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Impact of large periprocedural myocardial infarction on mortality after percutaneous coronary intervention and coronary artery bypass grafting for left main disease: an analysis from the EXCEL trial.
Ben-Yehuda, O, Chen, S, Redfors, B, McAndrew, T, Crowley, A, Kosmidou, I, Kandzari, DE, Puskas, JD, Morice, MC, Taggart, DP, et al
European heart journal. 2019;(24):1930-1941
Abstract
AIMS: The prognostic implications of periprocedural myocardial infarction (PMI) after percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) remain controversial. We examined the 3-year rates of mortality among patients with and without PMI undergoing left main coronary artery intervention randomized to PCI with everolimus-eluting stents vs. CABG in the large-scale, multicentre, prospective, randomized EXCEL trial. METHODS AND RESULTS By protocol, PMI was defined using an identical threshold for PCI and CABG [creatinine kinase-MB (CK-MB) elevation >10× the upper reference limit (URL) within 72 h post-procedure, or >5× URL with new Q-waves, angiographic vessel occlusion, or loss of myocardium on imaging]. Cox proportional hazards modelling was performed controlling for age, sex, hypertension, diabetes mellitus, left ventricular ejection fraction, SYNTAX score, and chronic obstructive pulmonary disease (COPD). A total of 1858 patients were treated as assigned by randomization. Periprocedural MI occurred in 34/935 (3.6%) of patients in the PCI group and 56/923 (6.1%) of patients in the CABG group [odds ratio 0.61, 95% confidence interval (CI) 0.40-0.93; P = 0.02]. Periprocedural MI was associated with SYNTAX score, COPD, cross-clamp duration and total procedure duration, and not using antegrade cardioplegia. By multivariable analysis, PMI was associated with cardiovascular death and all-cause death at 3 years [adjusted hazard ratio (HR) 2.63, 95% CI 1.19-5.81; P = 0.02 and adjusted HR 2.28, 95% CI 1.22-4.29; P = 0.01, respectively]. The effect of PMI was consistent for PCI and CABG for cardiovascular death (Pinteraction = 0.56) and all-cause death (Pinteraction = 0.59). Peak post-procedure CK-MB ≥10× URL strongly predicted mortality, whereas lesser degrees of myonecrosis were not associated with prognosis. CONCLUSION In the EXCEL trial, PMI was more common after CABG than PCI, and was strongly associated with increased 3-year mortality after controlling for potential confounders. Only extensive myonecrosis (CK-MB ≥10× URL) was prognostically important.
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Factors associated with postoperative atrial fibrillation and other adverse events after cardiac surgery.
Akintoye, E, Sellke, F, Marchioli, R, Tavazzi, L, Mozaffarian, D
The Journal of thoracic and cardiovascular surgery. 2018;(1):242-251.e10
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Abstract
OBJECTIVE The study objective was to evaluate the impact of various surgical characteristics and practices on the risk of postoperative atrial fibrillation and other adverse outcomes after cardiac surgery. METHODS By using the prospectively collected data of patients who underwent cardiac surgery in 28 centers across the United States, Italy, and Argentina, the details of surgery characteristics were collected for each patient and the outcomes, including postoperative atrial fibrillation, major adverse cardiovascular events, and mortality. These were evaluated via multivariable-adjusted models. RESULTS In 1462 patients, a total of 460 cases of postoperative atrial fibrillation, 33 major adverse cardiovascular events, 23 cases of 30-day mortality, and 46 cases of 1-year mortality occurred. We found that type of surgery and cardiopulmonary bypass use predicted the occurrence of postoperative atrial fibrillation. Compared with coronary artery bypass grafting alone, there was a higher risk of postoperative atrial fibrillation with valvular surgery alone (odds ratio, 1.4; 95% confidence interval, 1.1-1.9), and the risk was even higher with concomitant valvular and coronary artery bypass grafting surgery (odds ratio, 1.8; 95% confidence interval, 1.2-2.7). Compared with no bypass, use of cardiopulmonary bypass was associated with higher risk of postoperative atrial fibrillation (odds ratio, 2.4; 95% confidence interval, 1.7-3.5), but there were significant age and sex differences of the impact of bypass use among patients undergoing coronary artery bypass grafting (P for interaction = .04). In addition, compared with spontaneous return of rhythm, ventricular pacing was associated with a higher risk of major adverse cardiovascular events (odds ratio, 5.0; 95% confidence interval, 1.4-18), whereas concomitant coronary artery bypass grafting and valvular surgery was associated with a higher risk of 30-day mortality (hazard ratio, 4.3; 95% confidence interval, 1.2-14) compared with coronary artery bypass grafting alone. Occurrence of postoperative atrial fibrillation was associated with greater length of stay and 1-year mortality (hazard ratio, 2.2; 95% confidence interval, 1.2-3.9). CONCLUSIONS In this multicenter trial, we identified specific adverse outcomes that are associated with concomitant valvular and coronary artery bypass graft surgery, cardiopulmonary bypass, ventricular pacing, and occurrence of postoperative atrial fibrillation.
