting of the manuscript. SK, KK: revising the manuscript critically for important intellectual content. KK: drafting of the manuscript and revising the manuscript critically for important intellectual content. The residual authors for conception and design, revising the manuscript critically for important intellectual content and final approval of the manuscript submitted.
Competing interests None declared.
Ethics approval The study was approved by the institutional ethics committee.
Provenance and peer review Not commissioned; externally peer reviewed.