Interpretation of the Chinese expert consensus on the clinical application of drug-coated balloon(2nd Edition) / 中国介入心脏病学杂志

The Chinese Journal of Interventional Cardiology,Volume 31,Issue 6,published the Chinese expert consensus on the clinical application of drug coated balloon(2nd Edition)in June 2023.The new consensus incorporates the evidence-based medicine evidence of drug-coated balloons in the field of interventional therapy for coronary heart disease in recent years,updating the indications,standardized operations,intracoronary imaging,and the application of coronary functional studies in the treatment of drug-coated balloons.Based on clinical diagnosis and treatment practices and evidence-based medicine evidence,this article interprets the highlights of the new guidelines,aiming to provide references for clinical practice.

Efficacy and Safety Analysis of Drug-coated Balloon in the Treatment of De Novo Coronary Chronic Total Occlusion Lesions / 中国循环杂志

Objectives:To evaluate the efficacy and safety of drug-coated balloon in the treatment of de novo coronary chronic occlusive lesions. Methods:Consecutive patients with de novo coronary chronic occlusive lesions treated with drug-coated balloons only were included in this study.The general information,medical history,and surgical information of the patients were recorded,and major adverse cardiovascular events(MACE,including cardiac death,myocardial infarction,and target vessel revascularization)were recorded by telephone or outpatient follow-up. Results:A total of 160 patients were included.There were 26 ostial lesions(16.3%),42 bifurcated lesions(26.3%),117 diffuse lesions(73.1%),and 87 calcified lesions(54.4%).The reference vessel diameter was(2.3±0.4)mm.During hospitalization,there were no acute myocardial infarction,cardiac death,target lesion revascularization,or acute coronary thrombosis.Cardiac death occurred in 1 case and target vessel revascularization occurred in 6 cases during follow-up.The MACE rate is 4.4%. Conclusions:Drug balloon therapy for de novo coronary chronic occlusive lesions is safe and effective,and the prognosis is satisfactory.

Efficacy on the Acute Lumen Gain Post Excimer Laser Combined With Drug-coated Balloon for Instent Restenosis and the Relationship With Different Neointimal Tissues Defined by Optical Coherence Tomography / 中国循环杂志

Objectives:To compare the efficacy of the combination of excimer laser coronary angioplasty(ELCA)and drug-coated balloon(DCB)for in-stent restenosis(ISR)and to evaluate the impact of neointimal tissue characteristics on treatment outcomes. Methods:A total of 96 ISR lesions from 86 patients who underwent optical coherence tomography(OCT)evaluation and DCB with or without ELCA treatment at The First Medical Center of Chinese PLA General Hospital from January 2019 to May 2023 were retrospectively analyzed.ISR lesions were divided into ELCA+DCB group(n=30)and DCB group(n=66).Additionally,ISR lesions were classified as homogeneous and non-heterogeneous patterns based on the OCT characteristics of the neointimal tissue,and the impact on acute lumen gains was compared between different ISR patterns.Acute lumen gain(ΔMLA)was defined as the changes in minimum lumen area before and after the intervention. Results:The ELCA+DCB group had a significantly greater ΔMLA than the DCB group([3.2±0.8]mm2 vs.[2.6±1.4]mm2,P=0.015).Among the ISR with a homogeneous pattern,the ΔMLA of the ELCA+DCB group was significantly greater than that of the DCB group([3.0±0.9]mm2 vs.[2.2±1.1]mm2,P=0.030).There was no significant difference in ΔMLA between the two ISR groups with the non-homogeneous pattern([3.4±0.7]mm2 vs.[3.2±1.5]mm2,P=0.533).There was no death,the rate of target lesion revascularization was similar between the patients with lesions receiving DCB treatment and patients receiving ELCA +DCB treatment(7.4%vs.4.2%,P＞0.05). Conclusions:The combination of ELCA and DCB is an effective strategy for treating ISR,which can achieve greater acute lumen gain compared to DCB treatment alone,especially for the treatment of homogenous ISR pattern characterized by OCT.