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Influence of practice patterns on outcome among countries enrolled in the SYNTAX trial: 5-year results between percutaneous coronary intervention and coronary artery bypass grafting.
Milojevic, M, Head, SJ, Mack, MJ, Mohr, FW, Morice, MC, Dawkins, KD, Holmes, DR, Serruys, PW, Kappetein, AP
European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery. 2017;(3):445-453
Abstract
OBJECTIVES To examine differences among participating countries in baseline characteristics, clinical practice, medication strategies and outcomes of patients randomized to coronary artery bypass grafting and percutaneous coronary intervention in the SYNTAX trial. METHODS In SYNTAX, centres in 18 different countries enrolled 1800 patients, of which 8 countries enrolled ≥80 patients, what was projected to be a large enough sample size to be included in the analysis. Baseline characteristics, practice patterns and clinical outcomes were compared between the USA (n = 245), the UK (n = 267), Italy (n = 197), France (n = 208), Germany (n = 179), Netherlands (n = 148), Belgium (n = 91) and Hungary (n = 83). The remaining patients from other participating countries were pooled together (n = 382). RESULTS Five-year results demonstrated significantly different outcomes between countries. After adjustment, percutaneous coronary intervention patients in France had lower rates of major adverse cardiac and cerebrovascular events [hazard ratio (HR) = 0.60, 95% confidence interval (CI) 0.37-0.98], while the incidence of repeat revascularization was higher in Hungary (HR = 1.89, 95% CI 1.14-3.42). Coronary artery bypass grafting showed the lowest rate of repeat revascularization in the UK (HR = 0.32, 95% CI 0.12-0.85). There were numerous differences in the risk profile of patients between participating countries, as well as marked differences in surgical practice across countries in the use of blood cardioplegia (range 3.1-89.0%; P < 0.001), bilateral internal mammary artery usage (range 7.8-68.2%; P < 0.001) and off-pump procedures (range 3.9-44.4%; P < 0.001). Variation was also found for percutaneous coronary intervention in the number of implanted stents (range 4.0 ± 2.3 to 6.1 ± 2.6; P < 0.001) as well as for the entire stents length (range 69.0 ± 45.1 to 124.1 ± 60.9; P < 0.001). Remarkable differences were observed in the prescription of post-coronary artery bypass grafting medication in terms of acetylsalicylic acid (range 79.6-95.0%; P = 0.004), thienopyridine (6.8-31.1%; P < 0.001) and statins (41.3-89.1%; P < 0.001). CONCLUSIONS Patient characteristics and clinical patterns are significantly different between countries, resulting in significantly different 5-year outcomes. This article presents specific data that can further improve outcomes in each country. CLINICAL TRIALS REGISTRY NCT00114972.
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Blood levels of S-100 calcium-binding protein B, high-sensitivity C-reactive protein, and interleukin-6 for changes in depressive symptom severity after coronary artery bypass grafting: prospective cohort nested within a randomized, controlled trial.
