Conventional versus invaginated stripping of the great saphenous vein: a randomized, double-blind, controlled clinical trial.
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ABSTRACT:
SUBMITTER: Scheltinga MR
PROVIDER: S-EPMC2039792 | biostudies-other | 2007 Nov
REPOSITORIES: biostudies-other
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Project description:BackgroundFew studies have examined the efficacy of drug-eluting stents (DES) for reducing aortocoronary saphenous vein bypass graft (SVG) failure compared with bare-metal stents (BMS) in patients undergoing stenting of de-novo SVG lesions. We assessed the risks and benefits of the use of DES versus BMS in de-novo SVG lesions.MethodsPatients were recruited to our double-blind, randomised controlled trial from 25 US Department of Veterans Affairs centres. Eligible participants were aged at least 18 years and had at least one significant de-novo SVG lesion (50-99% stenosis of a 2·25-4·5 mm diameter SVG) requiring percutaneous coronary intervention with intent to use embolic protection devices. Enrolled patients were randomly assigned, in a 1:1 ratio, by phone randomisation system to receive a DES or BMS. Randomisation was stratified by presence or absence of diabetes and number of target SVG lesions requiring percutaneous coronary intervention (one or two or more) within each participating site by use of an adaptive scheme intended to balance the two stent type groups on marginal totals for the stratification factors. Patients, referring physicians, study coordinators, and outcome assessors were masked to group allocation. The primary endpoint was the 12-month incidence of target vessel failure, defined as the composite of cardiac death, target vessel myocardial infarction, or target vessel revascularisation. The DIVA trial is registered with ClinicalTrials.gov, number NCT01121224.FindingsBetween Jan 1, 2012, and Dec 31, 2015, 599 patients were randomly assigned to the stent groups, and the data for 597 patients were used. The patients' mean age was 68·6 (SD 7·6) years, and 595 (>99%) patients were men. The two stent groups were similar for most baseline characteristics. At 12 months, the incidence of target vessel failure was 17% (51 of 292) in the DES group versus 19% (58 of 305) in the BMS group (adjusted hazard ratio 0·92, 95% CI 0·63-1·34, p=0·70). Between-group differences in the components of the primary endpoint, serious adverse events, or stent thrombosis were not significant. Enrolment was stopped before the revised target sample size of 762 patients was reached.InterpretationIn patients undergoing stenting of de-novo SVG lesions, no significant differences in outcomes between those receiving DES and BMS during 12 months of follow-up were found. The study results have important economic implications in countries with high DES prices such as the USA, because they suggest that the lower-cost BMS can be used in SVG lesions without compromising either safety or efficacy.FundingUS Department of Veterans Affairs Cooperative Studies Program.
| S-EPMC6402785 | biostudies-literature
Project description:ObjectiveTo compare the clinical effects of modified above-knee and conventional surgery with the stripping of the great saphenous vein of varicose veins of the lower extremities.MethodsClinical data of patients with a varicose vein of the lower extremity from May 2016 to May 2018 were collected. A retrospective study was conducted on the patients receiving modified above-knee and conventional surgery with the great saphenous vein stripping. The baseline characteristics and long-term follow-up data were compared between the groups.ResultsThere were no significant differences in baseline characteristics between the two groups (P > 0.05). The surgeries were successfully performed by the same group of surgeons under local anesthesia and neuraxial anesthesia. The hospital stay, operation time, intraoperative blood loss, total length, and number of incisions in the above-knee group were comparable to those in the conventional surgery group (P > 0.05). The incidence of saphenous nerve injury and subcutaneous hematoma in the above-knee group was lower than that in the conventional surgery group (P < 0.05). There were no significant differences in recurrent varicose vein incidences (P > 0.05). After surgery, the venous clinical severity score (VCSS) and chronic venous insufficiency questionnaire (CIVIQ-14) scores of both groups were higher than those before operation (P < 0.05). There was no significant difference in VCSS score or CIVIQ-14 scores between the two groups postoperation (P > 0.05). At 24 months after surgery, the above-knee group (71.8%) and conventional surgery group (73.2%) resulted in changes of at least two CEAP-C clinical classes lower than baseline, respectively.ConclusionThe modified above-knee technique can ensure clinical outcomes, reduce intraoperative blood loss and complication incidences, and shorten the operative time. This gives evidence that the modified above-knee technique is worthy of clinical application.