The efficacy and influencing factors analysis of excimer laser combined with drug-coated balloon in the treatment of femoropopliteal arteriosclerosis obliterans / 中华放射学杂志

Objective:To investigate the efficacy of excimer laser atherectomy (ELA) combined with drug-coated balloon (DCB) in the treatment of femoropopliteal arteriosclerosis obliterans (ASO) and its influencing factors.Methods:The clinical data of patients with femoropopliteal ASO treated by ELA combined with DCB from July 2019 to March 2022 were retrospectively analyzed, including technical success rate, ankle-brachial index(ABI), primary patency rate and freedom from target lesion revascularization (TLR) rate. Cox regression was applied to analyze the risk factors affecting the decline in the rate of primary patency and freedom from TLR.Results:All 82 patients were treated with ELA+DCB. The technical success was 91.5%. The post-operative ABI (0.73±0.13) was significantly higher than preoperative ABI (0.39±0.11) ( t=35.26, P<0.001). The 24-month cumulative primary patency and TLR-free rates were 64.1% and 76.8%, respectively. Lesion length>15 cm ( HR=2.57, P=0.047) and severe calcification ( HR=3.26, P=0.021) were associated with loss of primary patency. Having diabetes ( HR=5.24, P=0.010) and a single postoperative outflow tract ( HR=4.18, P=0.008) were associated with a decrease in TLR-free rates. Conclusions:ELA combined with DCB for femoropopliteal ASO is safe and has good intermediate efficacy. Lesion length>15 cm and severe calcification were independent risk factors for primary patency rate, and diabetes and a single postoperative outflow tract were independent risk factors for TLR-free rate.

Rotarex Mechanical Thrombectomy Combined With Drug-coated Balloon for In-stent Restenosis of Femoropopliteal Artery / 中国微创外科杂志

Objective To investigate the efficacy and safety of Rotarex mechanical thrombectomy combined with drug-coated balloon(DCB)dilatation for the treatment of in-stent restenosis(ISR)in femoropopliteal atherosclerotic occlusive disease.Methods A total of 53 patients with in-stent restenosis after stent implantation(9 covered stents and 44 bare stents)from March 2020 to March 2022 were retrospectively analyzed.All the cases were treated with Rotarex mechanical thrombectomy combined with DCB dilatation.Antiplatelet and anticoagulant therapy were used after operation.Results All the 53 patients had successful recanalization of the lower limb arteries.Imaging after Rotarex mechanical thrombectomy combined with DCB dilatation showed 3 cases of residual thrombus in the stent treated with indwelling thrombolytic catheters for thrombolysis,with follow-up angiography showing blood flow recovery,and 5 cases of embolism of the below-knee arteries intraoperatively,including 3 cases at the opening of the tibiofibular trunk artery,which were opened with 6F peripheral thrombus aspiration catheter until unobstructed blood flow,and 2 cases of proximal occlusion of the posterior tibial artery,which were opened with balloon dilatation.Three cases of residual stenosis>30%were treated with remedial stents placement.There were no postoperative complications related to the puncture point,cardiovascular or cerebrovascular accidents,or deaths.The ankle brachial index(ABI)was0.33±0.06 preoperatively and0.84±0.07 postoperatively at the time of discharge(t =-39.443,P<0.001).All the 53 cases completed 3-month follow-ups,52 cases completed 6-month follow-ups,and 49 cases completed 12-month follow-ups.The phaseⅠpatency rates were 100%(53/53)at 3 months,92%(48/52)at 6 months,and 84%(41/49)at12 months,postoperatively.Recurrence of lower limb ischemic symptoms happened in 2 cases,which were given DCB dilatation at 9 and 10 months postoperatively,respectively.The 12-month freedom from clinically-driven target vessel reintervention was 95.9%(47/49).There were 4 deaths(1 case of gastrointestinal hemorrhage,2 cases of COVID-19,and 1 case of unknown cause)and 3 cases of amputation beyond the ankle joint.Conclusion The Rotarex mechanical thrombectomy combined with DCB is safe and effective in treating ISR of the femoropopliteal artery with satisfactory patency and reintervention rates.

