Orchid drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of femoropopliteal artery disease: 12-month result of the randomized controlled trial.

PURPOSE: To assess the efficacy and safety of the Orchid drug-coated balloon (coated with paclitaxel) for the treatment of femoropopliteal artery disease versus percutaneous transluminal angioplasty in Chinese population. METHODS: This is a prospective, single center, single-blinded, randomized controlled trial that randomized (1:1) 60 patients (38 men; mean age 68.7 ± 8.8) to drug-coated balloon group (n = 30) or percutaneous transluminal angioplasty group (n = 30). The primary efficacy endpoint was primary patency of the target lesion and clinically driven target lesion revascularization (CD-TLR) at 12 months. The primary safety end point was freedom from perioperative death at 30 days and freedom from limb-related death and major amputation at 12 months. RESULTS: Baseline characteristics were similar between the two groups. Drug-coated balloon group resulted in higher primary patency (82.8% vs. 48.3%, p = 0.005) and lower CD-TLR rates (3.5% vs. 27.6%; p = 0.001) versus percutaneous transluminal angioplasty group at 12 months. The ABI was significantly higher in drug-coated balloon group than percutaneous transluminal angioplasty group (0.86 ± 0.13 vs. 0.72 ± 0.18, p = 0.025). There were no perioperative death at 30 days, no limb-related death and no major amputation at 12 months in either group. CONCLUSIONS: The randomized controlled trial showed superior treatment effect with drug-coated balloon versus percutaneous transluminal angioplasty, with remarkably higher patency and lower CD-TLR rates. The result is consistent with other study and demonstrates the safety and efficacy of the Orchid drug-coated balloon for the treatment of femoropopliteal artery disease.

Randomized clinical trial of radiofrequency-induced thermotherapy combined with transilluminated powered phlebectomy versus high ligation and stripping for the treatment of lower limb varicose veins.

OBJECTIVE: The objective of this study was to evaluate the efficacy and safety of radiofrequency-induced thermotherapy (RFiTT) combined with transilluminated powered phlebectomy (TIPP) in the treatment of lower limb varicose veins (VVs) in comparison with high ligation and stripping (HLS) combined with TIPP. METHODS: The patients with lower limb VVs were randomly assigned to RFiTT combined with TIPP or HLS combined with TIPP. The primary end point was total closure rate of the great saphenous vein at 12 months. Secondary end points included Venous Clinical Severity Score and 14-item Chronic Venous Insufficiency Questionnaire score changes at 12 months and perioperative complications. RESULTS: The total closure rate of the great saphenous vein at 12 months was slightly lower in the RFiTT group (90.9% [90/99]) than in the HLS group (97.0% [98/101]) but not statistically significant (χ2 = 0.068; P = .08). Operation time, intraoperative blood loss, duration in hospital, duration in bed, and resumption of activities were statistically significantly better with RFiTT than with HLS. There were no significant differences between the groups in deep venous thrombosis, phlebitis, hematomas, pain, and infection. However, skin pigmentation and paresthesia were statistically significantly better with RFiTT than with HLS. At 12 months, both groups showed similar improvement from baseline in Venous Clinical Severity Score (1.28 ± 0.57 in the RFiTT group vs 1.33 ± 0.61 in the HLS group) and 14-item Chronic Venous Insufficiency Questionnaire score (67.32 ± 1.29 in the RFiTT group vs 67.45 ± 1.32 in the HLS group); however, neither group was superior to the other. CONCLUSIONS: RFiTT combined with TIPP is an effective treatment method for lower limb VVs and had a more satisfactory clinical outcome in surgical data, skin pigmentation, and paresthesia than HLS at the 12-month follow-up.

Randomized controlled trial of orchid drug-coated balloon versus standard percutaneous transluminal angioplasty for treatment of femoropopliteal artery in-stent restenosis.

BACKGROUND: To assess the efficacy and safety of Orchid drug-coated balloon (DCB) for treatment of femoropopliteal (FP) artery in-stent restenosis (ISR) in Chinese patients. METHODS: The study is a prospective, single center, single-blinded, randomized controlled trial (RCT) that randomized (1:1) 74 patients to DCB group (N.=38) and PTA group (N.=36). The primary efficacy endpoint was primary patency of the target lesion at 12 months. Second efficacy endpoint included clinically-driven target-lesion revascularization (CD-TLR) and ABI change at 12 months. The primary safety endpoint included peri-operative death at 30 days, all-cause death, major amputation, and other major adverse events (MAEs) at 12 months. The primary functional endpoint included Walking Impairment Questionnaire (WIQ), quality-of-life measures (EQ-5D) and 6-minute walking test (6MWT). RESULTS: The DCB group had higher primary patency (87.9% vs. 51.6%; P=0.001) and lower rates of CD-TLR (6.1% vs. 35.5%; P=0.003) than the PTA group at 12 months. There were no peri-operative deaths, and no major amputations at 12 months in two groups. There were 1(2.6%) in the DCB group and 2 (5.6%) in the PTA group of all-cause deaths (P=0.524). CONCLUSIONS: Results from the study showed superior treatment effect with Orchid DCB versus PTA for the treatment of FP ISR, and without an apparent difference in safety.

