Intravascular Ultrasound vs Angiography-Guided Drug-Coated Balloon Angioplasty: The ULTIMATE â ¢ Trial.

BACKGROUND: Drug-coated balloon (DCB) angioplasty seems a safe and effective option for specific de novo coronary lesions. However, the beneficial effect of intravascular ultrasound (IVUS)-guided DCB angioplasty in de novo lesions remains uncertain. OBJECTIVES: This study aimed to assess the benefits of IVUS guidance over angiography guidance during DCB angioplasty in de novo coronary lesions. METHODS: A total of 260 patients with high bleeding risk who had a de novo coronary lesion (reference vessel diameter 2.0-4.0 mm, and lesion length ≤15 mm) were randomly assigned to either an IVUS-guided or an angioplasty-guided DCB angioplasty group. The primary endpoint was in-segment late lumen loss (LLL) at 7 months after procedure. The secondary endpoint was target vessel failure at 6 months. RESULTS: A total of 2 patients in the angiography-guided group and 7 patients in the IVUS-guided group underwent bailout stent implantation (P = 0.172). The primary endpoint of 7-month LLL was 0.03 ± 0.52 mm with angiography guidance vs -0.10 ± 0.34 mm with IVUS guidance (mean difference 0.14 mm; 95% CI: 0.02-0.26; P = 0.025). IVUS guidance was also associated with a larger 7-month minimal lumen diameter (2.06 ± 0.62 mm vs 1.75 ± 0.63 mm; P < 0.001) and a smaller diameter stenosis (28.15% ± 13.88% vs 35.83% ± 17.69%; P = 0.001) compared with angiography guidance. Five target vessel failures occurred at 6 months, with 4 (3.1%) in the angiography-guided group and 1 (0.8%) in the IVUS-guided group (P = 0.370). CONCLUSIONS: This study demonstrated that IVUS-guided DCB angioplasty is associated with a lower LLL in patients with a de novo coronary lesion compared with angiography guidance. (Intravascular Ultrasound Versus Angiography Guided Drug-Coated Balloon [ULTIMATE-III]; NCT04255043).

Difference in one-year late lumen loss between high- and low-dose paclitaxel-coated balloons for femoropopliteal disease.

The objective of the study is to investigate the difference in 1-year late lumen loss (LLL) between the high- (IN.PACT Admiral) and low-dose (Lutonix) paclitaxel-coated balloon (PCB). Although a recent randomized clinical trial demonstrated no difference in efficacy endpoint between high- and low-dose PCB, it remains unclear whether high-dose PCB was superior to low-dose PCB in actual clinical practice. We enrolled 64 patients with 67 de novo femoropopliteal lesions who underwent PCB angioplasty at Kokura Memorial Hospital from May 2014 to March 2020 and subsequent follow-up angiography after 1 year. The primary endpoint was 1-year LLL, whereas the secondary endpoints were binary restenosis and clinically driven target lesion revascularization (CD-TLR) after 1 year. The high- and low-dose PCB groups had 45 and 22 lesions, respectively. Although the low-dose PCB group had higher rates of coronary artery disease, hemodialysis, and chronic limb-threatening ischemia than the high-dose PCB group, the latter had a longer lesion length and more lesions with a TASC classification C or D than the former. The high-dose PCB group had a significantly lower LLL than the low-dose PCB group (0.40 ± 1.05 vs. 1.19 ± 1.03 mm; P = 0.003, respectively). Moreover, the high-dose PCB group had significantly lower rates of binary restenosis at 1 year than the low-dose PCB group (22.2% vs. 50.0%; P = 0.02, respectively). Moreover, negative LLL was only observed in the high-dose PCB group (33.3% vs. 0%, P = 0.005). The high-dose PCB group had a significantly lower LLL than the low-dose PCB group.

Comparison of clinical effects of different protocols for drug-in stent restenosis after percutaneous coronary intervention / 中国基层医药

Objective To compare the clinical effect of three methods of treatment for the in-stent restenosis(ISR)after percutaneous coronary intervention(PCI),drug coated balloon(DCB)compared with common balloon and drug eluting stent(DES).Methods From August 2014 to January 2018,95 cases of ISR in the Second Affiliated Hospital of Southeast University were diagnosed by coronary angiography.They were treated with common balloon,DCB or second generation DES.The patients were assigned to the DCB group 25 cases or the second-generation DES group(23 cases)and balloon group(47 cases)according to the therapeutic strategies they accepted.Major adverse cardiac events(MACE)of patients were followed by telephone or hospital visit at 6-12 months.MACE was defined as a composite of cardiac death,nonfatal myocardial infarction(MI),and target vessel revascularization(TVR).Results In summary,95 patients with DES-ISR were enrolled,including 47 patients in the balloon group,23 patients in the DCB group and 25 patients in the second-generation DES group.Coronary angiography was performed 6-12 months after operation.The minimum lumen diameter(MLD)of the DCB group was significantly larger than those of the balloon and DES groups[(1.86 ±0.27)mm vs.(2.16 ±0.43)mm,t =3.57,P =0.00;(1.94 ±0.31)mm vs.(2.16 ± 0.43)mm,t=2.05,P=0.05].The restenosis rate of the DCB group was significantly lower than those of the balloon group and DES group[15 cases(31.91％)vs.2 cases(8.69％),χ2 =4.53,P=0.02;8 cases(32.00％)vs.2 cases(8.69％),χ2 =2.66,P=0.05].The rate of late lumen loss(LLL)in the DCB group was significantly lower than those of balloon group and DES group [(0.67 ±0.28)mm vs.(0.21 ±0.18)mm,t =7.17,P =0.00;(0.43 ± 0.28)mm vs.(0.21 ±0.18)mm,t=3.21,P=0.00].MACE was significantly lower than balloon group and DES group[16 cases(34.04％)vs.1 cases(4.76％),χ2 =7.02,P=0.01;8 cases(32.00％)vs.1 cases(4.76％),χ2 =4.06,P=0.02].Conclusion Drug balloon dilatation in stent restenosis is more effective and safer than common balloon dilatation and re-implantation of drug eluting stents.

Efficacy of 150 mg clopidogrel and triple antiplatelet in patients with acute anterior myocardial infarction undergoing PCI / 中国生化药物杂志

Objective To observe the efficacy and safety of 150 mg clopidogrel and triple antiplatelet in acute anterior myocardial infarction ( AMI) patients undergoing percutaneous coronary intervention ( PCI).Methods Totally 50 patients who had been diagnosed as acute anterior myocardial infarction and prepared to PCI treatment were randomly divided into two groups:150 mg clopidogrel group ( asprin 100 mg/d qd+clopidogrel 150 mg/d qd) and triple antiplatelet group ( cilostazol 100 mg bid+asprin 100 mg/d qd+clopidogrel 75 mg/d qd).The coronary lession through CAG, incidence of major cardiovascular events and safety in 6 months were observed and assessed.ResuIts There was no significant difference in level of target lesion diameter between two groups after PCI instantly (2.75 ±0.29 mm vs.2.69 ±0.31 mm).There were no significant differences of late lumen loss (LLL) and target lesion revascularization (TLR) between triple antiplatelet group and 150 mg clopidogrel group (0.22 ±0.46 mm vs.0.38 ±0.65 mm; 8%vs.24%) , but the two indexes were improved in a certain extent.There were no significant differences in hemorrhage and major adverse cardiovascular events ( MACE) between two groups.ConcIusion The triple antiplatelet therapy could reduce the late lumen loss and target lesion revascularization, and not increase hemorrhage and adverse cardiovascular events.