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Comparative effectiveness of anticoagulation on midterm infrainguinal bypass graft patency.

ABSTRACT: Therapeutic anticoagulation (AC) is used clinically for prolongation of infrainguinal bypass patency, but evidence for the efficacy of this practice is conflicting. The objective of our study was to determine the association of AC with bypass graft primary patency.Clinical and comorbid data of patients undergoing infrainguinal bypass grafts to a below-knee target with at least 1 year of follow-up performed from 2003 to 2015 were obtained from the Society for Vascular Surgery Vascular Quality Initiative. Inverse propensity of treatment-weighted Cox regression was used to assess the effect of AC on patency in the total cohort while adjusting for clinical, operative, and comorbid differences between treatment groups. Subgroup analyses of distal targets and conduit type were performed. Perioperative complications were analyzed using propensity-weighted logistic regression.We identified 7612 bypass grafts with intact 1-year follow-up information from 2003 to 2015. The mean age was 67.5 ± 11.2 years; 30.5% (n = 2320) were female, and 28.6% (n = 2165) were discharged on therapeutic AC. The anticoagulated group had a higher rate of tibial, ankle, and pedal targets (52.1% [n = 1127] vs 47.6% [n = 2269]; P < .001), had a greater use of non-single-segment vein conduits (44.3% [n = 951] vs 26.5% [n = 1426]; P < .001), and was more likely to have had a previous ipsilateral bypass (27.2% [n = 589] vs 14.7% [n = 794]; P < .001) or stent (25.4% [n = 550] vs 20.9% [n = 1130]; P < .001). Estimated unadjusted primary patency was 70.8% ± 0.6% at 1 year and lower for anticoagulated bypasses (66.9% ± 1.2% vs 72.4% ± 0.7%; P < .001). Propensity-weighted analysis showed no significant association of AC with primary patency in the overall cohort (hazard ratio [HR], 0.98; 95% confidence interval [CI], 0.86-1.11; P = .8) but demonstrated a trend toward improvement of primary patency in those with a non-single-segment vein conduit to a below-knee popliteal target (HR, 0.85; 95% CI, 0.80-1.02; P = .09). AC was associated with significantly improved secondary patency in those with prosthetic bypass grafts (HR, 0.77; 95% CI, 0.62-0.96; P = .02) or prosthetic bypasses to an infrapopliteal target (HR, 0.72; 95% CI, 0.54-0.97; P = .02). Odds of postoperative wound complications were significantly higher in those receiving AC (odds ratio, 1.33; 95% CI, 1.11-1.61; P = .002).This study does not demonstrate a significant impact of therapeutic AC on primary patency for infrainguinal bypass grafts. Treatment with AC may benefit secondary patency in those with a prosthetic bypass, especially to an infrapopliteal target, but at an increased risk of postoperative wound complications.

SUBMITTER: Liang NL

PROVIDER: S-EPMC5524600 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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Comparative effectiveness of anticoagulation on midterm infrainguinal bypass graft patency.

Liang Nathan L NL Baril Donald T DT Avgerinos Efthymios D ED Leers Steven A SA Makaroun Michel S MS Chaer Rabih A RA

Journal of vascular surgery 20170408 2

<h4>Objective</h4>Therapeutic anticoagulation (AC) is used clinically for prolongation of infrainguinal bypass patency, but evidence for the efficacy of this practice is conflicting. The objective of our study was to determine the association of AC with bypass graft primary patency.<h4>Methods</h4>Clinical and comorbid data of patients undergoing infrainguinal bypass grafts to a below-knee target with at least 1 year of follow-up performed from 2003 to 2015 were obtained from the Society for Vas ...[more]

PMID: 28400219

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Project description:PurposeCoronary artery bypass grafting (CABG) is performed either with the aid of cardiopulmonary bypass (on-pump) or without cardiopulmonary bypass (off-pump). There is a scarcity of angiographic data to support the non-inferiority of off-pump technique to on-pump technique. The objective of this study is to ascertain the non-inferiority of off-pump CABG when compared to on-pump CABG in terms of angiographically assessed graft patency at 3 months.MethodsA total of 320 patients with multivessel coronary artery disease were enrolled in a multicenter prospective randomized trial either to on-pump CABG (n = 162) or off-pump CABG (n = 158) between March 2016 through March 2017. Graft patency was evaluated by using either multidetector computerized tomographic angiography or conventional coronary angiography at 3 months. The major adverse cardiac and cardiovascular events (MACCE) were also analyzed at 3 months.ResultsThe median number of grafts per patient in off-pump was 3.00 (Q1:3.00 and Q3:4.00) vs on-pump 4.00 (Q1:3.00 to Q3:4.00), and the mean number of grafts per patient was lower in the off-pump CABG at 3.45 ± 0.75 vs 3.64 ± 0.70 in the on-pump CABG (p = 0.01). There was no significant difference in mortality at 3 months between the off-pump (0.63%) and on-pump groups (1.85%) with p value of 0.62. The cumulative combined MACCE showed significant difference between off-pump group (0.63%) and on-pump group (5.55%), p = 0.01. Follow-up angiograms were done in 239 (75%) patients with 120 off-pump and 119 in the on-pump group. The analysis was also done regarding graft patency in a graded manner-when analysis of A (excellent) grafts vs B (stenosed) grafts and O (occluded) grafts were made, there was no statistically significant difference in overall graft patency at 3 months between on-pump [376 /429 grafts (87.6%)] and off-pump [366 /420 grafts (87.1%)] groups (p = 0.82). The patency rates were similar among bypass conduits (left internal thoracic artery (ITA) in off-pump (91.4%) vs on-pump (92.9%) p = 0.66, right ITA in off-pump (82.1%) vs on-pump (81.8%) p = 0.97, radial artery in off-pump (84.4%) vs on-pump (82.6%) p = 0.81; saphenous vein in off-pump (85.8%) vs on-pump (86.3%), p = 0.86 and among 3 coronary territories.ConclusionsOff-pump CABG is non-inferior to on-pump CABG in terms of overall graft patency at 3 months and was associated with a fewer combined cumulative MACCE compared to on-pump CABG.

