RT Journal Article
SR Electronic
T1 Long-term (8–10 years) outcomes after biodegradable polymer-coated biolimus-eluting stent implantation
JF Heart
JO Heart
FD BMJ Publishing Group Ltd and British Cardiovascular Society
SP 1002
OP 1008
DO 10.1136/heartjnl-2016-310591
VO 103
IS 13
A1 Ohya, Masanobu
A1 Kubo, Shunsuke
A1 Kuwayama, Akimune
A1 Miura, Katsuya
A1 Shimada, Takenobu
A1 Amano, Hidewo
A1 Hyodo, Yusuke
A1 Otsuru, Suguru
A1 Habara, Seiji
A1 Tada, Takeshi
A1 Tanaka, Hiroyuki
A1 Fuku, Yasushi
A1 Katoh, Harumi
A1 Goto, Tsuyoshi
A1 Kadota, Kazushige
YR 2017
UL http://heart.bmj.com/content/103/13/1002.abstract
AB 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.