Network of treatment comparisons for saphenous vein graft failure (primary efficacy outcome) and major bleeding (primary safety outcome). Most people make a full recovery within 12 weeks of the operation. Interestingly, the recently published and prematurely terminated trial that compared ticagrelor with aspirin after coronary artery bypass graft surgery showed no important differences in major adverse cardiovascular events or bleeding between the monotherapies.50 These findings support the need for studies that evaluate dual antiplatelet therapy after coronary artery bypass graft surgery. Additionally, we evaluated incoherence assumption (the statistical disagreement between direct and indirect evidence in a closed loop) locally using a loop specific approach, and globally using a design by treatment interaction model.46 We used surface under the cumulative ranking (SUCRA)47 to rank the intervention’s hierarchy in the network meta-analysis and then we estimated mean ranks. Patients, who are randomized to the control arm and develop recurrent AF after 30 days, may be crossed-over to an OAC. Overall, we judged eight trials (40%)2425262728303940 to have a high risk of bias, primarily owing to failure to blind and missing outcome data. Eur J Vasc Endovasc Surg 1995; 9: 7. On the basis of the available evidence, how should one approach antithrombotic therapy following CABG? : "Efficacy and safety of edifoligide, an E2F transcription factor decoy, for prevention of vein graft failure following coronary artery bypass graft surgery: PREVENT IV: a randomized controlled trial". This approach is clinically preferable given that treatments are applied to patients (and not grafts). Conclusions: Post-CABG anticoagulation for new AF is associated with increased bleeding and no difference in stroke at 30 days. However, the tradeoff was an increased risk of major bleeding, although the risk did not differ among the drug interventions. Fifth, the trials in which most of patients underwent off pump coronary artery bypass graft surgery,163536 the dose of aspirin (monotherapy or dual antiplatelet therapy) was 81-100 mg daily. Generally, you should be able to sit in a chair after 1 day, walk after 3 days, and walk up and down stairs after 5 or 6 days. We performed an “all missing failure” analysis to explore the impact of missing data; this analysis assumed that all missing patients had a negative event.48 All outcomes of interest were binary and the relative treatment effects were reported as odds ratios with 95% confidence intervals. Data sources Medline, Embase, Web of Science, CINAHL, and the Cochrane Library from inception to 25 January 2019. 14. Arterial and venous conduits for coronary artery bypass. THE anticoagulant effect of heparin must be reversed after coronary artery bypass graft (CABG) surgery to avoid excess bleeding. and Smith P.K. However, the evidence does not support the efficacy of clopidogrel monotherapy in reducing saphenous vein graft failure compared with placebo (fig 3, top panel). Coronary artery bypass grafting (CABG) is a type of surgery that improves blood flow to the heart. Finally, additional research is needed into the optimal antithrombotic regimen for patients following CABG to maintain graft patency and, more importantly, improve clinical outcomes. The network evidence for dual antiplatelet therapy with aspirin plus ticagrelor and aspirin plus clopidogrel was of moderate certainty compared with aspirin monotherapy. The COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies) investigators add to our knowledge of antithrombotic therapy following CABG with the results of COMPASS-CABG (Cardiovascular Outcomes for People Using Anticoagulation Strategies-Coronary Artery Bypass Grafting), a prospectively planned substudy of the COMPASS trial (7,8). technical support for your product directly (links go to external sites): Thank you for your interest in spreading the word about The BMJ. Each of the nodes represents placebo or different drug interventions; aspirin was the most well connected intervention with all other interventions directly linked to it, except for clopidogrel monotherapy. These 20 trials comprised 4803 participants and investigated nine different interventions (eight active and one placebo). However, the eligibility criteria were purposefully stringent to reduce heterogeneity and risk of bias. Patients in COMPASS-CABG were enrolled globally and were well treated with evidence-based therapies including statins, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and beta-blockers. Transitivity assumption, the distribution of patient and study characteristics that modify treatment effects (effect modifiers) across treatment comparisons, was explored to assess whether these characteristics were sufficiently similar between comparisons. This experience differs from what was observed with high-dose dabigatran in RE-ALIGN (Randomized, Phase II Study to Evaluate the Safety and Pharmacokinetics of Oral Dabigatran Etexilate in Patients after Heart Valve Replacement) and is clinically important because many patients with an indication for oral anticoagulation early after CABG are currently treated with warfarin because of its slower onset and theoretical reversibility (9). © 2020 American College of Cardiology