Among patients with diabetes and stable heart disease, those with troponin T levels of 14 ng per liter or more had a 5-year rate of cardiovascular death, MI, or stroke of 27%, versus 13% in those ...with lower levels, but received no benefit from prompt revascularization.
Cardiac troponin concentration is the preferred marker of myocardial necrosis.
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Elevated concentrations of cardiac troponin have a strong association with an adverse prognosis in patients with acute coronary syndromes and are used to identify patients who are likely to benefit from an early invasive management strategy.
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High-sensitivity assays that allow the measurement of very low cardiac troponin levels in patients with stable heart disease are now available for clinical and research use. These low, previously undetectable troponin concentrations have shown strong associations with myocardial infarction, stroke, and death in a variety of primary and secondary prevention populations, including in . . .
Objectives This study evaluated data from 3 federally funded trials that focused on optimal medical therapy to determine if formalized attempts at risk factor control within clinical trials are ...effective in achieving guideline-driven treatment goals for diabetic patients with coronary artery disease (CAD). Background Despite clear evidence of benefit for CAD secondary prevention, the level of risk factor control in clinical practice has been disappointing. Methods We obtained data from the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) diabetes subgroup, (n = 766 of 2,287), the BARI 2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) trial (n = 2,368), and the FREEDOM (Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes) trial (n = 1,900) to evaluate the proportion of patients achieving guideline-based, protocol-driven treatment targets for systolic blood pressure, low-density lipoprotein cholesterol, smoking cessation, and hemoglobin A1c. The primary outcome measure was the proportion of diabetic CAD patients meeting all 4 pre-specified targets at 1 year after enrollment. Results The pooled data include 5,034 diabetic patients. The percentages of patients achieving the 1-year low-density lipoprotein cholesterol targets compared with baseline increased from 55% to 77% in COURAGE, from 59% to 75% in BARI 2D, and from 34% to 42% in FREEDOM. Although similar improved trends were seen for systolic blood pressure, glycemic control, and smoking cessation, only 18% of the COURAGE diabetes subgroup, 23% of BARI 2D patients, and 8% of FREEDOM patients met all 4 pre-specified treatment targets at 1 year of follow-up. Conclusions A significant proportion of diabetic CAD patients fail to achieve pre-specified targets for 4 major modifiable cardiovascular risk factors in clinical trials. We conclude that fundamentally new thinking is needed to explore approaches to achieve optimal secondary prevention treatment goals. (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation; NCT00007657 ) (Bypass Angioplasty Revascularization Investigation 2 Diabetes BARI 2D; NCT00006305 ) (Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes FREEDOM; NCT00086450 )
Abstract Background Previous studies have observed high rates of perioperative cardiovascular events in patients with coronary stents undergoing noncardiac surgery (NCS). It is uncertain whether this ...finding reflects an independent association. Objectives The goal of this study was to assess the independent relationship between prior coronary stent implantation and the occurrence of perioperative major adverse cardiac and cerebrovascular events (MACCE) and bleeding and its relation with time from stenting to NCS. Methods A total of 24,313 NCS cases at the Mayo Clinic (Rochester, Minnesota) from 2006 through 2011 were included in the study; 1,120 (4.6%) cases involved patients with coronary stents. MACCE was defined as death, myocardial infarction, cardiac arrest, or stroke. Age-adjusted odds ratios (aORs) were calculated after propensity adjustment for Revised Cardiac Risk Index factors and other conventional risk factors. Results The 30-day MACCE rates were 3.7% and 1.5% in stented and unstented patients, respectively (p < 0.001). The risk of MACCE was largely related to the time from stent implantation to NCS, indicating substantially elevated risk in the first year after stenting (aOR: 2.59; 95% confidence interval CI: 1.36 to 4.94) but not thereafter (aOR: 0.89; 95% CI: 0.59 to 1.36). Bleeding displayed a similar pattern, indicating elevated risk in the first year after stenting (aOR: 2.23; 95% CI: 1.55 to 3.21) but not thereafter (aOR: 1.07; 95% CI: 0.89 to 1.28). Subgroup analysis in patients with known stent type found that the increased risk of both MACCE and bleeding >1 month after stent implantation was not limited to only those with drug-eluting stents. Conclusions This study found that prior coronary stent implantation is an independent risk factor for MACCE and bleeding when time from stenting to NCS is <1 year, both in patients with bare-metal and drug-eluting stents.
