| 1. |
- An, Kevin R, et al.
(författare)
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Association between overweight and obesity with coronary artery bypass graft failure: an individual patient data analysis of clinical trials.
- 2024
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Ingår i: European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery. - 1873-734X.
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Tidskriftsartikel (refereegranskat)abstract
- The association between obesity and graft failure after coronary artery bypass grafting has not been previously investigated.We pooled individual patient data from randomized clinical trials with systematic post-operative coronary imaging to evaluate the association between obesity and graft failure at the individual graft and patient levels. Penalized cubic regression splines and mixed-effects multivariable logistic regression models were performed.Six trials comprising 3,928 patients and 12,048 grafts were included. The median time to imaging was 1.03 (IQR, 1.00-1.09) years. By body mass index (BMI) category, 800 (20.4%) patients were normal weight (BMI 18.5-24.9), 1,668 (42.5%) were overweight (BMI 25-29.9), 983 (25.0%) were obesity class 1 (BMI 30-34.9), 344 (8.8%) were obesity class 2 (BMI 35-39.9), and 116 (2.9%) were obesity class 3 (BMI 40+). As a continuous variable, BMI was associated with reduced graft failure (adjusted odds ratio [aOR] 0.98 [95% CI, 0.97-0.99]) at the individual graft level. Compared to normal weight patients, graft failure at the individual graft level was reduced in overweight (aOR 0.79 [95% CI, 0.64-0.96]), obesity class 1 (aOR 0.81 [95% CI, 0.64-1.01]), and obesity class 2 (aOR 0.61 [95% CI, 0.45-0.83]) patients, but not different compared to obesity class 3 (aOR 0.94 [95% CI, 0.62-1.42]) patients. Findings were similar, but did not reach significance, at the patient level.In a pooled individual patient data analysis of randomized clinical trials, BMI and obesity appear to be associated with reduced graft failure at one year after coronary artery bypass grafting.
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| 2. |
- An, Kevin R, et al.
(författare)
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Statistical primer: individual patient data meta-analysis and meta-analytic approaches in case of non-proportional hazards.
- 2024
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Ingår i: European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery. - 1873-734X.
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Tidskriftsartikel (refereegranskat)abstract
- Individual patient data (IPD) meta-analyses build upon traditional (aggregate data) meta-analyses by collecting IPD from the individual studies rather than using aggregated summary data. Although both traditional and IPD meta-analyses produce a summary effect estimate, IPD meta-analyses allow for the analysis of data to be performed as a single dataset. This allows for standardization of exposure, outcomes, and analytic methods across individual studies. IPD meta-analyses also allow the utilization of statistical methods typically used in cohort studies, such as multivariable regression, survival analysis, propensity score matching, uniform subgroup and sensitivity analyses, better management of missing data, and incorporation of unpublished data. However, they are more time-intensive, costly, and subject to participation bias. A separate issue relates to the meta-analytic challenges when the proportional hazards assumption is violated. In these instances, alternative methods of reporting time-to-event estimates, such as restricted mean survival time should be used. This statistical primer summarizes key concepts in both scenarios and provides pertinent examples.
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| 3. |
- Gaudino, Mario, et al.
(författare)
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Coronary artery bypass grafting versus medical therapy in patients with stable coronary artery disease: An individual patient data pooled meta-analysis of randomized trials.