Feasibility and safety of excimer laser coronary angioplasty combined with drug-coated balloon for recurrent in-stent restenosis patients / 中国介入心脏病学杂志

Objective To explore the safety and efficacy of combining excimer laser coronary angioplasty with drug-coated balloon in the treatment of recurrent in-stent restenosis(R-ISR).Methods Clinical data from a cohort of 27 patients with a total of 30 R-ISR lesions,who underwent treatment with combined excimer laser coronary angioplasty and drug-coated balloons at our hospital from October 2019 to April 2023,were retrospectively analyzed.Patient baseline information,coronary angiography results,procedural details,and in-hospital complications were collected.Follow-up assessments were conducted at 1,3,and 6 months post-intervention to document major clinical events.Results A total of 27 patients[mean age(66.4±9.8)years]with 30 lesions(100％)achieved procedural and treatment success.There were no cases of acute myocardial infarction,coronary perforation,cardiac tamponade,urgent target lesion revascularization,or death during hospitalization.After 6 months of follow-up,there were no occurrences of acute myocardial infarction or death.Two patients(with a total of two lesions)underwent target lesion revascularization,one patient received repeated drug-balloon dilatation,and one patient underwent coronary artery bypass grafting.Conclusions Excimer laser coronary angioplasty combined with drug-coated balloons is a safe and effective treatment strategy for recurrent in-stent stenosis,but further studies are needed for confirmation.

Efficacy and Safety of Drug Coated Balloon for Coronary de Novo Lesions in Real World / 中国循环杂志

Objectives:To analyze the efficacy and safety of drug coated balloon for coronary de novo lesions in real world. Methods:We enrolled consecutive patients with coronary de novo lesions treated with drug coated balloons from January 2020 to June 2021 in Fuwai Hospital.The baseline data,procedure data and in-hospital cardiac events were collected through case query.All patients were followed up by clinical visit or telephone call.Major adverse cardiac events(MACE)were defined as the composite of the cardiac death,acute myocardial infarction,target lesion revascularization.According to the diameter of the blood vessels,the patients are divided into the large vessel lesion group(vessel diameter≥2.75 mm,n=337),and the small vessel lesion group(vessel diameter<2.75 mm,n=575). Results:There were 940 coronary de novo lesions in 912 patients.A total of 974 drug balloons were used,average diameter was(2.6±0.8)mm,average length was(21.0±6.0)mm,average pressure was(10.0±3.8)atm.Among the 940 primary coronary artery lesions,343 lesions had a diameter≥2.75 mm,and 597 lesions had a diameter<2.75 mm.During hospitalization,two patients with acute ST-segment elevation myocardial infarction died of cardiac rupture after emergency coronary interventional treatment,acute vessel closure because of coronary hematoma occurred in 1 patient and bailout drug-eluting stent was used in this patient,five patients received salvage stent treatment due to type C dissection immediately after drug coated balloon treatment.During follow-up,Target lesion revascularization(TLR)occurred in 15(1.6%)patients(including coronary artery bypass grafting in 1 patient).Nonfatal acute myocardial infarction occurred in 1 patient,cardiac death occurred in 1 patient,2 patients died of cerebral hemorrhage,1 patient died of cerebral infarction,MACE rate was 1.9%(17/912).MACE rate during follow-up was similar between large vessels group and small vessels group(1.8%vs.1.9%,P>0.05). Conclusions:Our study indicates that drug coated balloon for coronary de novo lesion is safe and effective.There is no difference of MACE rate between large vessel group and small vessel group.

