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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Expression of platelet-derived growth factor in the vascular walls of patients with lower extremity arterial occlusive disease.

The aim of the present study was to quantitatively analyze the expression of platelet-derived growth factor (PDGF)-A and PDGF-B in the vascular walls of patients with lower extremity arterial occlusive disease (LEAOD). The expression levels of PDGF-A and PDGF-B in the lower extremity arteries of 19 LEAOD patients (case group) and three healthy subjects (control group) was determined using quantitative polymerase chain reaction. Intergroup comparisons revealed that the relative mRNA expression levels were higher in the case group, as compared with the control group, for PDGF-A (34.38±5.80 vs. 21.94±1.05; P<0.05) and PDGF-B (33.95±5.92 vs. 24.15±3.12; P<0.05). In addition, the expression of PDGF-A revealed a positive linear correlation with the expression of PDGF-B (P<0.05). Therefore, the expression levels of PDGF-A and PDGF-B were found to be higher in the vascular walls of LEAOD patients, while the expression of PDGF-A was found to correlate with the expression of PDGF-B. A significant increase in the expression levlels of PDGF-A and PDGF-B were observed in the vascular walls of patients with LEAOD, and the expression of PDGF-A was associated with the expression of PDGF-B.

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.

[Endovascular therapy and arterial bypass for subclavian artery occlusion].

OBJECTIVE: To investigate the effect of endovascular therapy and artery bypass for subclavian artery occlusion disease and to explore a suitable therapeutic procedure. METHODS: Thirty-nine patients with subclavian artery occlusive disease received endovascular therapy or arterial bypass from June 1997 to May 2004. Twenty-seven endovascular stenting were performed on 26 patients through the femoral artery (n = 14) or combined brachial artery (n = 12). Retrograde endovascular balloon angioplasty and stent placement were performed on 12 patients. Eight subclavian arteries were punctured with ultrasound localization. On account of unsuccessful stenting, 13 cases received arterial bypass. In addition, endovascular stenting were performed on 9 cases with carotid or vertebrarterial stenoses. RESULTS: The blood pressure difference was less than 10 mm Hg between the treated and the healthy arms in all 39 patients. The ratio of healthy/diseased side of the mean blood pressure index increased from 0.62 +/- 0.11 preoperatively to 0.98 +/- 0.04 postoperatively (P < 0.01). The mean patency time for endovascular therapy and arterial bypass was (57.6 +/- 3.7) and (60.2 +/- 7.2) months, respectively. CONCLUSIONS: Both endovascular therapy and arterial bypass have good curative effect for subclavian artery occlusion. Endovascular therapy is the preferred treatment for subclavian artery occlusion with mini-trauma and safety.

[Clinical analysis on treatment for superficial varicosities of low limbs with minimally invasive rotary varicotomy].

OBJECTIVE: To evaluate therapeutic efficacy of minimally invasive rotary varicotomy (TriVex) for superficial varicosities of low limbs and summarize our therapeutic experiences. METHODS: One hundred and eighty-two cases (totally 216 lower limbs) were applied minimally invasive rotary varicotomy (TriVex) and relative clinical data was analyzed. RESULTS: The average operation time for each limb was 48 min. Discomfort and pain of lower limbs disappeared in all of patients after operation. There was no residual of superficial varicosities. There was no severe complication and recurrence of varicosities. The postoperative complication rate was 21.3%. CONCLUSIONS: For treatment of superficial varicosities of low limbs, minimally invasive rotary varicotomy (TriVex) have many advantages including minimal invasion, quick recovery, safety and cosmetic effect. In addition, it has extensive indications and satisfactory therapeutic efficacy. It would be beneficial to master the operative techniques of key procedures. It could decrease complications and get better curative effects.

[Follow-up study in endovascular therapy for the renal artery stenosis].

OBJECTIVE: To evaluate the safety and efficacy of endovascular therapy for renal artery stenosis. METHODS: Percutaneous transluminal renal angioplasty with stent (PTRAS) was performed on 33 consecutive patients with severe renal artery stenosis who suffered from poorly controlled hypertension or renal dysfunction. They were subsequently underwent 7 to 49 months clinical follow up for the effect of the procedure on renal function, blood pressure control, mortality. RESULTS: Angiographic success was obtained in 32 (97.0%) of the 33 patients. The mortality was 18.2%. After PTRAS, two (6.1%) died of myocardial infarction within 4 months. Four (12.1%) patients with preoperative serum creatinine (Scr) > or = 177 micromol/L died of uraemia within 17 approximately 28 months. Twelve and twenty-four months after the procedure, systolic and diastolic blood pressure of 26 (78.8%) cases with preoperative Scr < 177 micromol/L significantly decreased (P < 0.05), with less antihypertensive medications taken and satisfactory renal function. CONCLUSION: For patients without serious cardiorenal disease, PTRAS has a beneficial effect on blood pressure and renal function. For patients with serious cardiorenal disease or preoperative Scr > or = 177 micromol/L, the mortality is higher. PTRAS should be performed prudently. The preservation of renal function may be enhance by using renal protection device.

Effect of ligand of peroxisome proliferator-activated receptor gamma on the biological characters of hepatic stellate cells.

