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Biomedical subjects

José López-Sendón

Publications and source records attributed to José López-Sendón.

At least 19 recordsLinked to original sources
PubMed2007

External validity of clinical trials in acute myocardial infarction.

BACKGROUND: Patients enrolled in randomized clinical trials (RCTs) may not reflect those seen in real-life practice. Our goal was to compare patients eligible for enrollment but not enrolled in contemporary RCTs of reperfusion therapy with patients who would have been ineligible and also with patients with acute myocardial infarction (AMI) participating in RCTs. METHODS: Consecutive patients with AMI (n = 8469) enrolled in the GRACE registry (Global Registry of Acute Coronary Events) were divided into 3 groups: RCT participants (11%; n = 953), eligible nonenrolled patients (55%; n = 4669), and ineligible patients (34%; n = 2847). Our main outcome measures were hospital mortality rates. RESULTS: Based on baseline characteristics or GRACE risk-score distribution, RCT participants had the lowest a priori risk of death; eligible patients had a higher risk; and ineligible patients had the highest risk. Actual hospital mortality showed a similar gradient (3.6%, 7.1%, and 11.4%, respectively) (P<.001). Multivariable analysis adjusting for baseline risk, use and type of reperfusion therapy, and delay from symptom onset to admission consistently showed a higher mortality rate for eligible nonenrolled patients than for RCT participants (odds ratio, 1.61; 95% confidence interval, 1.06-2.43; and odds ratio, 1.97; 95% confidence interval, 1.24-3.13, respectively). CONCLUSIONS: Patients with AMI participating in RCTs have a lower baseline risk and experience lower mortality than nonenrolled patients, even when they are trial eligible. This difference is not entirely explained by differences in baseline risk, use and type of reperfusion therapy, and/or delays in presentation. Caution is necessary when extending the findings obtained in RCTs to the general population with AMI.

Aged↗
PubMed2006

Antithrombotic treatment in real-life atrial fibrillation patients: a report from the Euro Heart Survey on Atrial Fibrillation.

AIMS: To describe guideline adherence and application of different stroke risk stratification schemes regarding antithrombotic therapy in real-life atrial fibrillation (AF) patients and to assess which factors influence antithrombotic management decisions. METHODS AND RESULTS: The Euro Heart Survey enrolled 5333 AF patients in 35 countries, in 2003 and 2004. Prescription of antithrombotic drugs, especially oral anticoagulation (OAC), was hardly tailored to the patient's stroke risk profile as indicated by the joint guidelines of the American College of Cardiology, American Heart Association, and the European Society of Cardiology, ACCP guidelines, or CHADS(2) and Framingham risk scores. In multivariable analysis, only a limited number of the well-known stroke risk factors triggered OAC prescription. In contrast, less relevant factors, of which clinical type of AF and availability of an OAC monitoring outpatient clinic were the most marked, played a significant role in OAC prescription. Electrical cardioversions and catheter ablations clearly triggered OAC prescription, whereas pharmacological cardioversions even in the presence of stroke risk factors did not. CONCLUSION: Antithrombotic therapy in AF is hardly tailored to the patient's stroke risk profile. Factors other than well-known stroke risk factors were significantly involved in antithrombotic management decisions. To facilitate this tailored treatment, guideline writers and physician educators should focus on providing one uniform and easy to use stroke risk stratification scheme.

Adult↗
PubMed2006

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.

Aged↗
PubMed2006

Association of peripheral artery disease with treatment and outcomes in acute coronary syndromes. The Global Registry of Acute Coronary Events (GRACE).