Clinical study of drug-coated balloon in the treatment of symptomatic intracranial atherosclerotic stenosis / 中华放射学杂志

Objective:To evaluate the safety and efficacy of drug-coated balloon (DCB) in the treatment of symptomatic intracranial atherosclerotic stenosis.Methods:Forty-nine patients with symptomatic intracranial atherosclerotic stenosis treated with DCB in the People′s Hospital of Zhengzhou University from January 2018 to August 2021 were retrospectively included. The location and number of lesions were as follows: 21 cases of the middle cerebral artery, 11 cases of the intracranial segment of vertebral artery, 12 cases of the basilar artery, and 5 cases of the intracranial segment of internal carotid artery. Pre-dilatation of the lesion with a normal balloon followed by DCB angioplasty. Clinical follow-up (outpatient or telephone) was carried out at 30 days, 3 months, 6 months, and 1 year after the operation. Imaging follow-up was carried out at 6 months postoperatively. The surgical success rate (defined as the proportion of patients with residual stenosis<50% after balloon dilatation), perioperative safety (any strokes, TIA, and deaths within 1 month), stroke recurrence, and restenosis were analyzed.Results:The operation was performed in all patients successfully. The median stenosis level was 80% (75%, 85%) preoperatively and 20% (15%, 30%) at the time after the operation. The success rate of the operation was 91.8% (45/49). Stenting was given in 11 cases (22.4%, 11/49) for severe flow-limiting vascular entrapment, or non-flow-limiting entrapment, owing to the concern of subsequent progression of the entrapment. Three cases (6.1%, 3/49) had significant vascular elastic retraction and implement stent implantation. One patient (2.0%, 1/49) developed symptomatic cerebral infarction during perioperative period, and the symptoms improved after treatment. No fatal or disabling stroke occurred. All patients were followed-up successfully. The median follow-up time was 12 months. Two patients (4.1%, 2/49) had a stroke in the responsible vascular area, and 1 (2.0%, 1/49) patient had a stroke in the non-responsible vascular area. Thirty-eight patients (77.6%, 38/49) had followed-up images. The median follow-up time of postoperative imaging was 6 months. Restenosis occurred in two cases (1 case had symptomatic restenosis), and the incidence of restenosis was 5.3% (2/38).Conclusions:DCB in the treatment of symptomatic intracranial atherosclerotic stenosis has a high technical success rate, good perioperative safety, and low stroke recurrence rate in short-term follow-up, demonstrating the good feasibility, safety, and efficacy of DCB.

Efficacy of chocolate balloon assisted drug-coated balloon angioplasty for the treatment of TASC Ⅱ type C/D femoropopliteal artery lesions / 实用医学杂志

Objective To evaluate the efficacy and safety of chocolate balloon assisted drug-coated balloon(DCB)angioplasty for the treatment of TASC Ⅱ type C/D femoropopliteal artery lesions.Methods The clinical data of 58 patients with TASC Ⅱ type C/D femoropopliteal artery lesions treated with chocolate balloon +DCB or plain balloon+DCB at Fuwai Central China Cardiovascular Hospital from January 2021 to October 2022 were retro-spectively analyzed.A total of 27 cases were assigned to the observation group(chocolate balloon + DCB)and 31 cases tothe control group(plain balloon + DCB).The rate of dissection and the clinical outcomes between the two groups were compared.Results The technical success rates of the observation and control groups were 88.9%and 80.6%,respectively.The rates of dissection,flow-limiting dissection,and bailout stenting were significantly lower in the observation group than of the control group(all P<0.05).Postoperative clinical symptoms of patients in both groups improved significantly compared with the preoperative period.The 12-month cumulative primary patency rate of the observation group was significantly higher than that of the control group(P<0.05).There was no significant difference in the 12-month cumulative freedom from clinically driven-target lesion revascularization rate between the two groups(P>0.05).Conclusion Chocolate balloonassisted DCB angioplasty was safe and effective for TASC Ⅱ type C/D femoropopliteal artery lesions.It reduced the rates of dissection and bailout stenting,and had better near-term outcomes than plain balloon + DCB.