- 2024
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Ingår i: The Journal of thoracic and cardiovascular surgery. - : Elsevier BV. - 1097-685X .- 0022-5223. ; 167:3
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Tidskriftsartikel (refereegranskat)abstract
- It is unclear whether coronary artery bypass grafting (CABG) improves survival compared with medical therapy (MT) in patients with stable coronary artery disease (CAD). The aim of this analysis was to perform an individual-patient data-pooled meta-analysis of contemporary randomized controlled trials that compared CABG and MT in patients with stable CAD.A systematic search was performed in January 2021 to identify randomized controlled trials enrolling adult patients with stable CAD, randomized to CABG or MT. Only trials using at least aspirin, beta-blockers, and statins in the MT arm were included. Individual patient data were obtained from all eligible studies and pooled. The primary outcome was all-cause mortality.Four trials involving 2523 patients (1261 CABG; 1262MT) were included with a median follow-up of 5.6 (4.0-9.2) years. CABG was associated with increased risk of all-cause mortality within 30days (hazard ratio [HR], 4.81; 95% confidence interval [CI], 1.95-11.83) but subsequent reduction in the long-term risk of death (HR, 0.79; 95% CI, 0.69-0.89). As such, the cumulative 10-year mortality rate was lower in patients treated with CABG compared with MT (45.1% vs 51.7%, respectively; odds ratio, 0.70; 95% CI, 0.58-0.85). Age and race were significant treatment effect modifier (interaction P=.003 for both).In patients with stable CAD, initial allocation to CABG was associated with greater periprocedural risk of death but improved long-term survival compared with MT. The survival advantage for CABG became significant after the fourth postoperative year and was particularly pronounced in younger and non-White patients.
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| 4. |
- Gaudino, Mario, et al.
(författare)
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European Association of Cardio-Thoracic Surgery (EACTS) expert consensus statement on perioperative myocardial infarction after cardiac surgery.
- 2024
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Ingår i: European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery. - 1873-734X. ; 65:2
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Tidskriftsartikel (refereegranskat)abstract
- Cardiac surgery may lead to myocardial damage and release of cardiac biomarkers through various mechanisms such as cardiac manipulation, systemic inflammation, myocardial hypoxia, cardioplegic arrest and ischaemia caused by coronary or graft occlusion. Defining perioperative myocardial infarction (PMI) after cardiac surgery presents challenges, and the association between the current PMI definitions and postoperative outcomes remains uncertain. To address these challenges, the European Association of Cardio-Thoracic Surgery (EACTS) facilitated collaboration among a multidisciplinary group to evaluate the existing evidence on the mechanisms, diagnosis and prognostic implications of PMI after cardiac surgery. The review found that the postoperative troponin value thresholds associated with an increased risk of mortality are markedly higher than those proposed by all the current definitions of PMI. Additionally, it was found that large postoperative increases in cardiac biomarkers are prognostically relevant even in absence of additional supportive signs of ischaemia. A new algorithm for PMI detection after cardiac surgery was also proposed, and a consensus was reached within the group that establishing a prognostically relevant definition of PMI is critically needed in the cardiovascular field and that PMI should be included in the primary composite outcome of coronary intervention trials.
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| 5. |
- Gaudino, Mario, et al.
(författare)
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Graft Failure After Coronary Artery Bypass Grafting and Its Association With Patient Characteristics and Clinical Events: A Pooled Individual Patient Data Analysis of Clinical Trials With Imaging Follow-Up.
- 2023
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Ingår i: Circulation. - 1524-4539.
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Tidskriftsartikel (refereegranskat)abstract
- Graft patency is the postulated mechanism for the benefits of coronary artery bypass grafting (CABG). However, systematic graft imaging assessment after CABG is rare, and there is a lack of contemporary data on the factors associated with graft failure and on the association between graft failure and clinical events after CABG.We pooled individual patient data from randomized clinical trials with systematic CABG graft imaging to assess the incidence of graft failure and its association with clinical risk factors. The primary outcome was the composite of myocardial infarction or repeat revascularization occurring after CABG and before imaging. A 2-stage meta-analytic approach was used to evaluate the association between graft failure and the primary outcome. We also assessed the association between graft failure and myocardial infarction, repeat revascularization, or all-cause death occurring after imaging.Seven trials were included comprising 4413 patients (mean age, 64.4±9.1 years; 777 [17.6%] women; 3636 [82.4%] men) and 13163 grafts (8740 saphenous vein grafts and 4423 arterial grafts). The median time to imaging was 1.02 years (Q1;Q3: 1.00;1.03). Graft failure occurred in 1487 (33.7%) patients and in 2190 (16.6%) grafts. Age (adjusted odds ratio [aOR], 1.08 [per 10-year increment] [95% CI, 1.01-1.15]; P=0.03), female sex (aOR, 1.27 [95% CI, 1.08-1.50]; P=0.004), and smoking (aOR, 1.20 [95% CI, 1.04-1.38]; P=0.01) were independently associated with graft failure, whereas statins were associated with a protective effect (aOR, 0.74 [95% CI, 0.63-0.88]; P<0.001). Graft failure was associated with an increased risk of myocardial infarction or repeat revascularization occurring between CABG and imaging assessment (8.0% in patients with graft failure versus 1.7% in patients without graft failure; aOR, 3.98 [95% CI, 3.54-4.47]; P<0.001). Graft failure was also associated with an increased risk of myocardial infarction or repeat revascularization occurring after imaging (7.8% versus 2.0%; aOR, 2.59 [95% CI, 1.86-3.62]; P<0.001). All-cause death after imaging occurred more frequently in patients with graft failure compared with patients without graft failure (11.0% versus 2.1%; aOR, 2.79 [95% CI, 2.01-3.89]; P<0.001).In contemporary practice, graft failure remains common among patients undergoing CABG and is strongly associated with adverse cardiac events.
