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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.
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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.
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Humans , Male , Aged , Aged, 80 and over , Female , Coronary Artery Disease/therapy , Percutaneous Coronary Intervention , Angioplasty, Balloon, Coronary/adverse effects , Retrospective Studies , Treatment OutcomeABSTRACT
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.
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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.
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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.
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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.
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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.
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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.
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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.
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Humans , Male , Female , Aged , Angioplasty, Balloon/methods , Peripheral Arterial Disease/therapy , Popliteal Artery , Prospective Studies , Retrospective Studies , Treatment Outcome , Coated Materials, Biocompatible , Femoral Artery , Middle AgedABSTRACT
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.
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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.
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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.
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Objective: To compare the safety profile, angiographic and clinical outcomes between drug-coated balloon(DCB) only strategy versus drug eluting stent(DES) implantation in primary percutaneous coronary intervention(PCI) for acute myocardial infarction(AMI) patients. Methods: A total of 380 AMI patients who underwent primary PCI in Beijing Chaoyang Hospital from January 2016 to May 2019 were enrolled. They were allocated into DEB group(n=180) or DES group(n=200). The Primary endpoint was the major adverse cardiac events(MACE) in hospital and within 3 months after discharge, the composite event of cardiac death, non-fatal myocardial infarction(MI), target vessel revascularization(TVR) and in stent thrombosis. The secondary endpoints included: (1)TIMI blood flow grade and myocardial perfusion grade (TMP grade) of infarct-related vessels before and after PCI. (2)The degree of ST segment resolution(STR) between half hour and two hours after PCI, and STR was represented by percentage of summed ST-segment reduction between baseline and post-PCI. Using the most significant lead of ST segment elevation, calculating the rate of decline in the ST segment after treatment; or the most significant lead of the ST segment depression, to calculate the rate of recovery in the ST segment after treatment. STR<50% was defined as incomplete STR. (3)The occurrence of coronary artery dissection during operation. (4)The peak value of myocardial enzymes. (5)The incidence of bleeding in hospital and within 3 months after discharge. The inverse probability weighting method based on propensity score (IPTW) was used to compare the effects of the two treatments on MACE occurrence in the logistic regression model. Results: There was no significant difference in sex, age, risk factors of coronary heart disease, type and site of AMI, interventional therapy data(P>0.05) between the two groups. The ratio of bifurcation lesions in DCB group was significantly higher than that in DES group, and the diameter of the DCB was smaller while the length was longer than that of DES (all P<0.05). One death occurred in each group during hospitalization. Compared with the DES group, the incidence of MI ［2.8%(5/180) vs. 0.5% (1/200), P=0.10］ and TVR ［2.8%(5/180) vs. 0.5%(1/200), P=0.10］ in the DCB group during hospitalization showed an increasing trend, and were mostly associated with delayed coronary dissection. The incidence of MACE was similar between the two groups (3.3%(6/180) and 1.0%(2/200), P=0.15) during hospitalization. There was no MACE occurred in the two groups within 3 months after discharge. There was no significant difference between the two groups in TIMI grade, TMP grade, incomplete STR rate and peak value of myocardial enzyme (all P>0.05). The incidence of coronary artery dissection was significantly higher in DCB group than in DES group (8.3%(15/180) and 3.0%(6/200), P=0.02), but most of them were type B or A dissection and did not need special treatment. There was no significant difference in bleeding event between the two groups(P=0.91). Logistic regression analysis showed that there was no difference in the risk of MACE during hospitalization between DES and DCB groups for AMI patients receiving PCI (compared with DCB, OR=0.35, 95%CI 0.08-1.43, P=0.13). Conclusions: The initial safety and efficacy profiles of DCB are similar with those of DES for the AMI patients during PCI. The study highlights that the incidence of coronary dissection (type A or B) is higher post DCB treatment than post DES, but it does not affect blood flow. However, the incidence of in-hospital MI due to delayed coronary dissection trends to be higher post DCB. So we should pay close attention to the risk of delayed coronary dissection after DCB in AMI patients with de novo lesion.