Drug-coated balloon-only strategy for percutaneous coronary intervention of de novo left main coronary artery disease: the importance of proper lesion preparation / 医学前沿

This retrospective single-center registry study included all consecutive patients who underwent percutaneous coronary intervention (PCI) for a de novo left main coronary artery lesion using drug coated-balloon (DCB)-only strategy between August 2011 and December 2018. To best of our knowledge, no previous studies of DCB-only strategy of treating de novo left main coronary artery disease, exist. The primary endpoint was major adverse cardiovascular events (MACEs) including cardiac death, non-fatal myocardial infarction, and target lesion revascularization (TLR). The cohort was divided into two groups depending on weather the lesion preparation was done according to the international consensus group guidelines. Sixty-six patients (mean age 75±8.6, 72% male), 52% of whom had acute coronary syndrome, underwent left main PCI with the DCB-only strategy. No procedural mortality and no acute closures of the treated left main occurred. At 12 months, MACE and TLR occurred in 24% and 6% of the whole cohort, respectively. If the lesion preparation was done according to the guidelines, the MACE and TLR rates were 21.2% and 1.9%. Left main PCI with the DCB only-strategy is safe leading to acceptable MACE and low TLR rates at one year, if the lesion preparation is done according to the guidelines.

Drug-coated balloon in the treatment of coronary bifurcation lesions: A hope or hype?

When compared to non-bifurcation lesions, percutaneous coronary intervention in coronary bifurcation lesions is technically demanding and has historically been limited by lower procedural success rates and inferior clinical results. Following the development of drug-eluting stents, dramatically better results have been demonstrated. In most of the bifurcation lesions, the provisional technique of implanting a single stent in the main branch (MB) remains the default approach. However, some cases require more complex two-stent techniques which carry the risk of side branch (SB) restenosis. The concept of leaving no permanent implant behind is appealing because of the complexity of bifurcation anatomy with significant size mismatch between proximal and distal MB which may drive rates of in-stent restenosis and the potential impact of MB stenting affecting SB coronary flow dynamics. With the perspective of leaving lower metallic burden, a drug-coated balloon (DCB) has been utilized to treat bifurcations in both the MB and SB. The author gives an overview of the existing state of knowledge and prospects for the future for using DCB to treat bifurcation lesions.

Application of drug-coated balloons in percutaneous coronary intervention / 中国基层医药

Percutaneous coronary intervention is the main treatment of coronary heart disease. Both the original bare metal stent and drug-coated stent have the possibility of developing in-stent restenosis, and have poor therapeutic effect on small vessel lesions and bifurcation lesions, which limit their clinical application. In recent years, drug-coated balloons have made considerable progress. They provide a new treatment method for in-stent restenosis, chronic total occlusion, bifurcation lesions and small vessel lesions, and can shorten the duration of dual antiplatelet therapy and reduce the risk of bleeding. This paper reviews the clinical research progress of drug-coated balloon.

Clinical features and treatment in patients with renovascular hypertension caused by renal arterial fibromuscular dysplasia / 中华普通外科杂志

Objective:To analyze the clinical characteristics and treatment of patients with renovascular hypertension (RVH) caused by renal arterial fibromuscular dysplasia (FMD).Methods:Clinical data and treatment result of 38 patients with renal arterial FMD and RVH admitted to our hospital from Jan 2014 to Dec 2020 were reviewed.Results:A total of 38 patients were enrolled in this study. Renal artery CTA showed that 40 renal arteries were involved, among these 6 branches had multifocal stenosis, and 34 branches had focal stenosis. Thity-three patients received surgical treatment, of which 32 patients underwent percutaneous transluminal renal angioplasty (PTRA), and 1 patient with renal aneurysm underwent renal artery stent implantation combined with aneurysm coil embolization. Postoperative blood pressure was significantly lower than that before the operation [(129.79±17.63) mmHg vs. (178.52±28.63) mmHg, t=-11.42, P<0.001]. The mean follow-up time was 35.5 months. Renal artery restenosis occurred in 4 patients and underwent reintervention. Conclusion:For patients with renal arterial FMD and RVH, PTRA is safe and effective, especially for patients with focal lesions, with fair short and mid-term prognosis.