| S-EPMC8769814 | biostudies-literature
Project description:Radiofrequency ablation (RFA) is associated with an excellent outcome in the treatment of great saphenous vein (GSV) incompetence. The use of thermal energy as a treatment source requires the instillation of tumescence anesthesia. Mechanochemical endovenous ablation (MOCA) combines mechanical endothelial damage, using a rotating wire, with the infusion of a liquid sclerosant. Tumescence anesthesia is not required. Preliminary experiences with MOCA showed good results and low post-procedural pain.The MARADONA (Mechanochemical endovenous Ablation versus RADiOfrequeNcy Ablation) trial is a multicenter randomized controlled trial in which 460 patients will be randomly allocated to MOCA or RFA. All patients with primary GSV incompetence who meet the eligibility criteria will be invited to participate in this trial. The primary endpoints are anatomic and clinical success at a one-year follow-up, and post-procedural pain. The secondary endpoints are technical success, complications, operation time, procedural pain, disease-specific quality of life, time taken to return to daily activities and/or work, and cost-efficiency analyses after RFA or MOCA. Both groups will be evaluated on an intention to treat base.The MARADONA trial is designed to show equal results in anatomic and clinical success after one year, comparing MOCA with RFA. In our hypothesis MOCA has an equal anatomic and clinical success compared with RFA, with less post-procedural pain.Clinicaltrials NCT01936168.
| S-EPMC3996515 | biostudies-literature
Project description:BackgroundThe objective of this study is to examine factors associated with thrombus extension after early experience with mechanochemical ablation, which combines mechanical damage to the venous endothelium with infusion of a sclerosant.MethodsA retrospective review was performed of patients who underwent mechanochemical ablation to treat saphenous vein insufficiency in the thigh including the saphenofemoral junction. Data abstracted included patient demographics, procedural details, and postprocedural outcomes. Thrombus extension was determined by postprocedural duplex ultrasound and classified as flush closure with the femoral vein and any extension of thrombus into the femoral vein.ResultsSeventy-three patients met inclusion criteria. The mean age of the population was 60, 17.8% were female, and the mean body mass index (BMI) was 30.7. Seven (9.6%) patients who underwent mechanochemical ablation experienced saphenous vein closure flush with the femoral vein. Eleven (15%) patients experience extension of thrombus to less than 50% of the diameter of the femoral vein and one patient experienced complete thrombosis of the femoral vein. There was no significant difference in age, sex, or comprehensive classification system for chronic venous disorders between the group with thrombus extension and the group without, with the exception of BMI. The mean BMI in the group with thrombus extension was 26.8 vs. 32 in the group without (P = 0.02). There was no significant difference between the 2 groups in sclerosant volume used, distance between catheter tip and SFJ, and mean diameter of GSV in the thigh.ConclusionsIn this cohort, the incidence of thrombus extension into the femoral vein with mechanochemical ablation was high relative to rates of thrombus extension associated with reported rates of thermal ablation. Further investigation with larger cohorts, and standardized reporting is required to characterize the true rate of thrombus extension after mechanochemical ablation and identify maneuvers which may prevent thrombus extension.
| S-EPMC8349781 | biostudies-literature
Project description:BackgroundDonor-recipient diameter discrepancy can be problematic when using an autologous great saphenous vein graft for internal jugular vein reconstruction. A triple-paneled method of saphenous vein grafting is one solution.Case presentationA 54-year-old man with a thyroid papillary carcinoma underwent total thyroidectomy and bilateral neck dissection. An 8-cm segment of the right internal jugular vein was resected. For reconstruction, a 30-cm segment of the great saphenous vein was harvested and divided into three pieces of equal length. After opening each piece longitudinally, they were sutured together in a side-by-side fashion to create a cylinder that was used to reconstruct the internal jugular vein defect. The graft was patent 10 months after the surgery.ConclusionThe triple-paneled method is feasible for autologous great saphenous vein graft reconstruction of the internal jugular vein.
