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Diabetes mellitus is a major cause of coronary artery disease (CAD). Despite improvement in the management of patients with stable CAD, diabetes remains a major cause of increased morbidity and mortality. There is no conclusive evidence that either modality is better than medical therapy alone for the treatment of stable multivessel CAD in patients with diabetes in a very long-term follow-up. Our aim was to compare 3 therapeutic strategies for stable multivessel CAD in a diabetic population and non-diabetic population. It was compared medical therapy (MT), percutaneous coronary intervention (PCI), and coronary artery bypass graft (CABG) in 232 diabetic patients and 379 nondiabetic patients with multivessel CAD. Endpoints evaluated were overall and cardiac mortality. Patients (n = 611) were randomized to CABG (n = 203), PCI (n = 205), or MT (n = 203). In a 10-year follow-up, more deaths occurred among patients with diabetes than among patients without diabetes (P = .001) for overall mortality. In this follow-up, 10-year mortality rates were 32.3% and 23.2% for diabetics and non-diabetics respectively (P = .024). Regarding cardiac mortality, 10-year cardiac mortality rates were 19.4% and 12.7% respectively (P = .031).Considering only diabetic patients and stratifying this population by treatment option, we found mortality rates of 31.3% for PCI, 27.5% for CABG and 37.5% for MT (P = .015 for CABG vs MT) and cardiac mortality rates of 18.8%, 12.5% and 26.1% respectively (P = .005 for CABG vs MT). Among patients with stable multivessel CAD and preserved left ventricular ejection fraction, the 3 therapeutic regimens had high rates of overall and cardiac-related deaths among diabetic compared with non-diabetic patients. Moreover, better outcomes were observed in diabetic patients undergoing CABG compared to MT in relation to overall and cardiac mortality in a 10-year follow-up.

To analyze the inflammation resulting from myocardial revascularization techniques with and without cardiopulmonary bypass, based on ultrasensitive C-reactive protein (US-CRP) behavior. A prospective non-randomized clinical study with 136 patients was performed. Sixty-nine patients were enrolled for Group 1 (on-pump coronary artery bypass - ONCAB) and 67 patients were assigned to Group 2 (off-pump coronary artery bypass - OPCAB). All study participants had blood samples collected for analysis of glucose, triglycerides, creatinine, total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and creatinephosphokinase (CPK) in the preoperative period. The samples of creatinephosphokinase MB (CKMB), troponin I (TnI) and US-CRP were collected in the preoperative period and at 6, 12, 24, 36, 48 and 72 hours after surgery. We also analyzed the preoperative biological variables of each patient (age, smoking, diabetes mellitus, left coronary trunk lesion, body mass index, previous myocardial infarction, myocardial fibrosis). All angiographically documented patients with >70% proximal multiarterial stenosis and ischemia, documented by stress test or classification of stable angina (class II or III), according to the Canadian Cardiovascular Society, were included. Reoperations, combined surgeries, recent acute myocardial infarction, recent inflammatory disease, deep venous thrombosis or recent pulmonary thromboembolism, acute kidney injury or chronic kidney injury were not included. Correlation values between the US-CRP curve and the ONCAB group, the treatment effect and the analyzed biological variables did not present expressive results. Laboratory variables were evaluated and did not correlate with the applied treatment (P>0.05). The changes in the US-CRP at each moment evaluated from the postoperative period did not show any significance in relation to the surgical technique applied.

