Factors related to heart rupture in acute coronary syndromes in the Global Registry of Acute Coronary Events.

AIMS: To determine the incidence and factors associated with heart rupture (HR) in acute coronary syndrome (ACS) patients. METHODS AND RESULTS: Among 60 198 patients, 273 (0.45%) had HR (free wall rupture, n = 118; ventricular septal rupture, n = 155). Incidence was 0.9% for ST-segment elevation myocardial infarction (STEMI), 0.17% for non-STEMI, and 0.25% for unstable angina. Hospital mortality was 58 vs. 4.5% in patients without HR (P < 0.001). The incidence was lower in STEMI patients with primary percutaneous coronary intervention (PCI) than in those without (0.7 vs. 1.1%; P = 0.01), but primary PCI was not independently related to HR in adjusted analysis (P = 0.20). Independent variables associated with HR included: ST-segment elevation (STE)/left bundle branch block; ST-segment deviation; female sex; previous stroke; positive initial cardiac biomarkers; older age; higher heart rate; systolic blood pressure/30 mmHg decrease. Conversely, previous MI and the use of low-molecular-weight heparin and beta-blockers during first 24 h were identified as protective factors for HR. CONCLUSION: The incidence of HR is low in patients with ACS, although its incidence is probably underestimated. Heart rupture occurs more frequently in ACS with STE and is associated with high hospital mortality. A number of variables are independently related to HR.

Presence of vulnerable coronary plaques in middle-aged individuals who suffered a brain death.

AIMS: Vulnerable plaques in coronary arteries are frequently found in individuals who died suddenly or due to an acute coronary syndrome. The prevalence and characteristics of these plaques in the middle-aged apparently healthy population are unknown. METHODS AND RESULTS: From a total of 652 hearts from transplant donors collected between 1996 and 2007, we selected those from apparently healthy individuals older than 40 years old who died of head trauma or stroke and had no evidence of prior vascular diseases. The coronary arteries were examined by serial sectioning at 3 mm intervals, and all areas of cross-sectional luminal narrowing were processed for histological, immunohistochemical, and morphometric studies. The atherosclerotic plaques were classified according to the American Heart Association Report. A total of 160 hearts were examined. Mean age was 50.3 +/- 5.8 years. Sixty-eight hearts had no advanced coronary atherosclerotic lesions (Type I, II, and III of the American Heart classification). In the remaining 92 hearts, we found 179 plaques considered high-risk lesions (American Heart Association Type IV, V, and VI). These plaques were more frequently found in males (P < 0.001) and in those with a higher heart weight (P < 0.001). The median (25th and 75th percentiles) vascular narrowing value using a planimetric analysis was 32% (21-53). No significant association with the cause of death was found (P = 0.09). CONCLUSION: High-risk coronary artery plaques not associated with significant vascular lumen reduction exist in 57% of patients who suffered a brain death with a mean of 1.11 lesions prone to rupture per individual.

Advances in coronary heart disease surgery in Latin America.

BACKGROUND: The beginnings of coronary artery bypass graft in Latin America could be set in the year 1971. Since then, improvements in technique and greater experience have resulted in a rapid increase in the rate of interventions performed in the region. METHODS AND RESULTS: Searches through PubMed and Literatura Latinoamericana y del Caribe en Ciencias de la Salud, as well as personal communications from specialists from Latin America, have been the source of information. Articles were selected by their content related to the theme, and the authors' nationality and information is mainly from Latin America. Demographic information of the population of Latin America denotes higher age averages, and this implies an increase in the severity of comorbidities in patients who undergo surgery. Longer life expectancy and improvements in medical therapy have implied that patients survive a first intervention beyond the expected time a bypass persists patent. Wall vessel properties of arterial conduits, plus a better anastomotic technique, seem to be the current solution to worsening in the coronary health of patients who undergo revascularization surgery in Latin America. CONCLUSIONS: Despite scarce economic investment in medical sciences, many academic groups contribute to the exploration of therapeutic pharmacological combinations and inclusively apply genetic strategies.

Increasing use of single and combination medical therapy in patients hospitalized for acute myocardial infarction in the 21st century: a multinational perspective.