Foundation. In COMPASS-CABG, 1,448 patients enrolled in COMPASS who had recently (4 to 14 days) undergone CABG were randomized to the same 3 treatment regimens used in COMPASS. Each node represents different active interventions or placebo. Routine postoperative care after CABG will occur in both groups. This lack of information could have led to inaccurate interpretation of the certainty of evidence. Lamy A., Eikelboom J., Sheth T.et al. Objective To assess the effects of different oral antithrombotic drugs that prevent saphenous vein graft failure in patients undergoing coronary artery bypass graft surgery. Relationship of Atrial Fibrillation and Stroke After Coronary Artery Bypass Graft Surgery: When is Anticoagulation Indicated? The author thanks Elizabeth E.S. : "Saphenous vein graft failure after coronary artery bypass surgery: pathophysiology, management, and future directions". Therefore, the risk of using inaccurate informative priors can cause even more damage to the validity of the results. In our sensitivity analyses we used per graft data, excluded off pump only trials,3536 and accounted for missing outcome data. Network meta-analyses showed no evidence of differences among all possible treatment comparisons. Ultimately, we are doing this for the patient and not for the bypass graft. We made the decision about combining per patient and per graft data after we compared the results from per patient14151625262728293031323334353637 and per graft1415161724252627282930313233343536383940 (accounting for clustering effects) meta-analyses. Approximately 18 hours later, he spontaneously reverted back to sinus rhythm. What is an intracluster correlation coefficient? More prudent use of presently available drugs to treat Afib could reduce morbidity, cost, and duration of hospital stay after CABG. A coronary artery bypass graft (CABG) isn't a cure for heart disease, so it's important to adopt a healthy lifestyle and continue taking any prescribed medication after the operation to reduce your risk of getting heart problems in the future. Across comparisons, the distribution of baseline characteristics by treatment was generally balanced, except for the type of coronary artery bypass graft technique (on pump versus off pump coronary artery bypass graft), and the timing of drug initiation (table 2). Therefore, in this study we aimed to systematically review randomised controlled trials that assessed the effects of oral antithrombotic drugs to prevent saphenous vein graft failure in patients undergoing coronary artery bypass graft surgery. Infrainguinal bypass grafts are not perfect. The protocol-specified duration of anticoagulation is 90 days. The primary efficacy outcome was the incidence of saphenous vein graft failure, defined as participants with at least one occluded saphenous vein graft as assessed by either invasive angiogram or computed tomography (table 1 and supplementary table 1). Pooled effect sizes also suggested that all active interventions increased bleeding compared with placebo, although without substantialstatistical evidence (fig 3, bottom panel). 5 The full text reports of potentially relevant studies were retrieved, and data on study and patient characteristics, treatment strategies, and results of all included studies were then independently extracted (KS and AAH/TC) using a data extraction form. Design Systematic review and network meta-analysis. Cook of the Duke Clinical Research Institute for editorial support. By Michael O'Riordan He was asymptomatic, and reversible causes of AF were ruled out. Compared with aspirin alone, rivaroxaban had no effect on bypass graft patency either with aspirin (odds ratio [OR]: 1.13; 95% confidence interval [CI]: 0.82 to 1.57) or without aspirin (OR: 0.95; 95% CI: 0.67 to 1.33) (8). The possibility of intransitivity could not be ruled out; however, between-trial heterogeneity and incoherence were low in all included analyses. thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC) to background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery. However, it was not possible to estimate the effect of publication year for all treatments owing to multicollinearity and missing linkage (supplementary table 12). The remaining authors have nothing to disclose. The main finding from COMPASS-CABG is that the addition of low-dose rivaroxaban to aspirin does not improve bypass graft patency. Hence, saphenous vein graft failure will occur because of physiological or functional causes rather than saphenous vein graft driven thrombotic mechanisms, yet without apparent clinical consequence.6061 Lopes and colleagues61 showed that saphenous vein graft failure was associated with an increased risk for the composite of death, myocardial infarction, or repeat revascularisation at four years after the angiogram. Most patients with stable coronary disease are managed with a single antiplatelet drug. Increasing thickness of lines between nodes is proportional to number of randomly assigned patients contributing to direct comparisons. Anticoagulation Clinic Request appointment Refer a patient Get a second opinion (415) 353-2143 If you regularly take certain anticoagulant medications, also known as blood thinners, your physician may refer you to the UCSF Anticoagulation Clinic. Alexander