Unique predictors of mortality in patients with pulmonary arterial hypertension associated with systemic sclerosis in the REVEAL registry.

BACKGROUND: Patients with pulmonary arterial hypertension (PAH) associated with systemic sclerosis (SSc-APAH) experience higher mortality rates than patients with idiopathic disease and those with other connective tissue diseases (CTD-APAH). We sought to identify unique predictors of mortality associated with SSc-APAH in the CTD-APAH population. METHODS: The Registry to Evaluate Early and Long-Term PAH Management (REVEAL Registry) is a multicenter, prospective US-based registry of patients with previously and newly diagnosed (enrollment within 90 days of diagnostic right-sided heart catheterization) PAH. Cox regression models evaluated all previously identified candidate predictors of mortality in the overall REVEAL Registry population to identify significant predictors of mortality in the SSc-APAH (n = 500) vs non-SSc-CTD-APAH (n = 304) populations. RESULTS: Three-year survival rates in the previously diagnosed and newly diagnosed SSc-APAH group were 61.4% ± 2.7% and 51.2% ± 4.0%, respectively, compared with 80.9% ± 2.7% and 76.4% ± 4.6%, respectively, in the non-SSc-CTD-APAH group (P < .001). In multivariate analyses, men aged > 60 years, systolic BP (SBP) ≤ 110 mm Hg, 6-min walk distance (6MWD) < 165 m, mean right atrial pressure (mRAP) > 20 mm Hg within 1 year, and pulmonary vascular resistance (PVR) > 32 Wood units remained unique predictors of mortality in the SSc-APAH group; 6MWD ≥ 440 m was protective in the non-SSc-CTD-APAH group, but not the SSc-APAH group. CONCLUSIONS: Patients with SSc-APAH have higher mortality rates than patients with non-SSc-CTD-APAH. Identifying patients with SSc-APAH who are at a particularly high risk of death, including elderly men and patients with low baseline SBP or 6MWD, or markedly elevated mRAP or PVR, will enable physicians to identify patients who may benefit from closer monitoring and more aggressive treatment. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT00370214; URL: www.clinicaltrials.gov.

Diabetes mellitus and trends in hospital survival after myocardial infarction, 1994 to 2006: data from the national registry of myocardial infarction.

BACKGROUND: Patients with diabetes mellitus (DM) are at high risk for mortality after myocardial infarction (MI). Despite an overall trend of reduced mortality after MI, the mortality gap between MI patients with and without DM did not decrease over time in previous analyses. We assessed recent trends in hospital mortality for patients with MI according to DM status. METHODS AND RESULTS: We analyzed data from the National Registry of Myocardial Infarction, a contemporary registry of MI patients treated in 1964 hospitals, representing approximately one fourth of all US acute care hospitals. The study comprised 1734431 MI patients enrolled from 1994 to 2006, including 502315 (29%) with DM. Crude hospital mortality decreased in all patients between 1994 and 2006 but remained higher in patients with DM compared with those without DM throughout the study. The absolute difference in mortality between patients with and without DM significantly narrowed over time, from 15.6% versus 11.5% in 1994 to 8.0% versus 6.8% in 2006 (P<0.001 for DM × time interaction). The adjusted odds ratio for mortality associated with DM declined from 1.24 (95% confidence interval, 1.16-1.32) in 1994 to 1.08 (95% confidence interval, 0.99-1.19) in 2006 (P<0.001 for trend). The largest improvement in hospital mortality was observed in diabetic women (17.9% in 1994 versus 8.4% in 2006; P<0.001). CONCLUSIONS: The hospital mortality gap between MI patients with and without DM narrowed significantly from 1994 to 2006, with the greatest improvement observed in women with DM.

Association of bleeding and in-hospital mortality in black and white patients with st-segment-elevation myocardial infarction receiving reperfusion.

BACKGROUND: Prior studies have suggested that blacks with acute ST-segment-elevation myocardial infarction have increased bleeding risks with fibrinolysis relative to whites, yet these data were quite limited. Additionally, it is unknown whether there are racial differences in bleeding risks among patients with ST-segment-elevation myocardial infarction receiving primary percutaneous coronary intervention. METHODS AND RESULTS: We evaluated data on blacks and whites with ST-segment-elevation myocardial infarction treated with either fibrinolysis or primary percutaneous coronary intervention from the National Registry of Myocardial Infarction (NRMI)-4 and 5 participating centers between July 2000 and December 2006. We compared differences between the 2 groups in rates of in-hospital major bleeding and mortality, adjusted with logistic regression analyses. In fibrinolytic-treated patients with ST-segment-elevation myocardial infarction, the bleeding rates were higher among blacks (n=2283) than whites (n=42 243; 10.9% versus 10.3%; adjusted odds ratio, 1.21; 95% confidence interval, 1.02-1.43). Similarly, in patients receiving primary percutaneous coronary intervention, the bleeding rates were higher in blacks (n=2826) than in whites (n=46 332; 10.3% versus 7.8%; adjusted odds ratio, 1.33; 95% confidence interval, 1.13-1.56). Bleeding was associated with higher risk of death in both ethnic groups. However, there was no overall racial difference in in-hospital mortality among those with bleeding or without bleeding treated with either fibrinolysis or primary percutaneous coronary intervention. CONCLUSIONS: Blacks with ST-segment-elevation myocardial infarction treated with either fibrinolysis or primary percutaneous coronary intervention had a higher risk of bleeding events than their white counterparts. Bleeding was associated with a similar increased risk of death in both ethnic groups treated by either reperfusion strategy.

