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Objectives: Using bilateral internal thoracic arteries (BITA) for coronary artery bypass grafting (CABG) has been suggested to improve survival compared to CABG using single internal thoracic arteries (SITA) for patients with advanced coronary artery disease. We used data from the Arterial Revascularisation Trial (ART) to assess long-term cost-effectiveness of BITA grafting compared to SITA grafting from an English health system perspective. Methods: Resource use, healthcare costs and quality-adjusted life-years (QALYs) were assessed across 10-years of follow-up. An intention-to-treat analysis of differences between trial arms was conducted. Missing data were addressed using multiple imputation. Incremental cost-effectiveness ratios were calculated with uncertainty characterised using non-parametric bootstrapping. Results were extrapolated beyond 10 years using Gompertz functions for survival and linear models for total cost and utility. Results: Total mean costs at 10 years of follow-up were estimated at £17,594736 in the BITA arm and £16,462594 in the SITA arm (mean difference £1,133118 95% CI £239195 to £2,026041, p= 0.01520). Total mean QALYs at 10 years were 6.54 in the BITA are and 6.57 in the SITA arm (adjusted mean difference -0.01 95% CI -0.2 to 0.1, p= 0.883). The estimated probability of BITA grafting being cost-effective compared to SITA grafting was 33% over 10 years of follow-up assuming a cost-effectiveness threshold of £20,000. Mean costs extrapolated to life-time increased to £20,760 in the SITA arm and £21,925 in the BITA arm. Mean QALYs extrapolated to life-time were 12.52 in the SITA arm and 12.61 in the BITA arm., The probability of BITA being cost-effective at a £20,000 threshold increased to 5160% when extrapolated to lifetime. Conclusions: BITA grafting has significantly higher costs but similar quality-adjusted survival at 10 years compared to SITA grafting.

Objective We performed a post hoc analysis of the Arterial Revascularization Trial to compare 10-year outcomes after off-pump versus on-pump surgery. Methods Among 3102 patients enrolled, 1252 (40% of total) and 1699 patients received off-pump and on-pump surgery (151 patients were excluded because of other reasons); 2792 patients (95%) completed 10-year follow-up. Propensity matching and mixed-effect Cox model were used to compare long-term outcomes. Interaction term analysis was used to determine whether bilateral internal thoracic artery grafting was a significant effect modifier. Results One thousand seventy-eight matched pairs were selected for comparison. A total of 27 patients (2.5%) in the off-pump group required conversion to on-pump surgery. The off-pump and on-pump groups received a similar number of grafts (3.2 ± 0.89 vs 3.1 ± 0.8; P = .88). At 10 years, when compared with on-pump, there was no significant difference in death (adjusted hazard ratio for off-pump, 1.1; 95% confidence interval, 0.84-1.4; P = .54) or the composite of death, myocardial infarction, stroke, and repeat revascularization (adjusted hazard ratio, 0.92; 95% confidence interval, 0.72-1.2; P = .47). However, off-pump surgery performed by low volume off-pump surgeons was associated with a significantly lower number of grafts, increased conversion rates, and increased cardiovascular death (hazard ratio, 2.39; 95% confidence interval, 1.28-4.47; P = .006) when compared with on-pump surgery performed by on–pump-only surgeons. Conclusions The findings showed that in the Arterial Revascularization Trial, off-pump and on-pump techniques achieved comparable long-term outcomes. However, when off-pump surgery was performed by low-volume surgeons, it was associated with a lower number of grafts, increased conversion, and a higher risk of cardiovascular death.

