Among patients with ischemic cardiomyopathy, coronary-artery bypass grafting added to medical therapy led to significantly lower rates of death from any cause and of cardiovascular death over 10 ...years than did medical therapy alone.
Advances in the management of cardiovascular risk factors and acute coronary syndromes have increased survival among patients with coronary artery disease, transforming it into a chronic disease that affects 15.5 million U.S. patients; however, coronary artery disease still accounts for more than 538,000 deaths yearly in the United States alone.
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The major long-term manifestations of coronary artery disease, left ventricular dysfunction, and heart failure are projected to affect 8 million patients by 2030, which has enormous societal implications.
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Landmark clinical trials have established coronary-artery bypass grafting (CABG) as an effective treatment for patients with disabling angina symptoms.
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In these . . .
Objectives The study objectives were to test the hypotheses that ischemia during stress testing has prognostic value and identifies those patients with coronary artery disease (CAD) with left ...ventricular (LV) dysfunction who derive the greatest benefit from coronary artery bypass grafting (CABG) compared with medical therapy. Background The clinical significance of stress-induced ischemia in patients with CAD and moderately to severely reduced LV ejection fraction (EF) is largely unknown. Methods The STICH (Surgical Treatment for IsChemic Heart Failure) trial randomized patients with CAD and EF ≤35% to CABG or medical therapy. In the current study, we assessed the outcomes of those STICH patients who underwent a radionuclide (RN) stress test or a dobutamine stress echocardiogram (DSE). A test was considered positive for ischemia by RN testing if the summed difference score (difference in tracer activity between stress and rest) was ≥4 or if ≥2 of 16 segments were ischemic during DSE. Clinical endpoints were assessed by intention to treat during a median follow-up of 56 months. Results Of the 399 study patients (51 women, mean EF 26 ± 8%), 197 were randomized to CABG and 202 were randomized to medical therapy. Myocardial ischemia was induced during stress testing in 256 patients (64% of the study population). Patients with and without ischemia were similar in age, multivessel CAD, previous myocardial infarction, LV EF, LV volumes, and treatment allocation (all p = NS). There was no difference between patients with and without ischemia in all-cause mortality (hazard ratio: 1.08; 95% confidence interval: 0.77 to 1.50; p = 0.66), cardiovascular mortality, or all-cause mortality plus cardiovascular hospitalization. There was no interaction between ischemia and treatment for any clinical endpoint. Conclusions In CAD with severe LV dysfunction, inducible myocardial ischemia does not identify patients with worse prognosis or those with greater benefit from CABG over optimal medical therapy. (Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease STICH; NCT00023595 )
Patients with CAD and LV dysfunction were assigned to either medical therapy alone or medical therapy plus CABG. At 5 years, there was no significant difference between the two study groups in the ...rate of death from any cause.
It is estimated that 5.8 million patients in the United States
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and 15 million in Europe
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have heart failure. Coronary artery disease is the most common substrate for heart failure in industrialized nations.
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However, the role of coronary-artery bypass grafting (CABG) in the treatment of patients with coronary artery disease and heart failure has not been clearly established.
In three landmark clinical trials in the 1970s, a total of 2234 patients with chronic stable angina were randomly assigned to undergo CABG or receive medical therapy alone.
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The findings from these trials led to recommendations supporting the use of CABG . . .
Patients with CAD and LV dysfunction were assigned to receive either medical therapy alone or medical therapy plus CABG. There was no evidence of significant interaction between myocardial viability ...and treatment assignment.
Coronary artery disease is an important contributor to the rise in the prevalence of heart failure and in associated mortality and morbidity.
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It has not been clearly established whether coronary-artery bypass grafting (CABG) has a role in improving the symptoms and the rate of survival of patients with coronary artery disease and heart failure. We conducted the multicenter Surgical Treatment for Ischemic Heart Failure (STICH) trial
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to examine two hypotheses, one of which (hypothesis 1) compared the efficacy of medical therapy alone with that of medical therapy plus CABG in patients with coronary artery disease and left ventricular . . .
