Showing papers by "Elliott M. Antman published in 2007"
TL;DR: In patients with acute coronary syndromes with scheduled percutaneous coronary intervention, prasugrel therapy was associated with significantly reduced rates of ischemic events, including stent thrombosis, but with an increased risk of major bleeding, including fatal bleeding.
Abstract: The primary efficacy end point occurred in 12.1% of patients receiving clopidogrel and 9.9% of patients receiving prasugrel (hazard ratio for prasugrel vs. clopidogrel, 0.81; 95% confidence interval [CI], 0.73 to 0.90; P<0.001). We also found significant reductions in the prasugrel group in the rates of myocardial infarction (9.7% for clopidogrel vs. 7.4% for prasugrel; P<0.001), urgent target-vessel revascularization (3.7% vs. 2.5%; P<0.001), and stent thrombosis (2.4% vs. 1.1%; P<0.001). Major bleeding was observed in 2.4% of patients receiving prasugrel and in 1.8% of patients receiving clopidogrel (hazard ratio, 1.32; 95% CI, 1.03 to 1.68; P = 0.03). Also greater in the prasugrel group was the rate of life-threatening bleeding (1.4% vs. 0.9%; P = 0.01), including nonfatal bleeding (1.1% vs. 0.9%; hazard ratio, 1.25; P = 0.23) and fatal bleeding (0.4% vs. 0.1%; P = 0.002). Conclusions In patients with acute coronary syndromes with scheduled percutaneous coronary intervention, prasugrel therapy was associated with significantly reduced rates of ischemic events, including stent thrombosis, but with an increased risk of major bleeding, including fatal bleeding. Overall mortality did not differ significantly between treatment groups. (ClinicalTrials.gov number, NCT00097591.)
6,021 citations
TL;DR: Information on myocardial infarction attack rates can provide useful data regarding the burden of coronary artery disease within and across populations, especially if standardized data are collected in a manner that demonstrates the distinction between incident and recurrent events.
Abstract: ![Graphic][1]
Myocardial infarction is a major cause of death and disability worldwide. Coronary atherosclerosis is a chronic disease with stable and unstable periods. During unstable periods with activated inflammation in the vascular wall, patients may develop a myocardial infarction. Myocardial infarction may be a minor event in a lifelong chronic disease, it may even go undetected, but it may also be a major catastrophic event leading to sudden death or severe haemodynamic deterioration. A myocardial infarction may be the first manifestation of coronary artery disease, or it may occur, repeatedly, in patients with established disease. Information on myocardial infarction attack rates can provide useful data regarding the burden of coronary artery disease within and across populations, especially if standardized data are collected in a manner that demonstrates the distinction between incident and recurrent events. From the epidemiological point of view, the incidence of myocardial infarction in a population can be used as a proxy for the prevalence of coronary artery disease in that population. Furthermore, the term myocardial infarction has major psychological and legal implications for the individual and society. It is an indicator of one of the leading health problems in the world, and it is an outcome measure in clinical trials and observational studies. With these perspectives, myocardial infarction may be defined from a number of different clinical, electrocardiographic, biochemical, imaging, and pathological characteristics.
In the past, a general consensus existed for the clinical syndrome designated as myocardial infarction. In studies of disease prevalence, the World Health Organization (WHO) defined myocardial infarction from symptoms, ECG abnormalities, and enzymes. However, the development of more sensitive and specific serological biomarkers and precise imaging techniques allows detection of ever smaller amounts of myocardial necrosis. Accordingly, current clinical practice, health care delivery systems, as well as epidemiology and clinical trials all require a …
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3,193 citations
TL;DR: Angina/Non-ST-Elevation Myocardial Infarction : ACC/AHA 2007 Guidelines for the Management of Patients With Unstable ISSN: 1524-4539 Copyright © 2007 American Heart Association.