Efficacy of drug-coated balloons in treatment of TASC Ⅱ C/D femoro-popliteal artery de novo stenosis and in-stent restenosis / 中华全科医师杂志

Objective:To evaluate the mid-term clinical efficacy of drug-coated balloons (DCB)in the treatment of femoro-popliteal artery TASC Ⅱ C/D de novo stenosis and in-stent restenosis.Methods:A total of 126 patients with TASC Ⅱ C/D femoro-popliteal artery stenosis treated with DCB in Renji Hospital and Pudong New Area People's Hospital from December 2016 to August 2020 were retrospectively enrolled, including 74 cases of de novo stenosis (de novo group) and 52 cases of in-stent restenosis (ISR group). The clinical data and lesion characteristics were analyzed; the primary patency rate, primary-assisted patency rate, secondary patency rate, and the freedom from target lesion revascularization (f-TLR)rate were evaluated; the perioperative complications, mortality and amputation rate were compared between two groups. Kaplan-Meier method was used to evaluate the patency rate of target vessel lesions, and Cox regression analysis was used to evaluate the relative risk factors.Results:There were 6 patients died in each group during the followup period. The lesion length of the de novo and ISR groups were (21.25±12.64) cm and (34.71±12.02) cm, respectively( t=33.74, P<0.001). The popliteal artery involvement was 33.8% (25/74) in the de novo group and 15.4% (8/52) in the ISR group (χ 2=5.35, P=0.021). The operational success rate was 100.0% in both groups, and the perioperative complication rate was 6.8% (5/74) in the de novo group and 1.9% (1/52) in ISR group. The median follow-up time was 22 month and 17 months; the mean follow-up time were(19.78 ± 11.02) months and (20.02 ± 11.32) months in the de novo group and ISR group, respectively. The primary patency rates at 6, 12 and 24 months after intervention were 89.1%, 73.4%, 50.8% in the Denovo group, and 87.8%, 68.8%, 42.0% in the ISR group, respectively; the primary assisted patency rate was 90.7%, 78.4%, 62.8% in the de novo group, and 89.3%,77.1%, 62.8% in the ISR group, respectively; the secondary patency rate was 95.1%,95.1%, 88.7% in de novo group, and 94.9%, 88.9%, 84.3% in ISR group, respectively; the f-TLR rate was 97.3%, 88.6%, 79.2% in de novo group, and 90.0%, 77.7%, 74.7% in ISR group, respectively (all P>0.05). Cox regression analysis showed that P2 and P3 segment involvement of the popliteal artery were independent factors affecting the patency rate of target lesion. Conclusions:The mid-term clinical efficacy of DCB in the treatment of TASC Ⅱ C/D femoro-popliteal artery de novo stenosis and in-stent restenosis is satisfactory.

Comparing plain old balloon and drug-coated balloon supported bare metal stents in the treatment of femoral-popliteal TASC D lesions / 中华普通外科杂志

Objective:To compare the efficacy between drug-coated balloon (DCB) combined with bare metal stenting (BMS) and plain old balloon angioplasty (POBA) with BMS placement in the treatment of femoral-popliteal TASC D lesions.Methods:According to the Trans-Atlantic Inter-Society Consensus (TASC) D grade femoral-popliteal lesions as the standard, we enrolled 115 cases (120 limbs) receiving DCB combined with BMS (group DCB, 37 limbs in 36 cases) and POBA combined with BMS (group POBA, 83 limbs in 79 cases) from Jan 2017 to Mar 2020 to observe patency rate, freedom from clinical-drived target lesion reintervention rate (FCD-TLR) and complications.Results:The mean follow-up time was 18.1 months and the average occlusion length was (29.1±6.5)mm. In group DCB vs group POBA, the primary patency rates at 3-month, 9-month, 1-year and 2-year were 89.2% vs. 86.7%, 86.4% vs. 76.9%, 66.8% vs. 70.9% and 63.1% vs. 56.9%, respectively ( P=0.73); FCD-TLRs were 100.0% vs. 95.1%, 94.3% vs. 82.3% , 78.5% vs. 80.6% and 74.1% vs. 68.9% ( P=0.69), respectively. Conclusion:The benefit of DCB combined with BMS over POBA combined with BMS in improving the early primary patency rate and reducing FCD-TLR was not definite.