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| 6. |
- Gaudino, Mario, et al.
(författare)
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Outcomes by sex in the International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA) trial.
- 2024
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Ingår i: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. - 1969-6213.
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Tidskriftsartikel (refereegranskat)abstract
- In the International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA) trial, among participants with stable coronary artery disease, the risk of cardiac events was similar between an invasive (INV) strategy of angiography and coronary revascularisation and a conservative (CON) strategy of initial medical therapy alone. Outcomes according to participant sex were not reported.We aimed to analyse the outcomes of ISCHEMIA by participant sex.We evaluated 1) the association between participant sex and the likelihood of undergoing revascularisation for participants randomised to the INV arm; 2) the risk of the ISCHEMIA primary composite outcome (cardiovascular death, any myocardial infarction [MI] or rehospitalisation for unstable angina, heart failure or resuscitated cardiac arrest) by participant sex; and 3) the contribution of the individual primary outcome components to the composite outcome by participant sex.Of 5,179 randomised participants, 1,168 (22.6%) were women. Female sex was independently associated with a lower likelihood of revascularisation when assigned to the INV arm (adjusted odds ratio 0.75, 95% confidence interval [CI]: 0.57-0.99; p=0.04). The INV versus CON effect on the primary composite outcome was similar between sexes (women: hazard ratio [HR] 0.96, 95% CI: 0.70-1.33; men: HR 0.90, 95% CI: 0.76-1.07; pinteraction=0.71). The contribution of the individual components to the composite outcome was similar between sexes except for procedural MI, which was significantly lower in women (9/151 [5.9%]) than men (67/519 [12.9%]; p=0.01).In ISCHEMIA, women assigned to the INV arm were less likely to undergo revascularisation than men. The effect of an INV versus CON strategy was consistent by sex, but women had a significantly lower contribution of procedural MI to the primary outcome.
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| 7. |
- Harik, Lamia, et al.
(författare)
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Intraoperative Anemia Mediates Sex Disparity in Operative Mortality After Coronary Artery Bypass Grafting.