Background The diagnosis of peri-procedural myocardial infarction is complex, especially after the emergence of high-sensitivity markers of myocardial necrosis. Methods In this study, patients with normal baseline cardiac biomarkers and formal indication for elective on-pump coronary bypass surgery were evaluated. Electrocardiograms, cardiac biomarkers, and cardiac magnetic resonance imaging with late gadolinium enhancement were performed before and after procedures. Myocardial infarction was defined as more than ten times the upper reference limit of the 99th percentile for troponin I and for creatine kinase isoform (CK-MB) and by the findings of new late gadolinium enhancement on cardiac magnetic resonance. We assessed the release of cardiac biomarkers in patients with no evidence of myocardial infarction on cardiac magnetic resonance. Results Of 75 patients referred for on-pump coronary bypass surgery, 54 (100%) did not have evidence of myocardial infarction on cardiac magnetic resonance. However, all had a peak troponin I above the 99th percentile; 52 (96%) had an elevation 10 times higher than the 99th percentile. Regarding CK-MB, 54 (100%) patients had a peak CK-MB above the 99th percentile limit, and only 13 (24%) had an elevation greater than 10 times the 99th percentile. The median value of troponin I peak was 3.15 (1.2 to 3.9) ng/mL, which represented 78.7 times the 99th percentile. Conclusion In this study, different from CK-MB findings, troponin was significantly increased in the absence of myocardial infarction on cardiac magnetic resonance. Thus, CK-MB was more accurate than troponin I for excluding procedure-related myocardial infarction. These data suggest a higher troponin cutoff for the diagnosis of coronary bypass surgery related myocardial infarction. Clinical trial registration http://www.isrctn.com/ISRCTN09454308 . Registered 08 May 2012.

Background We aim to evaluate in-hospital events and long-term clinical outcomes in patients over 60 years of age with stable coronary artery disease and preserved left ventricular ejection fraction undergoing off-pump or on-pump coronary artery bypass grafting. Methods The MASS III was a single-center randomized trial that evaluate 308 patients with stable coronary artery disease and preserved ventricular function assigned for: 155 to off-pump and 153 to on-pump CABG. Of this, 176 (58.3%) patients were 60 years or older at the time of randomization (90 of-pump and 86 on-pump). The primary short-term end point was a composite of myocardial infarction, stroke, and overall mortality occurring within 30 days after surgery or before discharge, whichever was later. The primary long-term end point was death from any cause within 5 years, non-fatal myocardial infarction between 30 days and 5 years, or additional revascularization between 30 days and 5 years. Results On-pump CABG had a higher incidence of 30-day composite outcome than off-pump CABG (15,1% and 5.6%, respectively; P  = 0.036). However, after the multivariate analysis, this association lost statistical significance, P  = 0.05. After 5-year follow-up, there were no significant differences between both strategies of CABG in the composite end points 16.7% and 15.1%; Hazard Ratio 1.07; CI 0.41 – 1.82; P  = 0.71, for off-pump and on-pump CABG respectively. Conclusions On-pump and off-pump CABG achieved similar results of combined events at short-term and 5-year follow-up. Trial registration Clinical Trial Registration Information—URL: http://www.controlled-trials.com . Registration number: ISRCTN59539154 .

The Off-pump versus On-pump Coronary Artery Bypass Grafting in Frail Patients (FRAGILE Trial) is a multicenter, randomized controlled trial comparing off-pump and on-pump coronary artery bypass grafting in frail or pre-frail patients undergoing coronary artery bypass grafting. This manuscript presents an update to the FRAGILE Trial study design, detailing protocol modifications made in response to the time gap between the study's conception and its actual implementation. These changes were implemented early in the trial and were formally approved by the Ethics Committee, ensuring the scientific and ethical integrity of the study and reinforcing its relevance to address a gap in a vulnerable patient population.

Background We aim to evaluate in-hospital events and long-term clinical outcomes in patients over 60 years of age with stable coronary artery disease and preserved left ventricular ejection fraction undergoing off-pump or on-pump coronary artery bypass grafting. Methods The MASS III was a single-center randomized trial that evaluate 308 patients with stable coronary artery disease and preserved ventricular function assigned for: 155 to off-pump and 153 to on-pump CABG. Of this, 176 (58.3%) patients were 60 years or older at the time of randomization (90 of-pump and 86 on-pump). The primary short-term end point was a composite of myocardial infarction, stroke, and overall mortality occurring within 30 days after surgery or before discharge, whichever was later. The primary long-term end point was death from any cause within 5 years, non-fatal myocardial infarction between 30 days and 5 years, or additional revascularization between 30 days and 5 years. Results On-pump CABG had a higher incidence of 30-day composite outcome than off-pump CABG (15,1% and 5.6%, respectively; P  = 0.036). However, after the multivariate analysis, this association lost statistical significance, P  = 0.05. After 5-year follow-up, there were no significant differences between both strategies of CABG in the composite end points 16.7% and 15.1%; Hazard Ratio 1.07; CI 0.41 – 1.82; P  = 0.71, for off-pump and on-pump CABG respectively. Conclusions On-pump and off-pump CABG achieved similar results of combined events at short-term and 5-year follow-up. Trial registration Clinical Trial Registration Information—URL: http://www.controlled-trials.com . Registration number: ISRCTN59539154 .