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Humans , Drug-Eluting Stents , Myocardial Infarction , Percutaneous Coronary Intervention , Stents , Treatment OutcomeABSTRACT
Objective@#To evaluate the efficacy and safety of intravascular ultrasound guidance drug-coated balloon (DCB) in percutaneous coronary intervention (PCI) of situ coronary artery lesions in patients with acute coronary syndrome (ACS), and its effect on thrombus precursor protein (TpP).@*Methods@#Seventy-eight patients with ACS in Central Hospital of Changchun City from January 2015 to January 2019 were selected, including 46 cases with unstable angina pectoris and 32 cases with acute non-ST-segment elevation myocardial infarction. The patients were divided into DCB group (38 cases) and drug-eluting stent (DES) group (40 cases) by random digits table method. Intravascular ultrasound was used to guide PCI in both groups, and DCB and DES were used respectively. Coronary angiography was performed immediately and 6 months after PCI in both groups. Minimum lumen diameter (MLD) was measured by QCA system, and the lumen loss (LLL) was calculated at 6 months after PCI. Plasma TpP before PCI, 1 and 6 months after PCI was measured by enzyme-linked immunosorbent assay (ELISA). Major adverse cardiovascular events (MACE) including cardiac death, myocardial infarction and target lesion revascularization (TLR) were followed up 1, 3, 6 and 12 months after PCI.@*Results@#Immediately after PCI, there was no statistical difference in MLD between DCB group and DES group: (1.87 ± 0.23) mm vs. (2.16 ± 0.15) mm, P>0.05; 6 months after PCI, the LLL in DCB group was significantly smaller than that in DES group: (0.31 ± 0.28) mm vs. (0.48 ± 0.19) mm, and there was statistical difference (P<0.05). There were no significant differences in the incidences of myocardial infarction, TLR and cardiac death in DCB group (P>0.05). Before PCI and 6 months after PCI, there was no statistical difference in TpP between 2 groups (P>0.05); 1 month after PCI, the TpP in DCB group was significantly lower than that in DES group: (15.31 ± 6.13) mg/L vs. (19.46 ± 8.24) mg/L, and there was statistical difference (P<0.05).@*Conclusions@#DCB is an accurate and effective treatment for ACS patients with situ coronary artery disease under the intravascular ultrasound guidance, and it can reduce the risk of thrombosis.
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Objective@#To evaluate the safety and efficacy of the drug coated balloon(DCB) for complex TASC C/D superficial femora-popliteal artery diseases.@*Methods@#Patency, target lesion revascularization (TLR) rate, clinical improvement and safety endpoints of femora-popliteal lesions in 68 patients from PLA General Hospital treated with DCB were retrospectively analyzed from June 2016 to June 2018. The mean age of the patients were (72.7±13.2) years old. Rutherford categories were from 2 to 5, and ABI baseline were 0.56±0.22.@*Results@#There were 76 limbs treated by DCB in total in this study. Mean lesion length was (26.7±15.3) cm. 73.6% of lesions were totally occluded, 26.4% were of stenosis and 61.8% were highly calcified. Stent implantation was performed in 36.8% cases. Kaplan Meier estimates of primary patency were 74.2%±7.6% and 67.7%±6.4% at 1 and 2 years, respectively, whereas freedom from TLR was 81.4%±5.1% and 73.6%±5.4%. ABI were 0.83±0.16 at 1 year, and 0.79±0.24 at 2 years. Major amputation rate was 2.9% and mortality rate was 2.9% and 4.4% at 1 year and 2 years respectively. Diabetes, highly calcification, renal insufficiency and re-stenotic lesions were identified as predictors of restenosis.@*Conclusions@#DCB are safe and effective in delaying restenosis in complex TASC C/D superficial femora-popliteal artery disease as found by midterm follow-up.
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Objective To evaluate the safety and efficacy of the drug coated balloon (DCB) for complex TASC C/D superficial femora-popliteal artery diseases.Methods Patency,target lesion revascularization (TLR) rate,clinical improvement and safety endpoints of femora-popliteal lesions in 68 patients from PLA General Hospital treated with DCB were retrospectively analyzed from June 2016 to June 2018.The mean age of the patients were (72.7 ± 13.2) years old.Rutherford categories were from 2 to 5,and ABI baseline were 0.56 ± 0.22.Results There were 76 limbs treated by DCB in total in this study.Mean lesion length was (26.7 ± 15.3) cm.73.6％ of lesions were totally occluded,26.4％ were of stenosis and 61.8％ were highly calcified.Stent implantation was performed in 36.8％ cases.Kaplan Meier estimates of primary patency were 74.2％ ± 7.6％ and 67.7％ ± 6.4％ at 1 and 2 years,respectively,whereas freedom from TLR was 81.4％ ±5.1％ and 73.6％ ±5.4％.ABI were 0.83 ±0.16 at 1 year,and 0.79 ±0.24 at 2 years.Major amputation rate was 2.9％ and mortality rate was 2.9％ and 4.4％ at 1 year and 2 years respectively.Diabetes,highly calcification,renal insufficiency and re-stenotic lesions were identified as predictors of restenosis.Conclusions DCB are safe and effective in delaying restenosis in complex TASC C/D superficial femora-popliteal artery disease as found by midterm follow-up.