- 2024
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Ingår i: Journal of the American College of Cardiology. - 1558-3597. ; 83:9, s. 918-928
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Tidskriftsartikel (refereegranskat)abstract
- Women undergoing coronary artery bypass grafting (CABG) have higher operative mortality than men.The purpose of this study was to evaluate the relationship between intraoperative anemia (nadir intraoperative hematocrit), CABG operative mortality, and sex.This was a cohort study of 1,434,225 isolated primary CABG patients (344,357 women) from the Society of Thoracic Surgeons Adult Cardiac Surgery Database (2011-2022). The primary outcome was operative mortality. The attributable risk (AR) (the risk-adjusted strength of the association of female sex with CABG outcomes) for the primary outcome was calculated. Causal mediation analysis derived the total effect of female sex on operative mortality risk and the proportion of that effect mediated by intraoperative anemia.Women had lower median nadir intraoperative hematocrit (22.0% [Q1-Q3: 20.0%-25.0%] vs 27.0% [Q1-Q3: 24.0%-30.0%], standardized mean difference 97.0%) than men. Women had higher operative mortality than men (2.8% vs 1.7%; P< 0.001; adjusted OR: 1.36; 95%CI: 1.30-1.41). The AR of female sex for operative mortality was 1.21 (95%CI: 1.17-1.24). After adjusting for nadir intraoperative hematocrit, AR was reduced by 43% (1.12; 95%CI: 1.09-1.16). Intraoperative anemia mediated 38.5% of the increased mortality risk associated with female sex (95%CI: 32.3%-44.7%). Spline regression showed a stronger association between operative mortality and nadir intraoperative hematocrit at hematocrit values <22.0% (P< 0.001).The association of female sex with increased CABG operative mortality is mediated to a large extent by intraoperative anemia. Avoiding nadir intraoperative hematocrit values below 22.0% may reduce sex differences in CABG operative mortality.
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| 8. |
- Redfors, Björn, et al.
(författare)
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Outcomes According to Coronary Revascularization Modality in the ISCHEMIA Trial.
- 2024
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Ingår i: Journal of the American College of Cardiology. - 1558-3597. ; 83:5, s. 549-558
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Tidskriftsartikel (refereegranskat)abstract
- In the ISCHEMIA trial, the risk of ischemic events was similar in patients with stable coronary artery disease treated with an invasive (INV) strategy of angiography and percutaneous (PCI) or surgical (CABG) coronary revascularization and a conservative (CON) strategy of initial medical therapy.To analyze separately the outcomes of INV patients treated with PCI or CABG.Patients without preceding primary outcome events were categorized as INV-PCI or INV-CABG from the time of revascularization. The ISCHEMIA primary outcome (composite of cardiovascular death, protocol-defined myocardial infarction (MI) or hospitalization for unstable angina, heart failure or resuscitated cardiac arrest) was used.Among INV-CABG patients, primary outcome events occurred in 84/512 (16.4%) at median follow-up of 2.85 years; 48 events (57.1%) occurred within 30 days after CABG, including 40 procedural MIs; among INV-PCI patients, primary outcome events occurred in 147/1500 (9.8%) at median follow-up of 2.94 years; 31 of which (21.1%) within 30 days after PCI, including 23 procedural MIs. In comparison, 352/2591 (13.6%) CON patients had primary outcome events at median follow-up 3.2 years, 22 of which (6.3%) within 30 days of randomization. The adjusted primary outcome risks (HR [95%CI]) were higher after both CABG and PCI within 30 days (16.25 (11.44-23.07) and 2.99 (1.97-4.53)) and lower thereafter (0.63 (0.44-0.89) and 0.66(0.53-0.82)).In ISCHEMIA, early revascularization by PCI and CABG was associated with higher early risks and lower long-term risks of cardiovascular events compared with CON. The early risk was greatest after CABG, due to protocol-defined procedural MIs.
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| 9. |
- Rong, Lisa Q, et al.
(författare)
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Distal aortic biomechanics after transcatheter versus surgical aortic valve replacement: a hypothesis generating study.