Combination of Rotarex Thrombectomy and Drug-Coated Balloon for the Treatment of Femoropopliteal Artery In-Stent Restenosis.

BACKGROUND: The optimal treatment method for femoropopliteal (FP) artery in-stent restenosis (ISR) remains controversial. We assess the efficacy and safety of combination of Rotarex thrombectomy and drug-coated balloon (DCB) for the treatment of FP ISR. METHODS: From June 2016 to July 2017, 32 patients with FP ISR who underwent combination of Rotarex thrombectomy and DCB angioplasty were included in a prospective registry. The primary end point was primary patency of the target lesion defined as a peak systolic velocity ratio <2.4 documented by duplex ultrasound at 12 months without clinically driven target lesion revascularization (CD-TLR). The secondary outcome measure was the rate of major adverse limb events. The primary functional end point was assessed using the Walking Impairment Questionnaire (WIQ). RESULTS: Twenty-nine (90.6%) patients completed 12-month follow-up. Mean ankle-brachial index was 0.45 ± 0.14 at baseline and 0.84 ± 0.12 at 12 months (P < 0.05). The WIQ score was 30.45 ± 21.14 at baseline and 52.68 ± 29.75 at 12 months (P < 0.05). The Kaplan-Meier estimate of the primary patency rate at 12 months was 86.2% (25/29), and freedom from CD-TLR rate at 12 months was 89.7% (26/29). CONCLUSIONS: The data suggest that combination of Rotarex thrombectomy and DCB for treatment of FP ISR is safe and effective with satisfying primary patency rate and freedom from CD-TLR rate at 12-month follow-up.

WITHDRAWN: Drug Coated Balloon vs. Standard Percutaneous Transluminal Angioplasty for the Treatment of Femoropopliteal Artery Disease: 12 - Month Results of the LEGFLOW OTW China Randomised Controlled Trial.

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Percutaneous transluminal renal angioplasty with stent is effective for blood pressure control and renal function improvement in atherosclerotic renal artery stenosis patients.

BACKGROUND: Percutaneous transluminal renal angioplasty with stent is an effective procedure for atherosclerotic renal artery stenosis. However, the decision to perform this procedure has recently raised considerable debate. The aim of this study was to assess the effects of percutaneous transluminal renal angioplasty with stent in atherosclerotic renal artery stenosis patients, especially as it relates to blood pressure control and renal function improvement. METHODS: A retrospective analysis was made of the clinical data from 125 atherosclerotic renal artery stenosis patients who underwent percutaneous transluminal renal angioplasty from July 2004 to June 2008 in the Department of Vascular Surgery of Beijing Chaoyang Hospital. We compared blood pressure, number of oral antihypertensive medications, and renal function changes pre and post-procedure at 24 months follow-up. RESULTS: A total of 125 atherosclerotic renal artery stenosis patients underwent percutaneous transluminal renal angioplasty and 143 stents were placed. At 24 months follow-up, both systolic and diastolic blood pressure and the number of oral antihypertensive medications were significantly reduced (P < 0.05). Overall, the estimated glomerular filtration rate did not change significantly (P > 0.05); however, a significant increase in estimated glomerular filtration rate was observed in the subgroup of patients with a lower baseline estimated glomerular filtration rate and in the subgroup of patients with bilateral renal artery stenosis (P < 0.05). CONCLUSION: Percutaneous transluminal renal angioplasty is a safe procedure for atherosclerotic renal artery stenosis patients, providing a significant improvement in blood pressure control and reduction in the number of oral antihypertensive medications.

Long-term results of endovascular therapy for proximal subclavian arterial obstructive lesions.

BACKGROUND: Endovascular therapy is a treatment option for localized occlusion of the subclavian artery. In this report the long-term experience with 59 patients is presented. METHODS: Between June 1998 and September 2008, we used endovascular therapy to treat 61 subclavian arterial obstructive lesions in 59 patients (46 males and 13 females, 34 - 82 years of age with a mean age (61.9 + or - 11.0) years). Twenty patients (34%) had clinical symptoms due to vertebrobasilar insufficiency, 26 (44%) had disabling arm ischemia, and 13 (22%) had both symptoms. We performed all procedures under local anesthesia. The approaches were from the femoral artery (n = 47), brachial artery (n = 1, involving bilateral subclavian disease) or both (n = 11). Sixty stents were implanted. All patients were followed-up at 1, 3, 6, and 12 months post-procedure, and annually thereafter. RESULTS: We achieved technical success in 58 (95.1%) arteries, all of which were stented. There were three technical failures; two were due to the inability to cross over an occlusion, necessitating the switch to an axillo-axillary bypass, and the third was due to shock after digital subtraction angiography and prior to stenting. Arterial stenosis pre- and post-stenting was (83.6 + or - 10.8)% and (2.5 + or - 12.5)% (P < 0.01). Clinical success was achieved in 55 of the 59 patients (93.4%). Of the four clinical failures, three were technical and the remaining patient had a stent thrombosis. Systolic blood pressure difference between the two brachial arteries was (44.7 + or - 18.5) vs. (2.2 + or - 3.9) mmHg (P < 0.01). Primary patency was 98% at 12 months, 93% at 24 months, and 82% at 5 years. Five patients were lost to follow-up by 12 months post-stenting. Significant recurrent obstruction developed in five patients with resumption of clinical symptoms. The overall survival rate was 98.2% at 12 months, 89.5% at 24 months, and 84.5% at 5 years. CONCLUSIONS: Endovascular therapy for proximal subclavian arterial obstructive lesions is effective and successful. This minimally invasive treatment may be the first choice of treatment for proximal subclavical arterial obstructive lesions.