Abstract: Angina/Non-ST-Elevation Myocardial Infarction : ACC/AHA 2007 Guidelines for the Management of Patients With Unstable ISSN: 1524-4539 Copyright © 2007 American Heart Association. All rights reserved. Print ISSN: 0009-7322. Online 72514 Circulation is published by the American Heart Association. 7272 Greenville Avenue, Dallas, TX doi: 10.1161/CIRCULATIONAHA.107.18194
2,605 citations
TL;DR: The 2007 Guidelines on Perioperative Cardiovascular Evaluation for Non-Cardiac Surgery (e159-e242) as discussed by the authors were developed by the American College of ACC/AHA Task Force on Practice Guidelines Care for Noncardiac Surgery.
1,397 citations
TL;DR: WRITING COMMITTEE MEMBERS Lee A. Fleisher, MD, FACC, FAHA, Chair; Joshua A. Beckman,MD, F ACC¶; Kenneth A. Kasper, MD; Judy R. Kersten,MD; Barbara Riegel, DNSc, RN,FAHA.
1,393 citations
TL;DR: Among patients undergoing cardiac catheterization with planned percutaneous coronary intervention, loading with 60 mg prasugrel resulted in greater platelet inhibition than a 600-mg clopidogrel loading dose.
Abstract: Background— The increasing use of higher-than-approved doses of clopidogrel in clinical practice is based in part on the desire for greater levels of inhibition of platelet aggregation (IPA). Prasugrel is a new thienopyridine that is more potent than standard-dose clopidogrel in healthy subjects and patients with stable coronary artery disease. The relative antiplatelet effects of prasugrel versus high-dose clopidogrel in percutaneous coronary intervention patients are unknown. Methods and Results— Prasugrel in Comparison to Clopidogrel for Inhibition of Platelet Activation and Aggregation–Thrombolysis in Myocardial Infarction 44 (PRINCIPLE-TIMI 44) was a randomized, double-blind, 2-phase crossover study of prasugrel compared with high-dose clopidogrel in patients undergoing cardiac catheterization for planned percutaneous coronary intervention. The primary end point of the loading-dose phase (prasugrel 60 mg versus clopidogrel 600 mg) was IPA with 20 μmol/L ADP at 6 hours. Patients with percutaneous coro...
878 citations
TL;DR: There was a significant increase in the rate ratio for myocardial infarction with COX-2 inhibitors compared with placebo, and regulatory authorities in several regions of the world have introduced warning statements and advisories to both healthcare professionals and the lay public about the use of various NSAIDs.
Abstract: Clinical trial data have prompted questions about the degree to which patients and their physicians should consider an increased risk of cardiovascular or cerebrovascular events when selecting medications for pain relief. Since the 2005 publication of a Science Advisory on the use of nonsteroidal antiinflammatory drugs (NSAIDs) by the American Heart Association,1 several important events have occurred that have served as the catalyst for this update for clinicians. (1) Additional data from randomized controlled trials of cyclooxygenase (COX)-2–selective agents have been reported and summarized in meta-analyses, which has reinforced the concern about cardiovascular events with COX-2 inhibitors (coxibs; Figure 1). (2) Several reports have appeared that have identified an increased risk of cardiovascular events even with the nonselective NSAIDs, which has raised concern about the use of those agents as well (Table). (3) Regulatory authorities in several regions of the world have introduced warning statements and advisories to both healthcare professionals and the lay public about the use of various NSAIDs (Figures 2 and 3⇓).
Figure 1. Comparison of effects of different selective COX-2 inhibitors vs placebo on myocardial infarction. Event numbers and person-years of exposure, with corresponding mean annual event rates in parentheses, are presented for patients allocated to selective COX-2 inhibitor or placebo. Event rate ratios for pooled data with 95% CIs are indicated by a diamond; rate ratios for individual selective COX-2 inhibitors, with 99% CIs, are indicated by a square and horizontal line. Diamonds to the right of the solid line indicate hazard with a selective COX-2 inhibitor compared with placebo. As noted, there was a significant increase in the rate ratio for myocardial infarction with COX-2 inhibitors compared with placebo. Similar analyses (data not shown) include rate ratios of 1.42 (1.13 to 1.78; P =0.003) for vascular events, 1.02 (0.71 to 1.47; P …
777 citations
TL;DR: Despite modern therapies for ACS, diabetes confers a significant adverse prognosis, which highlights the importance of aggressive strategies to manage this high-risk population with unstable ischemic heart disease.