J.H., Hafley G., Harrington R.A.et al. Lopes R.D., Mehta R.H., Hafley G.E.et al. Harskamp R.E., Lopes R.D., Baisden C.E.et al. We prespecified the research question and published a peer reviewed protocol23 for this systematic review of published randomised controlled trials of drug interventions to prevent saphenous vein graft failure after coronary artery bypass graft surgery. Another problem are delays in venous bypass graft endothelialization. Pooled effect sizes also suggested that all active interventions reduced saphenous vein graft failure compared with placebo. ABSTRACT. This will ensure that the surgically created shunt remains patent allowing for continued circulation of blood from … Graft failure within the first year occurred at similar rates after coronary artery bypass graft (CABG) surgery among patients on rivaroxaban vs … The distribution of potential effect modifiers was not balanced across comparisons; however, the evidence of intransitivity was inconclusive because of missing data in several comparisons (table 2). Eligibility criteria for selecting studies … The number of saphenous vein grafts ranged from 1.14 to 3.60 per patient, and drug interventions were started from seven days before coronary artery bypass graft surgery to 14 days after the procedure. Conclusions The results of this network meta-analysis suggest an important absolute benefit of adding ticagrelor or clopidogrel to aspirin to prevent saphenous vein graft failure after coronary artery bypass graft surgery. Conversely, the 2017 European guidelines state that there is insufficient evidence to generally recommend dual antiplatelet therapy to reduce saphenous vein graft failure.53 To mitigate the relative hypercoagulable state that off pump patients experience, the 2015 American Heart Association scientific statement18 recommends the combination of aspirin and clopidogrel after off pump coronary artery bypass graft surgery (class I, level of evidence A). Dual antiplatelet therapy after surgery should be tailored to the patient by balancing the safety and efficacy profile of the drug intervention against important patient outcomes. Generally, you should be able to sit in a chair after 1 day, walk after 3 days, and walk up and down stairs after 5 or 6 days. Online ahead of print. showing a relatively high rate of DVT after CABG (approximately 17%), in most cases without clinically significant symptoms. We could not thoroughly assess inconsistency because many of the comparisons consisted of a single study. Postoperative neurological complications represent 1 of the most devastating consequences of CABG surgery. Pathophysiologically, thrombosis has been implicated in both bypass graft occlusion and native coronary artery disease progression, and antithrombotic agents may prevent thrombosis in both grafts and native arteries. Type 1 injury, in which a significant, permanent, neurological injury is sustained, occurs in ≈3% of patients overall and is responsible for a 21% mortality. We judged only five unique trials1516353740to have a low risk of bias due to deviation from intended interventions. Davies M.G. Any discrepancies were resolved by consensus after consulting a third investigator (RB). In the absence of a clear indication, “triple therapy” with aspirin, ticagrelor, and oral anticoagulation should not be used because of the high associated risk of bleeding. RB is the guarantor. The same can be said about atherosclerosis. To increase the totality of evidence, we accounted for clustering effects of data expressed on a per graft basis, and made an inference at the patient level, which improved the applicability of the results in light of a newer P2Y12 inhibitor (ticagrelor) and direct factor Xa inhibitor (rivaroxaban). Graft occlusion after CABG cannot be good, but determining the impact of graft occlusion on recurrent clinical events is not straightforward (4,5). For those who require anticoagulation, an antiplatelet drug may not be required. It was unclear how the remaining trials with incomplete data handled missing outcome data. There is a current multicenter randomized trial comparing oral anticoagulation to no oral anticoagulation in patients who develop NOAF after CABG, which may provide further information on this topic. Aspirin is considered the preferred antiplatelet drug to prevent saphenous vein graft failure after coronary artery bypass surgery, Uncertainty remains about the benefits of adding a P2Y12 inhibitor or direct oral anticoagulant to aspirin monotherapy after bypass surgery, Dual antiplatelet therapy with either aspirin plus ticagrelor or aspirin plus clopidogrel was more efficacious than aspirin monotherapy in preventing saphenous vein graft failure after coronary artery bypass surgery, No strong evidence was found of differences in major bleeding, myocardial infarction, and death for different antithrombotics compared with aspirin monotherapy, Future guideline updates are needed to optimise antithrombotic management of patients undergoing coronary artery bypass graft surgery, Dual antiplatelet therapy with aspirin plus ticagrelor or aspirin plus clopidogrel could be considered for most patients after surgery. The rate of vein graft failure at 1 year (∼9%) was substantially lower than in other recent trials and lower than the investigators projected when designing the study. Alexander J.H. Hillis L.D., Smith P.K., Anderson J.L.et al. Postoperative AF occurs in approximately 30–40% of patients undergoing coronary artery bypass grafting (CABG) surgery and in as many as 64% of patients with concomitant valve surgery. The clinical benefits of adding a P2Y12 inhibitor to aspirin originate from the Clopidogrel in Unstable Angina to Prevent Recurrent Events (CURE) trial. There were also numeric increases in bleeding with rivaroxaban plus aspirin (HR: 1.41; 95% CI: 0.58 to 3.45) and rivaroxaban alone (HR: 2.43; 95% CI: 1.06 to 5.54). 