Comparison of bleeding and in-hospital mortality in Asian-Americans versus Caucasian-Americans with ST-elevation myocardial infarction receiving reperfusion therapy.

Concern has been raised that Asian-Americans may have a higher bleeding risk than Caucasian-Americans when treated with fibrinolytic and antithrombotic agents. To date there is limited evidence to support or refute this hypothesis or evaluate bleeding risk and its related outcomes in Caucasian-Americans versus Asian-Americans with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary interventions (PPCI). We evaluated Asian-Americans and Caucasian-Americans with STEMI receiving reperfusion therapy in the National Registry of Myocardial Infarction (NRMI) 4 and 5 (n = 90,317). We studied risk-adjusted major bleeding and in-hospital mortality. Major bleeding rates after fibrinolysis were similar in Asian-Americans (n = 705) and Caucasian-Americans (n = 42,243, 11.1% vs 10.3%, adjusted odds ratio [OR] 0.97, 95% confidence interval [CI] 0.69 to 1.36, p = 0.5002). Although the observed major bleeding rate was higher in Asian-Americans (n = 1,037) compared to Caucasian-Americans (n = 46,332) treated with PPCI (10.3% vs 7.8%, p = 0.0036), these rates differed only marginally after adjusting for baseline clinical variables (OR 1.24, 95% CI 0.97 to 1.59). Overall adjusted mortality was similar in Asian-Americans and Caucasian-Americans when treated with fibrinolysis (OR 0.96, 95% CI 0.56 to 1.65) or with PPCI (OR 1.35, 95% CI 0.85 to 2.13). Major bleeding after PPCI or fibrinolysis was associated with similar increased risks for mortality in these ethic groups. In conclusion, despite suggestions to the contrary, Asian-Americans with STEMI treated with fibrinolysis or PPCI had similar bleeding and bleeding-related mortality risks compared to Caucasian-Americans. Given the genotypic and phenotypic differences between the 2 cohorts, similar studies in the rapidly growing Asian-American population are needed to confirm our findings and to understand the safety and effectiveness of newer potent antiplatelet and antithrombotic agents in patients with coronary syndromes.

Characterization of connective tissue disease-associated pulmonary arterial hypertension from REVEAL: identifying systemic sclerosis as a unique phenotype.

BACKGROUND: REVEAL (the Registry to Evaluate Early and Long-term Pulmonary Arterial Hypertension Disease Management) is the largest US cohort of patients with pulmonary arterial hypertension (PAH) confirmed by right-sided heart catheterization (RHC), providing a more comprehensive subgroup characterization than previously possible. We used REVEAL to analyze the clinical features of patients with connective tissue disease-associated PAH (CTD-APAH). METHODS: All newly and previously diagnosed patients with World Health Organization (WHO) group 1 PAH meeting RHC criteria at 54 US centers were consecutively enrolled. Cross-sectional and 1-year mortality and hospitalization analyses from time of enrollment compared CTD-APAH to idiopathic disease and systemic sclerosis (SSc) to systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), and rheumatoid arthritis (RA). RESULTS: Compared with patients with idiopathic disease (n = 1,251), patients with CTD-APAH (n = 641) had better hemodynamics and favorable right ventricular echocardiographic findings but a higher prevalence of pericardial effusions, lower 6-min walk distance (300.5 ± 118.0 vs 329.4 ± 134.7 m, P = .01), higher B-type natriuretic peptide (BNP) levels (432.8 ± 789.1 vs 245.6 ± 427.2 pg/mL, P < .0001), and lower diffusing capacity of carbon monoxide (Dlco) (44.9% ± 18.0% vs 63.6% ± 22.1% predicted, P < .0001). One-year survival and freedom from hospitalization were lower in the CTD-APAH group (86% vs 93%, P < .0001; 67% vs 73%, P = .03). Compared with patients with SSc-APAH (n = 399), those with other CTDs (SLE, n = 110; MCTD, n = 52; RA, n = 28) had similar hemodynamics; however, patients with SSc-APAH had the highest BNP levels (552.2 ± 977.8 pg/mL), lowest Dlco (41.2% ± 16.3% predicted), and poorest 1-year survival (82% vs 94% in SLE-APAH, 88% in MCTD-APAH, and 96% in RA-APAH). CONCLUSIONS: Patients with SSc-APAH demonstrate a unique phenotype with the highest BNP levels, lowest Dlco, and poorest survival of all CTD-APAH subgroups. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT00370214; URL: clinicaltrials.gov.

