Clinical Study Of Drug-eluting Balloon Under The Guidance Of Intravascular Ultrasound In The Treatment Of Coronary Artery In-situ Primary Large Vessel Lesion

Objective: To compare and analyze under the guidance of Intravascular ultrasound the clinical effects of Drug eluting ballon(DEB)and Drug eluting stent(DES)in the treatment of coronary artery in-situ primary large vessel lesion.Methods:The prospective,randomized and controlled study included 110 consecutive patients with primary macroangiopathy of coronary(vessel diameter≥2.75mm),who underwent coronary intervention in our hospital.All patients were randomly divided into DEB group(n=55)and DES group(n=55).The basic clinical data,the results of immediate coronary intervention and re-examination of angiography,and major adverse cardiovascular events after procedure under the guidance of Intravascular ultrasound were compared between the 2 groups.Results:1.There were no significant differences in the basic clinical data between the two groups(P>0.05);2.There were no statistical differences in the minimal lumen diameter(MLD)between the DEB group and the DES group at pre-operation and post-operation period [before operation(1.96±0.20)mm vs.(2.01±0.14)mm,P=0.190;Immediately after the operation(2.72±0.13)mm vs.(2.78±0.17)mm,P=0.055].The DES group had various degrees of target lesion lumen loss at 9 months after the operation,while the blood vessel diameter in the DEB group had slightly increased[MLD(2.83±0.14)mm vs.(2.69±0.16)mm,P<0.001;LLL(-0.11±0.07)mm vs.(0.09±0.08)mm,P<0.001];3.Under the guidance of IVUS,there were no significant differences in the minimum lumen area(MLA)between the DEB group and the DES group before and after operation immediately(P<0.05),MLA in DEB group was greater than DES group at 9-month follow-up(P<0.05).There were no significant differences in plaque burden between the DEB group and the DES group at pre-operative,post-operative and 9-month follow-up period(P>0.05);4.There were no significant differences in the incidence of MACE between the DEB group and the DES group(3.6% vs.7.3%,P=0.401),but the bleeding events in the DEB group was significantly less than that in the DES group(21.8% vs.5.4%,P=0.012).Conclusions:1.Drug-eluting balloon is safe and effective in the treatment of primary macroangiopathy of coronary artery and seems to be superior than DES in late lumen loss.2.Drug-eluting balloon is suitable for the elderly with high bleeding risk and patients who are unable to tolerate sustain dual anti-platelet therapy.