CONTEXT The association between systolic blood pressure (SBP) at admission, clinical characteristics, and outcomes in patients hospitalized for heart failure who have reduced or relatively preserved ...systolic function has not been well studied. OBJECTIVE To evaluate the relationship between SBP at admission, clinical profile, and outcomes in patients hospitalized for acute heart failure. DESIGN, SETTING, AND PATIENTS Cohort study using data from the Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure (OPTIMIZE-HF) registry and performance-improvement program for patients hospitalized with heart failure at 259 US hospitals between March 2003 and December 2004. Patients were divided into quartiles by SBP at hospital admission (<120, 120-139, 140-161, and >161 mm Hg). In-hospital outcomes were based on 48 612 patients aged 18 years or older with heart failure. Of the 41 267 patients with left ventricular function assessed, 21 149 (51%) had preserved left ventricular function. Postdischarge outcomes were based on a prespecified subgroup (n = 5791, 10% of patients) with follow-up data assessed between 60 and 90 days. MAIN OUTCOME MEASURES In-hospital and postdischarge mortality. RESULTS Patients with higher SBP were more likely to be female and black and to have preserved systolic function. Fifty percent of the patients had SBP higher than 140 mm Hg at admission. Patients with lower SBP at admission had higher in-hospital and postdischarge mortality rates. Higher SBP at admission was associated with lower in-hospital mortality rates: 7.2% (<120 mm Hg), 3.6% (120-139 mm Hg), 2.5% (140-161 mm Hg), and 1.7% (>161 mm Hg) (P<.001 for overall difference). Postdischarge mortality rates in the follow-up cohort by SBP at admission were 14.0%, 8.4%, 6.0%, and 5.4%, respectively (P<.001 for overall difference). CONCLUSIONS Systolic hypertension is common in patients hospitalized for heart failure. Systolic blood pressure is an independent predictor of morbidity and mortality in patients with heart failure with either reduced or relatively preserved systolic function. Low SBP (<120 mm Hg) at hospital admission identifies patients who have a poor prognosis despite medical therapy. These findings may have important therapeutic implications because characteristics and outcomes differ greatly among patients with heart failure with varying SBP.
Whether mitral valve repair during coronary artery bypass grafting (CABG) improves survival in patients with ischemic mitral regurgitation (MR) remains unknown.
Patients with ejection fraction ≤35% ...and coronary artery disease amenable to CABG were randomized at 99 sites worldwide to medical therapy with or without CABG. The decision to treat the mitral valve during CABG was left to the surgeon. The primary end point was mortality. Of 1212 randomized patients, 435 (36%) had none/trace MR, 554 (46%) had mild MR, 181 (15%) had moderate MR, and 39 (3%) had severe MR. In the medical arm, 70 deaths (32%) occurred in patients with none/trace MR, 114 (44%) in those with mild MR, and 58 (50%) in those with moderate to severe MR. In patients with moderate to severe MR, there were 29 deaths (53%) among 55 patients randomized to CABG who did not receive mitral surgery (hazard ratio versus medical therapy, 1.20; 95% confidence interval, 0.77-1.87) and 21 deaths (43%) among 49 patients who received mitral surgery (hazard ratio versus medical therapy, 0.62; 95% confidence interval, 0.35-1.08). After adjustment for baseline prognostic variables, the hazard ratio for CABG with mitral surgery versus CABG alone was 0.41 (95% confidence interval, 0.22-0.77; P=0.006).
Although these observational data suggest that adding mitral valve repair to CABG in patients with left ventricular dysfunction and moderate to severe MR may improve survival compared with CABG alone or medical therapy alone, a prospective randomized trial is necessary to confirm the validity of these observations.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00023595.
Abstract Objectives This study sought to test the hypothesis that end-systolic volume (ESV), as a marker of severity of left ventricular (LV) remodeling, influences the relationship between ...myocardial viability and survival in patients with coronary artery disease and LV systolic dysfunction. Background Retrospective studies of ischemic LV dysfunction suggest that the severity of LV remodeling determines whether myocardial viability predicts improved survival with surgical compared with medical therapy, with coronary artery bypass grafting (CABG) only benefitting patients with viable myocardium who have smaller ESV. However, this has not been tested prospectively. Methods Interactions of end-systolic volume index (ESVI), myocardial viability, and treatment with respect to survival were assessed in patients in the prospective randomized STICH (Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease) trial of CABG versus medical therapy who underwent viability assessment (n = 601; age 61 ± 9 years; ejection fraction ≤35%), with a median follow-up of 5.1 years. Median ESVI was 84 ml/m2 . Viability was assessed by single-photon emission computed tomography or dobutamine echocardiography using pre-specified criteria. Results Mortality was highest among patients with larger ESVI and nonviability (p < 0.001), but no interaction was observed between ESVI, viability status, and treatment assignment (p = 0.491). Specifically, the effect of CABG versus medical therapy in patients with viable myocardium and ESVI ≤84 ml/m2 (hazard ratio HR: 0.85; 95% confidence interval CI: 0.56 to 1.29) was no different than in patients with viability and ESVI >84 ml/m2 (HR: 0.87; 95% CI: 0.57 to 1.31). Other ESVI thresholds yielded similar results, including ESVI ≤60 ml/m2 (HR: 0.87; 95% CI: 0.44 to 1.74). ESVI and viability assessed as continuous rather than dichotomous variables yielded similar results (p = 0.562). Conclusions Among patients with ischemic cardiomyopathy, those with greater LV ESVI and no substantial viability had worse prognosis. However, the effect of CABG relative to medical therapy was not differentially influenced by the combination of these 2 factors. Lower ESVI did not identify patients in whom myocardial viability predicted better outcome with CABG relative to medical therapy. (Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease STICH; NCT00023595 )
Anemia in heart failure (HF) is increasingly recognized and treated, but little is known about the prevalence and its relation to outcomes in patients hospitalized for decompensated HF in a situation ...of both reduced and preserved systolic function. We hypothesized that lower hemoglobin is correlated with death during hospitalization and 60 to 90 days postdischarge in patients with HF. The Organized Program to Initiate Lifesaving Treatment in Patients with Heart Failure is a registry and performance improvement program for hospitalized patients with HF. Study cohorts were defined by admission hemoglobin quartile. Data from 48,612 patients at 259 hospitals showed that half of the total cohort had low hemoglobin (<12.1 g/dl) and that 25% were moderately to severely anemic (lowest hemoglobin quartile, 5 to 10.7 g/dl). Patients with low hemoglobin were older, were more often women and Caucasian, and had preserved systolic function and elevated creatinine. They were also less likely to receive angiotensin-converting enzyme inhibitors and β blockers at discharge. Anemic patients had higher in-hospital mortality (4.8% vs 3.0%, lowest vs highest quartile), longer hospital length of stay (6.5 vs 5.3 days), and more readmissions by 90 days (33.1% vs 24.2%) (all p <0.0001). In conclusion, these data reveal a higher prevalence of low hemoglobin in hospitalized patients than noted in randomized HF trials and outpatient registries. Lower hemoglobin is associated with higher morbidity and mortality in hospitalized patients with HF.