BACKGROUND Multiple arterial grafts may result in longer survival than single arterial grafts after coronary-artery bypass grafting (CABG) surgery. We evaluated the use of bilateral internal-thoracic-artery grafts for CABG. METHODS We randomly assigned patients scheduled for CABG to undergo bilateral or single internal-thoracic-artery grafting. Additional arterial or vein grafts were used as indicated. The primary outcome was death from any cause at 10 years. The composite of death from any cause, myocardial infarction, or stroke was a secondary outcome. RESULTS A total of 1548 patients were randomly assigned to undergo bilateral internal-thoracic-artery grafting (the bilateral-graft group) and 1554 to undergo single internal-thoracic-artery grafting (the single-graft group). In the bilateral-graft group, 13.9% of the patients received only a single internal-thoracic-artery graft, and in the single-graft group, 21.8% of the patients also received a radial-artery graft. Vital status was not known for 2.3% of the patients at 10 years. In the intention-to-treat analysis at 10 years, there were 315 deaths (20.3% of the patients) in the bilateral-graft group and 329 deaths (21.2%) in the single-graft group (hazard ratio, 0.96; 95% confidence interval [CI], 0.82 to 1.12; P=0.62). Regarding the composite outcome of death, myocardial infarction, or stroke, there were 385 patients (24.9%) with an event in the bilateral-graft group and 425 patients (27.3%) with an event in the single-graft group (hazard ratio, 0.90; 95% CI, 0.79 to 1.03). CONCLUSIONS Among patients who were scheduled for CABG and had been randomly assigned to undergo bilateral or single internal-thoracic-artery grafting, there was no significant between-group difference in the rate of death from any cause at 10 years in the intention-to-treat analysis. Further studies are needed to determine whether multiple arterial grafts provide better outcomes than a single internal-thoracic-artery graft. (Funded by the British Heath Foundation and others; Current Controlled Trials number, ISRCTN46552265.)

Background The arterial revascularization trial (ART) has been designed to answer the question whether the use of bilateral internal thoracic arteries (BITA) can improve 10-year outcomes when compared to single internal thoracic artery (SITA). In the ART, a significant proportion of patients initially allocated to BITA received other conduit strategies. We sought to investigate the incidence and clinical implication of BITA grafts conversion in the ART. Methods Among patients enrolled in the ART (n=3102), we excluded those allocated to SITA (n=1554), those who did not undergo surgery (n=16) and those operated on but withdrew after randomization (n=7). Propensity score matching was used to compare converted vs non-converted BITA groups. Results A total of 1525 patients were operated with intention to receive BITA grafting. Of those, 233 (15.3%) were converted to other conduit selection strategies. Incidence of conversion largely varied across 28 centres involved (from 0% to 42.9%). The most common reason for BITA grafts conversion was the evidence of at least one internal thoracic artery not suitable which was reported in 77 cases. Patients with intraoperative BITA graft conversion received a lower number of grafts (2.95±0.84 vs 3.21±0.74; PConclusions The incidence of intraoperative BITA graft conversion is not irrelevant . BITA graft conversion is not associated with increased operative morbidity but its effect on late outcomes remain uncertain.

Background: The long-term effects of off-pump coronary artery bypass continue to be controversial because some studies have reported increased adverse event rates with off-pump coronary artery bypass when compared with on-pump coronary artery bypass. The Arterial Revascularization Trial compared survival after bilateral versus single internal thoracic artery grafting. The choice of off-pump coronary artery bypass versus on-pump coronary artery bypass was based on the surgeon's discretion. We performed a post hoc analysis of the Arterial Revascularization Trial to compare 5-year outcomes with 2 strategies. Methods: Among 3102 patients enrolled in the Arterial Revascularization Trial, we selected 1260 patients who underwent off-pump coronary artery bypass versus 1700 patients who underwent on-pump coronary artery bypass with cardioplegic arrest for the present comparison. Primary outcomes were 5-year mortality and incidence of major cardiac and cerebrovascular events, including cardiovascular death, myocardial infarction, cerebrovascular accident, and revascularization after index procedure. Propensity score matching selected 1260 pairs for final comparison. Stratified Cox models were used for treatment effect estimate. Results: Hospital mortality was comparable between off-pump coronary artery bypass and on-pump coronary artery bypass groups (12 [1.0%] vs 15 [1.2%]; P = .7). Conversion rate to on-pump during off-pump coronary artery bypass was 29 of 1260 (2.3%). When compared with off-pump coronary artery bypass not converted, off-pump coronary artery bypass converted to on-pump presented a remarkably higher hospital mortality (10.3% vs 0.7%; P < .001). At 5 years, the mortality rate was 110 (8.9%) versus 102 (8.3%) in the off-pump coronary artery bypass and on-pump coronary artery bypass groups, respectively, with no significant difference (hazard ratio, 1.14; 95% confidence interval, 0.86-1.52; P = .35). Incidence of major cardiac and cerebrovascular events was 175 (14.3) versus 169 (13.8) in the off-pump coronary artery bypass and on-pump coronary artery bypass groups, respectively, with no significant difference (hazard ratio, 1.05; 95% confidence interval, 0.84-1.31; P = .65). Conclusions: The present post hoc Arterial Revascularization Trial analysis supports the hypothesis that both off-pump coronary artery bypass and on-pump coronary artery bypass are equally effective and safe.