Advances in modern medicine have led to people living longer and healthier lives. Frailty is an emerging concept in medicine yet to be explored as a risk factor in cardiac surgery. When it comes to CABG surgery, randomized controlled clinical trials have primarily focused on low-risk (ROOBY, CORONARY), elevated-risk (GOPCABE) or high-risk patients (BBS), but not on frail patients. Therefore, we believe that off-pump CABG could be an important technique in patients with limited functional capacity to respond to surgical stress. In this study, the authors introduce the new national, multicenter, randomized, controlled trial \"FRAGILE\", to be developed in the main cardiac surgery centers of Brazil, to clarify the potential benefit of off-pump CABG in frail patients. FRAGILE is a two-arm, parallel-group, multicentre, individually randomized (1:1) controlled trial which will enroll 630 patients with blinded outcome assessment (at 30 days, 6 months, 1 year, 2 years and 3 years), which aims to compare adverse cardiac and cerebrovascular events after off-pump versus on-pump CABG in pre-frail and frail patients. Primary outcomes will be all-cause mortality, acute myocardial infarction, cardiac arrest with successful resuscitation, low cardiac output syndrome/cardiogenic shock, stroke, and coronary reintervention. Secondary outcomes will be major adverse cardiac and cerebrovascular events, operative time, mechanical ventilation time, hyperdynamic shock, new onset of atrial fibrillation, renal replacement therapy, reoperation for bleeding, pneumonia, length of stay in intensive care unit, length of stay in hospital, number of units of blood transfused, graft patency, rate of complete revascularization, neurobehavioral outcomes after cardiac surgery, quality of life after cardiac surgery and costs. FRAGILE trial will determine whether off-pump CABG is superior to conventional on-pump CABG in the surgical treatment of pre-frail and frail patients. ClinicalTrials.gov, ID: NCT02338947. Registered on August 29th 2014; last updated on March 21st 2016.

Background Although the release of cardiac biomarkers after percutaneous (PCI) or surgical revascularization (CABG) is common, its prognostic significance is not known. Questions remain about the mechanisms and degree of correlation between the release, the volume of myocardial tissue loss, and the long-term significance. Delayed-enhancement of cardiac magnetic resonance (CMR) consistently quantifies areas of irreversible myocardial injury. To investigate the quantitative relationship between irreversible injury and cardiac biomarkers, we will evaluate the extent of irreversible injury in patients undergoing PCI and CABG and relate it to postprocedural modifications in cardiac biomarkers and long-term prognosis. Methods/Design The study will include 150 patients with multivessel coronary artery disease (CAD) with left ventricle ejection fraction (LVEF) and a formal indication for CABG; 50 patients will undergo CABG with cardiopulmonary bypass (CPB); 50 patients with the same arterial and ventricular condition indicated for myocardial revascularization will undergo CABG without CPB; and another 50 patients with CAD and preserved ventricular function will undergo PCI using stents. All patients will undergo CMR before and after surgery or PCI. We will also evaluate the release of cardiac markers of necrosis immediately before and after each procedure. Primary outcome considered is overall death in a 5-year follow-up. Secondary outcomes are levels of CK-MB isoenzyme and I-Troponin in association with presence of myocardial fibrosis and systolic left ventricle dysfunction assessed by CMR. Discussion The MASS-V Trial aims to establish reliable values for parameters of enzyme markers of myocardial necrosis in the absence of manifest myocardial infarction after mechanical interventions. The establishments of these indices have diagnostic value and clinical prognosis and therefore require relevant and different therapeutic measures. In daily practice, the inappropriate use of these necrosis markers has led to misdiagnosis and therefore wrong treatment. The appearance of a more sensitive tool such as CMR provides an unprecedented diagnostic accuracy of myocardial damage when correlated with necrosis enzyme markers. We aim to correlate laboratory data with imaging, thereby establishing more refined data on the presence or absence of irreversible myocardial injury after the procedure, either percutaneous or surgical, and this, with or without the use of cardiopulmonary bypass.