Biomedical subjects

Karen S Pieper

Publications and source records attributed to Karen S Pieper.

At least 19 recordsLinked to original sources

PubMed2007

Complementary effects of thienopyridine pretreatment and platelet glycoprotein IIb/IIIa integrin blockade with eptifibatide in coronary stent intervention; results from the ESPRIT trial.

OBJECTIVES: This analysis sought to investigate the complementary effect of thienopyridine pretreatment and platelet glycoprotein (GP) IIb/IIIa integrin blockade in coronary stent intervention. BACKGROUND: Definitive evidence supporting combined antiplatelet therapy consisting of thienopyridine pretreatment and GP IIb/IIIa receptor blockade in patients undergoing percutaneous coronary intervention (PCI) with stent implantation is limited. METHODS: We retrospectively analyzed clinical outcomes by thienopyridine use in the 2,040 patients randomized to eptifibatide or placebo who underwent PCI in the ESPRIT trial. RESULTS: A total of 901 patients received a loading dose of thienopyridine before PCI (group 1), 123 received thienopyridine pretreatment without a loading dose (group 2), and 1,016 were not treated with thienopyridine before PCI (group 3). The composite incidence of death or myocardial infarction at 30 days was significantly lower in group 1 than in groups 2 and 3 combined (OR, 0.71 [95%CI, 0.52-0.99]; P = 0.0417). A similar trend was seen for the composite of death, myocardial infarction, or urgent target vessel revascularization (unadjusted OR, 0.77 [0.57-1.05]; P = 0.1025). After adjusting for baseline characteristics, these differences were no longer significant. No interactions were identified with eptifibatide assignment for any of the group comparisons. CONCLUSIONS: Pretreatment with a loading dose of thienopyridine lowers the rate of ischemic complications regardless of treatment with a GP IIb/IIIa inhibitor. Conversely, the efficacy of eptifibatide is maintained whether or not a loading dose of a thienopyridine is administered. Optimal outcomes are achieved in patients receiving thienopyridine pretreatment along with platelet GP IIb/IIIa inhibitor therapy.

Aged↗

PubMed2006

The impact of anthropomorphic indices on clinical outcomes in patients with acute ST-elevation myocardial infarction.

AIMS: Multiple studies have focused on the relationship of body anthropometric measures with clinical events in ST-elevation myocardial infarction (STEMI) patients, highlighting the 'obesity paradox'. However, the relative prognostic importance of these measures over other baseline variables is less known. METHOD AND RESULTS: We performed a retrospective analysis of 94,108 STEMI patients from seven clinical trials evaluating various reperfusion strategies to study the relationship and prognostic importance of height, weight, body mass index (BMI), and body surface area (BSA) with 30-day death and in-hospital cardiogenic shock, major bleeding, and stroke. Main outcome measures of interest included 30-day death and in-hospital cardiogenic shock, major bleeding, and stroke. Weight, BMI, and BSA were inversely and independently related to all clinical events. Despite being statistically significant (P<0.0001), the prognostic information contributed by weight beyond that conferred by baseline clinical factors was minimal (<1% of total prognostic information) making it of limited clinical relevance for predicting 30-day death and cardiogenic shock. In contrast, weight accounted for 8.4% and 4.3% of the prognostic information in the logistic regression models for major bleeding and for stroke. BMI or BSA added little incremental value over simple measure of weight. CONCLUSION: Although statistically significantly related to most outcomes in patients with STEMI including death and shock, body weight provided clinically relevant prognostic information only for the risk of major bleeding and of stroke. Furthermore, BMI or BSA contributed little incremental prognostic information beyond that provided by weight alone. Thus, the existing large body of information concerning the strong prognostic importance of anthropometric measures with outcomes after STEMI should be interpreted in the context of other more important risk factors.

Body Height↗

PubMed2006

Prediction of risk of death and myocardial infarction in the six months after presentation with acute coronary syndrome: prospective multinational observational study (GRACE).