- 2023
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Ingår i: Journal of cardiothoracic surgery. - 1749-8090. ; 18:1
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Tidskriftsartikel (refereegranskat)abstract
- Biomechanical effects of transcatheter (TAVR) versus surgical (SAVR) aortic valve interventions on the distal aorta have not been studied. This study utilized global circumferential strain (GCS) to assess post-procedural biomechanics changes in the descending aorta after TAVR versus SAVR.Patients undergoing TAVR or SAVR for aortic stenosis were included. Transesophageal (TEE) and transthoracic (TTE) echocardiography short-axis images of the aorta were used to image the descending aorta immediately before and after interventions. Image analysis was performed with two-dimensional speckle tracking echocardiography and dedicated software. Delta GCS was calculated as: post-procedural GCS-pre-procedural GCS. Percentage delta GCS was calculated as: (delta GCS/pre-procedural GCS)×100.Eighty patients, 40 TAVR (median age 81 y/o, 40% female) and 40 SAVR (median 72 y/o, 30% female) were included. The post-procedure GCS was significantly higher than the pre-procedural GCS in the TAVR (median 10.7 [interquartile range IQR 4.5, 14.6] vs. 17.0 [IQR 6.1, 20.9], p=0.009) but not in the SAVR group (4.4 [IQR 3.3, 5.3] vs. 4.7 [IQR 3.9, 5.6], p=0.3). The delta GCS and the percentage delta GCS were both significantly higher in the TAVR versus SAVR group (2.8% [IQR 1.4, 6] vs. 0.15% [IQR-0.6, 1.5], p<0.001; and 28.8% [IQR 14.6%, 64.6%] vs. 4.4% [IQR-10.6%, 5.6%], p=0.006). Results were consistent after multivariable adjustment for key clinical and hemodynamic characteristics.After TAVR, there was a significantly larger increase in GCS in the distal aorta compared to SAVR. This may impact descending aortic remodeling and long-term risk of aortic events.
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| 10. |
- Sandner, Sigrid, et al.
(författare)
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Antiplatelet therapy around CABG: the latest evidence.
- 2023
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Ingår i: Current opinion in cardiology. - 1531-7080.
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Tidskriftsartikel (refereegranskat)abstract
- The optimal antiplatelet strategy in patients after coronary artery bypass graft (CABG) surgery is unclear. We review the evidence on the efficacy and safety of DAPT after CABG and discuss potential novel antiplatelet strategies that reduce the risk of bleeding without loss of efficacy.Adding the potent P2Y12 inhibitor ticagrelor to aspirin for 1 year after CABG is associated with a reduction in the risk of vein graft failure, at the expense of an increased risk of clinically important bleeding. Ticagrelor monotherapy is not associated with better efficacy than aspirin alone, but is not associated with increased bleeding risk.Dual antiplatelet therapy (DAPT) is recommended after acute coronary syndrome events, but aspirin as single antiplatelet therapy remains the cornerstone of antithrombotic therapy in stable ischemic heart disease because of a lack of solid evidence on the benefit of DAPT on clinical outcomes. Shorter duration DAPT, based on the pathophysiology of vein graft failure, may be a promising strategy that requires testing in adequately powered randomized trials.
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| 11. |
- Sandner, Sigrid, et al.
(författare)
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Association of Dual Antiplatelet Therapy With Ticagrelor With Vein Graft Failure After Coronary Artery Bypass Graft Surgery: A Systematic Review and Meta-analysis.
- 2022
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Ingår i: JAMA. - 1538-3598. ; 328:6, s. 554-562
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Tidskriftsartikel (refereegranskat)abstract
- The role of ticagrelor with or without aspirin after coronary artery bypass graft surgery remains unclear.To compare the risks of vein graft failure and bleeding associated with ticagrelor dual antiplatelet therapy (DAPT) or ticagrelor monotherapy vs aspirin among patients undergoing coronary artery bypass graft surgery.MEDLINE, Embase, and Cochrane Library databases from inception to June 1, 2022, without language restriction.Randomized clinical trials (RCTs) comparing the effects of ticagrelor DAPT or ticagrelor monotherapy vs aspirin on saphenous vein graft failure.Individual patient data provided by each trial were synthesized into a combined data set for independent analysis. Multilevel