Objective Clinicians may give greater consideration to medical management versus coronary artery bypass grafting (CABG) for coronary artery disease (CAD) at the time of aortic valve intervention. We ...evaluated the prognostic impact of revascularization strategy during aortic valve replacement (AVR). Methods We studied 1308 consecutive patients with significant CAD (≥50% stenosis) undergoing AVR with or with out CABG between 2001 and 2010. Late mortality and its determinants were analyzed using multivariable Cox models. Results Patients undergoing CABG (n = 1043; 18%) had more frequent angina (50% vs 26%; P < .001), left ventricular dysfunction (22% vs 14%; P = .003), advanced (>70% stenosis) CAD (85% vs 48%; P < .001), and incidence of triple-vessel/left-main CAD (44% vs 8%; P < .001). Whereas operative mortality was comparable between patients undergoing AVR plus CABG versus isolated AVR (2.9% vs 3.0%; P = .90), 5-year (72% vs 64%) and 8-year (50% vs 39%) survival was higher following CABG ( P = .007). Adjusting for older age (hazard ratio HR, 1.28 per 5 years), female sex (HR, 1.23), peripheral vascular disease (HR, 1.71), New York Heart Association functional class III to IV (HR, 1.48), and diabetes (HR, 1.50) concomitant CABG at AVR reduced late mortality risk by more than one-third (HR, 0.62, 95% confidence interval, 0.49-0.79; P < .001). CABG continued to confer a survival advantage in patients with moderate (50%-70%) (HR, 0.62; P = .02) and severe (>70%) CAD (HR, 0.62; P = .002). Conclusions In patients undergoing AVR with coexistent CAD, concomitant CABG reduces risk of late death by more than one-third, without augmenting operative mortality. This survival advantage persists in moderate (50% to 70%) and severe (>70%) CAD. These findings underline the prognostic importance of revascularization in this population and should influence decisions regarding revascularization strategy in patients undergoing transcatheter valve therapy.
In this trial involving patients with type 2 diabetes and stable ischemic cardiovascular disease, prompt revascularization was compared with medical therapy, and insulin sensitization was compared ...with insulin provision, with patients stratified according to whether they underwent percutaneous coronary intervention or coronary-artery bypass grafting. Revascularization did not significantly reduce the rate of death from any cause or the rate of major cardiovascular events overall. Insulin sensitization and insulin provision also had similar cardiovascular outcomes.
In patients with type 2 diabetes and stable ischemic cardiovascular disease, revascularization did not significantly reduce the rate of death from any cause or the rate of major cardiovascular events overall, as compared to medical therapy. Insulin sensitization and insulin provision also had similar cardiovascular outcomes.
Patients with type 2 diabetes mellitus have a higher risk of cardiovascular events and death than those without diabetes.
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Few large, randomized trials have addressed the question of the optimal treatment for patients with diabetes and angiographically defined stable ischemic heart disease. The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial was designed to test treatment strategies for patients with coronary artery disease and diabetes. Our goal was to address the effects of therapy on the rate of myocardial ischemia, a major cause of death in patients with diabetes, and of insulin resistance, the fundamental mechanism underlying diabetes . . .
Coronary artery disease (CAD) accounts for a large fraction of the morbidity, mortality, and cost of diabetes. Recognizing this, nearly 10 years ago the American Diabetes Association published a ...consensus recommendation that clinicians consider a risk factor-guided screening approach to early diagnosis of CAD in both symptomatic and asymptomatic patients. Subsequent clinical trial results have not supported those recommendations. Since the prior consensus statement, newer imaging methods, such as coronary artery calcium scoring and noninvasive angiography with computed tomography (CT) techniques, have come into use. These technologies, which allow quantitation of atherosclerotic burden and can predict risk of cardiac events, might provide an approach to more widespread coronary atherosclerosis screening. However, over this same time interval, there has been recognition of diabetes as a cardiovascular disease (CVD) equivalent, clear demonstration that medical interventions should provide primary and secondary CVD risk reduction in diabetic populations, and suggestive evidence that percutaneous coronary revascularization may not provide additive survival benefit to intensive medical management in patients with stable CAD. This additional evidence raises the question of whether documenting asymptomatic atherosclerosis or ischemia in people with diabetes is warranted. More data addressing this issue will be forthcoming from the BARI 2-D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) trial. Until then, for patients with type 2 diabetes who are asymptomatic for CAD, we recommend that testing for atherosclerosis or ischemia, perhaps with cardiac CT as the initial test, be reserved for those in whom medical treatment goals cannot be met and for selected individuals in whom there is strong clinical suspicion of very-high-risk CAD. Better approaches to identify such individuals based on readily obtained clinical variables are sorely needed.
The article discusses some of the critical barriers to the successful recruitment and retention of participants in clinical trials. Various strategies for success with the same are highlighted
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