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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

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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.

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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.

Author information

Author notes

  1. Dr. Kazuaki Mitsudo deceased on 18. October 2015.

Authors and Affiliations

  1. Department of Cardiology, Saiseikai Yokohama City Eastern Hospital, 3-6-1 Shimosueyoshi Tsurumi, Yokohama, 230-8765, Japan

    Masahiro Yamawaki & Yoshiaki Ito

  2. Department of Cardiology, General Tokyo Hospital, Tokyo, Japan

    Toshiya Muramatsu

  3. Department of Cardiology, Yokohama Shintoshi Neurosurgery Hospital, Yokohama, Japan

    Kazuhiro Ashida

  4. Department of Cardiology, Tokushima Red Cross Hospital, Komatsushima, Japan

    Koichi Kishi

  5. Department of Cardiology, Iwate Medical University Hospital, Morioka, Japan

    Yoshihiro Morino

  6. Department of Cardiology, Toyohashi Heart Center, Toyohashi, Japan

    Yoshihisa Kinoshita

  7. Department of Cardiology, Ako City Hospital, Ako, Japan

    Takashi Fujii

  8. Department of Cardiology, Tsukuba Medical Center, Tsukuba, Japan

    Yuichi Noguchi

  9. Department of Cardiology, Kochi Medical Center, Kochi, Japan

    Shingo Hosogi

  10. Department of Cardiology, Chikamori Hospital, Kochi, Japan

    Kazuya Kawai

  11. Department of Cardiology, Yokohama City University Medical Center, Yokohama, Japan

    Kiyoshi Hibi

  12. Department of Cardiology, Miyazaki Medical Association Hospital, Miyazaki, Japan

    Yoshisato Shibata

  13. Department of Cardiology, Edogawa Hospital, Tokyo, Japan

    Hiroshi Ohira

  14. Department of Cardiology, Ogaki City Hospital, Ogaki, Japan

    Yasuhiro Morita

  15. Department of Cardiology, Okamura Memorial Hopsital, Shimizu-cho, Japan

    Yasuhiro Tarutani

  16. Department of Cardiology, Toho University Oomori Hospital, Tokyo, Japan

    Mikihito Toda

  17. Department of Cardiology, Shiroyama Hospital, Habikino, Japan

    Yoshihisa Shimada

  18. Department of Cardiology, Tokai University Hospital, Isehara, Japan

    Yuji Ikari

  19. Department of Cardiology, Tokyo University Hospital, Tokyo, Japan

    Jiro Ando

  20. Department of Cardiology, Saga University Hospital, Saga, Japan

    Yutaka Hikichi

  21. Department of Cardiology, Fukuoka Wajiro Hospital, Fukuoka, Japan

    Yoritaka Otsuka

  22. Department of Cardiology, Sankuro Hospital, Toyota, Japan

    Shigenori Ito

  23. Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan

    Yasushi Fuku, Harumi Katoh, Kazushige Kadota & Kazuaki Mitsudo

Authors
  1. Masahiro Yamawaki
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  2. Toshiya Muramatsu
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  3. Kazuhiro Ashida
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  4. Koichi Kishi
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  5. Yoshihiro Morino
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  6. Yoshihisa Kinoshita
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  7. Takashi Fujii
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  8. Yuichi Noguchi
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  9. Shingo Hosogi
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  10. Kazuya Kawai
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  11. Kiyoshi Hibi
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  12. Yoshisato Shibata
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  13. Hiroshi Ohira
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  14. Yasuhiro Morita
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  15. Yasuhiro Tarutani
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  16. Mikihito Toda
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  17. Yoshihisa Shimada
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  18. Yuji Ikari
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  19. Jiro Ando
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  20. Yutaka Hikichi
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  21. Yoritaka Otsuka
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  22. Yasushi Fuku
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  23. Shigenori Ito
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  24. Harumi Katoh
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  25. Kazushige Kadota
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  26. Yoshiaki Ito
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  27. Kazuaki Mitsudo
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Correspondence to Masahiro Yamawaki.

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Yamawaki, M., Muramatsu, T., Ashida, K. et al. 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. Heart Vessels 34, 1297–1308 (2019). https://doi.org/10.1007/s00380-019-01368-3

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