logistic regression models were used.The primary analysis assessed the incidence of saphenous vein graft failure per graft (primary outcome) in RCTs comparing ticagrelor DAPT with aspirin. Secondary outcomes were saphenous vein graft failure per patient and Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding events. A supplementary analysis included RCTs comparing ticagrelor monotherapy with aspirin.A total of 4 RCTs were included in the meta-analysis, involving 1316 patients and 1668 saphenous vein grafts. Of the 871 patients in the primary analysis, 435 received ticagrelor DAPT (median age, 67 years [IQR, 60-72 years]; 65 women [14.9%]; 370 men [85.1%]) and 436 received aspirin (median age, 66 years [IQR, 61-73 years]; 63 women [14.5%]; 373 men [85.5%]). Ticagrelor DAPT was associated with a significantly lower incidence of saphenous vein graft failure (11.2%) per graft than was aspirin (20%; difference, -8.7% [95% CI, -13.5% to -3.9%]; OR, 0.51 [95% CI, 0.35 to 0.74]; P < .001) and was associated with a significantly lower incidence of saphenous vein graft failure per patient (13.2% vs 23.0%, difference, -9.7% [95% CI, -14.9% to -4.4%]; OR, 0.51 [95% CI, 0.35 to 0.74]; P < .001). Ticagrelor DAPT (22.1%) was associated with a significantly higher incidence of BARC type 2, 3, or 5 bleeding events than was aspirin (8.7%; difference, 13.3% [95% CI, 8.6% to 18.0%]; OR, 2.98 [95% CI, 1.99 to 4.47]; P < .001), but not BARC type 3 or 5 bleeding events (1.8% vs 1.8%, difference, 0% [95% CI, -1.8% to 1.8%]; OR, 1.00 [95% CI, 0.37 to 2.69]; P = .99). Compared with aspirin, ticagrelor monotherapy was not significantly associated with saphenous vein graft failure (19.3% vs 21.7%, difference, -2.6% [95% CI, -9.1% to 3.9%]; OR, 0.86 [95% CI, 0.58 to 1.27]; P = .44) or BARC type 2, 3, or 5 bleeding events (8.9% vs 7.3%, difference, 1.7% [95% CI, -2.8% to 6.1%]; OR, 1.25 [95% CI, 0.69 to 2.29]; P = .46).Among patients undergoing coronary artery bypass graft surgery, adding ticagrelor to aspirin was associated with a significantly decreased risk of vein graft failure. However, this was accompanied by a significantly increased risk of clinically important bleeding.
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| 12. |
- Sandner, Sigrid, et al.
(författare)
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One-month DAPT with ticagrelor and aspirin for patients undergoing coronary artery bypass grafting: rationale and design of the randomised, multicentre, double-blind, placebo-controlled ODIN trial.
- 2024
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Ingår i: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. - 1969-6213. ; 20:5
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Tidskriftsartikel (refereegranskat)abstract
- The optimal antiplatelet strategy after coronary artery bypass graft (CABG) surgery in patients with chronic coronary syndromes (CCS) is unclear. Adding the P2Y12 inhibitor, ticagrelor, to low-dose aspirin for 1 year is associated with a reduction in graft failure, particularly saphenous vein grafts, at the expense of an increased risk of clinically important bleeding. As the risk of thrombotic graft failure and ischaemic events is highest early after CABG surgery, a better risk-to-benefit profile may be attained with short-term dual antiplatelet therapy followed by single antiplatelet therapy. The One Month Dual Antiplatelet Therapy With Ticagrelor in Coronary Artery Bypass Graft Patients (ODIN) trial is a prospective, randomised, double-blind, placebo-controlled, international, multicentre study of 700 subjects that will evaluate the effect of short-term dual antiplatelet therapy with ticagrelor plus low-dose aspirin after CABG in patients with CCS. Patients will be randomised 1:1 to ticagrelor 90 mg twice daily or matching placebo, in addition to aspirin 75-150 mg once daily for 1 month; after the first month, antiplatelet therapy will be continued with aspirin alone. The primary endpoint is a hierarchical composite of all-cause death, stroke, myocardial infarction, revascularisation and graft failure at 1 year. The key secondary endpoint is a hierarchical composite of all-cause death, stroke, myocardial infarction, Bleeding Academic Research Consortium (BARC) type 3 bleeding, revascularisation and graft failure at 1 year (net clinical benefit). ODIN will report whether the addition of ticagrelor to low-dose aspirin for 1 month after CABG reduces ischaemic events and provides a net clinical benefit in patients with CCS. (ClinicalTrials.gov: NCT05997693).
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