BACKGROUND: Current practice guidelines recommend the routine use of several effective cardiac medications in hospital survivors of acute myocardial infarction (AMI). METHODS: We explored a recent 5-year (2000-2005) trend in hospital use of aspirin, beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, lipid-lowering agents, and combinations thereof, in 26 413 adult men and women without contraindications to any of these therapies discharged after AMI from hospitals located in 14 countries that were included in the Global Registry of Acute Coronary Events. RESULTS: Relatively steady increases in the use of ACE inhibitors, beta-blockers, and statin therapy were observed over time, with particularly marked increases in the use of lipid-lowering therapy (from 45% in 2000 to 85% in 2005). Aspirin use remained high (by approximately 95% of patients after AMI) during all periods examined. The percentage of hospital survivors treated with all 4 cardiac medications increased from 23% in 2000 to 58% during 2005. Advancing age (>/= 65 years), female sex, medical history of heart failure or stroke, and development of atrial fibrillation during hospitalization were associated with underuse of combination medical therapy. Relatively similar factors were associated with the underuse of combination medical therapy in patients with ST-segment elevation AMI and non-ST-segment elevation AMI. CONCLUSIONS: Our results suggest encouraging increases over time in the use of combination medical therapy in patients hospitalized with AMI without contraindications to these medications. Educational efforts designed to increase the use of these therapies, as well as efforts to simplify medication regimens and enhance rates of adherence, remain warranted.

Racial differences among high-risk patients presenting with non-ST-segment elevation acute coronary syndromes (results from the SYNERGY trial).

Management and outcomes of patients with acute coronary syndromes (ACSs) may vary according to patient race and ethnicity. To assess racial differences in presentation and outcome in high-risk North American patients with non-ST-segment elevation (NSTE) ACS, we analyzed baseline racial/ethnic differences and all-cause death or nonfatal myocardial infarction (MI) in 6,077 white, 586 African-American, and 344 Hispanic patients through 30-day, 6-month, and 1-year follow-up. Frequencies of hypertension were 66% for whites, 83% for African-Americans, and 78% for Hispanics (overall p <0.001). Use of angiography was similar across groups. Use of percutaneous coronary intervention (46% for whites, 41% for African-Americans, and 45% for Hispanics, overall p = 0.046) and coronary artery bypass grafting (20% for whites, 16% for African-Americans, and 22% for Hispanics, overall p = 0.044) differed. African-American patients had significantly fewer diseased vessels compared with white patients (p = 0.0001). Thirty-day death or MI was 14% for whites, 10% for African-Americans, and 14% for Hispanics (overall p = 0.034). After adjustment for baseline variables, African-American patients had lower 30-day death or MI compared with white patients (odds ratio 0.73, 95% confidence interval 0.55 to 0.98). There were no differences in 6-month death or MI across racial/ethnic groups. In conclusion, baseline clinical characteristics differed across North American racial/ethnic groups in the SYNERGY trial. African-American patients had significantly better adjusted 30-day outcomes but similar 6-month outcomes compared with white patients.

The greatest benefit of enoxaparin over unfractionated heparin in acute coronary syndromes is achieved in patients presenting with ST-segment changes: the Enoxaparin in Non-Q-Wave Coronary Events (ESSENCE) Electrocardiogram Core Laboratory Substudy.

BACKGROUND: We undertook a prospective electrocardiogram (ECG) substudy in the ESSENCE trial and hypothesized that patient subgroups with ST-segment deviation would experience greater benefit from enoxaparin, as compared with unfractionated heparin (UFH). METHODS: Of the 3171 patients in the trial, 3087 had a qualifying ECG available for analysis by the core laboratory. Patients were divided into 4 mutually exclusive groups based upon the qualifying ECG: (1) ST-segment elevation, (2) ST-segment depression, (3) T-wave inversions, or (4) others. RESULTS: The 30-day and 1-year primary outcomes (death, myocardial infarction, or recurrent angina) were significantly lower among patients with ST elevation or ST depression who received enoxaparin, as compared with UFH (20.8% vs 28.0%, P = .0019 and 32% vs 40.4%, P = .0011, respectively). The greatest absolute benefit of enoxaparin over UFH was seen in patients with ST depression (primary end point at 30 days, 24.6% vs 32.4%, P = .018; at 1 year, 35.5% vs 44.5%, P = .012). CONCLUSION: Specific recognition of patients with ST-segment depression appears to identify those not only at high risk for adverse outcome, but also patients most likely to derive the greatest benefit from enoxaparin, as compared with UFH therapy.

The diagnostic and prognostic impact of the redefinition of acute myocardial infarction: lessons from the Global Registry of Acute Coronary Events (GRACE).