Pearlman, DM, Brown, JR, MacKenzie, TA, Hernandez, F, Najjar, S
PloS one. 2014;(10):e111110
Abstract
BACKGROUND Cross-sectional and retrospective studies have associated major depressive disorder with glial activation and injury as well as blood-brain barrier disruption, but these associations have not been assessed prospectively. Here, we aimed to determine the relationship between changes in depressive symptom severity and in blood levels of S-100 calcium-binding protein B (S-100B), high-sensitivity C-reactive protein, and interleukin-6 following an inflammatory challenge. METHODS Fifty unselected participants were recruited from a randomized, controlled trial comparing coronary artery bypass grafting procedures performed with versus without cardiopulmonary bypass for the risk of neurocognitive decline. Depressive symptom severity was measured at baseline, discharge, and six-month follow-up using the Beck Depression Inventory II (BDI-II). The primary outcome of the present biomarker study was acute change in depressive symptom severity, defined as the intra-subject difference between baseline and discharge BDI-II scores. Blood biomarker levels were determined at baseline and 2 days postoperative. RESULTS Changes in S-100B levels correlated positively with acute changes in depressive symptom severity (Spearman ρ, 0.62; P = 0.0004) and accounted for about one-fourth of their observed variance (R2, 0.23; P = 0.0105). This association remained statistically significant after adjusting for baseline S-100B levels, age, weight, body-mass index, or β-blocker use, but not baseline BDI-II scores (P = 0.064). There was no statistically significant association between the primary outcome and baseline S-100B levels, baseline high-sensitivity C-reactive protein or interleukin-6 levels, or changes in high-sensitivity C-reactive protein or interleukin-6 levels. Among most participants, levels of all three biomarkers were normal at baseline and markedly elevated at 2 days postoperative. CONCLUSIONS Acute changes in depressive symptom severity were specifically associated with incremental changes in S-100B blood levels, largely independent of covariates associated with either. These findings support the hypothesis that glial activation and injury and blood-brain barrier disruption can be mechanistically linked to acute exacerbation of depressive symptoms in some individuals.
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Comparison of the effects of desflurane and propofol anesthesia on the inflammatory response and s100β protein during coronary artery bypass grafting.
Baki, ED, Aldemir, M, Kokulu, S, Koca, HB, Ela, Y, Sıvacı, RG, Öztürk, NK, Emmiler, M, Adalı, F, Uzel, H
Inflammation. 2013;(6):1327-33
Abstract
Cardiopulmonary bypass (CPB) contributes to the secretion of anti-inflammatory cytokines that mediate the inflammatory response observed during open heart surgery. In addition to many factors, type of anesthesia management affects immune response and central nervous system in cardiac surgery. The aim of this study was to assess the effect of propofol versus desflurane anesthesia on systemic immune modulation and central nervous system on patients undergoing coronary artery bypass grafting. Forty patients undergoing elective coronary artery bypass graft surgery with CPB were included in this prospective randomized study. Patients were allocated to receive propofol (n = 20) or desflurane (n = 20) for maintenance of anesthesia. The blood samples for IL-6, IL-8, TNF-α, and S100β were drawn just prior to the operation before the induction of anesthesia, second before cardiopulmonary bypass, third after CPB, fourth 4 h postoperatively at the ICU. Major finding in our study is that S100β levels were lower in propofol group when compared to desflurane anesthesia. And also immune reaction was less in patients exposed to desflurane anesthesia when compared to propofol anesthesia as indicated by lower plasma concentrations of IL-8 and IL-6. Propofol is more preferable in terms of S100β for anesthetic management for CABG.
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Incidence, correlates, and significance of abnormal cardiac enzyme rises in patients treated with surgical or percutaneous based revascularisation: a substudy from the Synergy between Percutaneous Coronary Interventions with Taxus and Cardiac Surgery (SYNTAX) Trial.