AIM: To study the effect of rosiglitazone, which is a ligand of peroxisome proliferator-activated receptor gamma (PPARgamma), on the expression of PPARgamma in hepatic stellate cells (HSCs) and on the biological characteristics of HSCs. METHODS: The activated HSCs were divided into three groups: control group, 3 micromol/L rosiglitazone group, and 10 micromol/L rosiglitazone group. The expression of PPARgamma, alpha-smooth muscle actin (alpha-SMA), and type I and III collagen was detected by RT-PCR, Western blot and immunocytochemical staining, respectively. Cell proliferation was determined with methylthiazolyltetrazolium (MTT) colorimetric assay. Cell apoptosis was demonstrated with flow cytometry. RESULTS: The expression of PPARgamma at mRNA and protein level markedly increased in HSCs of 10 micromol/L rosiglitazone group (t value was 10.870 and 4.627 respectively, P<0.01 in both). The proliferation of HSCs in 10 micromol/L rosiglitazone group decreased significantly (t = 5.542, P<0.01), alpha-SMA expression level and type I collagen synthesis ability were also reduced vs controls (t value = 10.256 and 14.627 respectively, P<0.01 in both). The apoptotic rate of HSCs significantly increased in 10 micromol/L rosiglitazone group vs control (chi(2) = 16.682, P<0.01). CONCLUSION: By increasing expression of PPARgamma in activated HSCs, rosiglitazone, an agonist of PPARgamma, decreases alpha-SMA expression and type I collagen synthesis, inhibits cell proliferation, and induces cell apoptosis.

[Regulation of hepatic stellate cell activation by interleukin-10/platelet derived growth factor/mitogen-activated protein kinase pathway].

OBJECTIVE: To investigate the regulatory effect of interleukin-10 (IL10) on the activation of hepatic stellate cells (HSC) through platelet derived growth factor (PDGF) and mitogen-activated protein kinase (MAPK) pathways. METHODS: HSC were divided randomly into 4 groups. Group 1 served as a control. HSC were incubated with 1 ng/ml, 5 ng/ml, and 25 ng/ml IL-10 in groups 2, 3 and 4. RT-PCR and western blot were used to detect the expression of PDGF and MAPK protein ERK and p38 and alpha-SMA. RESULTS: Compared with the control group, expressions of ERK, p38 and alpha-SMA of groups 2, 3 and 4 were significantly lower (F values were 240.47, 21.39, 28.86 respectively. IL-10 inhibited PDGF and MAPK protein ERK and p38 and alpha-SMA expression in a dose-dependent way. CONCLUSION: IL-10 inhibits activation of HSC through the PDGF/MAPK pathway.

[The effect of somatostatin analogue on expression of connective tissue growth factor gene of rat hepatic stellate cells].

OBJECTIVE: To investigate the effect of somatostatin analogue-octreotide (OCT) on expression of connective tissue growth factor (CTGF) gene of murine hepatic stellate cells (HSCs) in vitro. METHODS: HSCs separated from Sprague Dawley rats by in situ perfusion and Nycodenz gradient were divided into 5 groups. HSCs in 4 out of 5 groups were co-cultured with octreotide at different dosages, and the remaining group served as control. The expression of CTGF and TGF-beta mRNA were assessed by reverse transcription-polymerase chain reaction (RT-PCR). RESULTS: OCT down-regulates the expression of CTGF and TGF-beta mRNA in HSCs. The effect is increased with a dose dependent manner. CONCLUSIONS: OCT could exert the inhibitory effect on HSCs by down-regulating the expression of CTGF and TGF-beta. This provides a potential for the prevention and management of hepatic fibrosis.

Expression of subtypes of somatostatin receptors in hepatic stellate cells.

AIM: To elucidate the mechanism by which somatostatin and its analogue exert the influence on liver fibrosis, and to investigate the mRNA expression of somatostatin receptors subtypes (SSTRs) and the distribution of somatostatin analogue octreotide in rat hepatic stellate cells (HSCs). METHODS: HSCs were isolated from Sprague Dawley (SD) rats by in situ perfusion and density gradient centrifugation. After several passages, the mRNA expression of 5 subtypes of SSTRs were assessed by reverse transcription-polymerase chain reaction (RT-PCR). HSCs were planted on coverslip and co-cultured with octreotide tagged by FITC. Then the distribution of FITC fluorescence was observed under laser scanning confocal microscope (LSCM) in 12-24 h. RESULTS: There were mRNA expression of SSTR2, SSTR3 and SSTR5 but not SSTR1 and SSTR4 in SD rat HSCs. The mRNA expression level of SSTR2 was significantly higher than that of other subtypes (P<0.01). FITC fluorescence of octreotide was clearly observed on the surface and in the cytoplasm, but not in the nuclei of HSCs under LSCM. CONCLUSION: The effect exerted by somatostatin and its analogues on HSCs may mainly depend on the expression of SSTR2, SSTR3 and SSTR5. Octreotide can perfectly combine with HSCs, and thereby exerts its biological activity on regulating the characters of active HSCs. This provides a potential prevention and management against liver fibrosis.