Paclitaxel coated balloon in the treatment of femoral popliteal artery disease / 中华普通外科杂志

Objective:To summarize the clinical efficiency of paclitaxel drug coated balloon (DCB) in femoral popliteal artery disease.Methods:Retrospective analysis was made on 125 patients (141 limbs) admitted from Jun 2016 to Jul 2019 for femoral popliteal disease treated with DCB.Results:Median follow-up time was 19 months. The average lesion length was (138±78) mm, with an overall cumulative primary patency rate of 81.4% and 60.8% at 12 and 24 months postoperatively and f-TLR rates of 90.1% and 83.0%, respectively. In a total of 109 primary lesions, subgroup analysis showed that among the TASC C/D primary lesions, the primary patency rate was significantly lower in those with combined severe calcification and the f-TLR rate in those with popliteal involved lesions. TASC grade C/D lesions, severe calcified lesions were independent risk factors for patency, while hypertension was an independent protective factor.In-stent restenosis (ISR) target lesions involving the popliteal segment had a significantly worse prognosis than ISR of the superficial femoral artery.Conclusion:DCB in the treatment of lower femoral popliteal artery lesions can achieve a satisfactory medium-term patency outcome, while the efficacy for complex lesions still needs further improvement.

Comparison of standard balloon and drug-coated balloon angioplasty in patients with the below-the-knee peripheral artery disease

SUMMARY OBJECTIVE: The objective of this study was to compare the interventions of percutaneous transluminal drug-coated balloon angioplasty (DCB PTA) and standard PTA in the treatment of patients with the below-the-knee peripheral artery disease (BTK PAD). METHODS: Overall, 196 patients (113 males and 83 females; mean age: 63.56±11.94 years; 45-83 years) were treated with PTA for BTK PAD between June 2014 and March 2019. RESULT: Standard PTA (group 1; 96 patients) and DCB PTA (group 2; 100 patients) results were analyzed and compared retrospectively. No statistically significant difference was found between the mean ages of group 1 and 2 patients (p=0.371, p>0.05). Demographic and clinical data were compared and no any statistically significant differences was found between the two groups. Comparing in terms of the iliac lesion, there was no statistically significant difference between the two groups. However, a statistically significant difference was found between the two groups in terms of frequency of popliteal lesions (p=0.001; p<0.05). There was not a statistically significant difference between the two groups in terms of other lesions. In addition, limb salvage rates were 82.0% (18 amputations) and 65.6% (33 amputations) in the drug-release balloon group and the naked balloon group, at the end of 1 year, respectively. No distal embolism, limb-threatening ischemia, and mortality were observed in any patients. CONCLUSIONS: Based on this study, patients in the DCB group had significantly higher rates of primary patency as compared with the other patients.