| S-EPMC9841726 | biostudies-literature
Project description:Background Efficacy data on drug-eluting stents (DES) versus bare-metal stents (BMS) in saphenous vein grafts are controversial. We aimed to compare DES with BMS among patients undergoing saphenous vein grafts intervention regarding long-term outcome. Methods and Results In this multinational trial, patients were randomized to paclitaxel-eluting or BMS. The primary end point was major adverse cardiac events (cardiac death, nonfatal myocardial infarction, and target-vessel revascularization at 1 year. Secondary end points included major adverse cardiac events and its individual components at 5-year follow-up. One hundred seventy-three patients were included in the trial (89 DES versus 84 BMS). One-year major adverse cardiac event rates were lower in DES compared with BMS (2.2% versus 16.0%, hazard ratio, 0.14; 95% CI, 0.03-0.64, P=0.01), which was mainly driven by a reduction of subsequent myocardial infarctions and need for target-vessel revascularization. Five-year major adverse cardiac event rates remained lower in the DES compared with the BMS arm (35.5% versus 56.1%, hazard ratio, 0.40; 95% CI, 0.23-0.68, P<0.001). A landmark-analysis from 1 to 5 years revealed a persistent benefit of DES over BMS (hazard ratio, 0.33; 95% CI, 0.13-0.74, P=0.007) in terms of target-vessel revascularization. More patients in the BMS group underwent multiple target-vessel revascularization procedures throughout the study period compared with the DES group (DES 1.1% [n=1] versus BMS 9.5% [n=8], P=0.013). Enrollment was stopped before the target sample size of 240 patients was reached. Conclusions In this randomized controlled trial with prospective long-term follow-up of up to 5 years, DES showed a better efficacy than BMS with sustained benefits over time. DES may be the preferred strategy in this patient population. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT00595647.
| S-EPMC7763393 | biostudies-literature
Project description:ObjectiveThe patency and quality of transplanted great saphenous vein (GSV) can seriously influence the physical state and life quality of patients who accepted the coronary artery bypass grafting (CABG). Quercetin is known for antioxidant, antithrombotic, anti-inflammatory, and antitumor properties. In this study, we examined the protection of quercetin to the great saphenous vein from oxidative and inflammatory damage.MethodsThe GSVs were collected from 15 patients undergoing CABG and cultured. Treated the veins by H2O2 and detected the NO, SOD, and MDA content by the relevant kits to explore the quercetin protection against oxidative damage. Then, for another group of GSVs, sheared them and detected the inflammatory cytokines, such as IL-6, TNFα, CCL20, PCNA, and VEGF. Collect the veins for H&E staining and PCNA and VEGF immunofluorescent staining.ResultsPretreatment by quercetin reduced the production of NO and MDA induced by H2O2, and increased SOD activity. Quercetin also supressed the mRNA expressions of IL-6, TNFα after mechanical damage and had no influence on CCL20 and VEGF. Consistent with the lower expression of PCNA treated by quercetin, the vein intima was thinner.ConclusionThese results demonstrated that quercetin protects GSVs by reducing the oxidative damage and inflammatory response and also suppresses the abnormal thickening of venous endothelium by inhibiting cell proliferation. It reminded that, to some extent, quercetin has the potential to release the great saphenous vein graft damage.
| S-EPMC8741364 | biostudies-literature
Project description:Objective:Saffron was found efficient and safe in treatment of neuropsychiatric disorders, in particular depression. We compared the efficacy of saffron with duloxetine in treatment of patients with fibromyalgia. Materials and Methods:In this double-blind parallel-group clinical trial, outpatients with fibromyalgia were randomized to receive either saffron 15 mg or duloxetine 30 mg starting with 1 capsule per day in the first week followed by 2 capsules per day from week 2 until the end of week 8. Participants were men and women aged 18-60 years diagnosed with fibromyalgia based on the American College of Rheumatology 2010 criteria who also had a pain score?40 based on visual analogue scale. Participants were excluded in case they had rheumatologic diseases, inflammatory/infectious/autoimmune arthritis, comorbid neuropsychiatric disorders except depressive disorders, pain due to traumatic injuries, drug history of duloxetine or saffron use, current use of psychoactive medications, recent use of muscle relaxants, steroids, opioid analgesics, benzodiazepines, anti-epileptics, or injective analgesics. Primary outcomes included differences in mean score changes from baseline to endpoint between the treatment arms for Hamilton Rating Scale for Depression, Fibromyalgia Impact Questionnaire, and Brief Pain Inventory. Results:Socio-demographic characteristics and baseline scores were similarly distributed between the two treatment arms (2n=46). No significant difference was detected for any of the scales neither in terms of score changes from baseline to endpoint between the two treatment arms (Mean score changes: -4.26 to 2.37; p-values: 0.182-0.900) nor in terms of timetreatment interactions (p-values: 0.209-0.964). Conclusions:Saffron and duloxetine demonstrated comparable efficacy in treatment of fibromyalgia symptoms.