Sex differences in mortality after acute myocardial infarction: changes from 1994 to 2006.

BACKGROUND: Previous studies have shown that women younger than 55 years have higher hospital mortality rates after acute myocardial infarction (MI) than age-matched men. We examined whether such mortality differences have decreased in recent years. METHODS: We investigated temporal trends in the hospital case-fatality rates of MI by sex and age from June 1, 1994, through December 31, 2006. The study population included 916,380 patients from the National Registry of Myocardial Infarction with a confirmed diagnosis of MI. RESULTS: In-hospital mortality decreased markedly between 1994 and 2006 in all patients but more so in women than men. The mortality reduction in 2006 relative to 1994 was largest in women younger than 55 years (52.9%) and lowest in men younger than 55 years (33.3%). In patients younger than 55 years, the absolute decrease in mortality was 3 times larger in women than men (2.7% vs 0.9%). As a result, the excess mortality in younger women (<55 years) compared with men was less pronounced in 2004-2006 (unadjusted odds ratio, 1.32; 95% confidence interval, 1.07-1.67) than it was in 1994-1995 (unadjusted odds ratio, 1.93; 95% confidence interval, 1.67-2.24). The sex difference in mortality decrease was lower in older patients (P = .004 for the interaction among sex, age, and year). Changes in comorbidity and clinical severity features at admission accounted for more than 90% of these mortality trends. CONCLUSIONS: In recent years, women, particularly younger ones, experienced larger improvements in hospital mortality after MI than men. The narrowing of the mortality gap between younger women and men is largely attributable to temporal changes in risk profiles.

Trends in quality of care for patients with acute myocardial infarction in the National Registry of Myocardial Infarction from 1990 to 2006.

BACKGROUND: Trends in the use of guideline-based treatment for acute myocardial infarction (AMI) as well as its association with patient outcomes have not been summarized in a large, longitudinal study. Furthermore, it is unknown whether gender-, race-, and age-based care disparities have narrowed over time. METHODS AND RESULTS: Using the National Registry of Myocardial Infarction database, we analyzed 2,515,106 patients with AMI admitted to 2,157 US hospitals between July 1990 and December 2006 to examine trends overall and in select subgroups of guideline-based admission, procedural, and discharge therapy use. The contribution of temporal improvements in acute care therapies to declines in in-hospital mortality was examined using logistic regression analysis. From 1990 to 2006, the use of all acute guideline-recommended therapies administered rose significantly for patients with ST-segment elevation myocardial infarction and patients with non-ST-segment myocardial infarction but remained below 90% for most therapies. Cardiac catheterization and percutaneous coronary intervention use increased in patients with ST-segment elevation myocardial infarction and patients with non-ST-segment myocardial infarction, whereas coronary bypass surgery use declined in both groups. Despite overall care improvements, women, blacks, and patients > or =75 years old were significantly less likely to receive revascularization or discharge lipid-lowering therapy relative to their counterparts. Temporal improvements in acute therapies may account for up to 37% of the annual decline in risk for in-hospital AMI mortality. CONCLUSION: Adherence to American Heart Association/American College of Cardiology practice guidelines has improved care of patients with AMI and is associated with significant reductions in in-hospital mortality rates. However, persistent gaps in overall care as well as care disparities remain and suggest the need for ongoing quality improvement efforts.

Acute reperfusion therapy in ST-elevation myocardial infarction from 1994-2003.

BACKGROUND: Appropriate utilization of acute reperfusion therapy is not a national performance measure for ST-elevation myocardial infarction at this time, and the extent of its contemporary use among ideal patients is unknown. METHODS: From the National Registry of Myocardial Infarction, we identified 238,291 patients enrolled from June 1994 to May 2003 who were ideally suited for acute reperfusion therapy with fibrinolytic therapy or primary percutaneous coronary intervention. We determined rates of not receiving therapy across 3 time periods (June 1994-May 1997, June 1997-May 2000, June 2000-May 2003) and evaluated factors associated with underutilization. RESULTS: The proportion of ideal patients not receiving acute reperfusion therapy decreased by one half throughout the past decade (time period 1: 20.6%; time period 2: 11.4%; time period 3: 11.6%; P <.001). Utilization remained significantly lower in key subgroups in the most recent time period: those without chest pain (odds ratio [OR] 0.29; 95% confidence interval [CI], 0.27-0.32); those presenting 6 to 12 hours after symptom onset (OR 0.57; 95% CI, 0.52-0.61); those 75 years or older (OR 0.63 compared with patients <55 years old; 95% CI, 0.58-0.68); women (OR 0.88; 95% CI, 0.84-0.93); and non-whites (OR 0.90; 95% CI, 0.83-0.97). CONCLUSIONS: Utilization of acute reperfusion therapy in ideal patients has improved over the last decade, but more than 10% remain untreated. Measuring and improving its use in this cohort represents an important opportunity to improve care.