Short-term efficacy of paclitaxel -coated balloon in the treatment of femoropopliteal artery disease / 中华普通外科杂志

Objective:To evaluate the efficacy and safety of drug-coated balloon (DCB) with paclitaxel in the treatment of femoropopliteal arteriosclerosis obliterans (ASO).Methods:From Dec 2016 to Dec 2018, clinical data of femoropopliteal artery disease patients treated with paclitaxel DCB in Renji Hospital, School of Medicine, Shanghai Jiaotong University were retrospectively analyzed.Results:A total of 83 patients (95 lower limbs) underwent DCB therapy. Including 50 chronic total occlusion (CTO) lesions (52.6%) with mean lesion length of (18.35±10.61) cm. Twenty-four lesions (25.3%) were moderately or severely calcified. Bail-out stent implantation was performed in 29.5% cases. The mean follow-up time was 17.5 months. Twelve months after intervention, the all-cause mortality rate was 6.0%, the major amputation rate was 4.3%, the primary patency rate was 60.6%, the primary assisted patency rate was 72.4%, the secondary patency rate was 83.4%, and the freedom rate from clinically-driven target lesion revascularization(F-TLR) was 77.0%. Moderate to severe calcification was an independent risk factor for the primary patency of DCB therapy.Conclusion:DCB is a safe and effective endovascular therapy for femoropopliteal artery disease.

Safety of drug-coated balloon versus drug-eluting stents in the treatment of type 2 diabetes mellitus complicated by coronary artery small vessel disease in older adult patients / 中国组织工程研究

BACKGROUND: It has been found that drug-coated balloons can reduce the loss of lumen in the advanced stage of coronary small-vessel disease, and the incidence of major adverse cardiovascular events at 6 months after surgery with drug-coated balloons is similar to that of drug-eluting stents. However, clinical studies on the efficacy of drug-eluting stents in older adult patients with type 2 diabetes mellitus complicated by coronary artery small vessel disease are still lacking. OBJECTIVE: To investigate the efficacy and safety of drug-coated balloon versus drug-eluting stent in the treatment of type 2 diabetes mellitus complicated by coronary artery small vessel disease in older adult patients. METHODS: A total of 122 older adult patients with type 2 diabetes mellitus complicated by coronary artery small vessel disease who received treatment in Jiaozuo People’s Hospital between January 2016 and September 2018 were included in this study. These patients were randomly divided into a drug-eluting stent group (n=62) and a drug-coated balloon group (n=60). Patients in both groups underwent coronary artery predilation with a semi-compliant balloon, followed by implantation of corresponding stents. Selective quantitative coronary angiography was performed before surgery, immediately, 6 months and 12 months after surgery. The minimum lumen diameter, residual stenosis, lumen increase and late lumen loss of target lesions were observed in the two groups. At 6 and 12 months after surgery, major adverse cardiovascular events and bleeding events were followed up. This study was approved by the Medical Ethics Committee of Jiaozuo People’s Hospital, China (approval No. 201503). RESULTS AND CONCLUSION: (1) The success rate of surgery in the drug-coated balloon group was significantly higher than that in the drug-eluting group (P=0.028). (2) Immediately after surgery, the minimum lumen diameter and lumen increase in the drug-coated balloon group were less than those in the drug-eluting stent group (both P < 0.01). The residual stenosis in the drug-coated balloon group was significantly greater than that in the drug-eluting stent group (P < 0.01). (3) At 6 months after surgery, late lumen loss of target vessels in the drug-coated balloon group was smaller than that in the drug-eluting stent group (P < 0.001). The rates of target vessel revascularization and major adverse cardiovascular events in the drug-coated balloon group were lower than those in the drug-eluting stent group (P=0.028, 0.010). (4) At 12 months after surgery, the minimum lumen diameter in the drug-coated balloon group was larger than that in the drug-eluting stent group (P=0.033). The residual stenosis and late lumen loss in the drug-coated balloon group were lower than those in the drug-eluting stent group (P=0.008, 0.002, 0.019). (5) These results suggest that drug-coated balloon for treatment of type 2 diabetes mellitus complicated by coronary artery small vessel disease is simple and easy to operate, with a high surgical success rate. Drug-coated balloon can reduce residual stenosis degree and late lumen loss, decrease the revascularization rate of target vessels, and reduce the incidences of major adverse cardiovascular disease and bleeding events. The clinical prognosis of drug-coated balloon is superior to that of drug-eluting stent.

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

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.