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AbstractObjectiveTo assess the three year outcomes of the no-touch vein harvesting technique in coronary artery bypass grafting surgery compared with the conventional approach.DesignThree year extended follow-up of the randomised PATENCY (graft patency between the no-touch vein harvesting technique and conventional approach in coronary artery bypass graft surgery) trial.SettingSeven cardiac surgery centres in China; enrolment between April 2017 and June 2019.Participants2655 participants aged 18 and older undergoing isolated coronary artery bypass grafting surgery.InterventionsPatients were randomly assigned 1:1 to the no-touch vein harvesting technique group or the conventional approach group during surgery and followed up.Main outcome measuresVein graft occlusion (based on computed tomography angiography) at three years.ResultsMean age of participants was 61 years (standard deviation ±8 years) and 22% were women. 99.4% (2621) attended the three year follow-up visit, while 86.5% (2281) received computed tomography angiography. At three years, the no-touch group showed a significantly lower vein graft occlusion rate (5.7% v 9.0%, P<0.001) than the conventional group (odds ratio 0.62, 95% confidence interval 0.48 to 0.80), with absolute risk difference of −3.2% (95% confidence interval −5.0% to −1.4%). The intention-to-treat analysis, including all 2655 randomised patients with multiple imputations for missing data, showed consistent findings, with occlusion rates of 6.1% in the no-touch group versus 9.3% in the conventional group (odds ratio 0.63, 95% confidence interval 0.51 to 0.81; absolute risk difference−3.1%, 95% confidence interval −4.9% to −1.4%; P<0.001). These results confirm the robustness of the no-touch technique in reducing vein graft occlusion.ConclusionsThe no-touch technique consistently and robustly reduced the risk of vein graft occlusion and several cardiac events by one third to one half within three years after coronary artery bypass grafting surgery.Trial registrationClinicalTrials.gov NCT03126409.

Endoscopic vein-graft harvesting is often used in coronary-artery bypass grafting (CABG) to prevent postoperative wound complications. However, in this study, which had a 3-year follow-up, endoscopic harvesting was associated with a higher rate of graft failure and adverse clinical outcomes. Although this is not a randomized study, it calls into question the use of endoscopic vein-graft harvesting in CABG. Endoscopic vein-graft harvesting is often used in coronary-artery bypass grafting (CABG) to prevent postoperative wound complications. However, in this study, endoscopic harvesting was associated with a higher rate of graft failure and adverse clinical outcomes. Coronary-artery bypass grafting (CABG) is one of the most commonly performed surgical procedures and improves the clinical outcomes in appropriately selected patients. 1 , 2 Despite increased use of an arterial conduit, the greater saphenous vein remains the conduit that is used most often in CABG. 1 Traditionally, the saphenous vein is harvested under direct vision (open harvesting) with the help of linear incisions along the course of the vein. This approach is associated with discomfort and the risk of complications, including edema, hematoma, delayed healing, cellulitis, and wound dehiscence. 3 – 7 Endoscopic vein-graft harvesting, a procedure that was developed to eliminate the need . . .

The SWEDEGRAFT study (ClinicalTrials.gov Identifier: NCT03501303) tests the hypothesis that saphenous vein grafts (SVGs) harvested with the “no-touch” technique improves patency of coronary artery bypass grafts compared with the conventional open skeletonized technique. This article describes the rationale and design of the randomized trial and baseline characteristics of the population enrolled during the first 9 months of enrollment. The SWEDEGRAFT study is a prospective, binational multicenter, open-label, registry-based trial in patients undergoing first isolated nonemergent coronary artery bypass grafting (CABG), randomized 1:1 to no-touch or conventional open skeletonized vein harvesting technique, with a planned enrollment of 900 patients. The primary end point is the proportion of patients with graft failure defined as SVGs occluded or stenosed >50% on coronary computed tomography angiography at 2 years after CABG, earlier clinically driven coronary angiography demonstrating an occluded or stenosed >50% vein graft, or death within 2 years. High-quality health registries and coronary computed tomography angiography are used to assess the primary end point. The secondary end points include wound healing in the vein graft sites and the composite outcome of major adverse cardiac events during the first 2 years based on registry data. Demographics of the first 200 patients enrolled in the trial and other CABG patients operated in Sweden during the same time period are comparable when the exclusion criteria are taken into consideration. RCT# NCT03501303