Abstract: ContextThe worldwide epidemic of diabetes mellitus is increasing the burden of cardiovascular disease, the leading cause of death among persons with diabetes The independent effect of diabetes on mortality following acute coronary syndromes (ACS) is uncertainObjectiveTo evaluate the influence of diabetes on mortality following ACS using a large database spanning the full spectrum of ACSDesign, Setting, and PatientsA subgroup analysis of patients with diabetes enrolled in randomized clinical trials that evaluated ACS therapies Patients with ACS in 11 independent Thrombolysis in Myocardial Infarction (TIMI) Study Group clinical trials from 1997 to 2006 were pooled, including 62 036 patients (46 577 with ST-segment elevation myocardial infarction [STEMI] and 15 459 with unstable angina/non-STEMI [UA/NSTEMI]), of whom 10 613 (171%) had diabetes A multivariable model was constructed to adjust for baseline characteristics, aspects of ACS presentation, and treatments for the ACS eventMain Outcome MeasuresMortality at 30 days and 1 year following ACS among patients with diabetes vs patients without diabetesResultsMortality at 30 days was significantly higher among patients with diabetes than without diabetes presenting with UA/NSTEMI (21% vs 11%, P < 001) and STEMI (85% vs 54%, P < 001) After adjusting for baseline characteristics and features and management of the ACS event, diabetes was independently associated with higher 30-day mortality after UA/NSTEMI (odds ratio [OR], 178; 95% confidence interval [CI], 124-256) or STEMI (OR, 140; 95% CI, 124-157) Diabetes at presentation with ACS was associated with significantly higher mortality 1 year after UA/NSTEMI (hazard ratio [HR], 165; 95% CI, 130-210) or STEMI (HR, 122; 95% CI, 108-138) By 1 year following ACS, patients with diabetes presenting with UA/NSTEMI had a risk of death that approached patients without diabetes presenting with STEMI (72% vs 81%)ConclusionDespite modern therapies for ACS, diabetes confers a significant adverse prognosis, which highlights the importance of aggressive strategies to manage this high-risk population with unstable ischemic heart disease
639 citations
TL;DR: This article views 3 potential strategies to increase the number of ST-segment myocardial infarction patients with timely access to primary percutaneous coronary intervention (PCI) from the perspective of the PCI-capable hospital that “receives” STEMI patients (STEMI-receiving hospital).
Abstract: Advances in the treatment of ST-elevation myocardial infarction (STEMI) over the past 20 years have resulted in dramatic reductions in death attributable to STEMI. In large part, this reduction has been due to early reperfusion and advances in medical therapy.1 The American College of Cardiology (ACC)/American Heart Association (AHA) guidelines and the European Society of Cardiology guidelines for STEMI are in agreement that early and complete reperfusion is optimal, with the goal of door-to-balloon times within 90 minutes and door-to-needle times within 30 minutes.2,3 Most disturbing is that as many as one third of patients do not receive any reperfusion therapy in the absence of contraindications to its use.1,4 In the group of patients who do not receive any reperfusion, both short- and long-term outcomes are significantly worse. Advances in medical therapy, including use of aspirin, heparin, β-blockers, and angiotensin-converting enzyme inhibitors, have also dramatically improved outcomes. Hospitals that are most compliant with the guideline recommendations have better outcomes than those that follow the guidelines less well.5–7
In addition, one of the major delays in patients receiving rapid reperfusion is the delay in the patient seeking care and arrival at the emergency department.8 The National Heart, Lung, and Blood Institute, the AHA, and others have initiated a number of programs to attempt to improve public awareness of this problem and to reduce the time between symptom onset and hospital arrival. Despite these programs, little progress has been made.9 The European Society of Cardiology has identified the need for the establishment of networks for reperfusion at regional and national levels with the ready availability of primary percutaneous coronary intervention (PCI) and adequate quality control.10 Although there are some differences in the delivery of STEMI care between the United States and Europe, both locations are …
264 citations
238 citations
TL;DR: Although bleeding was increased with enoxaparin, this increase was offset by a reduction in death or MI, which was associated with superior efficacy as adjunctive antithrombin therapy among >49 000 patients across the ACS spectrum.