BACKGROUND: The impact and prognostic value of the redefinition of myocardial infarction (MI) with more sensitive markers have not been evaluated prospectively in a large, less selected population with acute coronary syndrome (ACS). METHODS: We evaluated the attack and case-fatality rates of MI based on initial and/or peak creatine kinase (CK), creatine kinase-MB (CK-MB), and cardiac troponin (the upper limit of normal [ULN] was defined according to the local hospital's standard) in a prospective observational registry of 26,267 patients with ACS admitted to 106 hospitals in 14 countries. RESULTS: The addition of cardiac troponin-positive status to CK status as a criterion for the diagnosis of MI resulted in as many as 1 in 4 additional patients meeting the redefined criteria. Compared with patients without elevated levels of CK and cardiac troponin, the crude odds for dying during hospitalization were significantly higher for patients with elevated troponin but not CK levels of greater than or equal to the ULN (odds ratio [OR] 2.2, 95% CI 1.6-2.9), those without CK levels >2 times the ULN (OR 2.8, 95% CI 2.2-3.5), and those with nonelevated levels of CK-MB (OR 2.1, 95% CI 1.4-3.2). The addition of cardiac troponin-positive status significantly increased the multivariable-adjusted odds for hospital death in patients with CK < or =2 times the ULN (OR 1.6, 95% CI 1.2-2.1) but not for patients without elevated levels of CK or CK-MB. CONCLUSIONS: The prognostic value of cardiac troponin, beyond that supplied by CK status or important baseline characteristics, assists in the identification of patients with ACS who are at increased risk for death.

Influenza vaccine pilot study in acute coronary syndromes and planned percutaneous coronary interventions: the FLU Vaccination Acute Coronary Syndromes (FLUVACS) Study.

BACKGROUND: Recent reports have detected an increase in the number of patients with acute coronary syndromes during the flu season. In addition, the World Health Organization recommended vaccination against influenza infection for the Southern hemisphere in the winter of 2001. We evaluated the preventive impact of vaccination on subsequent ischemic events in myocardial infarction patients and in subjects undergoing planned percutaneous coronary angioplasty. METHODS AND RESULTS: We included 200 myocardial infarction patients admitted in the first 72 hours and 101 planned angioplasty/stent (PCI) patients without unstable coronary artery disease, prior bypass surgery, angioplasty, or tissue necrosis, in a prospective, multicenter log during the winter season. Infarct patients received a standard therapy and were then randomly allocated in a single-blind manner to either a unique intramuscular influenza vaccination or a control group. Similarly, PCI patients were allocated to either vaccination or control groups. Combined end points (death, reinfarction, and rehospitalization for ischemia) were assessed at 6 months' follow-up. The first primary outcome, cardiovascular death, occurred in 2% of the patients in the vaccine group compared with 8% in the control group (relative risk with vaccine as compared with controls, 0.25; 95% CI 0.07 to 0.86; P=0.01). The triple composite end point occurred in 11% of the patients in the vaccine group compared with 23% in controls (P=0.009). CONCLUSIONS: Influenza vaccination may reduce the risk of death and ischemic events in patients suffering from infarction and those recovering from angioplasty during flu season. This response could be related to a humoral immune response with positive consequences during flu seasons.

Prospective evaluation of clinical outcomes after acute ST-elevation myocardial infarction in patients who are ineligible for reperfusion therapy: preliminary results from the TETAMI registry and randomized trial.