OBJECTIVE: To develop a clinical risk prediction tool for estimating the cumulative six month risk of death and death or myocardial infarction to facilitate triage and management of patients with acute coronary syndrome. DESIGN: Prospective multinational observational study in which we used multivariable regression to develop a final predictive model, with prospective and external validation. SETTING: Ninety four hospitals in 14 countries in Europe, North and South America, Australia, and New Zealand. POPULATION: 43,810 patients (21,688 in derivation set; 22,122 in validation set) presenting with acute coronary syndrome with or without ST segment elevation enrolled in the global registry of acute coronary events (GRACE) study between April 1999 and September 2005. MAIN OUTCOME MEASURES: Death and myocardial infarction. RESULTS: 1989 patients died in hospital, 1466 died between discharge and six month follow-up, and 2793 sustained a new non-fatal myocardial infarction. Nine factors independently predicted death and the combined end point of death or myocardial infarction in the period from admission to six months after discharge: age, development (or history) of heart failure, peripheral vascular disease, systolic blood pressure, Killip class, initial serum creatinine concentration, elevated initial cardiac markers, cardiac arrest on admission, and ST segment deviation. The simplified model was robust, with prospectively validated C-statistics of 0.81 for predicting death and 0.73 for death or myocardial infarction from admission to six months after discharge. The external applicability of the model was validated in the dataset from GUSTO IIb (global use of strategies to open occluded coronary arteries). CONCLUSIONS: This risk prediction tool uses readily identifiable variables to provide robust prediction of the cumulative six month risk of death or myocardial infarction. It is a rapid and widely applicable method for assessing cardiovascular risk to complement clinical assessment and can guide patient triage and management across the spectrum of patients with acute coronary syndrome.

Epidemiologic Methods↗

PubMed2006

Clinical characteristics predict benefits from eptifibatide therapy during coronary stenting: insights from the Enhanced Suppression of the Platelet IIb/IIIa Receptor With Integrilin Therapy (ESPRIT) trial.

OBJECTIVES: In order to determine a differential benefit from treatment, we compared the long-term outcome of high-risk versus low-risk patients and evaluated survival free from death or myocardial infarction at one year. BACKGROUND: Newer anticoagulant strategies during percutaneous coronary intervention have necessitated a reanalysis of the role of intravenous GP IIb/IIIa inhibitors. The Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy trial randomized 2,064 patients undergoing nonurgent coronary stent implantation to eptifibatide or placebo. METHODS: High-risk characteristics were defined as age >75 years, diabetes, elevated cardiac markers, ST-segment elevation myocardial infarction within 7 days, or unstable angina within 48 h of randomization. Age <5 years, absence of diabetes, and any other reason for admission were considered low risk characterstics. RESULTS: There were 1,018 patients in the high-risk group (50.8% eptifibatide, 49.2% placebo) and 1,045 patients in the low-risk group (50.0% eptifibatide, 50.0% placebo). Baseline demographics were similar in both groups except for more hypertension (63% vs. 55%, respectively), peripheral vascular disease (8.2% vs. 5.2%, respectively), prior stroke (5.5% vs. 3.2%, respectively), and female gender (33% vs. 22%, respectively) in the high-risk than the low-risk group. At one year, the composite end point of death or myocardial infarction occurred in 15.89% of placebo patients and 7.99% of eptifibatide patients in the high-risk group and 9.02% of the placebo and 8.11% of eptifibatide patients in the low-risk group. CONCLUSIONS: Although eptifibatide treatment improved outcomes for all patients, preprocedural clinical characteristics can define a subgroup of patients who may derive greatest benefit from its use during coronary stent placement.

Aged↗

PubMed2006

A comparison of the clinical impact of bleeding measured by two different classifications among patients with acute coronary syndromes.