Farooq, V, Serruys, PW, Vranckx, P, Bourantas, CV, Girasis, C, Holmes, DR, Kappetein, AP, Mack, M, Feldman, T, Morice, MC, et al
International journal of cardiology. 2013;(6):5287-92
Abstract
AIMS: The aim of the present investigation was to determine the long-term prognostic association of post-procedural cardiac enzyme elevation within the randomised Synergy between Percutaneous Coronary Intervention (PCI) with TAXUS and Cardiac Surgery (SYNTAX) Trial. METHODS 1800 patients with unprotected left main or de novo three-vessel coronary artery disease were randomised to undergo coronary artery bypass graft (CABG) surgery or PCI. Per protocol patients underwent post-procedural blood sampling with creatine kinase (CK), and the cardiac specific MB iso-enzyme (CK-MB) only if the preceding CK ratio was ≥ 2 × the upper limit of normal (ULN). An independent chemistry laboratory evaluated all collected blood samples. RESULTS Post-procedural CK sampling was available in 1629 of 1800 patients (90.5%). As per protocol, CK-MB analyses were undertaken in 474 of 491 patients (96.5%) in the CABG arm, and 53 of 61 patients (86.9%) in the PCI arm. Within the CABG arm, despite the limitations of incomplete data, a post-procedural CK-MB ratio <3/≥3 ULN separated 4-year mortality into low- and high-risk groups (2.3% vs. 9.5%, p=0.03). Additionally, in the CABG arm, a post-procedural CK-MB ratio ≥3 ULN was associated with an increased frequency of a high SYNTAX Score (≥33) tertile (high [≥33] SYNTAX Score: 39.5%, intermediate [23-32] SYNTAX Score 31.0%, low [≤22] SYNTAX Score 29.5%, p=0.02). Within the PCI arm, a post-procedural CK ratio of <2 or ≥2 ULN separated 4-year mortality into low- and high-risk groups (10.8% vs. 23.3%, p=0.001). Notably, there was an early (within 6 months) and late (after 2 years) peak in mortality in patients with a post-PCI CK ratio of ≥2 ULN. Lack of pre-procedural thienopyridine, carotid artery disease, type 1 diabetes, and presence of coronary bifurcations were independent correlates of a CK ratio ≥2 ULN post-PCI. CONCLUSION Cardiac enzyme elevations post-CABG or post-PCI are associated with an adverse long-term mortality; the causes of which are multifactorial.
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Coronary stenting with MGuard: extended follow-up of first human trial.
Grube, E, Hauptmann, KE, Müller, R, Uriel, N, Kaluski, E
Cardiovascular revascularization medicine : including molecular interventions. 2011;(3):138-146
Abstract
OBJECTIVES To evaluate feasibility and safety of MGuard based percutaneous coronary interventions (PCI) in vein grafts (VG) and native coronaries (NC). BACKGROUND Distal embolization is a frequent complication of PCI of VG and NC during acute coronary syndromes (ACS). MGuard was a stent designed to reduce embolization. METHODS Prospective, single arm, two-center trial assessing the feasibility and safety of MGuard-based PCI with post-PCI clinical and laboratory monitoring including: cardiac biomarkers, ECG and 6-month angiography. RESULTS Forty-one patients with mean age of 68.2±10.1 years were enrolled. Mean VG age (n=23) was 14.4±4.3 years. All patients received heparin, clopidogrel and aspirin; while none received glycoprotein IIb/IIIa inhibitors, or embolic protection device (EPD). Device and procedural success were 100% and 95.1% respectively. Two patients (4.9%) experienced procedure-related creatinine phosphokinase rise. At 6 months one patient had myocardial infarction and 19.5% had target vessel revascularization (TLR). Late follow up (12-27 months) revealed one additional TLR. CONCLUSION MGuard based PCI of NC and VG appears encouraging especially in view of unfavorable patient and lesion characteristics. Efficacy needs to be further established in larger randomized trials.
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Control of lipids at baseline in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial.
Pambianco, G, Lombardero, M, Bittner, V, Forker, A, Kennedy, F, Krishnaswami, A, Mooradian, AD, Pop-Busui, R, Rana, JS, Rodriguez, A, et al
Preventive cardiology. 2009;(1):9-18
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In order to examine lipids, a major treatment parameter in those with diabetes and heart disease, the authors analyzed baseline data from the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial. The study consisted of 2368 participants with type 2 diabetes and coronary artery disease from 49 sites in 6 countries (2295 provided lipid measurements). Fifty-nine percent of participants had a low-density lipoprotein (LDL) cholesterol level < 100 mg/dL. Levels of total, LDL, and non-high-density lipoprotein (HDL) cholesterol and triglycerides differed by age group (younger than 55, 55-64, and 65 years and older); they were lowest in those aged 65 years. Women had higher total, LDL, and non-HDL cholesterol values. Education was associated with lower total, LDL, and non-HDL cholesterol levels. LDL cholesterol and triglyceride values were lower in the United States and Canada. Adjustment for age, sex, education level, randomization year, and medication did not eliminate these differences. Geographic variation was seen and was not fully accounted for by demographic or treatment characteristics (all P values < .05).