[Surgical treatment of 154 patients with non-traumatic acute lower limb ischemia].

OBJECTIVE: To analyze the surgical treatment and prognosis of non-traumatic acute lower limb ischemia, and compare the morbidity and prognosis of acute arterial embolism and acute arterial thrombosis. METHODS: The clinical data of 154 acute lower limb ischemia patients surgically treated from July 1999 to December 2007 were retrospectively analyzed. Fogarty catheter embolectomy was used in all patients; in which, 128 cases underwent Fogarty catheter embolectomy only, 8 cases Fogarty catheter embolectomy combined with endarterectomy, 13 cases Fogarty catheter embolectomy combined with vascular reconstruction with prosthetic graft or great saphenous vein, 5 cases Fogarty catheter embolectomy combined with amputation. The patients were divided into two groups according to pathogenesis: acute arterial embolism group (99 cases) and acute arterial thrombosis group (55 cases). The morbidity, amputation, perioperative mortality rates and high risk factors of amputation in the two groups were compared. RESULTS: Female experienced acute arterial embolism more often than man (60.6% vs 39.4%, P < 0.05), and more acute arterial thrombosis occurred in man (72.7% vs 27.3%, P < 0.05). The amputation rate of all cases was 9.7%, and perioperative mortality rate was 11.7%. The amputation rate in acute arterial embolism group was lower than acute arterial thrombosis group (5.1% vs 18.2%, P < 0.05). The perioperative mortality rates in the two groups were equal (11.1% vs 12.7%, P > 0.05). The statistically high risk factor of amputation for two groups was ischemic time, and smoking and diabetes were high risk factors for acute arterial thrombosis. CONCLUSIONS: Men experiences acute arterial thrombosis more often, and women experiences acute arterial embolism more often. The amputation rate of acute arterial embolism is lower than acute arterial thrombosis, and acute arterial thrombosis has more high risk factors of amputation.

[Preliminary in vivo evaluation of tissue engineered venous grafts fabricated based on endothelial progenitor cells].

OBJECTIVE: To explore the feasibility of the tissue engineered venous grafts (TEVGs) constructed in vitro based on canine autologous bone marrow-derived endothelial progenitor cells (EPCs) and porcine decellularized aortic scaffolds implanted into the canine inferior vena cava. METHODS: To draw out a volume of 8 - 12 ml of bone marrow from the canine (n = 8), to culture and expand EPCs in vitro using conditioned medium. After labeled with a red fluorescent dye PKH26-GL, the cells were seeded onto the luminal surface of decellularized porcine scaffolds with single, rotative method for 4 h. Following static culture for 24 - 72 h, the hybrids were implanted to replace autologous canine inferior vena cava about 4 cm long. Meantime one femoral artery-venous shunt about 1 cm long was performed. The non-seeded decellularized scaffolds (n = 4) were performed the same as control. Angiography was performed and the hybrids were explanted for morphology and labeled cells' immuno-fluorescence examinations at postoperative 10 d, 4 weeks and 12 weeks, respectively. RESULTS: The patent number of experiment (control) group were 7/7 (2/4), 6/6 (2/2) and 4/4 (1/2) at postoperative 10 d, 4 weeks and 12 weeks, respectively. At 12 weeks, tightly confluence endothelial cells which covered the whole inner luminal surface of the explants were detected by immunohistochemistry of factor VIII and scanning electron microscopy, while fibrin-based pseudo-intima was detected on the inner luminal surface of matrix in the solo patent dog from the control group. Meanwhile, fibroblasts and alpha-actin positive cells in the matrices were found by transmission electron microscopy and alpha-actin immunohistochemistry. PKH26-GL labeled EPCs sustained on the luminal surface at a rather proportion accompanied by newly formed endothelial cells. However, the explants in both groups showed partial stenosis. CONCLUSIONS: Such constructed tissue engineered venous graft based on canine autologous bone marrow-derived endothelial progenitor cells and porcine decellularized aortic matrices is promising and deserve to further improvement and testing.