OBJECTIVES: The goal of this study was to determine the association between Thrombolysis In Myocardial Infarction (TIMI) and Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) bleeding and clinical outcomes. BACKGROUND: There are limited data on the relative utility of either scale at predicting clinical outcomes in patients with non-ST-segment elevation acute coronary syndromes (ACS). METHODS: Pooled data from two randomized trials of patients with ACS (n = 15,454) were analyzed to determine the association between TIMI and GUSTO bleeding and 30-day and 6-month death/myocardial infarction (MI) using Cox proportional hazards modeling that included bleeding as a time-dependent covariate. RESULTS: There was a stepwise increase in the adjusted hazard of 30-day death/MI with worsening GUSTO bleeding (hazard ratio [95% confidence interval], GUSTO mild 1.20 [1.05 to 1.37]; moderate 3.28 [2.88 to 3.73]; severe 5.57 [4.33 to 7.17]), and an increased risk with all three levels of TIMI bleeding (TIMI minimal 1.84 [1.63 to 2.08]; TIMI minor 1.64 [1.31 to 2.04]; major 1.45 [1.23 to 1.70]). When both bleeding scales were included in the same model, the risk with GUSTO bleeding persisted; however, the association between TIMI bleeding and outcome was no longer significant. CONCLUSIONS: Both scales identify ACS patients with bleeding complications at risk for adverse outcomes. In a model that included both definitions, the risk with GUSTO bleeding persisted while the risk with TIMI bleeding did not. This suggests that bleeding assessed with clinical criteria is more important than that assessed by laboratory criteria in terms of outcomes. Future clinical trials should consider using a combination of the GUSTO bleeding scale and the need for transfusion to assess bleeding complications.

Angina, Unstable↗

PubMed2006

Efficacy and safety of enoxaparin compared with unfractionated heparin in high-risk patients with non-ST-segment elevation acute coronary syndrome undergoing percutaneous coronary intervention in the Superior Yield of the New Strategy of Enoxaparin, Revascularization and Glycoprotein IIb/IIIa Inhibitors (SYNERGY) trial.

BACKGROUND: Enoxaparin reduces ischemic events more effectively than unfractionated heparin (UFH) in patients treated conservatively for non-ST-segment elevation acute coronary syndrome. The SYNERGY trial compared these agents in high-risk patients undergoing early invasive treatment. Enoxaparin was noninferior to UFH for the 30-day primary end point of death/myocardial infarction (MI), but modestly increased bleeding. METHODS AND RESULTS: This article compares the outcomes of the 4687 SYNERGY patients (47%) undergoing percutaneous coronary intervention, who were randomized to receive enoxaparin or UFH. Antithrombotic therapy was administered prerandomization in 78%. Crossover (usually in the catheterization laboratory) to the alternative antithrombotic occurred in 14.6% of enoxaparin patients and 2.9% of UFH-treated patients (P < .0001). Stenting was performed in 86.3%. Abrupt vessel closure occurred in 1.3% of enoxaparin patients and 1.7% of UFH-treated patients (P = .318). The rates of death/MI were similar at 30 days (13.1% with enoxaparin vs 14.2% with UFH, P = .289). GUSTO severe bleeding occurred with similar frequency in both groups (1.5% vs 1.6%, P = .688). TIMI major bleeding was more common with enoxaparin (3.7% vs 2.5% with UFH, P = .028). Transfusions were more frequent with enoxaparin than with UFH (6.8% vs 5.4%, P = .047). TIMI major bleeding increased with crossover from enoxaparin to UFH (from 3.7% to 7.8%) and from UFH to enoxaparin (from 2.5% to 8.6%). Statistical adjustment to model reasons for crossover did not affect the overall safety and efficacy outcomes. CONCLUSIONS: In high-risk patients undergoing early percutaneous coronary intervention for acute coronary syndrome, enoxaparin avoids the need for monitoring and achieves similar effectiveness to UFH but is associated with more bleeding.

Acute Disease↗

PubMed2006

Differences in the clinical features and outcomes in African Americans and whites with myocardial infarction.

PURPOSE: Less is known about the differences in clinical and angiographic features and the outcomes of African Americans with ST-elevation myocardial infarction compared with whites with ST-elevation myocardial infarction. Accordingly, the current study examines the relationship of African American race to patient-related clinical factors, angiographic findings, and clinical events. METHODS: We evaluated data from 32419 patients with ST-elevation myocardial infarction who received fibrinolysis. The primary outcomes of interest were 30-day and 5-year mortality. RESULTS: African Americans comprised 5.1% of the study population (1664/32419). Compared with white patients, black patients were younger, were more likely female, had a higher prevalence of coronary risk factors, and were more likely to have higher presenting heart rate, blood pressure, and Killip Class. Coronary angiography rates were similar in the two groups, but blacks were less likely to undergo coronary revascularization. The patency of the infarct-related artery after thrombolysis or mechanical reperfusion was higher in blacks, who were more likely to have no significant coronary artery disease and less likely to have disease in two or more vessels. In-hospital stroke (adjusted odds ratio 1.75, 95% confidence interval [CI] 1.19-2.59) and major bleeding (adjusted odds ratio 1.32, 95% CI 1.13-1.55) were higher among African Americans. Although no differences were observed in the 30-day mortality between the two groups, African Americans who survived to 30 days had higher 5-year mortality than whites (17% vs 12.5%, adjusted hazard ratio 1.63, 95% CI 1.41-1.90). CONCLUSIONS: Although 30-day survival was similar between African Americans and whites with ST-elevation myocardial infarction, in-hospital stroke and bleeding and 5-year mortality among 30-day survivors were significantly higher among blacks despite their younger age.