Effectiveness and safety of glycoprotein IIb/IIIa inhibitors and clopidogrel alone and in combination in non-ST-segment elevation myocardial infarction (from the National Registry of Myocardial Infarction-4).

We investigated whether a combination of clopidogrel and glycoprotein (GP) IIb/IIIa inhibitors safely decreases hospital mortality, reinfarction, and major bleeding beyond either therapy alone in patients with non-ST-elevation myocardial infarction (NSTEMI). GP IIb/IIIa inhibitors and clopidogrel, separately, have been shown to decrease adverse outcomes in patients with non-ST-elevation acute coronary syndromes, but the need for combination therapy is uncertain. Multivariate and propensity analyses compared the frequency of death, reinfarction, and major bleeding during hospitalization in 38,691 patients with NSTEMI who were enrolled in the National Registry of Myocardial Infarction 4 from July 2000 to December 2003. Of these, 65% received GP IIb/IIIa inhibitors only, 16.1% clopidogrel only, and 18.8% combination therapy. Among patients who did not undergo percutaneous coronary intervention (PCI), the composite end point of death, reinfarction, and major bleeding was significantly lower with combination therapy than with GP IIb/IIIa inhibitors alone (odds ratio 0.77, 95% confidence interval 0.67 to 0.88). In contrast, this composite end point was significantly higher when combination therapy was employed rather than clopidogrel alone (odds ratio 1.55, 95% confidence interval 1.33 to 1.81). However, among patients who underwent PCI, the composite end point was similar between combination therapy and GP IIb/IIIa inhibitor-only groups (odds ratio 1.01, 95% confidence interval 0.89 to 1.14). Further, there was a strong trend toward a higher composite end point among patients who received combination therapy rather than clopidogrel alone (odds ratio 1.31, 95% confidence interval 0.99 to 1.72). In conclusion, commonly employed strategies using a GP IIb/IIIa inhibitor alone or with the combination of clopidogrel plus GP IIb/IIIa inhibitor in NSTEMI may not be justified in comparison with a simpler strategy of clopidogrel used alone, especially in patients who have not undergone PCI.

Effect of cuts in Medicare reimbursement on process and outcome of care for acute myocardial infarction patients.

BACKGROUND: The Balanced Budget Act (BBA) of 1997 was designed to reduce Medicare reimbursements by $116.4 billion from 1998 to 2002. The objective of this study was to determine whether the process of care for acute myocardial infarction (AMI) worsened to a greater degree in hospitals under increased financial strain from the BBA and whether vulnerable populations such as the uninsured were disproportionately affected. METHODS AND RESULTS: We examined how process-of-care measures and in-hospital mortality for AMI patients changed in accordance with the degree of BBA-induced financial stress using data on 236,506 patients from the National Registry of Myocardial Infarction (NRMI) and Medicare Cost Reports from 1996 to 2001. BBA-induced reductions in hospital net revenues were estimated at 1.5% (2.9 million dollars) for hospitals with low BBA impact and 3.2% (3.7 million dollars) for hospitals with a high impact in 1998, worsening to 2.2% (4.4 million dollars) and 4.7% (6.0 million dollars), respectively, by 2001. For both insured and uninsured patients in high- versus low-impact hospitals, there was no systematic worsening of time to thrombolytic therapy, balloon inflation, medication use on admission, medication use on discharge, or mortality. There was no systematic pattern of different treatment among the insured and uninsured. Operating margins decreased to a degree commensurate with the degree of revenue reduction in high- versus low-impact hospitals. CONCLUSIONS: BBA created a moderate financial strain on hospitals. However, process-of-care measures for both insured and uninsured patients with AMI were not appreciably affected by these revenue reductions. It is important to note that these results apply only to AMI patients; we do not know the degree to which these findings generalize to other conditions.

Quality of care by classification of myocardial infarction: treatment patterns for ST-segment elevation vs non-ST-segment elevation myocardial infarction.