5 CONCLUSIONS. Notably, the combination of aspirin plus rivaroxaban 2.5 mg twice daily or rivaroxaban 5 mg twice daily alone did not reduce saphenous vein graft failure compared with aspirin alone in the COMPASS (Cardiovascular OutcoMes for People Using Anticoagulation StrategieS) coronary artery bypass graft trial.17 However, the combination of aspirin plus rivaroxaban 2.5 mg twice daily was associated with similar reductions in major adverse cardiovascular events, and this was consistent with the findings of the main COMPASS trial.57 Therefore, because major bleeding has been associated with increased morbidity and mortality,5859 the risk of bleeding should be carefully balanced against the benefits when planning long term (>12 months) dual antiplatelet therapy in patients undergoing coronary artery bypass graft surgery. Each node represents different active interventions or placebo. In prosthetic grafts neointimal hyperplasia is more typical at the anastemoses. The primary objective of this study is to evaluate the effectiveness (prevention of thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC) to background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery. 5. Given what we know about ticagrelor in patients with a recent acute coronary syndrome and with chronic coronary artery disease, it is very likely that ticagrelor also reduces recurrent ischemic events and increases bleeding (13,14). : "Rivaroxaban, aspirin, or both to prevent early coronary bypass graft occlusion: the COMPASS-CABG study". The study found no strong evidence of differences in major bleeding, myocardial infarction, and death among different antithrombotic therapies. Increasing thickness of lines between nodes is proportional to number of randomly assigned patients contributing to direct comparisons. There is emerging evidence on the potential benefits of dual antiplatelet therapy with aspirin and clopidogrel or ticagrelor after coronary artery bypass graft surgery, but these combinations have not been directly compared with other antithrombotic therapies in randomised controlled trials. Most heart operations depend on cardiopulmonary bypass with systemic heparinisation and, postoperatively, every patient’s thrombotic and haemorrhagic tendency must be carefully managed.. Therefore, changes in adjunct medical treatment over time could potentially affect treatment estimates. Postoperative aspirin use is associated with improved graft patency in patients undergoing CABG and is a significant predictor of inhospital survival. Dr. Alexander has received institutional research grants from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, CryoLife, CSL Behring, U.S. Food and Drug Administration, National Institutes of Health, Sanofi, Tenax, and VoluMetrix; and has received consulting fees and honoraria from Abbvie, Bristol-Myers Squibb, CSL Behring, Janssen, Pfizer, Portola, Teikoku, VA Cooperative Studies Program, and Zafgen. Network meta-analysis showed that dual antiplatelet therapy with either aspirin plus ticagrelor (odds ratio 0.50, 95% confidence interval 0.31 to 0.79, number needed to treat 10) or aspirin plus clopidogrel (0.60, 0.42 to 0.86, 19) was more efficacious than aspirin monotherapy to prevent saphenous vein graft failure. Learn who needs it, the risks and benefits of CABG, and how to participate in clinical trials. 2020 Nov 30:e017966. There was no patient or public involvement in measuring the outcomes, in providing interpretations of the findings, or writing of the results. Sixth, our network meta-analysis included trials published over a 39 year period, which might not reflect the current clinical practice; for example, patient characteristics, surgical techniques (eg, off pump coronary artery bypass graft), drug regimens (early trials were more likely to compare against placebo and later trials were more likely to be active comparator trials), and secondary prevention strategies18 (statins, angiotensin converting enzyme inhibitors, or angiotensin receptor blockers and β blockers). Recovering from a coronary artery bypass graft procedure takes time and everyone recovers at slightly different speeds. The COMPASS investigators are to be commended for embedding this prospectively designed ancillary study into COMPASS. 