1. Department of Medicine, Division of Cardiology, Teikyo University School of Medicine, Tokyo, Japan; 2. Department of Cardiology, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan; 3. Department of Cardiology, Saiseikai Yokohama City Eastern Hospital, Yokohama, Japan; 4. Department of Cardiology, Toyohashi Heart Center, Toyohashi, Japan; 5. Department of Cardiology, Gifu Heart Center, Gifu, Japan; 6. Department of Cardiology, Yokohama Rosai Hospital, Yokohama, Japan; 7. Department of Cardiology, Ageo Central General Hospital, Ageo, Japan; 8. Department of Cardiology, Kobe University Graduate School of Medicine, Kobe, Japan; 9. Department of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan; 10. Department of Cardiology, Tokai University School of Medicine, Isehara, Japan; 11. Department of Cardiology, Japanese Red Cross Ashikaga Hospital, Ashikaga, Japan; 12. Department of Cardiology, Nagoya Heart Center, Nagoya, Japan; 13. Department of Cardiology, Osaka Saiseikai Nakatsu Hospital, Osaka, Japan; 14. Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine, Ube, Japan; 15. Department of Cardiology, Ogaki Municipal Hospital, Ogaki, Japan; 16. Department of Biostatistics, Division of Health Sciences and Nursing, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; 17. Department of Cardiology, Ramsay Générale de Santé, Institut Cardiovasculaire Paris Sud, Hopital Privé Jacques Cartier, Massy, France; 18. Division of Cardiology, Teikyo University Mizonokuchi Hospital, Kawasaki, Japan
Background: Clinical implications of the proximal optimisation technique (POT) for bifurcation lesions have not been investigated in a randomised controlled trial.
Aims: This study aimed to investigate whether POT is superior in terms of stent apposition compared with the conventional kissing balloon technique (KBT) in real-life bifurcation lesions using optical coherence tomography (OCT).
Methods: A total of 120 patients from 15 centres were randomised into two groups - POT followed by side branch dilation or KBT. Finally, 57 and 58 patients in the POT and KBT groups, respectively, were analysed. OCT was performed at baseline, immediately after wire recrossing to the side branch, and at the final procedure.
Results: The primary endpoint was the rate of malapposed struts assessed by the final OCT. The rate of malapposed struts did not differ between the POT and KBT groups (in-stent proximal site: 10.4% vs 7.7%, p=0.33; bifurcation core: 1.4% vs 1.1%, p=0.67; core’s distal edge: 6.2% vs 5.3%, p=0.59). More additional treatments were required among the POT group (40.4% vs 6.9%, p<0.01). At one-year follow-up, only one patient in each group underwent target lesion revascularisation (2.0% vs 1.9%).
Conclusions: POT followed by side branch dilation did not show any advantages over conventional KBT in terms of stent apposition; however, excellent midterm clinical outcomes were observed in both strategies.