BACKGROUND: Treatment with lytics or primary percutaneous coronary interventions (PCI) reduces the mortality rate of patients with ST-elevation myocardial infarction (STEMI) presenting within 12 hours. Patients presenting >12 hours are generally considered to be ineligible for reperfusion therapy, and there are currently no specific treatment recommendations for this subgroup.Methods- All patients with STEMI <24 hours were included in the Treatment with Enoxaparin and Tirofiban in Acute Myocardial Infarction (TETAMI) randomized trial or registry. Those patients who were ineligible for acute reperfusion, had no cardiogenic shock, and were not planned for revascularization within 48 hours were randomized to 1 of 4 antithrombotic regimens involving enoxaparin or unfractionated heparin (UFH), in combination with tirofiban or placebo for 2 to 8 days. A concurrent registry tracked STEMI patients coming in within <12 hours, and who underwent reperfusion. This registry also tracked the remaining STEMI patients who neither received reperfusion nor were enrolled in the TETAMI randomized trial. The demographics and clinical outcomes of all three groups (received reperfusion therapy, too late for reperfusion and enrolled in the randomized trial, neither received reperfusion therapy nor were enrolled in the randomized trial) were prospectively tracked. RESULTS AND CONCLUSIONS: There were 2,737 patients who presented with STEMI or a new left branch bundle block (LBBB), of which 1,654 (60%) presented < or =12 hours. There were 1,196 (72%) of 1,654 patients who received reperfusion therapy. There were 458 (28%) of the 1,654 patients deemed "ineligible" for reperfusion, mostly because of a contraindication to lytics or for being "too old." In contrast, 1,083 (40%) of 2,737 patients presented >12 hours. Apart from 34 of these patients who had a stuttering infarction and were referred for reperfusion, the remaining patients did not receive reperfusion therapy. Registry patients who received reperfusion therapy, compared with TETAMI randomized patients (all of whom received antithrombotic therapy) and registry patients who did not receive reperfusion, were younger (61 years versus 63 years and 67 years), were more likely to be male (78% versus 73% and 63%), and had persistent ST-segment elevation as opposed to LBBB or Q waves. Registry patients who received reperfusion therapy had better clinical outcomes, even after adjusting for admission Killip class, compared with TETAMI randomized patients and registry patients who did not receive reperfusion therapy. TETAMI randomized patients had better outcomes than registry patients who did not receive reperfusion therapy. The major obstacle to expanding the delivery of reperfusion therapy to patients with STEMI is the large fraction of patients who present too late for reperfusion therapy. Examination of prospectively gathered data on STEMI patients who are ineligible for reperfusion may help optimize their treatment.

The safety and efficacy of subcutaneous enoxaparin versus intravenous unfractionated heparin and tirofiban versus placebo in the treatment of acute ST-segment elevation myocardial infarction patients ineligible for reperfusion (TETAMI): a randomized trial.

OBJECTIVES: The aims of the Safety and Efficacy of Subcutaneous Enoxaparin Versus Intravenous Unfractionated Heparin and Tirofiban Versus Placebo in the Treatment of Acute ST-Segment Elevation Myocardial Infarction Patients Ineligible for Reperfusion (TETAMI) study were to demonstrate that enoxaparin was superior to unfractionated heparin (UFH) and that tirofiban was better than placebo in patients with acute ST-segment elevation myocardial infarction (STEMI) who do not receive timely reperfusion. BACKGROUND: An optimal treatment strategy has not been identified for the many STEMI patients ineligible for acute reperfusion. METHODS: A total of 1224 patients were enrolled in 91 centers in 14 countries between July 1999 and July 2002. Patients with STEMI ineligible for reperfusion were randomized to enoxaparin, enoxaparin plus tirofiban, UFH, or UFH plus tirofiban. All patients received oral aspirin. The primary efficacy end point was the 30-day combined incidence of death, reinfarction, or recurrent angina; the primary analysis was the comparison of the pooled enoxaparin and UFH groups. RESULTS: The incidence of the primary efficacy end point was 15.7% enoxaparin versus 17.3% for UFH (odds ratio 0.89 [95% confidence interval CI = 0.66 to 1.21]) and 16.6% for tirofiban versus 16.4% for placebo (odds ratio 1.02 [95% CI 0.75 to 1.38]). The Thrombolysis In Myocardial Infarction (TIMI) major hemorrhage rate was 1.5% for enoxaparin versus 1.3% for UFH (odds ratio 1.16 [95% CI 0.44 to 3.02]) and 1.8% versus 1% for tirofiban versus placebo (odds ratio 1.82 [95% CI 0.67 to 4.95]). CONCLUSIONS: This study did not show that enoxaparin significantly reduced the 30-day incidence of death, reinfarction, and recurrent angina compared with UFH in non-reperfused STEMI patients. However, enoxaparin appears to have a similar safety and efficacy profile to UFH and may be an alternative treatment. Additional therapy with tirofiban did not appear beneficial.

Socio economic crisis and mortality. Epidemiological testimony of the financial collapse of Argentina.