BACKGROUND: Practice guidelines for acute ST-segment elevation myocardial infarction (STEMI) and non-STEMI (NSTEMI) recommend similar therapies and interventions, but differences in patterns of care between MI categories have not been well described in contemporary practice. METHODS: In-hospital treatments with similar recommendations from practice guidelines were compared with outcomes in 185 968 eligible patients (without listed contraindications) with STEMI (n = 53 417; 29%) vs NSTEMI (n = 132 551; 71%) from 1247 US hospitals participating in the National Registry of Myocardial Infarction 4 between July 1, 2000, and June 30, 2002. Hierarchical logistic regression modeling was used to determine adjusted differences in treatment patterns in MI categories. RESULTS: Unadjusted in-hospital mortality rates were high for NSTEMI (12.5%) and STEMI (14.3%), and the use of guideline-recommended medications and interventions was suboptimal in both categories of patients with MI. The adjusted likelihood of receiving early (within 24 hours of presentation) aspirin, beta-blockers, and angiotensin-converting enzyme inhibitors was higher in patients with STEMI. Similar patterns of care were noted at hospital discharge: the adjusted likelihood of receiving aspirin, beta-blockers, angiotensin-converting enzyme inhibitors, lipid-lowering agents, smoking cessation counseling, and cardiac rehabilitation referral was higher in patients with STEMI. CONCLUSIONS: Evidence-based medications and lifestyle modification interventions were used less frequently in patients with NSTEMI. Quality improvement interventions designed to narrow the gaps in care between NSTEMI and STEMI and to improve adherence to guidelines for both categories of patients with MI may reduce the high mortality rates associated with acute MI in contemporary practice.

The association between white blood cell count and acute myocardial infarction in-hospital mortality: findings from the National Registry of Myocardial Infarction.

OBJECTIVES: Although cross-sectional and prospective studies have shown that the white blood cell (WBC) count is associated with long-term mortality for patients with ischemic heart disease, the role of the WBC count as an independent predictor of short-term mortality in patients with acute myocardial infarction (AMI) has not been examined as extensively. The objective of this study was to determine whether the WBC count is associated with in-hospital mortality for patients with ischemic heart disease after controlling for potential confounders. METHODS: From July 31, 2000, to July 31, 2001, the National Registry of Myocardial Infarction 4 enrolled 186,727 AMI patients. A total of 115,273 patients were included in the analysis. RESULTS: WBC counts were subdivided into intervals of 1,000/mL, and in-hospital mortality rates were determined for each interval. The distribution revealed a J-shaped curve. Patients with WBC counts >5,000/mL were subdivided into quartiles, whereas patients with WBC counts <5,000/mL were assigned to a separate category labeled "subquartile" and were analyzed separately. A linear increase in in-hospital mortality by WBC count quartile was found. The unadjusted odds ratio (OR) for the fourth versus the first quartile showed strong associations with in-hospital mortality among the entire population and by gender: 4.09 (95% confidence interval [95% CI] = 3.83 to 4.73) for all patients, 4.31 (95% CI = 3.93 to 4.73) for men, and 3.65 (95% CI = 3.32 to 4.01) for women. Following adjustment for covariates, the magnitude of the ORs attenuated, but the ORs remained highly significant (OR, 2.71 [95% CI = 2.53 to 2.90] for all patients; OR, 2.87 [95% CI = 2.59 to 3.19] for men; OR, 2.61 [95% CI = 2.36 to 2.99] for women). Reperfused patients had consistently lower in-hospital mortality rates for all patients and by gender (p < 0.0001). CONCLUSIONS: The WBC count is an independent predictor of in-hospital AMI mortality and may be useful in assessing the prognosis of AMI in conjunction with other early risk-stratification factors. Whether elevated WBC count is a marker of the inflammatory process or is a direct risk factor for AMI remains unclear. Given the simplicity and availability of the WBC count, the authors conclude that the WBC count should be used in conjunction with other ancillary tests to assess the prognosis of a patient with AMI.

Relation of age and race with hospital death after acute myocardial infarction.

BACKGROUND: Prior studies have suggested that young blacks with acute myocardial infarction (AMI) may have higher hospital mortality rates than whites of similar age. However, the influence of age and race on short-term death has not been explored in detail. We examined the relation of age and race on short-term death in a large AMI population and ascertained the factors that may have contributed to differences in mortality rates. METHODS: We compared the crude and adjusted hospital mortality rates stratified by age among 40,903 blacks and 501,995 whites with AMI enrolled in the National Registry of Myocardial Infarction-2 in 1482 participating US hospitals from June 1994 through March 1998. RESULTS: Overall crude mortality was lower among blacks compared with whites (10.9% vs 12.0%, P <.0001). However, blacks had a significantly higher crude mortality rate compared with the whites in the age groups <65 years (<45 years, and 5-year age groups between 45 and 64 years). There was a statistically significant interaction between age and black race on hospital death (P value for interaction <.001). Each 5-year decrement in age from 85 years was associated with 7.2% higher odds of death in blacks compared with whites (95% CI, 5.7% to 7.6%). After adjusting for differences in the baseline, clinical presentation, early treatment, and hospital characteristics, 5-year decrements in age was still associated with increases in the odds for death in blacks compared with whites (5.4%; 95% CI, 3.6% to 7.2%). This interaction between age and black race was present in both sexes but was stronger among men. CONCLUSIONS: Blacks younger than 65 years had higher hospital mortality rates compared with whites hospitalized for AMI, and decreasing age was associated with progressively higher risk of hospital death for blacks. Differences in the clinical presentation, early treatment, and hospital characteristics could only partly explain this age-race interaction.