Saphenous vein graft (SVG) failure remains a substantial challenge after coronary artery bypass graft (CABG). LDL cholesterol (LDL-C) is a causal risk factor for atherosclerosis, but its role in SVG failure is not well established. We evaluated whether early initiation of intensive LDL-C lowering with evolocumab could reduce SVG failure. NEWTON-CABG CardioLink-5 was a multicentre, double-blind, randomised, placebo-controlled trial conducted at 23 sites in Canada, the USA, Australia, and Hungary. Eligible participants were adults (age ≥18 years) who underwent CABG with at least two SVGs and were being treated with statin therapy of moderate or high intensity. Participants were randomly allocated (1:1; variable block size) within 21 days of CABG to subcutaneous evolocumab 140 mg or placebo every 2 weeks. The primary endpoint was the 24-month vein graft disease rate (VGDR; the proportion of SVGs with ≥50% occlusion on coronary CT angiography or clinically indicated invasive angiography) in the modified intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT03900026, and is completed. Between June 17, 2019, and Nov 10, 2022, 782 individuals were randomly assigned (389 to evolocumab and 393 to placebo). At baseline, among the 554 participants with primary outcome data available, the median age was 66 years (IQR 60–72), 471 (85%) of 554 participants were male and 83 (15%) were female, and the median LDL-C was 1·85 mmol/L (IQR 1·25–2·84) in the evolocumab group and 1·86 mmol/L (1·20–2·76) in the placebo group. Evolocumab resulted in a mean 48·4% placebo-adjusted reduction in LDL-C at 24 months (–52·4% vs –4·0%). The 24-month VGDR was 21·7% (149 of 686 grafts) in the evolocumab group and 19·7% (127 of 644 grafts) in the placebo group (difference 2·0% [95% CI –3·1 to 7·1]; p=0·44). Treatment was well tolerated, with similar adverse event profiles between the groups. Among patients who underwent CABG, evolocumab did not reduce SVG disease at 24 months following the index surgery despite substantial LDL-C lowering. Further LDL-C lowering does not appear to meaningfully affect the pathophysiological mechanisms responsible for early SVG failure. Amgen Canada.

BackgroundTicagrelor was shown to reduce mortality in patients who underwent coronary artery bypass grafting (CABG), but its effect on graft patency is unknown.MethodsWe performed a prospective, randomised, double-blind, placebo-controlled trial, comparing ticagrelor 90 mg twice daily versus placebo for 3 months added to aspirin 81 mg/day, following isolated CABG. Aspirin was started within 12 h, and study medication within 72 h after CABG. Primary outcome was graft occlusion on CT angiography (CTA) performed 3 months post CABG. Patients were followed to 12 months for death, myocardial infarction, stroke, repeat revascularisation and bleeding.ResultsThe study was terminated prematurely after randomising 70 patients between September 2011 and August 2014 because of slow recruitment. CTA was performed in 56 patients who completed >1 month of study drug. Graft occlusion occurred in 7/25 (28.0%) patients on ticagrelor and 17/31 (48.3%) on placebo, p=0.044. Of 207 analysable grafts, graft occlusion occurred in 9/87 (10.3%) with ticagrelor and 22/120 (18.3%) with placebo, p=0.112. Graft occlusion or stenosis ≥50% occurred in 10/87 (11.5%) ticagrelor vs 32/120 (26.7%) placebo, p=0.007. There was no major bleeding, but minor bleeding was higher with ticagrelor (31.4% vs 2.9%, p=0.003). In univariate analysis, ticagrelor use reduced graft occlusion (OR 0.32, 95% CI 0.10 to 0.97, p=0.047), which remained significant on multivariable analysis (OR 0.25, 95% CI 0.073 to 0.873, p=0.03).ConclusionsTicagrelor added to aspirin after CABG reduced the proportion of patients with graft occlusion, and was a significant univariate and multivariable predictor of graft occlusion. These results are hypothesis-generating and should be confirmed in larger studies.Trial registration numberNCT01373411: Results.