BACKGROUND: National guidelines recommend the use of secondary prevention modalities for patients with peripheral artery disease (PAD) and coronary artery disease. The effect of prior PAD on the treatment and outcomes of patients with acute coronary syndromes (ACS), however, is not well characterized. The objectives of this study were to assess treatment practices and hospital outcomes in patients with ACS and prior PAD. METHODS: Data were analyzed from 41,108 patients aged > or =18 years with ACS and enrolled in the large multinational GRACE between 1999 and 2004. RESULTS: Of the 41,108 patients, 4003 (9.7%) had prior PAD. Patients with PAD were older, more likely to be men, to have a variety of prior comorbidities, and to present with non-ST-segment elevation myocardial infarction and a higher Killip class than patients without PAD. Patients with PAD were less likely to be treated with effective cardiac medications than patients without PAD. At the time of hospital presentation, patients with prior PAD had low rates of use of beneficial cardiac medications, including angiotensin-converting enzyme inhibitors, aspirin, beta-blockers, and lipid-lowering agents. Patients with PAD were significantly more likely to experience the composite hospital end point (death, shock, recurrent angina, stroke) than patients without prior PAD (adjusted OR 1.17; 95% CI 1.08-1.26). CONCLUSIONS: Patients with prior PAD received less aggressive treatment with proven cardiac medications during hospitalization for an ACS than patients without PAD. Utilization of beneficial medical therapies in patients with PAD before hospitalization with ACS was also less than optimal. Given the poorer hospital outcomes in patients with PAD, our findings suggest considerable opportunity to improve care for these high-risk patients.

Acute Disease↗
PubMed2006

Patterns of use and potential impact of early beta-blocker therapy in non-ST-elevation myocardial infarction with and without heart failure: the Global Registry of Acute Coronary Events.

BACKGROUND: Early beta-blocker (BB) therapy improves outcomes in ST-segment elevation myocardial infarction; however, limited data are available on its early use and its impact in non-ST-segment elevation myocardial infarction (NSTEMI). METHODS: We evaluated data from 7106 patients with NSTEMI, without contraindications to BBs, enrolled in the Global Registry of Acute Coronary Events between April 1999 and September 2004. Baseline characteristics, management, and outcomes were analyzed according to the use of oral (+/-intravenous) BB within 24 hours of presentation. Multivariable analysis was conducted adjusting for comorbidities using the Global Registry of Acute Coronary Events risk model (c statistic 0.83). RESULTS: Beta-blocker therapy was initiated within the first 24 hours in 76% of patients with NSTEMI (79% with Killip class I vs 62% with class II/III; P < .001). Failure to initiate BBs within the first 24 hours was associated with lower rates of subsequent BB therapy (P < .001) and other evidence-based therapies. Early BB therapy was correlated with lower hospital mortality for NSTEMI patients (OR 0.58, 95% CI 0.42-0.81) and for those with Killip class II/III (OR 0.39, 95% CI 0.23-0.68) with a trend toward lower mortality in the Killip class I group (OR 0.77, 95% CI 0.49-1.21). At 6 months postdischarge, early BB use was associated with lower mortality in NSTEMI patients (OR 0.75, 95% CI 0.56-0.997) with a trend toward lower mortality in patients with Killip class I or II/III. CONCLUSIONS: Many eligible patients do not receive early BB therapy. Treatment with early BBs may have a beneficial impact on hospital and 6-month mortality in all patients, including those presenting with heart failure.

Adrenergic beta-Antagonists↗
PubMed2005

Medication performance measures and mortality following acute coronary syndromes.

PURPOSE: To identify patient and health care factors which are related to the use of medical treatments that comprise quality measures and to assess the relation of these measures with mortality. METHODS: The study sample consisted of 20 140 patients with acute coronary syndromes from the international GRACE registry. Multivariable logistic regression modeling was used to determine predictors of quality performance. Quality indicators were use of aspirin and beta-blockers within 24 hours and at hospital discharge, use of angiotensin-converting enzyme (ACE) inhibitors at discharge, and in-hospital mortality. RESULTS: Use of medications in eligible patients at discharge ranged from 73% for ACE inhibitors to 93% for aspirin. High-risk features (eg, heart failure, older age) were related to failure to use aspirin and beta-blockers. Being at a teaching hospital and care by a cardiologist were associated with better use of aspirin and beta-blockers. Coronary artery bypass surgery was associated with failure to use ACE inhibitors and aspirin. When hospitals were divided into quartiles of quality performance, adjusted in-hospital mortality was 4.1% in the top versus 5.6% in the bottom quartile, representing a 27% (95% confidence interval: 11% to 42%) lower relative mortality. CONCLUSION: Identification of factors associated with failure to use proven treatments, including high-risk groups that would derive particular benefit from effective therapies, provides an opportunity to focus quality improvement interventions. The association of lower hospital mortality with better use of selected medical treatments supports their measurement to improve quality of care.