Is there evidence of implicit exclusion criteria for elderly subjects in randomized trials? Evidence from the GUSTO-1 study.

BACKGROUND: Some experts have raised concerns about the ability to generalize randomized trials, emphasizing that patients who participate in these studies are often not representative of those seen in clinical practice, particularly in the case of elderly patients. To determine the effect of implicit exclusion criteria on a trial study sample, we compared data from the Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO) trial with data from a retrospective registry from selected hospitals, the National Registry of Myocardial Infarction (NRMI), and a nationally representative study of myocardial infarction care, the Cooperative Cardiovascular Project (CCP). METHODS: We compared GUSTO subjects aged 65 years and older who were enrolled in the United States with similarily aged patients in the 2 observational studies who met the trial's eligibility criteria. We examined baseline characteristics, clinical presentation, treatments, procedures, clinical events, and in-hospital mortality rates. RESULTS: We found modest, although significant, differences between patients in NRMI, CCP, and GUSTO in demographic and clinical characteristics, treatment, and outcome. For example, GUSTO patients were significantly younger (73.1 +/- 5.7 vs 74.7 +/- 6.8 for NRMI and 75.8 +/- 7.2 for CCP), less likely to have Killip class III/IV at presentation (3.1% vs 6.2% for NRMI and 32.7% for CCP), and more likely to receive aspirin (95.5% vs 86.3% for NRMI and 86.5% for CCP) and beta-blockers (71.9% vs 43.5% for NRMI and 52.7% for CCP). Overall, NRMI and CCP patients had a lower risk of 30-day mortality after adjustment for demographic, clinical, and hospital characteristics than patients in GUSTO (odds ratio, 0.79; 95% CI, 0.73-0.86 for NRMI; odds ratio, 0.65; 95% CI, 0.59-0.71 for CCP). CONCLUSIONS: Older patients enrolled in a randomized trial without an age restriction had many similarities compared with patients seen in clinical practice. The higher mortality rate of the GUSTO patients does not support the hypothesis that the trial enrolled a healthier cohort than is seen in practice.

Mortality benefit of immediate revascularization of acute ST-segment elevation myocardial infarction in patients with contraindications to thrombolytic therapy: a propensity analysis.

CONTEXT: There are no definitive recommendations for the management of acute myocardial infarction (AMI) in patients with ST-segment elevation who have contraindications to thrombolytic therapy. It is not clear whether, and the extent to which, immediate mechanical reperfusion (IMR) reduces in-hospital mortality in this population. OBJECTIVE: To determine whether IMR (defined as percutaneous coronary intervention or coronary artery bypass graft surgery) is associated with a mortality benefit in patients with acute ST-segment elevation AMI who are eligible for IMR but have contraindications to thrombolytic therapy. DESIGN, SETTING, AND PATIENTS: From June 1994 to January 2003, the National Registry of Myocardial Infarction 2, 3, and 4 enrolled 1 799 704 patients with AMI. A total of 19 917 patients with acute ST-segment elevation were eligible for IMR but had thrombolytic contraindications after excluding patients who were transferred in from or out to other facilities, patients who received intracoronary thrombolytics, and those who received no medications within 24 hours of arrival. MAIN OUTCOME MEASURE: In-hospital mortality. RESULTS: Of the 19 917 patients, 4705 patients (23.6%) received IMR and 5173 patients (25.9%) died. In-hospital mortality rates in the IMR and non-IMR treated groups in the unadjusted analysis were 11.1%, representing 521 of 4705 patients, and 30.6%, representing 4652 of 15 212 patients, respectively, for a risk reduction of 63.7% (odds ratio [OR], 0.28; 95% confidence interval [CI], 0.26-0.31). In a further analysis using a propensity matching score to reduce the effects of bias, 3905 patients who received IMR remained at lower risk for in-hospital mortality than 3905 matched patients (10.9% vs 20.1%, respectively, for a risk reduction of 45.8%; OR, 0.48; 95% CI, 0.43-0.55). Following a second logistic model applied to the matched groups to adjust for residual differences, a significant treatment effect persisted (OR, 0.64; 95% CI, 0.56-0.75). CONCLUSIONS: In this population, IMR was associated with a reduced risk of in-hospital mortality after appropriate adjustments. Of those we studied who were eligible for IMR, 15 212 patients (76.4%) did not receive it. These results suggest that using IMR in patients with acute ST-segment elevation AMI and contraindications to thrombolytics should be strongly considered.