Previous studies suggested only the radial artery and the No-touch (NT) technique were effective in reducing graft occlusion after coronary artery bypass grafting (CABG) surgery. However, there is no randomized trial comparing these 2 graft conduits. The optimum second conduit for CABG remains undetermined. This study is a prospective, single-center randomized clinical trial, aiming to compare the graft patency between the radial artery and the NT vein graft. All patients undergoing isolated CABG with left internal mammary artery (LIMA) plus at least 2 additional grafts will be considered eligible. About 774 cases (516 in the radial artery group and 258 in the NT vein group) will be enrolled in over 1 to 2 years. Participants will be randomized and allocated to two bypass strategies: the LIMA plus 1 radial artery and 1 conventional vein graft, or the LIMA plus 2 NT vein grafts. The primary outcome is graft occlusion at 1 year after CABG evaluated by CT angiography. The secondary outcomes include graft occlusion at 3 and 5 years and major adverse cardiac or cerebrovascular events at 1, 3, and 5 years follow-ups. This study will define whether or not the NT vein has a lower graft occlusion rate than the radial artery in short and mid-term follow-ups, and provide new evidence for the second conduit choice in CABG surgery. ClinicalTrials.gov NCT06014047. Registered on October 15th, 2023.

Background Externally stenting saphenous vein grafts reduces intimal hyperplasia, improves lumen uniformity and reduces oscillatory shear stress 1 year following surgery. The present study is the first to present the longer-term (4.5 years) performance and biomechanical effects of externally stented saphenous vein grafts. Methods Thirty patients previously implanted with the VEST external stent in the randomized, within-patient-controlled VEST I study were followed up for adverse events; 21 of these were available to undergo coronary angiography and intravascular ultrasound. Results Twenty-one stented and 29 nonstented saphenous vein grafts were evaluated by angiography and ultrasound at 4.5 ± 0.3 years. Vein graft failure rates were comparable between stented and nonstented grafts (30 and 23% respectively; p  = 0.42). All failures were apparent at 1 year except for one additional nonstented failure at 4.5 years. In patent vein grafts, Fitzgibbon perfect patency remained significantly higher in the stented versus nonstented vein grafts (81 and 48% respectively, p  = 0.002), while intimal hyperplasia area (4.27 mm 2  ± 1.27 mm 2 and 5.23 mm 2  ± 1.83 mm 2 respectively, p  < 0.001) and thickness (0.36 mm ± 0.09 mm and 0.42 mm ± 0.11 mm respectively, p  < 0.001) were significantly reduced. Intimal hyperplasia proliferation correlated with lumen uniformity and with the distance between the stent and the lumen ( p  = 0.04 and p  < 0.001 respectively). Conclusions External stenting mitigates saphenous vein graft remodeling and significantly reduces diffuse intimal hyperplasia and the development of lumen irregularities 4.5 years after coronary artery bypass surgery. Close conformity of the stent to the vessel wall appears to be an important factor. Trial registration NCT01415245 . Registered 11 August 2011.

