Efficacy of cutting balloon versus semi-compliant balloon for predilation of coronary bifurcation lesions / 中国组织工程研究

ABSTRACT

BACKGROUND: There is no efficient and unified optimal scheme for treating coronary bifurcation diseases. Simple strategies such as drug-eluting stent implantation in the main branch and drug-coated balloon dilation in the sub-branches are mostly adopted. However, direct drug-coated balloon dilation cannot overcome the problem of elastic retraction of vascular wall, and there is still a risk of branch loss in the long term. OBJECTIVE: To investigate the efficacy and safety of a cutting balloon versus a semi-compliant balloon for predilation of coronary bifurcation lesions. METHODS: From August 2016 to May 2018, 110 patients with coronary bifurcation lesions admitted at Jiaozuo People’s Hospital were selected, including 83 males and 27 females, aged 18-88 years. The patients were randomized into observation and control groups (n=55/group) and received percutaneous coronary intervention. The main branch in the observation group was predilated by a cutting balloon prior to drug-eluting stent implantation, and the sub-branches were predilated by a cutting balloon prior to drug-coated balloon dilation. The main branch in the control group was predilated by a semi-compliant balloon prior to drug-eluting stent implantation, and the sub-branches were predilated by a semi-compliant balloon prior to drug-coated balloon dilation. Immediate postoperative angiography was performed to determine the forward blood flow TIMI grading of main branches and sub-branches and whether vascular dissection occurred. Coronary angiography quantitative analysis was used to detect the reference diameter, minimum inner diameter and stenosis degree of main and sub-branches before, immediately, 6 and 12 months after surgery. Major cardiovascular adverse events within 12 months after surgery were recorded in both groups. The study was approved by the Ethics Committee of Jiaozuo People’s Hospital. RESULTS AND CONCLUSION: (1) Immediate postoperative angiography showed that the TIMI level 3 rate of the main branches and sub-branches in the observation group was higher than that in the control group (P=0.007, 0.015), the incidence of vascular dissection was lower than that in the control group (P=0.023, 0.012), and the emergency target vessel reconstruction rate was lower than that in the control group (P=0.006, 0.026). (2) The success rate of coronary artery maintenance immediately and at 6 and 12 months after surgery in the observation group was higher than that in the control group (all P < 0.001). (3) The minimum inner diameter of main branches and sub-branches in the observation group was larger than that in the control group immediately and at 6 and 12 months after surgery (all P < 0.01). The degree of inner diameter stenosis was smaller than that in the control group (all P < 0.01). (4) The target vessel restenosis rate of main branch and sub-branches in the observation group was lower than that in the control group within 12 months after surgery (P=0.038, 0.043). The incidence of major cardiovascular adverse events was lower than that in the control group (P=0.025). (5) These results indicate that in coronary bifurcation lesions, drug-eluting stent implantation is suitable for main branch lesions and drug coated balloon is suitable for sub-branch lesion. Cutting balloon predilation is safer and more effective than semi-compliant balloon predilation. Cutting balloon predilation can also reduce the rate of target restenosis and the incidence of major cardiovascular adverse events.