The ECG in acute coronary syndromes: new tricks from an old dog.

The ECG remains the pre-eminent test for myocardial ischaemia, directing therapeutic management and prognostic stratification.

Impact of preprocedural white blood cell count on long term mortality after percutaneous coronary intervention: insights from the EPIC, EPILOG, and EPISTENT trials.

BACKGROUND: Raised inflammatory markers are associated with worse outcome after percutaneous coronary interventions (PCI). An increase in the white blood cell (WBC) count is a non-specific response to inflammation. We hypothesised that a raised baseline WBC count would be a predictor of mortality in patients undergoing PCI. METHODS: The association between preprocedural WBC count and long term mortality was studied in 7179 patients enrolled in the EPIC, EPILOG, and EPISTENT trials. The end points were the incidence of myocardial infarction at one year, and one and three year mortality. RESULTS: There were 188 deaths and 582 myocardial infarctions at one year. While WBC count was a strong predictor of death at one year, with every increase of 1 k/micro l (1x10(6)/l) being associated with a hazard ratio (HR) of 1.109 (95% confidence interval (CI) 1.072 to 1.147, p < 0.001), there was no association with myocardial infarction at one year (HR 1.020, 95% CI 0.990 to 1.052, p = 0.195). There were a total of 406 deaths at three years with a strong association between WBC count and three year mortality (HR for every 1 k/microl increase 1.089, 95% CI 1.058 to 1.121, p < 0.001). WBC count remained a significant predictor of mortality after multivariable adjustment (HR for every 1 k/micro l increase 1.100, 95% CI 1.069 to 1.131, p < 0.001). The association was significant across multiple subgroups, including diabetes, female sex, clinical presentation, and cigarette smoking. CONCLUSION: A raised pre-procedural WBC count in patients undergoing PCI is associated with an increased risk of long term death. These results suggest a key role for inflammation in coronary artery disease.

Gender bias in clinical trials: do double standards still apply?

Differential enrollment into clinical trials by gender has been described previously. In 1993, the National Institutes of Health (NIH) Revitalization Act was enacted to promote the inclusion of women in clinical trials. The purpose of this study was to review patterns in clinical trial enrollment among studies published in a major medical journal to determine the effects of this policy. A systematic search was conducted of all articles published in the Original Articles section of The New England Journal of Medicine from 1994 to 1999. Two independent observers abstracted information from the randomized clinical trials using standardized forms. All randomized clinical trials in which the primary end point was total mortality or included mortality in a composite end point were considered for review. Trials were analyzed for enrollment of women with respect to disease state, funding source, site of trial performance, and use of gender-specific data analysis. From 1994 to 1999, 1322 original articles were published in The New England Journal of Medicine, including 442 randomized, controlled trials of which 120 met our inclusion criteria. On average, 24.6% women were enrolled. Gender-specific data analysis was performed in 14% of the trials. The NIH Revitalization Act does not appear to have improved gender-balanced enrollment or promoted the use of gender-specific analyses in clinical trials published in an influential medical journal. Overcoming this trend will require rigorous efforts on the part of funding entities, trial investigators, and journals disseminating study results.

Profile and prevalence of aspirin resistance in patients with cardiovascular disease.