Relation between hospital intra-aortic balloon counterpulsation volume and mortality in acute myocardial infarction complicated by cardiogenic shock.

BACKGROUND: Increasing evidence suggests an inverse relationship between outcome and the total number of invasive cardiac procedures performed at a given hospital. The purpose of the present study was to determine if a similar relationship exists between the number of intra-aortic balloon counterpulsation (IABP) procedures performed at a given hospital per year and the in-hospital mortality rate of patients with acute myocardial infarction complicated by cardiogenic shock. METHODS AND RESULTS: We analyzed data of 12 730 patients at 750 hospitals enrolled in the National Registry of Myocardial Infarction 2 from 1994 to 1998. The hospitals were divided into tertiles (low-, intermediate-, and high-IABP volume hospitals) according to the number of IABPs performed at the given hospital per year. The median number of IABPs performed per hospital per year was 3.4, 12.7, and 37.4 IABPs at low-, intermediate-, and high-volume hospitals, respectively. Of those patients who underwent IABP, there were only minor differences in baseline patient characteristics between the 3 groups. Crude mortality rate decreased with increasing IABP volume: 65.4%, lowest volume tertile; 54.1%, intermediate volume tertile; and 50.6%, highest volume tertile (P for trend <0.001). This mortality difference represented 150 fewer deaths per 1000 patients treated at the high IABP hospitals. In the multivariate analysis, high hospital IABP volume for patients with acute myocardial infarction was associated with lower mortality (OR=0.71, 95% CI=0.56 to 0.90), independent of baseline patient characteristics, hospital factors, treatment, and procedures such as PTCA. CONCLUSIONS: Among the myocardial infarction patients with cardiogenic shock who underwent IABP placement, mortality rate was significantly lower at high-IABP volume hospitals compared with low-IABP volume hospitals.

Early use of glycoprotein IIb/IIIa inhibitors in non-ST-elevation acute myocardial infarction: observations from the National Registry of Myocardial Infarction 4.

OBJECTIVES: We sought to identify patient and hospital features associated with early glycoprotein (GP) IIb/IIIa inhibitor therapy for non-ST-elevation (NSTE) myocardial infarction (MI) and to relate this treatment to in-hospital outcomes. BACKGROUND: Glycoprotein IIb/IIIa inhibitors have improved outcomes in randomized trials of NSTE MI, leading national treatment guidelines to recommend their use. Their actual use, safety, and effectiveness have not been well characterized beyond trial populations. METHODS: We studied 60,770 patients with NSTE MI treated between July 2000 and July 2001 at 1,189 hospitals in a U.S. registry. Using logistic regression, we identified patient and hospital features associated with GP IIb/IIIa inhibition within 24 h after presentation. We also compared outcomes by early treatment versus no treatment after adjusting for patient and hospital characteristics and treatment propensity. RESULTS: Only 25% of eligible patients received early GP IIb/IIIa therapy. Elderly patients, women, minority patients, and those without private insurance received such therapy less often than their counterparts. Treated patients had lower unadjusted in-hospital mortality (3.3% vs. 9.6%, p < 0.0001) remaining significantly lower after adjustment for patient risk, treatment propensity, and hospital characteristics (adjusted odds ratio, 0.88; 95% confidence interval, 0.79 to 0.97). Hospitals that adopted early GP IIb/IIIa inhibition more rapidly also had lower adjusted mortality rates than those slower to adopt such therapy. CONCLUSIONS: Glycoprotein IIb/IIIa inhibitor therapy appears to be underused in early management of NSTE MI patients. Because this therapy is associated with better outcomes, it represents a target for quality improvement.

Hospital outcomes in patients presenting with congestive heart failure complicating acute myocardial infarction: a report from the Second National Registry of Myocardial Infarction (NRMI-2).

