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Randomized comparison between 2-link cell design biolimus A9-eluting stent and 3-link cell design everolimus-eluting stent in patients with de novo true coronary bifurcation lesions: the BEGIN trial

  • Masahiro YamawakiEmail author
  • Toshiya Muramatsu
  • Kazuhiro Ashida
  • Koichi Kishi
  • Yoshihiro Morino
  • Yoshihisa Kinoshita
  • Takashi Fujii
  • Yuichi Noguchi
  • Shingo Hosogi
  • Kazuya Kawai
  • Kiyoshi Hibi
  • Yoshisato Shibata
  • Hiroshi Ohira
  • Yasuhiro Morita
  • Yasuhiro Tarutani
  • Mikihito Toda
  • Yoshihisa Shimada
  • Yuji Ikari
  • Jiro Ando
  • Yutaka Hikichi
  • Yoritaka Otsuka
  • Yasushi Fuku
  • Shigenori Ito
  • Harumi Katoh
  • Kazushige Kadota
  • Yoshiaki Ito
  • Kazuaki Mitsudo
Original Article
  • 52 Downloads

Abstract

The appropriate stent platform for treating coronary bifurcation lesions (CBLs) remains controversial. Previous bench tests have demonstrated the superiority of a 2-link cell design to 3-link cell design for creating inter-strut dilation at the side branch ostium. This randomized multicenter prospective BEGIN trial compared the biodegradable polymer-based biolimus A9-eluting stent (2-link BES) with the durable polymer-based cobalt chromium everolimus-eluting stent (3-link EES) in 226 patients with de novo CBLs. Patients with true bifurcations, defined as > 50% stenosis in the main vessel and side branch (SB) and an SB diameter > 2.25 mm, were enrolled. Guide wire re-crossing to the distal cell (near the carina) in the jailed SB and final kissing inflation were recommended. The SB angiographic endpoint was < 50% stenosis diameter. Left-main CBLs (13.5% vs. 13.0%) and 2-stent technique (30.6% vs. 22.6%) rates were similar. The primary endpoints (minimum lumen diameter at the SB ostium measured at an independent core laboratory at the 8-month follow-up) were comparable (1.64 ± 0.50 mm vs. 1.63 ± 0.51 mm, p = 0.976). There was no significant difference in composite outcomes of cardiac death, myocardial infarction, or target vascular revascularization at 12 months (7.4% vs. 8.0%, p = 0.894). Two-link BES and 3-link EES showed similar 8-month angiographic and 1-year clinical outcomes for true CBLs.

Keywords

Randomized study Coronary bifurcation lesions Drug-eluting stent Biolimus A9-eluting stent Everolimus-eluting stent 

Notes

Acknowledgements

We thank the late Dr. Kazuaki Mitsudo for proposing and providing valuable advice about this study as well as all collaborators of the BEGIN trial for their support.

Funding

This study was supported by a funding from Terumo, Tokyo, Japan.

Supplementary material

380_2019_1368_MOESM1_ESM.docx (15 kb)
Supplementary material 1 (DOCX 15 kb)

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Copyright information

© Springer Japan KK, part of Springer Nature 2019

Authors and Affiliations

  • Masahiro Yamawaki
    • 1
    Email author
  • Toshiya Muramatsu
    • 2
  • Kazuhiro Ashida
    • 3
  • Koichi Kishi
    • 4
  • Yoshihiro Morino
    • 5
  • Yoshihisa Kinoshita
    • 6
  • Takashi Fujii
    • 7
  • Yuichi Noguchi
    • 8
  • Shingo Hosogi
    • 9
  • Kazuya Kawai
    • 10
  • Kiyoshi Hibi
    • 11
  • Yoshisato Shibata
    • 12
  • Hiroshi Ohira
    • 13
  • Yasuhiro Morita
    • 14
  • Yasuhiro Tarutani
    • 15
  • Mikihito Toda
    • 16
  • Yoshihisa Shimada
    • 17
  • Yuji Ikari
    • 18
  • Jiro Ando
    • 19
  • Yutaka Hikichi
    • 20
  • Yoritaka Otsuka
    • 21
  • Yasushi Fuku
    • 23
  • Shigenori Ito
    • 22
  • Harumi Katoh
    • 23
  • Kazushige Kadota
    • 23
  • Yoshiaki Ito
    • 1
  • Kazuaki Mitsudo
    • 23
  1. 1.Department of CardiologySaiseikai Yokohama City Eastern HospitalYokohamaJapan
  2. 2.Department of CardiologyGeneral Tokyo HospitalTokyoJapan
  3. 3.Department of CardiologyYokohama Shintoshi Neurosurgery HospitalYokohamaJapan
  4. 4.Department of CardiologyTokushima Red Cross HospitalKomatsushimaJapan
  5. 5.Department of CardiologyIwate Medical University HospitalMoriokaJapan
  6. 6.Department of CardiologyToyohashi Heart CenterToyohashiJapan
  7. 7.Department of CardiologyAko City HospitalAkoJapan
  8. 8.Department of CardiologyTsukuba Medical CenterTsukubaJapan
  9. 9.Department of CardiologyKochi Medical CenterKochiJapan
  10. 10.Department of CardiologyChikamori HospitalKochiJapan
  11. 11.Department of CardiologyYokohama City University Medical CenterYokohamaJapan
  12. 12.Department of CardiologyMiyazaki Medical Association HospitalMiyazakiJapan
  13. 13.Department of CardiologyEdogawa HospitalTokyoJapan
  14. 14.Department of CardiologyOgaki City HospitalOgakiJapan
  15. 15.Department of CardiologyOkamura Memorial HopsitalShimizu-choJapan
  16. 16.Department of CardiologyToho University Oomori HospitalTokyoJapan
  17. 17.Department of CardiologyShiroyama HospitalHabikinoJapan
  18. 18.Department of CardiologyTokai University HospitalIseharaJapan
  19. 19.Department of CardiologyTokyo University HospitalTokyoJapan
  20. 20.Department of CardiologySaga University HospitalSagaJapan
  21. 21.Department of CardiologyFukuoka Wajiro HospitalFukuokaJapan
  22. 22.Department of CardiologySankuro HospitalToyotaJapan
  23. 23.Department of CardiologyKurashiki Central HospitalKurashikiJapan

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