Black or African American↗

PubMed2006

Racial differences in the characteristics of patients admitted for acute decompensated heart failure and their relation to outcomes: results from the OPTIME-CHF trial.

BACKGROUND: Recent data suggest that differences in response to therapy and survival exist between African Americans and Caucasians with heart failure. Whether these differences exist in acute decompensated heart failure (ADHF) is uncertain. METHODS AND RESULTS: We analyzed data from the OPTIME-CHF (Outcomes of a Prospective Trial of Intravenous Milrinone for Exacerbations of Chronic Heart Failure) study, a randomized trial of intravenous milrinone versus placebo in 949 patients hospitalized with ADHF. We evaluated differences in clinical characteristics, outcomes, and response to milrinone therapy in African American patients compared with Caucasians. The primary end point of OPTIME-CHF was days hospitalized for cardiovascular causes or death within 60 days of randomization. Thirty-three percent (n = 310) of patients were African American. African American patients were younger (57 vs. 70 years, P < .0001) and more likely to have non-ischemic cardiomyopathy (74% vs. 36%, P < .0001). In unadjusted analysis, African American patients had a lower 60-day mortality (5% vs. 12%, P = .0004) and tended to have better overall clinical outcomes. After adjustment for baseline differences, however, these differences were no longer significant. We found no differential effect of milrinone therapy by race. CONCLUSION: African American patients with acute decompensated heart failure present with a different clinical profile than Caucasian patients. Although unadjusted clinical outcomes are better for African Americans presenting with ADHF, these differences diminished after adjustment for baseline characteristics.

Acute Disease↗

PubMed2006

Can one assess whether missing data are missing at random in medical studies?

For handling missing data, newer methods such as those based on multiple imputation are generally more accurate than older ones and entail weaker assumptions. Yet most do assume that data are missing at random (MAR). The issue of assessing whether the MAR assumption holds to begin with has been largely ignored. In fact, no way to directly test MAR is available. We propose an alternate assumption, MAR+, that can be tested. MAR+ always implies MAR, so inability to reject MAR+ bodes well for MAR. In contrast, MAR implies MAR+ not universally, but under certain conditions that are often plausible; thus, rejection of MAR+ can raise suspicions about MAR. Our approach is applicable mainly to studies that are not longitudinal. We present five illustrative medical examples, in most of which it turns out that MAR+ fails. There are limits to the ability of sophisticated statistical methods to correct for missing data. Efforts to try to prevent missing data in the first place should therefore receive more attention in medical studies than they have heretofore attracted. If MAR+ is found to fail for a study whose data have already been gathered, extra caution may need to be exercised in the interpretation of the results.

Biomedical Research↗

PubMed2005

Predictors of mortality and morbidity in patients with chronic heart failure.

AIMS: We aimed to develop prognostic models for patients with chronic heart failure (CHF). METHODS AND RESULTS: We evaluated data from 7599 patients in the CHARM programme with CHF with and without left ventricular systolic dysfunction. Multi-variable Cox regression models were developed using baseline candidate variables to predict all-cause mortality (n=1831 deaths) and the composite of cardiovascular (CV) death and heart failure (HF) hospitalization (n=2460 patients with events). Final models included 21 predictor variables for CV death/HF hospitalization and for death. The three most powerful predictors were older age (beginning >60 years), diabetes, and lower left ventricular ejection fraction (EF) (beginning <45%). Other independent predictors that increased risk included higher NYHA class, cardiomegaly, prior HF hospitalization, male sex, lower body mass index, and lower diastolic blood pressure. The model accurately stratified actual 2-year mortality from 2.5 to 44% for the lowest to highest deciles of predicted risk. CONCLUSION: In a large contemporary CHF population, including patients with preserved and decreased left ventricular systolic function, routine clinical variables can discriminate risk regardless of EF. Diabetes was found to be a surprisingly strong independent predictor. These models can stratify risk and help define how patient characteristics relate to clinical course.