BACKGROUND: Natural disasters, war, and terrorist attacks, have been linked to cardiac mortality. We sought to investigate whether a major financial crisis may impact on the medical management and outcomes of acute coronary syndromes. METHODS: We analyzed the Argentine cohort of the international multicenter Global Registry of Acute Coronary Events (GRACE). The primary objective was to estimate if there was an association between the financial crisis period (April 1999 to December 2002) and in- hospital cardiovascular mortality, with the post-crisis period (January 2003 to September 2004) as the referent. Each period was defined according to the evolution of the Gross Domestic Product. We investigated the demographic characteristics, diagnostic and therapeutic procedures, morbidity and mortality. RESULTS: We analyzed data from 3220 patients, 2246 (69.8%) patients in the crisis period and 974 (30.2%) in the post-crisis frame. The distribution of demographic and clinical baseline characteristics were not significantly different between both periods. During the crisis period the incidence of in-hospital myocardial infarction was higher (6.9% Vs 2.9%; p value < 0.0001), as well as congestive heart failure (16% Vs 11%; p value < 0.0001). Time to intervention with angioplasty was longer during the crisis, especially among public sites (median 190 min Vs 27 min). The incidence proportion of mortality during hospitalization was 6.2% Vs 5.1% after crisis. The crude OR for mortality was 1.2 (95% C.I. 0.87, 1.7). The odds for mortality were higher among private institutions {1.9 (95% C.I. 0.9, 3.8)} than for public centers {1.2 (95% C.I. 0.83, 1.79)}. We did not observe a significant interaction between type of hospital and crisis. CONCLUSION: Our findings suggest that the financial crisis may have had a negative impact on cardiovascular mortality during hospitalization, and higher incidence of medical complications.

Late Consequences of Acute Coronary Syndromes: Global Registry of Acute Coronary Events (GRACE) Follow-up.

PURPOSE: Short-term outcomes have been well characterized in acute coronary syndromes; however, longer-term follow-up for the entire spectrum of these patients, including ST-segment-elevation myocardial infarction, non-ST-segment-elevation myocardial infarction, and unstable angina, is more limited. Therefore, we describe the longer-term outcomes, procedures, and medication use in Global Registry of Acute Coronary Events (GRACE) hospital survivors undergoing 6-month and 2-year follow-up, and the performance of the discharge GRACE risk score in predicting 2-year mortality. METHODS: Between 1999 and 2007, 70,395 patients with a suspected acute coronary syndrome were enrolled. In 2004, 2-year prospective follow-up was undertaken in those with a discharge acute coronary syndrome diagnosis in 57 sites. RESULTS: From 2004 to 2007, 19,122 (87.2%) patients underwent follow-up; by 2 years postdischarge, 14.3% underwent angiography, 8.7% percutaneous coronary intervention, 2.0% coronary bypass surgery, and 24.2% were re-hospitalized. In patients with 2-year follow-up, acetylsalicylic acid (88.7%), beta-blocker (80.4%), renin-angiotensin system inhibitor (69.8%), and statin (80.2%) therapy was used. Heart failure occurred in 6.3%, (re)infarction in 4.4%, and death in 7.1%. Discharge-to-6-month GRACE risk score was highly predictive of all-cause mortality at 2 years (c-statistic 0.80). CONCLUSION: In this large multinational cohort of acute coronary syndrome patients, there were important later adverse consequences, including frequent morbidity and mortality. These findings were seen in the context of additional coronary procedures and despite continued use of evidence-based therapies in a high proportion of patients. The discriminative accuracy of the GRACE risk score in hospital survivors for predicting longer-term mortality was maintained.

Adherence to evidence-based therapies after discharge for acute coronary syndromes: an ongoing prospective, observational study.

PURPOSE: To determine the rates of patient adherence to key evidence-based therapies at 6 months after hospital discharge for an acute coronary syndrome. METHODS: In this nonrandomized, prospective, multinational, multicenter study, adherence to aspirin, beta-blockers, statins, or angiotensin-converting enzyme (ACE) inhibitors 6 months after discharge for myocardial infarction or unstable angina was assessed in 21,408 patients aged 18 years or older. Patients were enrolled at 104 tertiary and community hospitals representing a broad range of care facilities and practice settings (e.g., teaching vs. nonteaching). RESULTS: Of 13,830 patients, discontinuation of therapy was observed at 6-month follow-up in 8% of those taking aspirin on discharge, 12% of those taking beta-blockers, 20% of those taking ACE inhibitors, and 13% of those taking statins. In a multivariate analysis, adherence to beta-blocker therapy was higher in patients with a myocardial infarction (odds ratio [OR] = 1.25; 95% confidence interval [CI]: 1.06 to 1.47), hypertension (OR = 1.33; 95% CI: 1.15 to 1.54), ST-segment elevation myocardial infarction (OR = 1.33; 95% CI: 1.11 to 1.61), or non-ST-segment elevation myocardial infarction (OR = 1.25; 95% CI: 1.08 to 1.45). Aspirin adherence was higher among patients cared for by cardiologists (OR = 1.45; 95% CI: 1.19 to 1.75; P <0.001) than among those cared for by nonspecialists. Male sex and prior heart failure were associated with improved adherence to ACE inhibitor therapy. Hypertension was associated with poorer adherence to statin therapy (OR = 0.85; 95% CI: 0.74 to 0.99; P = 0.04). CONCLUSION: Among patients prescribed key evidence-based medications at discharge, 8% to 20% were no longer taking their medication after 6 months. The reasons for noncompliance are complex, and may be elucidated by future studies of medical and social determinants.

