Study On The Effectiveness,safety And Clinical Prognosis Of Drug-coated Balloons In The Treatment Of True Bifurcation Lesions

Objective:To investigate the effectiveness and safety of drug-coated balloon treatment for true bifurcation lesions by comparing the clinical prognosis of true bifurcation lesions under different procedures.Methods:A total of 151 patients diagnosed with true bifurcation lesions after coronary angiographic analysis at our hospital from March 2019 to June 2021 were selected.Based on the PCI procedure received by the enrolled patients,the patients were divided into jailed-balloon technique group(43 patients);Modified jailed-balloon technique group(43patients);and main branch drug stent [DES] + branch drug-coated balloon [DCB] group(45patients)for treatment.Remedial T-stent group(20 patients).Baseline information such as demographic characteristics and laboratory tests of the enrolled patients was collected;data related to PCI treatment;values of reference vessel diameter(RVD),minimum lumen diameter(MLD),diameter stenosis(DS),and immediate lumen acquisition of the diseased vessels were measured before and after the PCI procedure and at the 6-month post-procedure follow-up of the patients;and all enrolled patients were followed up in an outpatient clinic or by telephone within 12 months after the procedure,with the main The endpoint was major adverse cardiovascular events(MACE)at 12 months post-operatively.The secondary endpoint was late branch vessel lumen loss(LLL)at 6 months.Results:(1)The results of the baseline data in the jailed-balloon technique group,modified jailed-balloon technique group and main branch DES + branch DCB group were not statistically different between the groups(p > 0.05).There was no statistical difference in the results between the PCI-related data of the three groups(P > 0.05).(2)There were no statistical differences in outcomes between the jailed-balloon technique group,the Modified jailed-balloon technique group and the main branch DES +branch DCB group before and after the procedure and at 6-month follow-up between the reference vessel diameter and minimum lumen diameter of the main branch vessels,the diameter stenosis rate and immediate scale lumen acquisition and late lumen loss(P>0.05).There was no statistical difference between the branch vessel reference vessel diameter,minimum lumen diameter,diameter stenosis rate and immediate scale lumen acquisition before and after surgery in the three groups(P > 0.05).At the 6-month postoperative follow-up,there was no statistical difference in the reference vessel diameter results for the three groups of branch vessels(P > 0.05).There were no statistical differences in the minimum lumen diameter,diameter stenosis rate,or late lumen loss results between the jailed-balloon technique group and the modified jailed-balloon technique group(P > 0.05).Compared with the remaining two groups,the main branch DES + branch DCB group had lower diameter stenosis rate,late lumen loss,and the minimum lumen diameter in the main branch DES + branch DCB group,was higher than the remaining two groups,with statistically significant results(P < 0.05).Compared to the main branch DES + branch normal balloon group(jailed-balloon technique and Modified jailed-balloon technique),the branch vessels in the main branch DES + branch DCB group had lower DS,LLL and higher MLD at follow-up,with statistically significant results(p < 0.05).(3)During clinical follow-up at 12 months after surgery,the incidence of MACE in the three groups was: 16.3% in the active balloon detainment group;18.6% in the passive balloon detainment group;and 4.4% in the main branch DES + branch DCB group.There was no statistical difference in the results of the three groups(P > 0.05).In contrast,the incidence of MACE in the normal balloon group(jailed-balloon technique and Modified jailed-balloon technique)was 17.4%.The main branch DES + branch DCB procedure had a lower incidence of MACE compared to the normal balloon group [jailed-balloon technique and Modified jailed-balloon technique],and the results were statistically significant(P < 0.05).(4)There was no statistical difference between the remedial T-stent group and the main branch DES + branch DCB group in terms of baseline information and PCI-related data(p >0.05).(5)The remedial T-stent group had higher postoperative minimum lumen diameter and immediate lumen acquisition in the branch vessels than the main branch DES+branch DCB and lower postoperative diameter stenosis rates than the main branch DES+branch DCB,with statistically significant results(P < 0.05).In contrast,there was no statistical difference in the minimum lumen diameter,diameter stenosis rate,and late lumen loss results between the two reference vessel diameters during postoperative follow-up(P > 0.05).(6)After 12 months postoperatively,a total of 1(5%)patient who received a remedial T-stent developed MACE.when compared with the main branch DES + branch DCB procedure(incidence 4.4%),the difference in the incidence of MACE between the two groups was not statistically significant(P > 0.05).Conclusions:(1)Drug-coated balloons for bifurcation lesions have a better clinical prognosis than plain balloons.(2)When treating bifurcation lesions with a drug stent in the main branch vessel and a balloon to protect the side branch vessel,a good clinical prognosis was achieved with a drug-coated balloon.(3)When PCI of bifurcation lesions is performed using the common balloon detaining technique,the modified jailed-balloon technique and jailed-balloon technique have the same clinical prognostic outcome in the short term.(4)The remedial T-stent group may have the same safety and efficacy in the short term as the main branch drug stent + side branch drug balloon,this result needs to be verified in more quality trials.