Adult↗

PubMed2005

Impact of bleeding severity on clinical outcomes among patients with acute coronary syndromes.

Bleeding is a complication of current therapies for acute coronary syndrome (ACS). No studies have examined the effect of bleeding events on clinical outcomes. We analyzed pooled data from 4 multicenter, randomized clinical trials of patients who had ACS (n = 26,452) to determine an association between bleeding severity as measured by the GUSTO scale and 30-day and 6-month mortality rates using Cox proportional hazards modeling that incorporated bleeding as a time-dependent covariate. The analysis was repeated to examine procedure- and non-procedure-related bleeding and after censoring at the time of coronary artery bypass grafting. Of all the patients included, 27.6% had > or =1 bleeding episode. Patients who bled were older and sicker at presentation than were those who did not bleed. Unadjusted rates of 30-day and 6-month mortality increased as bleeding severity increased. There were stepwise increases in the adjusted hazards of 30-day mortality (mild bleeding, hazard ratio [HR] 1.6, 95% confidence interval [CI] 1.3 to 1.9; moderate bleeding, HR 2.7, 95% CI l 2.3 to 3.4; severe bleeding, HR 10.6, 95% CI 8.3 to 13.6) and 6-month mortality (mild bleeding, HR 1.4, 95% CI 1.2 to 1.6; moderate bleeding, HR 2.1, 95% CI 1.8 to 2.4; severe bleeding, HR 7.5, 95% CI 6.1 to 9.3) as bleeding severity increased. Results were consistent after censoring for coronary artery bypass grafting and for procedure- and non-procedure-related bleeds. In conclusion, the GUSTO bleeding classification identifies patients who are at risk for short- and long-term adverse events. Therapies that minimize bleeding risk and maintain an anticoagulant effect may improve outcomes among patients who have ACS.

Acute Disease↗

PubMed2005

Extent of ST-segment depression and cardiac events in non-ST-segment elevation acute coronary syndromes.

AIMS: We sought to determine whether the extent of myocardial ischaemia on the admission electrocardiogram (ECG) has independent predictive value for short-term risk stratification of patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS). Although the presence of ischaemic ECG changes on admission has been shown to predict outcome, the relationship between the extent of ECG changes and the risk of cardiac events is still ill defined. METHODS AND RESULTS: We analysed the admission ECGs of 5192 ACS patients enrolled in the GUSTO-IIb trial, without an ECG indication for thrombolysis. ECG tracings showing one or more of the following were eligible: ST-segment depression >0.5 mm, T-wave inversion >1 mm, and ST-segment elevation >0.5 mm but <1 mm. ECG variables associated with unfavourable 30 day outcomes in a univariable analysis were further assessed in a multivariable logistic regression model including independent clinical predictors. In the multivariable clinical, enzymatic, and ECG model, the sum of ST-segment depression (in millimetres) in all leads was a powerful independent predictor of 30 day death (P<0.0001), with a continuous increase in risk with the extent of ST-segment depression. The sum of ST-segment depression (P<0.0001) and the presence of minimal inferior ST-segment elevation (P<0.0001) or anterior ST-segment elevation (P=0.0182) were also independent predictors of the composite of death and myocardial infarction or reinfarction. The extent of ST-segment depression showed a highly significant correlation with the prevalence of three-vessel (P<0.0001) or left main coronary disease (P<0.0001), and also with the peak levels of creatine kinase (P<0.0001) during the index episode of ACS. CONCLUSION: In patients with NSTE ACS, the sum of ST-segment depression in all ECG leads is a powerful predictor of all-cause mortality at 30 days, independent of clinical variables and correlates with the extent and severity of coronary artery disease. The presence of even minimal (<1 mm) ST-segment elevation in anterior or inferior leads is independently associated with adverse outcomes.