Impact of aspirin on presentation and hospital outcomes in patients with acute coronary syndromes (The Global Registry of Acute Coronary Events [GRACE]).

The long-term use of aspirin (ASA) reduces the risk of subsequent acute coronary syndromes in patients with coronary artery disease (CAD). It is less clear whether ASA therapy benefits patients who develop an acute coronary syndrome despite its use. Baseline characteristics, type of acute coronary syndrome, and in-hospital events were compared on the basis of previous use of ASA in 11,388 patients with and without a history of CAD presenting to 94 multinational hospitals. A total of 73.0% of patients with a history of CAD (n = 4,974) were previously on long-term ASA therapy compared with 19.4% of patients without a history of CAD (n = 6,414). After multivariate regression analysis controlling for various potentially confounding factors, patients with a history of CAD who were previously taking ASA were significantly less likely to present with ST-segment elevation myocardial infarction (MI) (adjusted odds ratio [OR] 0.52, 95% confidence intervals [CI] 0.44 to 0.61) or die during hospitalization (OR 0.69, 95% CI 0.50 to 0.95) in comparison to patients who were not taking ASA. Patients without a history of CAD and who were previously taking ASA also had a lower risk of developing ST-segment elevation MI (OR 0.35, 95% CI 0.30 to 0.40) and a trend toward a decreased hospital death rate (OR 0.77, 95% CI 0.55 to 1.07). These results demonstrate that patients with a history of CAD who present with an acute coronary syndrome despite prior ASA use have less severe clinical presentation, fewer hospital complications, and lower in-hospital death rates than patients not previously taking ASA.

Revascularization, stenting, and outcomes of patients with acute myocardial infarction complicated by cardiogenic shock.

Randomized clinical trials have demonstrated a reduction in mortality with early revascularization of patients with acute myocardial infarction (AMI) complicated by cardiogenic shock, and recent single-center studies have particularly suggested further benefit for coronary stenting. The purpose of this study was to examine the use of revascularization and coronary stenting for patients with shock from a multicenter, international perspective. Patients with AMI complicated by cardiogenic shock (n = 583) who enrolled between April 1999 and June 2001 were prospectively identified from the large, multinational, observational Global Registry of Acute Coronary Events. We examined the use of coronary reperfusion strategies, adjunctive therapy, and hospital mortality in this group of patients. Cardiac catheterization (52%) and revascularization (43%) were performed in approximately half of the cardiogenic shock patients. Elderly patients (age >/=75 years) comprised 40% of the shock cohort. Regional differences were seen in the use of revascularization, adjunctive medical therapy, and type of revascularization used (coronary stenting). Total hospital mortality was 59%, but case fatality rates ranged from 35% for patients who underwent coronary stenting to 74% for patients who did not undergo any cardiac catheterization. Percutaneous coronary intervention with coronary stenting was the most powerful predictor of hospital survival (odds ratio 3.99, 95% confidence interval 2.41 to 6.62). Thus, cardiogenic shock continues to be a devastating complication of AMI, and relative underuse of a revascularization strategy may be related to the large proportion of elderly patients in this population. In this multinational registry study, coronary stenting was the most powerful independent predictor of hospital survival.

Nadroparine calcium or enoxaparine in acute coronary syndrome patients suffering renal insufficiency: The nadroparin versus enoxaparin (NaVe) study design.