Abstract: Aims To determine whether the low-molecular weight heparin enoxaparin remains favourable when compared with unfractionated heparin (UFH) among patients with acute coronary syndromes (ACS) when incorporating efficacy and safety of these adjunctive therapies using a net clinical endpoint.
Methods and results We performed a meta-analysis of randomized trials of enoxaparin vs. UFH in ST-elevation-MI (STEMI) or non-ST-elevation-ACS (NSTEACS) ( n = 49 088 patients in 12 trials). The net clinical endpoint was defined as death, MI, or major bleeding by 30 days. Death or myocardial infarction (MI) was significantly reduced with enoxaparin when compared with UFH (9.8 vs. 11.4%, OR 0.84, P < 0.001). The net clinical endpoint occurred less frequently with enoxaparin than UFH (12.5 vs. 13.5%, OR 0.90, P = 0.051). Major bleeding was higher with enoxaparin (4.3 vs. 3.4%, OR 1.25, P = 0.019). Among STEMI trials, the net clinical endpoint was significantly lower with enoxaparin (OR 0.84, P = 0.015), but there was no difference in NSTEACS trials (OR 0.97).
Conclusions When compared with UFH, enoxaparin was associated with superior efficacy as adjunctive antithrombin therapy among >49 000 patients across the ACS spectrum. Although bleeding was increased with enoxaparin, this increase was offset by a reduction in death or MI. The net clinical benefit in favour of enoxaparin was evident among the STEMI population and was neutral among the NSTEACS population.
01 Jan 2007
TL;DR: Smaller sheaths, radial access, and timely sheath removal may mitigate the bleeding risk associated with potent antithrombotic/platelet therapy and early catheterization.
Abstract: Objectives: Our objective was to analyze the impact of arterial access site, sheath size, timing of sheath removal, and use of access site closure devices on high-risk patients with acute coronary syndromes (ACS). Background: In the SYNERGY trial, 9,978 patients with ACS were randomly assigned to receive enoxaparin or unfractionated heparin. Methods: This analysis includes 9,404 patients for whom sheath access information was obtained for the first PCI procedure or diagnostic catheterization. Comparisons of baseline, angiographic, and procedural characteristics were carried out according to access site and sheath size. Results: Overall, 9,404 (94%) patients underwent angiography at a median of 21 hr (25th and 75th percentiles: 5, 42) and 4,687 (50%) underwent PCI at a median of 23 hr (6,49) of enrollment. The access site was femoral for 94.9% of cases, radial for 4.4%, and brachial for 0.7%. Radial access was associated with fewer transfusions than femoral access (0.9% vs. 4.8%, P = 0.007). For femoral access, the rates of noncoronary artery bypass grafting (CABG)-related TIMI major bleeding by sheath size was 1.5% for 4 or 5 French (Fr), 1.6% for 6 Fr, 3.3% for 7 Fr, and 3.8% for ≥ 8 Fr (P < 0.0001). After adjustment for baseline characteristics, femoral access site, larger sheath size, and delayed sheath removal were independent predictors of need for transfusion. Conclusions: Smaller sheaths, radial access, and timely sheath removal may mitigate the bleeding risk associated with potent antithrombotic/platelet therapy and early catheterization. © 2006 Wiley-Liss, Inc.
TL;DR: The strategy of ENOX support for fibrinolytic therapy followed by PCI is superior to UFH and provides a seamless transition from the medical management to the interventional management phase of STEMI without the need for introducing a second anticoagulant in the cardiac catheterization laboratory.
TL;DR: A dose reduction of ENOX in the elderly appears to be helpful in ameliorating bleeding risk and was superior to UFH in both young and elderly patients with STEMI treated with fibrinolysis.
