| Background and objective: Percutaneous coronary intervention(PCI)has become the main treatment for coronary heart disease,With the continuous improvement of interventional devices and interventional techniques,the indications of modern PCI treatment become wider and wider.Many types of lesions can now be safely treated,but it is considered difficult to treat and may even be contraindicated in the past.However,the interventional treatment of bifurcation lesions is still challenging,and the therapeutic effect is still not ideal.Drug-coated balloon(DCB)as a new technology in recent years has brought a new concept of interventional therapy for coronary heart disease.Its application in small vessel lesions and bifurcation lesions in effect previews advantage,However,there are relatively few clinical studies,and most of them are small sample size,and the clinical evidence needs to be further strengthened.In this paper,a randomized controlled clinical trial was conducted in our hospital to compare the effectiveness of the drug-coated balloon and normal balloon in the treatment of coronary bifurcation lesions,objective to evaluate the safety and efficacy of drug-coated balloon in the treatment of bifurcation lesions by comparative analysis.To accumulate more clinical evidences for the application of DCB in bifurcation lesions and small vessel lesions,also to explore a more concise and effective method for interventional treatment of bifurcation lesions.Methods: From March 2015 to December 2015,40 patients in No.1 Hospital of Jilin University were selected,they were diagnosed as coronary heart disease and the coronary angiography confirmed true bifurcation lesions,the operation method is to use a single stent implantation,drug-eluting stents implanted only in the main branch,the side branch does not consider the stent implantation,only take a kissing expansion with main branch.The patients were randomly divided into experimental group and control group with 20 cases in each group,the side branches were treated with the drug-coated balloon and the normal balloon expanded by 60 S,then take a kissing expansion with main branch.Coronary angiography follow-up was performed 270±30 days after operation.Basic clinical data and PCI related data of two groups were collected to make a baseline data comparison.Quantitative coronary angiography(QCA)was used to statistically analyze the difference of the degree of stenosis in the follow-up and immediately after operation of the side branch target blood vessels.Results: 1.Quantitative data comparison: The baseline data of age,operation time,preoperative MV diameter,preoperative MV stenosis,preoperative SB diameter,preoperative SB stenosis,MV/SB angle,immediate postoperative SB stenosis of two groups were compared.The difference was not statistically significant(P > 0.05).The degree of SB stenosis during postoperative review,experimental group 20(20.00-30.00)VS control group of 35(22.5.-50.00),the difference was statistically significant between the two groups(P=0.009);2.Qualitative data comparison: The baseline data of gender,smoking history,hypertension,diabetes,hyperlipidemia,Stenosis site,bifurcation lesion type of two groups were compared.The difference was not statistically significant(P > 0.05);3.Qualitative data comparison about degree of SB stenosis during postoperative review: The changes of SB stenosis during postoperative review and immediate postoperative SB stenosis were converted into qualitative data.The situation was defined as "progress" when the degree of SB stenosis during postoperative review heavier than before.The situation was defined as " maintain" when the degree of SB stenosis during postoperative review basically the same as before.The situation was defined as " improve" when the degree of SB stenosis during postoperative review lighter than before.The difference between the three groups was statistically significant(P=0.001).Three groups were compared pairwise,"progress" VS "maintain" and "progress" VS "improve",the difference was statistically significant(P < 0.016)."maintain" VS "improve",the difference was not statistically significant(P > 0.016);Conclusion: 1.Kissing expansion after single-stent implantation is a simple,feasible and successful coronary interventional therapy,can be routinely applied to coronary bifurcation lesions;2.The bifurcation lesions were treated with kissing expansion after single-stent implantation,the clinical effect of the drug-coated balloon in side branch was better than normal balloon.Helps to reduce the restenosis rate of side branch;3.The bifurcation lesions were treated with kissing expansion after single-stent implantation,drug-eluting stent combined with drug-coated balloon seems to be a more effective method;... |
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