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Objective@#To evaluate the efficacy and safety of drug-coated balloons (DCB) for de novo large coronary vessels.@*Methods@#One hundred and two patients were retrospectively enrolled in this study, there were 104 lesions with the reference lumen diameter of target vessel more than 2.8 mm and patients were treated with DCB in de novo lesions during May 2015 and July 2017 in our center. Coronary artery angiography and quantitative coronary angiography were performed in 82 (80.4%) patients at follow up period ((8.1±1.7) months post procedure). The endpoints were late lumen loss (LLL) at follow up,and major adverse cardiac events (MACE) including cardiac death, myocardial infarction (MI), target lesion revascularization (TLR) and stent or target lesion thrombosis at 12 months post procedure.@*Results@#Ninety-eight lesions were treated with DCB only, 6 (5.9%) bailout drug-eluting stent (DES) were used because of severe coronary dissection, 2 patients (2.0%) received revascularization driven by acute ischemic events during hospitalization. Cutting balloons and NSE balloons were used in 65.4% (68/104) and 26.0% (27/104) lesions. The lesion length was (12.57±3.58) mm and the DCB length was (19.87±4.55) mm. The late lumen loss was (0.01±0.52) mm during angiographic follow up. The TLR rate and overall MACE rate was 3.9% (4/102) and 3.9% (4/102) and there was no death,MI and target lesion thrombosis at 12 months follow up.@*Conclusion@#DCB treatment for de novo large coronary vessels is effective and safe.
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Objective To investigate the clinical effect of paclitaxel coated balloon in the treatment of symptomatic lower extremity arteriosclerosis obliterans.Methods From January 2016 to April 2017,64 patients with symptomatic lower limb arteriosclerosis obliterans ( ASO ) of femoral and popliteal artery stenosis admitted to Chongming Branch Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine were selected as the research subjects.According to the principle of randomization, they were divided into two groups, 32 cases in each group.In the drug?coated group, ordinary balloon was pre?expanded,and then paclitaxel drug?coated balloon was used to expand.If there were still retraction and stenosis of diseased vessels, which affected the blood flow of lower limbs, remedial stents were implanted.Bare stent group used a slightly smaller balloon to pre?expand superficial femoral artery and then release the stent.After one year follow?up, the changes of ankle?brachial index ( ABI), restenosis rate of target lesion vessels, Rutherford grading changes, clinical drive target vessel revascularization rate, perioperative period,death rate of patients during follow?up period, amputation rate and complication rate were observed.Results There were no amputations or deaths in the whole group during the perioperative period and follow?up.The incidence of complications in the drug?coated group was 3.1%( 1／32 ), significantly lower than that in the bare stent group 18.8%( 6／32) ( χ2 ＝4.010, P＝ 0.045).Before treatment,the ABI of patients in drug?coated group and bare stent group at 6 months and 12 months after treatment were significantly different ( Finter?group ＝ 7.028, Pinter?group ＝ 0.024, Fintra?group ＝ 219.028, Pintra?group＝0.000,Finteraction＝350.028,Pinteraction＝0.000),and ABI of the two groups at 12 months after treatment were (0.73± 0.11) and ( 0.68 ± 0.09),respectively, the difference was statistically significant ( t＝1.990, P＝0.025).Six months after operation, the restenosis rates of target lesions in the two groups were 9.4%(3／32) and 15.6%(5／32), respectively, with no significant difference ( χ2 ＝0.571, P＝0.450); The restenosis rate of bare stent group was 37.5%(12／32) 12 months after operation,which was significantly higher than that of drug?coated group by 15.6%(5／32) (χ2＝3.925,P＝0.048).Clinical observation results showed that 12 months after operation,the target?lesion revascularization (TLR) of the drug?coated group was 3.1%(1／32) and that of the bare stent group was 9.4%(3／32),with no significant difference.Rutherford grading was improved in both groups(χ2＝1.067,P＞0.05). Conclusion Paclitaxel drug?coated balloon is safe and effective in the treatment of symptomatic lower limb arteriosclerosis obliterans,which is worthy of clinical application.
ABSTRACT
Femoropopliteal arteriosclerosis obliteration has been a common disease affecting human health. Currently, endovascular treatment has become the mainstream of operation, but the postoprative restenosis rate is still very high. Directional atherectomy (DA) can improve blood vessel compliance by removing plaque, but it has no obvious effect in reducing the restenosis rate. The emergence of drug-coated balloon (DCB) has brought the dawn to solve this problem. Through the entry of its loaded drug into the vascular wall to prevent the proliferation of endothelial cells and smooth muscle cells, DCB exerts its long-term anti-intimal hyperplasia effect. A number of studies have shown that DCB can reduce the late lumen loss and the restenosis rate, thus decrease the re-operation rate. Combination use of DA and DCB can improve the uptake of drugs, then, better results can be expected. However, the present research results are not sufficient to support the above theoretical speculation, and large sample and more multicenter randomized controlled studies need to be done before it can be validated.