Abstract: Aims To determine the effects of age on outcomes in patients with STEMI treated with a strategy of enoxaparin (ENOX) vs. unfractionated heparin (UFH). Methods and results In the ExTRACT-TIMI 25 trial, 20 479 patients with STEMI were randomized in a double-blind fashion to UFH or ENOX. A novel reduced dose of ENOX was administered to patients � 75 years, and a reduced dose in those with an estimated creatinine clearance of , 30 mL/min. Anti-Xa levels were measured in a subset of patients (n ¼ 73). The exposure to anti-Xa over time was lower in the elderly (AUC0–12h P , 0.0001; AUCsteady-state P ¼ 0.0046). The relative risk reduction (RR) with ENOX on the primary endpoint, i.e. death or non-fatal recurrent myocardial infarction, was greater in patients , 75 years (20%) than . 75 years (6%), but the absolute benefits were similar. When compared with UFH, ENOX was associated with an RR of 1.67 for major bleeding, but the magnitude of the excess risk tended to be lower (RR ¼ 1.15) in patients � 75 years assigned to ENOX. Conclusion A dose reduction of ENOX in the elderly appears to be helpful in ameliorating bleeding risk. A strategy of ENOX was superior to UFH in both young and elderly patients with STEMI treated with fibrinolysis.
TL;DR: Enoxaparin was superior to UFH for the majority of subjects and the net clinical benefit between ENOX and UFH did not differ, despite the rise in adverse events in both treatment groups.
TL;DR: The analysis suggests that covering combination therapy for underused patients after a myocardial infarction will save both lives and money.
Abstract: Taken in combination, aspirin, beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, and statins (combination pharmacotherapy) greatly reduce cardiac events. These therapies are underused, even among patients with drug insurance. Out-of-pocket spending is a key barrier to adherence. We estimated the impact of providing combination pharmacotherapy without cost sharing (“full coverage”) to insured patients after a myocardial infarction (MI). Under base-case assumptions, compared to standard coverage, three years of full coverage will reduce mortality and reinfarction rates and will save $5,974 per patient. Our analysis suggests that covering combination therapy for such patients will save both lives and money.
TL;DR: Death, nonfatal MI, or major bleeding was significantly reduced with enoxaparin in the fibrin-specific cohort (OR(adj) 0.82; 95% CI 0.74-0.91; P < 0.001) and the benefits of an en oxaparin strategy over UFH were observed in both SK and fibrIn-specific-treated STEMI patients.
Abstract: Aims We compared outcomes of ST-elevation myocardial infarction (STEMI) patients randomized to a strategy of either enoxaparin or unfractionated heparin (UFH) to support fibrinolysis.
Methods and results In the Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment-Thrombolysis in Myocardial Infarction Study 25 (ExTRACT-TIMI 25) trial, 20 479 patients undergoing fibrinolysis for STEMI with a fibrin-specific agent ( N = 16 283) or streptokinase (SK) ( N = 4139) were randomized to enoxaparin throughout their hospitalization or UFH for at least 48 h. The primary end point of death or nonfatal recurrent MI through 30 days occurred in 12.0% of patients in the UFH and 9.8% in the enoxaparin groups when treated with fibrin-specific lytics [odds ratioadjusted (ORadj) 0.78; 95% CI 0.70–0.87; P < 0.001] and 11.8 vs. 10.2%, respectively, when treated with SK (ORadj 0.83; 95% CI 0.66–1.04; P = 0.10; P interaction = 0.58). Major bleeding rates including intracranial hemorrhage within the fibrin-specific cohort were 1.2 and 2.0% in the UFH and enoxaparin groups, respectively ( P < 0.001) and 2.0% in UFH and 2.4% in enoxaparin patients in the SK cohort ( P = 0.16). Interaction tests between antithrombin- and lytic-type were non-significant ( P = 0.20). Death, nonfatal MI, or major bleeding was significantly reduced with enoxaparin in the fibrin-specific cohort (ORadj 0.82; 95% CI 0.74–0.91; P < 0.001) and favoured enoxaparin in the SK cohort (ORadj 0.89; 95% CI 0.72–1.10; P = 0.29; P interaction = 0.53).