Abstract Background Patients with ischemic left ventricular dysfunction have higher operative risk with coronary artery bypass graft surgery (CABG). However, those whose early risk is surpassed by ...subsequent survival benefit have not been identified. Objectives This study sought to examine the impact of anatomic variables associated with poor prognosis on the effect of CABG in ischemic cardiomyopathy. Methods All 1,212 patients in the STICH (Surgical Treatment of IsChemic Heart failure) surgical revascularization trial were included. Patients had coronary artery disease (CAD) and ejection fraction (EF) of ≤35% and were randomized to receive CABG plus medical therapy or optimal medical therapy (OMT) alone. This study focused on 3 prognostic factors: presence of 3-vessel CAD, EF below the median (27%), and end-systolic volume index (ESVI) above the median (79 ml/m2 ). Patients were categorized as having 0 to 1 or 2 to 3 of these factors. Results Patients with 2 to 3 prognostic factors (n = 636) had reduced mortality with CABG compared with those who received OMT (hazard ratio HR: 0.71; 95% confidence interval CI: 0.56 to 0.89; p = 0.004); CABG had no such effect in patients with 0 to 1 factor (HR: 1.08; 95% CI: 0.81 to 1.44; p = 0.591). There was a significant interaction between the number of factors and the effect of CABG on mortality (p = 0.022). Although 30-day risk with CABG was higher, a net beneficial effect of CABG relative to OMT was observed at >2 years in patients with 2 to 3 factors (HR: 0.53; 95% CI: 0.37 to 0.75; p<0.001) but not in those with 0 to 1 factor (HR: 0.88; 95% CI: 0.59 to 1.31; p = 0.535). Conclusions Patients with more advanced ischemic cardiomyopathy receive greater benefit from CABG. This supports the indication for surgical revascularization in patients with more extensive CAD and worse myocardial dysfunction and remodeling. (Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease STICH; NCT00023595 )
Objectives This study sought to assess the effect of the addition of coronary artery bypass grafting (CABG) to medical therapy on mode of death in heart failure. Background Although CABG therapy is ...widely used in ischemic cardiomyopathy patients, there are no prospective clinical trial data on mode of death. Methods The STICH (Surgical Treatment for Ischemic Heart Failure ) trial compared the strategy of CABG plus medical therapy to medical therapy alone in 1,212 ischemic cardiomyopathy patients with reduced ejection fraction. A clinical events committee adjudicated deaths using pre-specified definitions for mode of death. Results In the STICH trial, there were 462 deaths over a median follow-up of 56 months. The addition of CABG therapy tended to reduce cardiovascular deaths (hazard ratio HR: 0.83; 95% confidence interval CI: 0.68 to 1.03; p = 0.09) and significantly reduced the most common modes of death: sudden death (HR: 0.73; 95% CI: 0.54 to 0.99; p = 0.041) and fatal pump failure events (HR: 0.64; 95% CI: 0.41 to 1.00; p = 0.05). Time-dependent estimates indicate that the protective effect of CABG principally occurred after 24 months in both categories. Deaths post-cardiovascular procedures were increased in CABG patients (HR: 3.11; 95% CI: 1.47 to 6.60), but fatal myocardial infarction deaths were lower (HR: 0.07; 95% CI: 0.01 to 0.57). Noncardiovascular deaths were infrequent and did not differ between groups. Conclusions In the STICH trial, the addition of CABG to medical therapy reduced the most common modes of death: sudden death and fatal pump failure events. The beneficial effects were principally seen after 2 years. Post-procedure deaths were increased in patients randomized to CABG, whereas myocardial infarction deaths were decreased.
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