In the general population, mild renal impairment is associated with increases risk for coronary artery disease and stroke, suggesting that cardiovascular disease begins to develop early in the natural history of renal dysfunction. Patients with renal failure are known to be at increased risk of death following acute myocardial infarction or congestive heart failure.In such sense, anticoagulation in addition to antiplatelet inhibitor drugs became the standard of care, particularly, among high risk unstable angina patients associated with a scarce side effects.The Nadroparin calcium Versus Enoxaparin (NaVe) Study will evaluate in a head to head basis the anti Xa activity reached by nadroparine or enoxaparine, both low molecular weight heparins, in patients at high risk for ischemic episodes, and renal insufficiency to eventually be undergone to angiographic diagnosis studies, and in consequence proposing the best anticoagulant strategies for these patients before being invasively treated.Patients will be randomly assigned to one of the two groups: Group 1: thirty patients will be given with subcutaneous enoxaparine injections into the abdominal wall in a dose of 0,85 mg/kg every 12 hours for a maximum of 48 hours. A saline infusion dose will be given in between. Total number of injections: 6. Group 2:Thirty patients will be receiving subcutaneous injections into the abdominal wall in a doses of 30% less in relationship with his / her body weight every 8 hours for a maximum of 48 hours.In order to achieve the goal of the study, the antiXa activity will be measure using venous blood samples taken as follows: Group 1:*Within 3rd and 4 hour of the second doses of HBPM for enoxaparine.*Within 11 th and 12 th hour next to fourth doses of enoxaparine. Group 2: *Within 3rd and 4 th hour next to 3rd doses of HBPM for the nadroparine.*Within 7th and 8th hour next to 4th doses HBPM for the nadroparine.The primary end point is to analyze during the in-hospital stay phase the stability of the anti Xa activity within the therapeutic ranges which will be estimated between 0.5 to 1.0 IU during the first 48 hours.

Two-year follow-up of the FLU Vaccination Acute Coronary Syndromes (FLUVACS) Registry.

We have previously determined that there is a significant benefit of vaccination against influenza in patients hospitalized due to an acute coronary event. The purpose of this study is to determine whether the observed benefits of vaccination were maintained over a 2-year follow-up among those who were re-vaccinated during the subsequent winter season. During the winter season of 2001, a total of 301 acute coronary patients were prospectively enrolled within 72 hours of the onset of symptoms. Follow-up was conducted at 6 and 12 months. Patients who survived participated in a registry 1 year after the 2nd influenza vaccination period (winter 2002), as a cohort of chronic and stable coronary patients. The incidence of the primary endpoint cardiovascular death at 1 year was significantly lower in patients receiving vaccination than in controls (6% vs 17%, respectively) by intention-to-treat analysis. The relative risk with vaccination in comparison with controls was 0.34; 95% confidence interval, 0.17-0.71; P = 0.002. In the winter of 2002, 116 patients were vaccinated according to their physicians' instructions, and 114 subjects remained unvaccinated. The combined endpoints of total death plus myocardial infarction 1 year later were 4 (3.4%) in the vaccinated group vs 11 (9.7%) among those who were not vaccinated (P = 0.05). Influenza vaccination may reduce the risk of death and ischemic events in patients admitted with acute coronary syndromes. There is also a beneficial trend in the quiescent phase of ischemia.

[Secondary prevention of coronary artery disease. Flu vaccinations and new evidence of the role of infection in acute coronary syndromes]. / Prevención secundaria de la cardiopatía isquémica con la vacuna antigripal. Nueva evicencia sobre el papel de la infección y los sídromes coronarios agudos.

Recent reports have detected an increase in the number of patients with acute coronary syndromes during the flu season. More recently, case-control studies of patients with prior infarction have shown that flu vaccination significantly reduces the risk of myocardial necrosis and strokes. The World Health Organization recommended flu vaccination for the Southern Hemisphere in the winter of 2001. We evaluated the preventive impact of flu vaccination on subsequent ischemic events in myocardial infarction patients and in subjects undergoing scheduled percutaneous coronary angioplasty. In the first study we included 200 myocardial infarction patients admitted in the first 72 hours and 100 patients scheduled for angioplasty/stent (PCI) without unstable coronary artery disease, prior bypass surgery, angioplasty or tissue necrosis, were included in a prospective, multicenter registry, during the winter season. Infarction patients received standard therapy, and then were randomly allocated in a single-blind manner as a unique intramuscular Influenza vaccination or as controls. Similarly, PCI patients were allocated to either vaccination or control. The first primary outcome -cardiovascular death- occurred within 6 months in 2% of the patients in the vaccinnated group vs 8% of controls (RR: 0.25; 95% CI, 0.07-0.86; p = 0.01). The triple composite end point occurred in 11% of the patients in the vaccinnated group vs 23% of controls (p = 0.009) at 6 months. Although our study is the first to demonstrate lower rates of cardiovascular ischemic events in patients vaccinated against Influenza during the flu season, the modification of flu vaccination recommendations in patients admitted for cardiovascular events merits further study before being considered.