Conclusion The benefits of an enoxaparin strategy over UFH were observed in both SK and fibrin-specific-treated STEMI patients. Therefore, an enoxaparin strategy is preferred over UFH to support fibrinolysis for STEMI regardless of lytic agent.
TL;DR: Women had similar relative and greater absolute risk reductions than men when treated with enoxaparin compared with unfractionated heparin as adjunctive therapy with fibrinolysis in the ExTRACT-TIMI 25 study.
Abstract: Background— The manifestations, complications, and outcomes of cardiovascular disease differ between women and men. The safety and efficacy of pharmacological reperfusion therapy in women with ST-elevation myocardial infarction are of particular interest. Methods and Results— We investigated outcomes in the Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment–Thrombolysis in Myocardial Infarction (ExTRACT-TIMI) 25 study, which randomized ST-elevation myocardial infarction patients with planned fibrinolysis to enoxaparin or unfractionated heparin. Compared with men (n=15 696), women (n=4783) were older and more likely to have hypertension and diabetes (P 2-fold higher than for men (13.2% versus 5.4%; odds ratio, 2.66; 95% CI, 2.40 to 2.96). After adjustment for age, fibrinolytic therapy, revascularization, region, and elements of the TIMI Risk Score, women had a 1.25-fold-higher 30-day risk of death (95% CI, 1.08 to 1....
TL;DR: A decrease in the time to coronary angiography was associated with fewer ischemic outcomes and no increase in bleeding and Randomized clinical trials are needed to provide definitive evidence on optimal timing of coronaryAngiography.
Abstract: Background— Optimal timing for an early invasive strategy in patients with non–ST-segment–elevation acute coronary syndrome remains unclear. We evaluated the relationship between time from hospital admission to coronary angiography and outcomes in high-risk patients with non–ST-segment–elevation acute coronary syndrome who underwent angiography within 48 hours of admission. Methods and Results— Data from 10 027 patients enrolled in the Superior Yield of the New Strategy of Enoxaparin, Revascularization, and Glycoprotein IIb/IIIa Inhibitors (SYNERGY) trial were analyzed. Patients were grouped by 6-hour intervals of time from hospital admission to coronary angiography. Primary outcomes were 30-day death or myocardial infarction, in-hospital Thrombolysis In Myocardial Infarction (TIMI) and Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) major bleeding, and blood transfusion. Adjusted estimates of event rates were obtained by use of a multivariable m...
TL;DR: The totality of trial data suggest that the combination of a fibrinolytic, aspirin, clopidogrel, and ENOX offers an attractive pharmacologic reperfusion strategy in STEMI.
TL;DR: Key perspectives from the patient and public point ofview of the current system of care for STEMI patients are addressed and barriers and gaps that must be addressed are highlighted.
Abstract: Creating an ideal system of care to address the care forpatients with ST-elevation myocardial infarction (STEMI) iscomplex from both the system’s and patient/family’s perspec-tives. In general, this care is unlike most other hospital care.It typically involves very fast and complex decision makingand, often, sudden transportation to another facility forpercutaneous coronary intervention (PCI). All of this occurswith a potentially critically ill patient and at a time when thefamily is often not immediately available. In this report, weaddress key perspectives from the patient and public point ofview of the current system of care for STEMI patients andhighlight the barriers and gaps that must be addressed by anideal system of care (Table 1).
TL;DR: Thrombocytopenia is a significant correlate of adverse events in patients presenting with non-ST-elevation ACS treated with either enoxaparin or UFH.