Project description:ImportanceIn vitro and animal model data suggest that intraoperative preservation solutions may influence endothelial function and vein graft failure (VGF) after coronary artery bypass graft (CABG) surgery. Clinical studies to validate these findings are lacking.ObjectiveTo evaluate the effect of vein graft preservation solutions on VGF and clinical outcomes in patients undergoing CABG surgery.Design, setting, and participantsData from the Project of Ex-Vivo Vein Graft Engineering via Transfection IV (PREVENT IV) study, a phase 3, multicenter, randomized, double-blind, placebo-controlled trial that enrolled 3014 patients at 107 US sites from August 1, 2002, through October 22, 2003, were used. Eligibility criteria for the trial included CABG surgery for coronary artery disease with at least 2 planned vein grafts.InterventionsPreservation of vein grafts in saline, blood, or buffered saline solutions.Main outcomes and measuresOne-year angiographic VGF and 5-year rates of death, myocardial infarction, and subsequent revascularization.ResultsMost patients had grafts preserved in saline (1339 [44.4%]), followed by blood (971 [32.2%]) and buffered saline (507 [16.8%]). Baseline characteristics were similar among groups. One-year VGF rates were much lower in the buffered saline group than in the saline group (patient-level odds ratio [OR], 0.59 [95% CI, 0.45-0.78; P < .001]; graft-level OR, 0.63 [95% CI, 0.49-0.79; P < .001]) or the blood group (patient-level OR, 0.62 [95% CI, 0.46-0.83; P = .001]; graft-level OR, 0.63 [95% CI, 0.48-0.81; P < .001]). Use of buffered saline solution also tended to be associated with a lower 5-year risk for death, myocardial infarction, or subsequent revascularization compared with saline (hazard ratio, 0.81 [95% CI, 0.64-1.02; P = .08]) and blood (0.81 [0.63-1.03; P = .09]) solutions.Conclusions and relevancePatients undergoing CABG whose vein grafts were preserved in a buffered saline solution had lower VGF rates and trends toward better long-term clinical outcomes compared with patients whose grafts were preserved in saline- or blood-based solutions.Trial registrationclinicaltrials.gov Identifier: NCT00042081.

Project description:BackgroundArteriovenous graft stenosis leading to thrombosis is a major cause of complications in patients undergoing hemodialysis. Procedural interventions may restore patency but are costly. Although there is no proven pharmacologic therapy, dipyridamole may be promising because of its known vascular antiproliferative activity.MethodsWe conducted a randomized, double-blind, placebo-controlled trial of extended-release dipyridamole, at a dose of 200 mg, and aspirin, at a dose of 25 mg, given twice daily after the placement of a new arteriovenous graft until the primary outcome, loss of primary unassisted patency (i.e., patency without thrombosis or requirement for intervention), was reached. Secondary outcomes were cumulative graft failure and death. Primary and secondary outcomes were analyzed with the use of a Cox proportional-hazards regression with adjustment for prespecified covariates.ResultsAt 13 centers in the United States, 649 patients were randomly assigned to receive dipyridamole plus aspirin (321 patients) or placebo (328 patients) over a period of 4.5 years, with 6 additional months of follow-up. The incidence of primary unassisted patency at 1 year was 23% (95% confidence interval [CI], 18 to 28) in the placebo group and 28% (95% CI, 23 to 34) in the dipyridamole-aspirin group, an absolute difference of 5 percentage points. Treatment with dipyridamole plus aspirin significantly prolonged the duration of primary unassisted patency (hazard ratio, 0.82; 95% CI, 0.68 to 0.98; P=0.03) and inhibited stenosis. The incidences of cumulative graft failure, death, the composite of graft failure or death, and serious adverse events (including bleeding) did not differ significantly between study groups.ConclusionsTreatment with dipyridamole plus aspirin had a significant but modest effect in reducing the risk of stenosis and improving the duration of primary unassisted patency of newly created grafts. (ClinicalTrials.gov number, NCT00067119.)

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Comparative effectiveness of anticoagulation on midterm infrainguinal bypass graft patency.

Publications

Comparative effectiveness of anticoagulation on midterm infrainguinal bypass graft patency.

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