3. The lack of different doses of clopidogrel precludes further analysis. Recovering from a coronary artery bypass graft procedure takes time and everyone recovers at slightly different speeds. This retrospective analysis does not support the use of aggressive anticoagulation, particularly full intravenous heparinization as a bridging therapy to decrease the already low incidence of postoperative strokes after routine coronary artery bypass grafting surgery. Accrual is expected to take 36 months. The next question is whether oral anticoagulation is beneficial—difficult to prove when stroke risk in this group is quite low. Keywords. Bonaca M.P., Bhatt D.L., Cohen M.et al. The goal of this study was to determine whether prolonged hospital stay associated with atrial fibrillation or flutter (AF) after coronary artery bypass graft (CABG) surgery is attributable to the characteristics of patients who develop this arrhythmia or to the rhythm disturbance itself. Additionally, these studies should report long term (that is, five or 10 years) incidence of saphenous vein graft failure, and patient important outcomes (mortality, ischaemic, or bleeding events). Size of nodes is proportional to number of studies comparing respective nodes. Although our sensitivity analysis showed no substantial differences in effect estimates between per graft and per patient analyses for most comparisons, the credibility of this data driven approach remains unclear. Coronary artery disease (CAD) is the narrowing of the coronary arteries – the blood vessels that supply oxygen and nutrients to the heart muscle. The lead author (RB) affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned in the peer-reviewed published protocol have been explained. Lopes R.D., Williams J.B., Mehta R.H.et al. In patients with complex multivessel coronary artery disease, CABG improves survival (1); however, a proportion of bypass grafts become occluded, and some patients have recurrent cardiovascular events (2,3). CABG is used to treat people who have severe CAD. This benefit can be increased by using two antiplatelet drugs. Our analysis adds new data on the use of dual antiplatelet therapy with aspirin plus ticagrelor and direct oral anticoagulation with rivaroxaban, thereby providing a better understanding of the role of these drug interventions to prevent saphenous vein graft failure after coronary artery bypass graft surgery. However, comparisons with moderate certainty evidence should be interpreted with caution mainly because of inconsistency and publication bias. Several hours after surgery, the patient developed atrial fibrillation (AF). When we performed a sensitivity analysis that excluded studies considered at serious risk of bias, the effect estimates did not change substantially, except for aspirin plus clopidogrel versus vitamin K antagonist, which became non-significant (supplementary figure 2). Patients underwent computed tomography angiography to evaluate bypass graft patency at an average of 1.13 years. 2. Given the high rates of depression after surgery, it is reasonable to screen for depression after CABG. We judged two randomised controlled trials2739 to have a high risk of bias arising from the randomisation process and five randomised controlled trials2425263040 to have a high risk of bias because of missing outcome data (supplementary table 7). : "Coronary-artery bypass grafting". The review compared eight active antithrombotic interventions in a single framework to assess saphenous vein graft failure. Background The long-term impact of new-onset postoperative atrial fibrillation (POAF) after coronary artery bypass grafting and the benefit of early-initiated oral anticoagulation (OAC) in patients with POAF are uncertain. Not all the included trials reported the actual data on duration of treatment. Secondary outcomes were all cause mortality and myocardial infarction. : "2011 ACCF/AHA guideline for coronary artery bypass graft surgery: a report of the ACCF/AHA Task Force on Practice Guidelines". : "Edifoligide and long-term outcomes after coronary artery bypass grafting: Project of Ex-vivo Vein Graft Engineering via Transfection IV (PREVENT-IV) 5-year results". Prospective randomized studies are needed to formalize safe and efficacious short- and long-term management strategies. Not all bypass graft failure leads to an adverse clinical event, and not all clinical events following CABG are caused by graft failure. Comparison of novel oral anticoagulants versus warfarin for post-operative atrial fibrillation after coronary artery bypass grafting. Although 1 year is early in the process of vein graft failure, the absence of any benefit of rivaroxaban at this time makes a later benefit unlikely. 13. Relationship of Atrial Fibrillation and Stroke After Coronary Artery Bypass Graft Surgery: When is Anticoagulation Indicated? We calculated and used effective sample size instead of originally reported outcome data to account for clustering effects for per graft data.414243 The effective sample size was estimated by using a design effect that includes an intra cluster correlation coefficient.43 We obtained the intra cluster correlation coefficient needed to calculate the effective sample size from an external source.42 The size of the intra cluster correlation coefficient and the number of observations sampled within each cluster influence the power of the study.43 We used an intra cluster correlation coefficient of 0.177 for this review.42 Additionally, if studies reported the incidence of saphenous vein graft failure at multiple time points, we included the longest available follow-up period in our base case analysis. 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