In this randomized, double-blind, placebo-controlled trial of twice-daily extended-release dipyridamole and aspirin, used after the placement of a new arteriovenous graft, the primary outcome was loss of primary unassisted patency; secondary outcomes included cumulative graft failure and death. Active treatment had a significant but modest effect of reducing the risk of stenosis and improving the primary unassisted patency of newly created grafts. Dipyridamole and aspirin, used after the placement of a new arteriovenous graft, had a significant but modest effect of reducing the risk of stenosis and improving the primary unassisted patency of newly created grafts. A functioning vascular access is necessary for hemodialysis. However, vascular-access failure is common and is a major source of complications. 1 Vascular access for hemodialysis can be provided by means of an autogenous fistula, arteriovenous graft, or central venous catheter. The arteriovenous graft, typically created by using a synthetic tube connecting an artery and a vein, was until recently the most common type of access used in the United States. 2 Grafts are generally more readily cannulated than fistulas and can be used for hemodialysis sooner after surgery. With grafts, however, stenosis frequently develops at the venous anastomosis, leading to access thrombosis, . . .

Background Autologous arteriovenous fistulae (AVFs) are the best type of vascular access in patients with kidney failure. However, the conventional technique has a high failure rate. We performed a randomised controlled trial to investigate whether the no-touch technique has a higher maturation and patency rate than that of the conventional technique for creating AVFs. Methods This study was a single-centre randomised controlled trial involving patients with kidney failure requiring an AVF for haemodialysis access. A total of 179 patients undergoing their first radial artery-cephalic fistula were randomized 1:1 to the no-touch technique ( n  = 90) or conventional technique ( n  = 89). The maturation and patency rate of the two techniques were compared and analysed. Results The preoperative baseline data showed no differences between groups. When comparing the no-touch technique to the conventional technique, the maturation rate was 93% vs. 89% and the 1-year primary function patency was 72% vs. 62%, respectively. Factors associated with AVF failure included age > 55 years (OR = 2.417, 95% CI 1.242–4.703), female sex (OR = 2.149, 95% CI 1.099–4.202), and vein diameter ≤ 1.8 mm (OR = 3.664, 95% CI 1.714–7.832). For patients with small veins the maturation rate was 92.98% vs. 80% and the 1-year primary function patency was 68.42% vs. 40% for the no-touch technique and conventional technique, respectively. Conclusions The no-touch technique has a higher maturation and patency rate than the conventional technique for creating an autologous AVF, especially in patients with small veins. This technique may provide a better outcome for patients with small cephalic veins. Graphical abstract

Background In view of the conflicting results from previous studies, the benefit of paclitaxel-coated balloons for arteriovenous fistulas is uncertain and equipoise remains. Although an industry-led trial testing the efficacy of sirolimus-coated balloons in AVFs is in progress, the benefit of sirolimus-coated balloons for arteriovenous fistulas is currently unknown. The purpose of this trial is to compare the efficacy of additional paclitaxel-coated or sirolimus-coated balloons on outcomes after a plain balloon fistuloplasty to preserve the patency of arteriovenous fistulae used for haemodialysis. Methods The study design is a multicentre randomised controlled trial. Following a successful plain balloon fistuloplasty, participants will be randomised to further treatment with a paclitaxel-coated balloon, a sirolimus-coated balloon, or an uncoated control balloon. We will recruit 642 patients, each with one or two treatment segments, over a 3-year period. Patients will remain in the trial and be followed up for 1 year. The primary endpoint is time to loss of treatment segment primary patency. Cox-proportional hazards models will be used to estimate hazard ratios for the time to loss of treatment segment primary patency for each treatment group relative to the control group. Analysis of the primary endpoint will be based on treatment segments rather than participants and a shared frailty will be estimated to account for the clustering of treatment segments within patients. Secondary endpoints are time to loss of primary patency at any treatment segment; time to end of access circuit primary patency; time to AVF abandonment; number of radiological or surgical interventions; adverse events; intima-media thickness and degree of stenosis at 3 months on ultrasound; and patient quality of life assessed by EQ-5D-5L and VASQoL. Discussion The three-armed design in this proposal will provide an answer on the efficacy of both paclitaxel- and sirolimus-coated balloons in the same trial. This trial is likely to provide a clear answer regarding the efficacy of drug-coated balloons for arteriovenous fistulas. Trial registration ISRCTN ISRCTN40182296. Registered on 4 August 2023.