OBJECTIVES: The purpose of this study was to examine treatment and outcomes in patients admitted to the hospital with acute myocardial infarction (AMI) complicated by congestive heart failure (CHF). BACKGROUND: Although cardiogenic shock complicating AMI has been studied extensively, the hospital course of patients presenting with CHF is less well established. METHODS: The Second National Registry of Myocardial Infarction (NRMI-2) was analyzed to determine hospital outcomes for patients with ST-elevation AMI admitted with CHF (Killip classes II or III). RESULTS: Of 190,518 patients with AMI, 36,303 (19.1%) had CHF on admission. Patients presenting with CHF were older (72.6 +/- 12.5 vs. 63.2 +/- 13.5 years), more often female (46.8% vs. 32.1%), had longer time to hospital presentation (2.80 +/- 2.6 vs. 2.50 +/- 2.4 h), and had higher prevalence of anterior/septal AMI (38.8% vs. 33.3%), diabetes (33.1% vs. 19.5%), and hypertension (54.6% vs. 46.1%) (all p < 0.0005). Also, they had longer lengths of stay (8.1 +/- 7.1 vs. 6.8 +/- 5.3 days, p < 0.00005) and greater risk for in-hospital death (21.4% vs. 7.2%; p < 0.0005). Patients with CHF were less likely to receive aspirin (75.7% vs. 89.0%), heparin (74.6% vs. 91.1%), oral beta-blockers (27.0% vs. 41.7%), fibrinolytics (33.4% vs. 58.0%), or primary angioplasty (8.6% vs. 14.6%), and more likely to receive angiotensin-converting enzyme inhibitors (25.4% vs. 13.0%). Congestive heart failure on admission was one of the strongest predictors of in-hospital death (adjusted odds ratio 1.68; 95% confidence interval 1.62, 1.75). CONCLUSIONS: Patients with AMI presenting with CHF are at higher risk for adverse in-hospital outcomes. Despite this, they are less likely to be treated with reperfusion therapy and medications with proven mortality benefit.

Risk of sudden versus nonsudden cardiac death in patients with coronary artery disease.

BACKGROUND: Patients at high risk of sudden cardiac death, yet at low risk of nonsudden death, might be ideal candidates for antiarrhythmic drugs or devices. Most previous studies of prognostic markers for sudden cardiac death have ignored the competitive risk of nonsudden cardiac death. The goal of the present study was to evaluate the ability of clinical factors to distinguish the risks of sudden and nonsudden cardiac death. METHODS: We identified all deaths during a 3.3-year follow-up of 30,680 patients discharged alive after admission to the cardiac care unit of a Seattle hospital. Detailed chart reviews were conducted on 1093 subsequent out-of-hospital sudden deaths, 973 nonsudden cardiac deaths, and 442 randomly selected control patients. RESULTS: Patients who died in follow-up (suddenly or nonsuddenly) were significantly different for many clinical factors from control patients. In contrast, patients with sudden cardiac death were insignificantly different for most clinical characteristics from patients with nonsudden cardiac death. The mode of death was 20% to 30% less likely to be sudden in women, patients who had angioplasty or bypass surgery, and patients prescribed beta-blockers. The mode of death was 20% to 30% more likely to be sudden in patients with heart failure, frequent ventricular ectopy, or a discharge diagnosis of acute myocardial infarction. A multivariable model had only modest predictive capacity for mode of death (c-index of 0.62). CONCLUSION: Standard clinical evaluation is much better at predicting overall risk of death than at predicting the mode of death as sudden or nonsudden.

Primary angioplasty and selection bias inpatients presenting late (>12 h) after onset of chest pain and ST elevation myocardial infarction.

OBJECTIVES: This study was designed to compare the in-hospital outcome of patients presenting with >12 h from onset of chest pain and acute ST elevation myocardial infarction (AMI) who received either immediate invasive or conservative therapy. BACKGROUND: The benefits of fibrinolytic therapy diminish in patients presenting with AMI and onset of chest pain >12 h. Primary angioplasty has been suggested as a possible treatment for such patients, but they have been excluded from most trials of primary angioplasty. It remains unclear if an invasive treatment strategy is beneficial to these patients. METHODS: Patients presenting with >12 h of chest pain and AMI were identified from the National Registry of Myocardial Infarction 2 database. Patients receiving invasive therapy <6 h after hospital admission were compared with those receiving conservative therapy. Short-term outcomes were compared on the basis of the initial therapy received. To help control for baseline differences in the groups, patients were matched with controls by propensity score methodology. RESULTS: On preliminary analysis, in-hospital outcome was improved in terms of recurrent ischemia, angina, myocardial infarction and mortality in patients receiving initial invasive therapy (odds ratio [OR] = 0.67; 95% confidence interval [CI] 0.49 to 0.92 for mortality). After matching by propensity score, the mortality benefit persisted on bivariate analysis (3.5% vs. 5.0%, p = 0.036), though on multivariate analysis, only a non-significant but strong trend toward decreased mortality remained (OR = 0.73; 95% CI 0.53 to 1.01). CONCLUSIONS: Patients receiving early invasive therapy had lower risk features on presentation. Selection bias may play an important role in choosing these patients' course of treatment and their subsequent outcomes. Certain patients presenting with AMI and duration of chest pain >12 h may benefit from early invasive therapy. These patients could be characterized in a randomized trial.