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Frequency of coronary artery bypass grafting following implantation of a paclitaxel-eluting or a bare-metal stent into a single coronary artery.
Martin, JL, Ellis, SG, Colombo, A, Grube, E, Maloney, T, Friedman, MI, Baim, DS, Dawkins, K, Caputo, R, Stone, GW
The American journal of cardiology. 2009;(1):11-6
Abstract
Limited data are available on the relative effect of drug-eluting versus bare-metal stents on the requirement for subsequent coronary artery bypass grafting (CABG). The aim of this study was to evaluate the incidence and predictors of CABG after bare-metal and paclitaxel-eluting coronary stent implantation. A patient-level, pooled analysis was conducted of 2,736 patients from 3 double-blind, randomized trials comparing the slow-release paclitaxel-eluting Taxus stent with an otherwise identical bare-metal stent control in single de novo coronary lesions, with 5-year follow-up. The rate of target lesion revascularization by CABG (TLR-CABG) was reduced from 4.1% in patients with bare-metal stents to 1.4% in those with Taxus stents (p <0.001). The use of the Taxus stent was the strongest predictor of freedom from TLR-CABG on multivariate analysis (hazard ratio 0.33, p <0.001). Significant reductions in TLR-CABG with Taxus compared with bare-metal stents were seen in the treatment of left anterior descending artery lesions (6.1% vs 1.8%, p <0.001) and non-left anterior descending artery lesions (2.8% vs 1.3%, p = 0.037), in patients with diabetes (6.0% vs 1.0%, p <0.01), and in those without diabetes (3.5% vs 1.6%, p <0.01). In conclusion, referral to CABG is significantly less common after stenting single coronary lesions with Taxus compared with bare-metal stents. The relative reductions in TLR-CABG of 54% in patients without diabetes, 87% in patients with diabetes, 70% in left anterior descending artery lesions, and 54% in non-left anterior descending artery lesions with Taxus compared with bare-metal stents should be considered during stent selection.
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Pleiotropic effect of lovastatin, with and without cholestyramine, in the post coronary artery bypass graft (Post CABG) trial.
Domanski, M, Tian, X, Fleg, J, Coady, S, Gosen, C, Kirby, R, Sachdev, V, Knatterud, G, Braunwald, E
The American journal of cardiology. 2008;(8):1023-7
Abstract
This study evaluated patients in the Post Coronary Artery Bypass Graft (Post CABG) trial for evidence of statin pleiotropic effects in preventing atherosclerotic progression in saphenous vein grafts (SVGs). We studied 1,116 of the 1,351 patients in the Post CABG trial who were randomized to aggressive (low-density lipoprotein [LDL] cholesterol target <85 mg/dl) or moderate (target LDL cholesterol <140 mg/dl) lovastatin treatment and who had sufficient data available. The generalized estimating equation models, adjusting for important covariates, were applied to estimate the odds ratios (ORs) and probability of substantial atherosclerotic SVG progression (decrease in lumen diameter >or=0.6 mm) and the difference in minimum lumen diameter change between treatment groups. Aggressive lovastatin treatment compared with moderate treatment was associated with a significant decrease in risk of significant SVG atherosclerotic progression after adjustment for baseline cholesterol level, LDL cholesterol on treatment, high-density lipoprotein cholesterol, and triglyceride changes on treatment and other independent predictors (OR 0.68, 95% confidence interval 0.49 to 0.94, p = 0.019). Results were similar when the change or percent change from baseline of LDL cholesterol level on treatment was adjusted for rather than on-treatment LDL cholesterol and in the subset achieving a year-1 LDL cholesterol level from 90 to 135 mg/dl (OR 0.64, 95% confidence interval 0.42 to 0.98, p = 0.042). Mean decrease in minimum lumen diameter was also significantly smaller in the aggressive than the moderate treatment arm (-0.256 vs -0.343 mm, p = 0.042). In conclusion, aggressive versus moderate lovastatin treatment appeared therapeutic in slowing the atherosclerotic process in SVGs from Post CABG patients, independent of its greater LDL cholesterol-lowering effect.