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

• Published in: Heart and vessels Vol. 34; no. 8; pp. 1297 - 1308
• Main Authors: Yamawaki, Masahiro, Muramatsu, Toshiya, Ashida, Kazuhiro, Kishi, Koichi, Morino, Yoshihiro, Kinoshita, Yoshihisa, Fujii, Takashi, Noguchi, Yuichi, Hosogi, Shingo, Kawai, Kazuya, Hibi, Kiyoshi, Shibata, Yoshisato, Ohira, Hiroshi, Morita, Yasuhiro, Tarutani, Yasuhiro, Toda, Mikihito, Shimada, Yoshihisa, Ikari, Yuji, Ando, Jiro, Hikichi, Yutaka, Otsuka, Yoritaka, Fuku, Yasushi, Ito, Shigenori, Katoh, Harumi, Kadota, Kazushige, Ito, Yoshiaki, Mitsudo, Kazuaki
• Format: Journal Article
• Language: English
• Published: Tokyo Springer Japan 01-08-2019; Springer Nature B.V
• Subjects: Absorbable Implants; Aged; Aged, 80 and over; Bifurcations; Biodegradability; Biodegradation; Biomedical Engineering and Bioengineering; Blood vessels; Cardiac Surgery; Cardiology; Chromium; Cobalt; Composite materials; Coronary Artery Disease - diagnosis; Coronary Artery Disease - mortality; Coronary Artery Disease - therapy; Coronary Thrombosis - etiology; Coronary Thrombosis - mortality; Design; Drug-Eluting Stents; Everolimus - administration & dosage; Female; Guide wires; Humans; Implants; Japan; Kaplan-Meier Estimate; Lesions; Male; Manufacturing cells; Medicine; Medicine & Public Health; Middle Aged; Myocardial infarction; Myocardial Infarction - etiology; Myocardial Infarction - mortality; Original Article; Patients; Percutaneous Coronary Intervention; Polymers; Polymers - chemistry; Prospective Studies; Prosthesis Design; Randomization; Sirolimus - administration & dosage; Sirolimus - analogs & derivatives; Stenosis; Stents; Surgical implants; Time Factors; Treatment Outcome; Vascular Surgery; Japan; Coronary bifurcation lesions; Randomized study; Biolimus A9-eluting stent; Everolimus-eluting stent; Drug-eluting stent
• ISSN: 0910-8327; 1615-2573
• DOI: 10.1007/s00380-019-01368-3

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.