Background: Whether the use of the radial artery (RA) can improve clinical outcomes in coronary artery bypass graft surgery remains unclear. The ART (Arterial Revascularization Trial) was designed to compare survival after bilateral internal thoracic artery (BITA) over single left internal thoracic artery (SITA). In the ART, a large proportion of patients (≈20%) also received an RA graft instead of a saphenous vein graft (SVG). We aimed to investigate the associations between using the RA instead of an SVG to supplement SITA or BITA grafts and outcomes by performing a post hoc analysis of the ART. Methods: Patients enrolled in the ART (n=3102) were classified on the basis of conduits actually received (as treated). The analysis included 2737 patients who received an RA graft (RA group; n=632) or SVG only (SVG group; n=2105) in addition to SITA or BITA grafts. The primary end point was the composite of myocardial infarction, cardiovascular death, and repeat revascularization at 5 years. Propensity score matching and stratified Cox regression were used to compare the 2 strategies. Results: Myocardial infarction, cardiovascular death, and repeat revascularization cumulative incidence was 2.3% (95% confidence interval [CI], 1.1–3.4), 3.5% (95% CI, 2.1–5.0), and 4.4% (95% CI, 2.8–6.0) in the RA group and 3.4% (95% CI, 2.0–4.8), 4.0% (95% CI, 2.5–5.6), and 7.6% (95% CI, 5.5–9.7) in the SVG group, respectively. The composite end point was significantly lower in the RA group (8.8%; 95% CI, 6.5–11.0) compared with the SVG group (13.6%; 95% CI, 10.8–16.3; P =0.005). This association was present when an RA graft was used to supplement both SITA and BITA grafts (interaction P =0.62). Conclusions: This post hoc ART analysis showed that an additional RA was associated with lower risk for midterm major adverse cardiac events when used to supplement SITA or BITA grafts. Clinical Trial Registration: URL: https://www.situ.ox.ac.uk/surgical-trials/art . Unique identifier: ISRCTN46552265.

OBJECTIVE: Coronary artery bypass grafting (CABG) using bilateral internal mammary arteries (BIMA) may improve survival over CABG using single internal mammary arteries (SIMA), but may be surgically more complex (and therefore costly) and associated with impaired sternal wound healing. We report, for the first time, a detailed comparison of healthcare resource use and costs over 12 months, as part of the Arterial Revascularisation (ART) Trial. METHODS: 3102 patients in 28 hospitals in seven countries were randomised to CABG surgery using BIMA (n=1548) or SIMA (n=1554). Detailed resource use data were collected covering surgery, the initial hospital episode, and for 12 months post randomisation. Using UK unit costs, total costs were calculated and compared between trial arms and for subgroups. RESULTS: Patients randomised to BIMA spent 20 min longer in theatre (95% CI 15 to 25, pCONCLUSIONS: At 12 months from randomisation, mean costs were approximately 9% higher in BIMA than SIMA patients, primarily due to longer time in theatre and in-hospital stay, and slightly higher costs related to sternal wound problems during follow-up. Follow-up to the primary trial endpoint of 10 years will reveal whether longer-term differences emerge in graft patency or in overall survival. TRIAL REGISTRATION NUMBER: Controlled-trials.com (ISRCTN46552265).