Abstract: Thrombocytopenia is associated with an increased risk for adverse cardiac events and bleeding in patients presenting with acute coronary syndromes (ACS) treated with unfractionated heparin (UFH). Enoxaparin has been shown to improve outcomes in ACS; however, its effect on the development of thrombocytopenia in this population is not well documented. This study was conducted to examine the incidence and clinical importance of thrombocytopenia in patients presenting with non-ST-elevation ACS randomized to treatment with enoxaparin or UFH. Thrombocytopenia was defined as a platelet count 50% decrease from baseline. Thrombocytopenia developed in a total of 93 of 3,910 patients during the follow-up period of 14 days; the incidence was similar between study arms. The development of thrombocytopenia was associated with more frequent death, nonfatal myocardial infarction, and urgent revascularization during the study period (odds ratio 2.96, p = 0.001). This association was independent of assignment to treatment with enoxaparin or UFH (p for interaction = 0.47). Major bleeding was also more common in patients with thrombocytopenia regardless of treatment. In conclusion, thrombocytopenia is a significant correlate of adverse events in patients presenting with non-ST-elevation ACS treated with either enoxaparin or UFH.
01 Jan 2007
TL;DR: In this article, a random-effects empirical Bayes model was used to evaluate the outcomes of enoxaparin vs unfractionated heparin at 30 days and showed no significant difference in the combined end point of death or nonfatal MI.
Abstract: Data Synthesis Systematic evaluation of the outcomes for 21946 patients was performed using a random-effects empirical Bayes model. No significant difference was found in death at 30 days for enoxaparin vs unfractionated heparin (3.0% vs 3.0%; odds ratio [OR], 1.00; 95% confidence interval [CI], 0.85-1.17). A statistically significant reduction in the combined end point of death or nonfatal MI at 30 days was observed for enoxaparin vs unfractionated heparin in the overall trial populations (10.1% vs 11.0%; OR, 0.91; 95% CI, 0.83-0.99; number needed to treat, 107). A statistically significant reduction in the combined end point of death or MI at 30 days was also observed for enoxaparin in the populations receiving no prerandomization antithrombin therapy (8.0% vs 9.4%; OR, 0.81; 95% CI, 0.70-0.94; number needed to treat, 72). No significant difference was found in blood transfusion (OR, 1.01; 95% CI, 0.891.14) or major bleeding (OR, 1.04; 95% CI, 0.83-1.30) at 7 days after randomization in the overall safety population or in the population of patients receiving no prerandomization antithrombin therapy.
TL;DR: Patients in the registry had higher mortality than those in the trial; they had more extensive prior cardiac histories and more comorbidities, and the GNI of the country in which the patient presented did not contribute to predicting in-hospital mortality.
TL;DR: In a subgroup analysis, a reperfusion strategy including enoxaparin significantly improved outcomes compared with UFH among high-risk STEMI patients with DM undergoing fibrinolysis.
TL;DR: Periprocedural myocardial injury, even at low levels, during PCI is associated with increased hemodynamic stress as measured by increasing NT-pro-BNP, and this finding supports the physiologic relevance of procedural MI and the continued effort to define therapies that decrease the risk of this complication.
Abstract: The clinical relevance of periprocedural myocardial injury related to percutaneous coronary intervention (PCI) remains controversial. N-terminal pro-B-type natriuretic peptide (NT-pro-BNP) is a sensitive indicator of hemodynamic stress and when increased is associated with higher mortality in patients with acute and chronic ischemic heart disease. We measured the serum level of NT-pro-BNP using the Elecsys 2010 proBNP assay at baseline, 4 to 6 hours, and 12 to 24 hours in 747 patients undergoing elective or urgent PCI and enrolled in the JUMBO-TIMI 26 trial. Periprocedural myocardial infarction (MI) was independently adjudicated and required a new increase in creatine kinase-MB >3 times the upper limit of normal distinct from MI as the indication for PCI. Patients with procedural MI had significantly higher levels of NT-pro-BNP at 12 to 24 hours (405 vs 146 pg/ml, p <0.001). Moreover, the greater increase in NT-pro-BNP in patients with periprocedural MI was independent of each clinical and other procedural correlates of NT-pro-BNP after PCI (p <0.001). In addition, the magnitude of increase in NT-pro-BNP correlated strongly with extent of myocardial injury, including in patients with evidence of injury (creatine kinase-MB 1 to 3 times upper limit of normal) not meeting criteria for MI (p = 0.001) or low-level increase in troponin T (p = 0.001). In conclusion, periprocedural myocardial injury, even at low levels, during PCI is associated with increased hemodynamic stress as measured by increasing NT-pro-BNP. This finding supports the physiologic relevance of procedural MI and the continued effort to define therapies that decrease the risk of this complication.
