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 Yamawaki, 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
Heart and Vessels 2019 March 11
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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