Adrenergic beta-Antagonists↗
PubMed2004

Determinants and prognostic impact of heart failure complicating acute coronary syndromes: observations from the Global Registry of Acute Coronary Events (GRACE).

BACKGROUND: Few data are available on the impact of heart failure (HF) across all types of acute coronary syndromes (ACS). METHODS AND RESULTS: The Global Registry of Acute Coronary Events (GRACE) is a prospective study of patients hospitalized with ACS. Data from 16 166 patients were analyzed: 13 707 patients without prior HF or cardiogenic shock at presentation were identified. Of these, 1778 (13%) had an admission diagnosis of HF (Killip class II or III). HF on admission was associated with a marked increase in mortality rates during hospitalization (12.0% versus 2.9% [with versus without HF], P<0.0001) and at 6 months after discharge (8.5% versus 2.8%, P<0.0001). Of note, HF increased mortality rates in patients with unstable angina (defined as ACS with normal biochemical markers of necrosis; mortality rates: 6.7% with versus 1.6% without HF at admission, P<0.0001). By logistic regression analysis, admission HF was an independent predictor of hospital death (odds ratio, 2.2; P<0.0001). Admission HF was associated with longer hospital stay and higher readmission rates. Patients with HF had lower rates of catheterization and percutaneous cardiac intervention, and fewer received beta-blockers and statins. Hospital development of HF (versus HF on presentation) was associated with an even higher in-hospital mortality rate (17.8% versus 12.0%, P<0.0001). In patients with HF, in-hospital revascularization was associated with lower 6-month death rates (14.0% versus 23.7%, P<0.0001; adjusted hazard ratio, 0.5; 95% CI, 0.37 to 0.68, P<0.0001). CONCLUSIONS: In this observational registry, heart failure was associated with reduced hospital and 6-month survival across all ACS subsets, including patients with normal markers of necrosis. More aggressive treatment of these patients may be warranted to improve prognosis.

Acute Disease↗
PubMed2004

Effects of carvedilol on left ventricular remodeling after acute myocardial infarction: the CAPRICORN Echo Substudy.

BACKGROUND: The CAPRICORN trial has shown that carvedilol improved outcome in patients with left ventricular dysfunction after acute myocardial infarction treated with ACE inhibitors. The aim of this substudy was to determine the effects of carvedilol on left ventricular remodeling in this patient group. METHODS AND RESULTS: Patients entering the CAPRICORN trial from 13 centers in New Zealand, Australia, and Spain were recruited for this echocardiographic substudy. In 127 patients, quantitative 2D echocardiography was performed according to a standard protocol before randomization and repeated after 1, 3, and 6 months of treatment with carvedilol or placebo. Left ventricular volumes, ejection fraction (Simpson's method), and wall motion score index were determined in a blinded analysis at the Core Echo Laboratory. At 6 months, left ventricular end systolic volume was 9.2 mL less in the carvedilol group than in the placebo group (P=0.023), and left ventricular ejection fraction was 3.9% higher (P=0.015). Left ventricular end diastolic volume and wall motion score index were not statistically different between the 2 groups at 6 months. CONCLUSIONS: In patients with left ventricular dysfunction after acute myocardial infarction treated with ACE inhibitors, carvedilol had a beneficial effect on ventricular remodeling, which may, in part, mediate the substantial clinical beneficial effects of carvedilol in this patient population.

Adrenergic beta-Antagonists↗
PubMed2004

Elevated leukocyte count and adverse hospital events in patients with acute coronary syndromes: findings from the Global Registry of Acute Coronary Events (GRACE).