[Flu vaccination in patients with acute coronary syndromes: treatment benefit in prespecified subgroups]. / Vacunación antigripal en pacientes con síndromes coronarios agudos: beneficio del tratamiento en diferentes subgrupos.

BACKGROUND: The first prospective clinical Flu Vaccination in Acute Coronary Syndromes (FLUVACS) Trial has provided some evidence that flu vaccination together with standard therapy may be useful during the winter season to reduce the risk of death and major cardiac events in patients with acute myocardial infarction. PATIENTS AND METHOD: Information available in the FLUVACS database was analyzed to evaluate the efficacy of flu vaccination in different subgroups. Logistic regression was used to identify features related with better therapeutic results. RESULTS: Flu vaccination was effective in reducing the incidence of the composite endpoint (death, nonfatal myocardial reinfarction or recurrent angina prompting urgent revascularization) in most subgroups at 6 months after inclusion. The regression model showed a greater benefit of flu vaccination in patients with no ST-segment elevation or older than 65 years, nonsmokers and patients with a TIMI risk score higher than 6. CONCLUSIONS: Our data suggest that vaccination for secondary prevention of flu during the acute phase of myocardial infarction may be effective in a broad range of patients with acute coronary artery disease, regardless of their initial clinical risk.

Enoxaparin vs unfractionated heparin in high-risk patients with non-ST-segment elevation acute coronary syndromes managed with an intended early invasive strategy: primary results of the SYNERGY randomized trial.

CONTEXT: Enoxaparin has demonstrated advantages over unfractionated heparin in low- to moderate-risk patients with non-ST-segment elevation acute coronary syndromes (ACS) treated with a conservative strategy. OBJECTIVES: To compare the outcomes of patients treated with enoxaparin vs unfractionated heparin and to define the role of enoxaparin in patients with non-ST-segment elevation ACS at high risk for ischemic cardiac complications managed with an early invasive approach. DESIGN, SETTING, AND PARTICIPANTS: The Superior Yield of the New Strategy of Enoxaparin, Revascularization and Glycoprotein IIb/IIIa Inhibitors (SYNERGY) trial was a prospective, randomized, open-label, multicenter, international trial conducted between August 2001 and December 2003. A total of 10 027 high-risk patients with non-ST-segment elevation ACS to be treated with an intended early invasive strategy were recruited. INTERVENTIONS: Subcutaneous enoxaparin (n = 4993) or intravenous unfractionated heparin (n = 4985) was to be administered immediately after enrollment and continued until the patient required no further anticoagulation, as judged by the treating physician. MAIN OUTCOME MEASURES: The primary efficacy outcome was the composite clinical end point of all-cause death or nonfatal myocardial infarction during the first 30 days after randomization. The primary safety outcome was major bleeding or stroke. RESULTS: The primary end point occurred in 14.0% (696/4993) of patients assigned to enoxaparin and 14.5% (722/4985) of patients assigned to unfractionated heparin (odds ratio [OR], 0.96; 95% confidence interval [CI], 0.86-1.06). No differences in ischemic events during percutaneous coronary intervention (PCI) were observed between enoxaparin and unfractionated heparin groups, respectively, including similar rates of abrupt closure (31/2321 [1.3%] vs 40/2364 [1.7%]), threatened abrupt closure (25/2321 [1.1%] vs 24/2363 [1.0%]), unsuccessful PCI (81/2281 [3.6%] vs 79/2328 [3.4%]), or emergency coronary artery bypass graft surgery (6/2323 [0.3%] vs 8/2363 [0.3%]). More bleeding was observed with enoxaparin, with a statistically significant increase in TIMI (Thrombolysis in Myocardial Infarction) major bleeding (9.1% vs 7.6%, P =.008) but nonsignificant excess in GUSTO (Global Utilization of Streptokinase and t-PA for Occluded Arteries) severe bleeding (2.7% vs 2.2%, P =.08) and transfusions (17.0% vs 16.0%, P =.16). CONCLUSIONS: Enoxaparin was not superior to unfractionated heparin but was noninferior for the treatment of high-risk patients with non-ST-segment elevation ACS. Enoxaparin is a safe and effective alternative to unfractionated heparin and the advantages of convenience should be balanced with the modest excess of major bleeding.