TL;DR: It is suggested that a strategy of ENOX improves outcomes by preventing re-occlusion in patients achieving initial successful reperfusion after fibrinolytic therapy rather than by facilitating initial reperfusions.
Abstract: Aims To determine the relationship between a strategy of enoxaparin (ENOX), early ST-segment resolution (STRes), and clinical outcomes on patients with ST-segment elevation myocardial infarction (STEMI) after fibrinolysis.
Methods and results Baseline and 180 min ECGs were analysed in 3208 of the 20 479 patients in the ExTRACT-TIMI 25 trial, which randomifzed patients with STEMI to ENOX vs. unfractionated heparin (UFH) as adjunctive therapy. STRes was defined as complete (70%), partial (30–70%), or none (<30%). There was no evidence for a difference in STRes between the groups assigned to the ENOX or UFH (median 69.4 vs. 67.2%; P = 0.13). Among patients with complete STRes ( n = 1100), ENOX significantly reduced death or non-fatal recurrent MI at 30 days when compared with UFH (4.4 vs. 9.9%; ORadj 0.39; P < 0.001), whereas there was no difference in patients with only partial or no STRes [14.2 vs. 12.5%; ORadj 1.0; P = 0.98 ( n = 368) and 16.2 vs. 15.9%; ORadj 1.0; P = 0.97 ( n = 830), P for interaction = 0.008].
Conclusion When compared with UFH, a strategy of ENOX significantly reduces death or non-fatal recurrent MI in patients who achieved complete STRes, but not in patients with less STRes. These data suggest that a strategy of ENOX improves outcomes by preventing re-occlusion in patients achieving initial successful reperfusion after fibrinolytic therapy rather than by facilitating initial reperfusion.
TL;DR: Patients with EMI had lower rates of death or re-infarction at 30 days compared with patients presenting with positive troponin results and initial treatment patterns were similar among patients with E MI and MI in the SYNERGY trial.
Abstract: Aims Patients with myocardial infarction (MI) presenting immediately after symptom onset may be treated less aggressively due to their non-elevated troponin status. We compared the initial treatment and clinical outcomes of patients presenting with evolving MI (EMI) with those presenting with MI.
Methods and results This study analysed data from the Superior Yield of the New strategy of Enoxaparin, Revascularisation, and Glycoprotein IIb/IIIa inhibitors (SYNERGY) trial, which enrolled patients meeting at least two of the following: age ≥ 60 years, elevated cardiac biomarkers, or ST-segment changes. Patients were stratified by troponin results obtained within 12 h of presentation: EMI [initial troponin (−), second troponin (+)], MI [initial troponin (+)], and no MI at enrolment [first and second troponin (−)]. Comparisons were made using Wilcoxon rank-sum and χ2 tests. Of the 8309 patients with complete data, 5503 (66%) had MI, 1686 (20%) had EMI, and 1120 (13%) had no MI. Treatment patterns prior to enrolment were similar among EMI and MI patients [aspirin (88 vs. 86%), beta-blockers (62 vs. 61%), heparin (83 vs. 81%), and glycoprotein IIb/IIIa inhibitors (23 vs. 24%)]. Similar rates of percutaneous coronary intervention (48 vs. 50%) and coronary artery bypass grafting (21 vs. 22%) were seen after enrolment. Patients presenting with MI had a higher rate of death or recurrent MI compared with patients with EMI [16 vs. 13%, adjusted OR 1.22 (95% CI 1.04, 1.44)].
Conclusion Initial treatment patterns were similar among patients with EMI and MI in the SYNERGY trial. Patients with EMI had lower rates of death or re-infarction at 30 days compared with patients presenting with positive troponin results.