OBJECTIVE: To examine the association between elevated leukocyte count and hospital mortality and heart failure in patients enrolled in the multinational, observational Global Registry of Acute Coronary Events (GRACE). BACKGROUND: Elevated leukocyte count is associated with adverse hospital outcomes in patients presenting with acute myocardial infarction (AMI). The association of this prognostic factor with hospital mortality and heart failure in patients with other acute coronary syndromes (ACS) is unclear. METHODS: We examined the association between admission leukocyte count and hospital mortality and heart failure in 8269 patients presenting with an ACS. This association was examined separately in patients with ST-segment elevation AMI, non-ST-segment elevation AMI, and unstable angina. Leukocyte count was divided into 4 mutually exclusive groups (Q): Q1 <6000, Q2 = 6000-9999, Q3 = 10,000-11,999, Q4 >12,000. Multiple logistic regression analysis was performed to examine the association between elevated leukocyte count and hospital events while accounting for the simultaneous effect of several potentially confounding variables. RESULTS: Increasing leukocyte count was significantly associated with hospital death (adjusted odds ratio [OR] 2.8, 95% CI 2.1-3.6 for Q4 compared to Q2 [normal range]) and heart failure (OR 2.7, 95% CI 2.2-3.4) for patients presenting with ACS. This association was seen in patients with ST-segment elevation AMI (OR for hospital death 3.2, 95% CI 2.1-4.7; OR for heart failure 2.4, 95% CI 1.8-3.3), non-ST-segment elevation AMI (OR for hospital death 1.9, 95% CI 1.2-3.0; OR for heart failure 1.7, 95% CI 1.1-2.5), or unstable angina (OR for hospital death 2.8, 95% CI 1.4-5.5; OR for heart failure 2.0, 95% CI 0.9-4.4). CONCLUSION: In men and women of all ages with the spectrum of ACS, initial leukocyte count is an independent predictor of hospital death and the development of heart failure.

Adult↗
PubMed2004

[Rationale and clinical evidence for the effects of new pharmacological treatments for heart failure].

Congestive heart failure is a leading cause of cardiovascular morbidity and mortality, and is the main cause of hospitalization among patients older than 65 years. Moreover, its prevalence is expected to reach nearly epidemic proportions, so that the need for new treatments is clear. In this article we review current and future strategies for the treatment of systolic heart failure that are based on a better understanding of the pathophysiology of this disorder and on the results of controlled clinical trials of different treatments. Drugs under development (phase II and III clinical trials) have been classified into four main groups: neurohumoral antagonists, inotropic agents, modulators of myocardial remodeling, and future approaches to treatment such as gene therapy and anti-apoptotic drugs. We also discuss new strategies for the treatment of diastolic heart failure.

Cardiotonic Agents↗
PubMed2003

Predictors of major bleeding in acute coronary syndromes: the Global Registry of Acute Coronary Events (GRACE).

AIMS: There have been no large observational studies attempting to identify predictors of major bleeding in patients with acute coronary syndromes (ACS), particularly from a multinational perspective. The objective of our study was thus to develop a prediction rule for the identification of patients with ACS at higher risk of major bleeding. METHODS AND RESULTS: Data from 24045 patients from the Global Registry of Acute Coronary Events (GRACE) were analysed. Factors associated with major bleeding were identified using logistic regression analysis. Predictive models were developed for the overall patient population and for subgroups of patients with ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI) and unstable angina. The overall incidence of major bleeding was 3.9% (4.8% in patients with STEMI, 4.7% in patients with NSTEMI and 2.3% in patients with unstable angina). Advanced age, female sex, history of bleeding, and renal insufficiency were independently associated with a higher risk of bleeding (P<0.01). The association remained after adjustment for hospital therapies and performance of invasive procedures. After adjustment for a variety of potential confounders, major bleeding was significantly associated with an increased risk of hospital death (adjusted odds ratio 1.64, 95% confidence interval 1.18, 2.28). CONCLUSIONS: In routine clinical practice, major bleeding is a relatively frequent non-cardiac complication of contemporary therapy for ACS and it is associated with a poor hospital prognosis. Simple baseline demographic and clinical characteristics identify patients at increased risk of major bleeding.

Adult↗