| S-EPMC6235666 | biostudies-other
Project description:Would letrozole as a primary ovulation induction agent generate better pregnancy rates than clomiphene citrate (CC) in subfertile women with anovulatory polycystic ovarian syndrome (PCOS)?Participants receiving letrozole as a primary treatment achieved a significantly (P = 0.022) higher clinical pregnancy rate per patient (61.2%) compared to CC (43.0%).According to a recent Cochrane systematic review (2014), letrozole appears to improve live-birth (LB) and pregnancy rates in anovulatory women with PCOS, compared to CC. However, the review concluded that the quality of evidence was low due to poor reporting of study methods and possible publication bias.This double-blind randomized controlled trial (RCT) included 159 participants between April 2007 and June 2014. Subjects were randomly allocated to either CC (n = 79) or letrozole (n = 80) in a 1:1 ratio. Both drugs were encapsulated to look identical. Randomization was performed in mixed blocks and stratified by patients' BMI (<30 and 30-35 kg/m2).The trial included subfertile women diagnosed with PCOS. Treatment started with one tablet (CC 50 mg, letrozole 2.5 mg) increasing to two in non-responders and continuing until pregnancy or for up to six ovulatory cycles. Non-responders were crossed over to the other treatment after a 6-week break. Cycles were initially monitored with ultrasound follicle tracking then mid-luteal serum progesterone measurement in subsequent cycles.Amongst the 159 participants included in the intention-to-treat analysis, four women conceived before treatment and six were lost-to-follow-up. The remaining 149 participants (74 on CC and 75 on letrozole) completed at least the first treatment. Women receiving letrozole achieved a significantly (P = 0.022; absolute difference [95% confidence interval] 18% [3-33%]) higher pregnancy rate (61.%) than those on CC (43%). The median number of treatment cycles received until pregnancy was significantly (log rank P = 0.038) smaller with letrozole (4[3-5] cycles) compared to CC (6[4-7] cycles). LB rates were not statistically (P = 0.089) different between the two groups, although there was a trend towards higher rates on letrozole (48.8%) compared to CC (35.4%). After the crossover, pregnancy and LB rates on letrozole (n = 45; 28.9 and 24.4%, respectively) were not statistically (P = 0.539 and P = 0.601) different from CC (n = 31; 22.6 and 19.4%).One possible limitation of this trial may be the exclusion of PCOS women with BMI > 35 kg/m2, which would limit the applicability of the results in this subgroup of PCOS. However, this group of women are generally excluded from treatment in the majority of fertility centres, especially in Europe, due to the associated challenges and risks.The results of this trial are consistent with the recent Cochrane systematic review. However, with its robust design, the current RCT provides more valid and compelling evidence for the superiority of letrozole over CC as a primary ovulation induction agent in PCOS women with 40% increase in pregnancy rates and with a shorter time-to-pregnancy. Furthermore, the participants in this RCT are a good representation of subfertile PCOS population receiving fertility treatment in Europe and worldwide. The results are therefore globally generalizable for clinical practice.This RCT was mainly funded by the R&D Funding Scheme of Derby Hospitals NHS Foundation Trust. The study also received funds from School of Medicine, University of Nottingham. The Trust R&D department was involved in the development of the protocol and the running of the trial. The trial was sponsored and monitored by the University of Nottingham. The authors have no conflicts of interest.www.Clinicaltrials.gov: NCT00478504.Registration was verified on 23/05/2007.25/04/2007.
| S-EPMC5850470 | biostudies-other
Project description:IntroductionEndovenous microwave ablation (EMA) is a relatively novel thermal ablation treatment for great saphenous vein (GSV) varicosis, and its efficacy and safety are rarely reported. This study aims to explore whether EMA can be comparable to endovenous laser ablation (EVLA), which is a widely used thermal ablation treatment in clinical practice.Methods and analysisThis is a multicentre, randomised controlled non-inferiority trial to compare the efficacy and safety of EMA and EVLA in patients with GSV varicosis. We will recruit 180 patients in 6 centres and randomly assign them into treatment group (EMA group) and control group (EVLA group) in a 1:1 ratio. The patients will return to the hospitals at 7 days, 3 months, 6 months and 12 months, and will be called at 1 month after the treatment for follow-up visits. The primary outcome is the occlusion rate of GSV immediately, at 6 months, and at 12 months after the treatment. The secondary outcomes are Venous Clinical Severity Score (VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ) Score, operation time and instrument performance evaluation.Ethics and disseminationThis protocol has been approved by the Clinical Trial Ethics Committee of Beijing Hospital (2020BJYYEC-126-02), Peking Union Medical College Hospital (KS2020393), Beijing Tsinghua Changgung Hospital (No.20279-2-02), Beijing Luhe Hospital.Capital Medical University (2020-LHYW-030-01), the First Hospital of Hebei Medical University (No.2020249), and the First Affiliated Hospital of Xi'an Jiaotong University (XJTU1AF2021LSY-12). The trial results will be published in peer-reviewed journals.Trial registration numberNCT04726124.
| S-EPMC9134177 | biostudies-literature