Objective(s) The question of whether skeletonized internal mammary artery (IMA) harvesting reduces the incidence of sternal wound complications in comparison to the pedicled technique, in the context of single or bilateral IMAs, remains controversial. We studied the impact IMA harvesting strategy on sternal wound complication in the Arterial Revascularization Trial (ART). Methods Patients enrolled in the ART (n=3102) were randomised to coronary artery bypass grafting with single or bilateral IMAs. Sternal wound complication rates were examined according to the harvesting technique that was documented in 2056 patients. The IMA harvesting technique, based on surgeon preference, resulted in 4 groups: pedicled single IMA (P-SIMA, n=607), pedicled bilateral IMA (P-BIMA, n=459), skeletonized single IMA (S-SIMA, n=512) and skeletonized bilateral IMA (S-BIMA, n=478). Propensity Scores weighting was used to estimate the impact of the harvesting technique on sternal wound complications. Results A total of 219 of 2056 patients (10.6%) experienced a sternal wound complication within 1 year from the index operation. Of those, only 25 (1.2%) patients required sternal wound reconstruction. P-BIMA (OR 1.80; 95%CI 1.23 to 2.63) but not S-BIMA (OR 1.00; 95%CI 0.65 to 1.53) or S-SIMA (OR 0.89; 95%CI 0.57-1.38) was associated with a significantly increased risk of any sternal wound complications compared to P-SIMA. Conclusions The present ART sub-study suggests that, with a skeletonization technique, the risk of sternal wound complication with BIMA grafting is similar to that after standard pedicled SIMA harvesting whilst skeletonized SIMA harvesting did not add any further benefit when compared to pedicled SIMA harvesting.

Background: Acute Coronary Syndromes account for 15% of deaths in the UK, and patients remain at significant risk of re-admission for future complications and death. Pathologically the underlying process of atherosclerosis is driven by inflammatory mechanisms, which are activated in ACS patients. Previous studies have investigated the role of inflammatory markers in this process, including interleukin 1 (IL-1) and C Reactive Protein (CRP). Pre-clinical studies indicate that IL-1 may be a primary driver of ACS and that the naturally occurring interleukin-1 receptor antagonist (IL-1ra) may inhibit the atherosclerotic process. This study will investigate the effects of IL-1ra on inflammatory markers in man.\ud \ud Methods/design: Three centres in the UK are planning to recruit 186 Non-ST elevation myocardial infarction patients to receive either interleukin-1 receptor antagonist (Anakinra) or matching placebo. Patients will receive a daily subcutaneous injection of either study drug or placebo over a 14 day period. The primary outcome is area under the curve of high sensitivity C-Reactive Protein (CRP) over the first 7 days.\ud \ud Discussion: The MRC-ILA-HEART Study is a proof of concept clinical trial investigating the effects of IL-1ra upon markers of inflammation in patients with Non-ST elevation myocardial infarction. It is hoped this will provide new and exciting information in relation to an "anti-inflammatory" strategy for patients with acute coronary syndrome.

Loss of ovarian function at the menopause results in an increased risk for cardiovascular disease and osteoporosis. Hormone replacement therapy (HRT) in postmenopausal women may reduce or remove this increased risk. The high hepatic bolus seen with oral steroid administration, which may produce unwanted metabolic effects, is avoided by transdermal administration. We studied the metabolic effects of transdermal HRT in comparison with oral HRT or no treatment in 96 healthy postmenopausal women over 3 years. Treatment consisted of either continuous oral conjugated equine estrogens, 0.625 mg daily, with sequential oral dl-norgestrel, 0.15 mg daily, for 12 days per month or continuous transdermal estradiol-17 beta, 0.05 mg daily, with sequential transdermal norethindrone acetate, 0.25 mg daily, for 14 days per month. We measured bone biochemistry and density, serum lipids, lipoproteins and apolipoproteins, and glucose, insulin, and C-peptide concentrations following an intravenous glucose bolus. Minimal modelling analyses provided measures of glucose and insulin kinetics. Both HRT regimens were effective in preventing bone loss, and produced generally favourable lipid and lipoprotein changes. Progestin addition prevented increases in HDL2 cholesterol, but lowered triglycerides. Transdermal estrogen lowered triglycerides, whereas oral estrogen increased them. Furthermore, oral HRT resulted in a deterioration in glucose tolerance and an overall increase in insulin secretion. Transdermal HRT appears at least as effective as oral HRT in preventing postmenopausal osteoporosis, and produces as good, if not better, changes in metabolic risk markers for cardiovascular disease.