Acute Disease↗

PubMed2005

Association of height with outcomes in patients with acute myocardial infarction receiving reperfusion therapy.

Data were evaluated for patients with acute ST-elevation myocardial infarction (n = 94,182) enrolled in 6 large clinical trials evaluating the efficacy of various reperfusion strategies. It was found that compared with the tallest quartile, incidences of in-hospital reinfarction, stroke, major bleeding, cardiogenic shock, heart failure, and death in the shortest group were 1.4, 1.7, 1.7, 1.8, 1.9, and 2.4 times greater, respectively. Although a strong inverse association of height was observed with unadjusted 30-day mortality (p <0.001), it was attenuated after adjustment for confounders, including weight, and appeared to be nonlinear, such that for height </=165 cm, the odds ratio [OR] for a 10-cm increment in height was 1.115 (95% confidence interval [CI] 1.014 to 1.223) and for height >165 cm, the OR for a 10-cm increase in height was 0.962 (95% CI 0.896 to 1.033). These data indicate that height-related differences in 30-day mortality are explained in large part by height-related differences in patients' clinical characteristics.

Aged↗

PubMed2005

Relationship of incorrect dosing of fibrinolytic therapy and clinical outcomes.

CONTEXT: Incorrect dosing of alteplase has been associated with worse clinical outcomes in patients. However, patients at high risk of adverse events are more prone to dosing errors, thus confounding this relationship. OBJECTIVE: To determine if the association between incorrect dosing of alteplase and adverse outcomes is related to cause and effect or to confounding. DESIGN, SETTING, AND PATIENTS: Observational analysis in May 2004 of a double-blind, double-dummy trial of 16,949 patients with ST-segment elevation myocardial infarction who were enrolled in the Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT-2) trial and were assigned to either a bolus of tenecteplase (with alteplase placebo bolus plus infusion) or a bolus of alteplase (with tenecteplase placebo plus infusion). MAIN OUTCOME MEASURES: Thirty-day mortality, in-hospital stroke, and major bleeding associated with incorrect dosing of active alteplase compared with placebo alteplase. RESULTS: Incorrect dosing occurred in 4.9% of patients who received active alteplase and in 4.6% of patients who received alteplase placebo. Patients receiving incorrect doses of alteplase or alteplase placebo were more likely to be older, female, black, shorter, have lower body weight and systolic blood pressure, and have a higher Killip class at presentation. Thirty-day mortality was higher in patients who received an overdose (9.8%) or underdose (19.5%) of alteplase compared with those who received a correct dose (5.4%). The same pattern was present in patients who received an alteplase placebo (10.0% for overdose, 23.5% for underdose, and 5.4% for correct dose). Similar patterns were seen for in-hospital intracranial hemorrhage and major bleeding. The higher rates of adverse outcomes with incorrect dosing were largely accounted for by adjusting for baseline characteristics. CONCLUSIONS: The relationship between incorrect dosing and patient outcome in ASSENT-2 is primarily due to confounding factors rather than incorrect dosing itself. These data highlight the need for caution when ascribing a causal relationship to associations between incorrect dosing and adverse outcomes.

Aged↗

PubMed2005

Pulmonary artery catheterization in acute coronary syndromes: insights from the GUSTO IIb and GUSTO III trials.

PURPOSE: To correlate pulmonary artery catheterization (PAC) use and 30-day outcomes and to characterize the use of pulmonary artery catheters among patients with acute coronary syndromes (ACS). SUBJECTS AND METHODS: We retrospectively studied 26437 ACS patients from two large multicenter, international randomized clinical trials. Multivariable and causal inference analyses were applied to adjust for differences in baseline risk. RESULTS: PAC was performed in 735 patients (2.8%), with a median time to insertion of 24 hours. Patients undergoing PAC were older (median, 67 vs. 64 years), more often diabetic (25.7% vs.16.2%), and more likely to present with ST-segment elevation (81.6% vs. 70.2%) or Killip class III or IV (7.9% vs. 1.4%). US patients were 3.8 times more likely than non-US patients to undergo PAC. Patients managed with PAC also underwent more procedures, including percutaneous intervention (40.7% vs. 18.1%), coronary artery bypass grafting (12.5% vs. 7.7%), and endotracheal intubation (29.3% vs. 2.2%). Mortality at 30 days was substantially higher among patients with PAC for both unadjusted (odds ratio [OR] 8.7; 95% confidence interval [CI] 7.3-10.2) and adjusted analyses (OR 6.4; 95% CI 5.4-7.6) in all groups except in patients with cardiogenic shock (OR 0.99; 95% CI 0.80-1.23). CONCLUSIONS: PAC was associated with increased mortality, both before and after adjustment for baseline patient differences and subsequent events that may have led to PAC use, except in patients with cardiogenic shock. The definitive role of PAC in managing patients with ACS is still to be determined.