We determined the prevalence and clinical predictors of aspirin resistance by prospectively studying 325 patients with stable cardiovascular disease who were receiving aspirin (325 mg/day for > or =7 days) but no other antiplatelet agents. We also compared the detection of aspirin resistance with optical platelet aggregation, a widely accepted method, with a newer, more rapid method, the platelet function analyzer (PFA)-100, a whole blood test that measures platelet adhesion and aggregation ex vivo. Blood samples were analyzed in a blinded fashion for aspirin resistance by optical aggregation using adenosine diphosphate (ADP) and arachidonic acid, and by PFA-100 using collagen and/or epinephrine and collagen and/or ADP cartridges to measure aperture closure time. Aspirin resistance was defined as a mean aggregation of > or =70% with 10 microM ADP and a mean aggregation of > or =20% with 0.5 mg/ml arachidonic acid. Aspirin semiresponders were defined as meeting one, but not both of the above criteria. Aspirin resistance by PFA-100 was defined as having a normal collagen and/or epinephrine closure time (< or =193 seconds). By optical aggregation, 5.5% of the patients were aspirin resistant and 23.8% were aspirin semiresponders. By PFA-100, 9.5% of patients were aspirin resistant. Of the 18 patients who were aspirin resistant by aggregation, 4 were also aspirin resistant by PFA-100. Patients who were either aspirin resistant or aspirin semiresponders were more likely to be women (34.4% vs 17.3%, p = 0.001) and less likely to be smokers (0% vs 8.3%, p = 0.004) compared with aspirin-sensitive patients. There was a trend toward increased age in patients with aspirin resistance or aspirin semiresponders (65.7 vs 61.3 years, p = 0.06). There were no differences in aspirin sensitivity by race, diabetes, platelet count, renal disease, or liver disease.

Framing procedural risks to patients: is 99% safe the same as a risk of 1 in 100?

PURPOSE: A patient's willingness to consent to a procedure may be influenced by various factors, including the patient's rapport with the physician, nonverbal cues he or she receives during the discussion of risks, and other elements of the discussion of risks. Previous reports address these influences, but the effect of the actual wording used to describe risks is unclear. The purpose of this study was to better understand how framing the risk involved in a procedure affects a patient's likelihood to consent to the procedure. METHOD: In a 1997 study at the Cleveland Clinic Foundation, the authors randomly assigned 116 patients to view one of two short videos describing angioplasty and its associated risks. Sixty-three participants viewed the first video, which framed the procedure as 99% safe, and 53 viewed the second, which framed the likelihood of complication as 1 in 100. Participants were then asked to rate their consent to two hypothetical treatment scenarios on a four-point Likert-type scale (1 = definitely, 4 = definitely not). RESULTS: When asked to consent to a treatment scenario that would relieve chest pain but offer no survival benefit, respondents who viewed the first video were more likely to consent than were those who viewed the second (p<.001). There was no significant difference in the two groups' likelihoods to consent when the potential health benefit was to reduce the risk of future heart attack. CONCLUSION: This study's finding provides evidence that how a physician describes a procedure's risks when obtaining a patient's informed consent significantly influences the likelihood of consent. This fact should be considered when teaching communication skills, including interviewing and patient education skills, so that patients will be more likely to make health care decisions that are consistent with their own values and beliefs.

Proteinuria is a key determinant of death in patients with diabetes after isolated coronary artery bypass grafting.

BACKGROUND: Proteinuria is a marker for underlying diabetic nephropathy and may be a surrogate marker for advanced atherosclerosis. It is unknown if proteinuria is a determinant of death in patients with diabetes after coronary artery bypass grafting. We hypothesized that diabetic patients with evidence of proteinuria would have increased mortality and clinical event rates after isolated coronary artery bypass grafting compared with nonproteinuric diabetic patients. METHODS AND RESULTS: We performed an observational of study of 905 diabetic patients with urinalysis and available follow-up data (nonproteinuria, n = 651; proteinuria, n = 254) after isolated coronary artery bypass grafting at the Cleveland Clinic Foundation between January 1989 and December 1992. The proteinuria group was further prospectively stratified into low-concentration (n = 225) and high-concentration (n = 29) groups. The end points of this study were all-cause mortality and the composite end point of death, nonfatal myocardial infarction, and need for repeat revascularization. The mean follow-up time was 66 months. The 5-year mortality rate for the nonproteinuria and proteinuria groups was 20.2% and 29.1% (P <.001), respectively. The 5-year rate of death, nonfatal myocardial infarction, and need for repeat revascularization for the nonproteinuria and proteinuria groups was 25.2% and 36.2% (P <.001), respectively. Significant multivariate predictors of 5-year mortality included age, not using a left internal mammary artery graft to the left anterior descending coronary artery, proteinuria, lower body weight, and increased creatinine level. CONCLUSIONS: Among diabetic patients, proteinuria appears to be an important predictor of death after isolated coronary artery bypass grafting.