Acute Disease↗

PubMed2004

Optimal duration of eptifibatide infusion in percutaneous coronary intervention (an ESPRIT substudy).

Although randomized trials have clearly demonstrated the clinical efficacy with regimens of platelet glycoprotein IIb/IIIa antagonists that result in >80% inhibition of baseline platelet aggregation in percutaneous coronary intervention (PCI), there are no data available concerning the optimal duration of infusion of these agents. In an era when the length of hospitalization has a major impact on health care costs, the determination of the optimal duration of the infusion of these drugs after PCI is of great relevance. The investigators therefore sought to determine the optimal length of the infusion of eptifibatide after PCI by analyzing the outcomes of patients enrolled in the Enhanced Suppression of the Platelet IIb/IIIa Receptor With Integrilin Therapy trial who were randomized to treatment with eptifibatide.

Angioplasty, Balloon, Coronary↗

PubMed2004

A validated prediction model for all forms of acute coronary syndrome: estimating the risk of 6-month postdischarge death in an international registry.

CONTEXT: Accurate estimation of risk for untoward outcomes after patients have been hospitalized for an acute coronary syndrome (ACS) may help clinicians guide the type and intensity of therapy. OBJECTIVE: To develop a simple decision tool for bedside risk estimation of 6-month mortality in patients surviving admission for an ACS. DESIGN, SETTING, AND PATIENTS: A multinational registry, involving 94 hospitals in 14 countries, that used data from the Global Registry of Acute Coronary Events (GRACE) to develop and validate a multivariable stepwise regression model for death during 6 months postdischarge. From 17,142 patients presenting with an ACS from April 1, 1999, to March 31, 2002, and discharged alive, 15,007 (87.5%) had complete 6-month follow-up and represented the development cohort for a model that was subsequently tested on a validation cohort of 7638 patients admitted from April 1, 2002, to December 31, 2003. MAIN OUTCOME MEASURE: All-cause mortality during 6 months postdischarge after admission for an ACS. RESULTS: The 6-month mortality rates were similar in the development (n = 717; 4.8%) and validation cohorts (n = 331; 4.7%). The risk-prediction tool for all forms of ACS identified 9 variables predictive of 6-month mortality: older age, history of myocardial infarction, history of heart failure, increased pulse rate at presentation, lower systolic blood pressure at presentation, elevated initial serum creatinine level, elevated initial serum cardiac biomarker levels, ST-segment depression on presenting electrocardiogram, and not having a percutaneous coronary intervention performed in hospital. The c statistics for the development and validation cohorts were 0.81 and 0.75, respectively. CONCLUSIONS: The GRACE 6-month postdischarge prediction model is a simple, robust tool for predicting mortality in patients with ACS. Clinicians may find it simple to use and applicable to clinical practice.

Aged↗

PubMed2004

Differential treatment benefit of platelet glycoprotein IIb/IIIa inhibition with percutaneous coronary intervention versus medical therapy for acute coronary syndromes: exploration of methods.

BACKGROUND: Although many believe that platelet glycoprotein IIb/IIIa inhibitors should be used only in acute coronary syndrome patients undergoing percutaneous coronary intervention, supporting data from randomized clinical trials are tenuous. The assumption that these agents are useful only in conjunction with percutaneous coronary intervention is based primarily on inappropriate subgroup analyses performed across the glycoprotein IIb/IIIa inhibitor trials. METHODS AND RESULTS: We describe the problems with these analytical techniques and demonstrate that different approaches to the question can result in opposing answers. CONCLUSIONS: Clinical-practice decisions and practice guidelines should be based on overall trial results and not analyses of post-randomization subgroups.

Acute Disease↗