Aspirin for Stroke Prevention in WomenSpeaker: Julie E. Buring, ScD, Professor of Medicine, Harvard Medical School, and Deputy Director of the Division of Preventive Medicine, Department of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts

The Women’s Health Study, a large randomized, double-blind, placebo-controlled, 10-year trial funded by the National Heart, Lung and Blood Institute and the National Cancer Institute, was conducted to evaluate the benefits of low-dose aspirin 100 mg every other day, as well as vitamin E supplementation 600 IU every other day, for the primary prevention of cardiovascular disease. The trial enrolled 39,876 apparently healthy women 45 years of age and older. The women were monitored for 10 years for first-time myocardial infarction (MI), stroke, and death from cardiovascular causes.

Although it has not been not widely recognized, women, when compared with men, tend to have more strokes than MIs. Aspirin was administered because it had been demonstrated to be effective for both men and women in the secondary prevention of cardiovascular disease and acute coronary ischemia.

During the follow-up period, 477 major cardiovascular events were confirmed for the women taking aspirin, compared with 522 with placebo—a 9% overall reduction that was not statistically significant. In a pattern seemingly different to that previously observed in men, the benefit of aspirin in the Women’s Health Study was attributed almost entirely to a statistically significant reduction in stroke events but with no reduction in MI rates.

The most consistent benefits were observed among women 65 years of age and older. These patients comprised 10% of the study population, yet they experienced one third of all cardiovascular events. Among such women, low-dose aspirin resulted in a 26% reduction in risk of major cardiovascular events.

Overall, the risk reduction for a first stroke was 17% and that for an ischemic stroke was 24%. Low-dose aspirin (Bayer Aspirin®) reduced the risk of total strokes, ischemic strokes, and transient ischemic attacks but resulted in neither benefit nor harm for endpoints of MI, cardiovascular mortality, or total mortality, which led to the nonsignificant finding with respect to the primary trial endpoint. It showed little benefit for younger women. This finding raises an important issue because low-dose aspirin resulted in a significant risk of gastrointestinal bleeding, with patients needing transfusions, and a nonsignificant increase in hemorrhagic stroke.
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Nesiritide for Refractory Heart Failure After Cardiac Surgery

Speaker: Saugato Sanyal, MD, Cardiovascular Surgeon, Division of Cardiothoracic Surgery, Beth Israel Medical Center, New York, New York

When administered to selected patients with refractory fluid overload and congestive heart failure (CHF) after cardiac surgery, nesiritide (Natrecor®, Scios), a recombinant form of human B-type natriuretic peptide (BNP), improved urine out­put, reduced filling pressures, and enhanced extubation rates.

Because significant fluctuations in endogenous BPN levels occur after cardiac surgery, a study was designed to give nesiritide only to cardiac surgery patients who were unresponsive to conventional therapy(vasopressor agents and diuretics).

The study population consisted of 50 patients with postoperative worsening of CHF and urine output. Nesiritide was added to the conventional therapy for CHF and was titrated to achieve diuresis. Mathematical equations were used to assess hemodynamic parameters, tolerance of medications, and clinical outcomes.
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Compared with the pre-nesiritide average trends, pulmonary artery diastolic pressure and central venous pressure were significantly reduced within eight hours of infusion. Urine output increased, from 46.2 ± 20 ml/hour to 89 ± 15 ml/hour; oxygen requirements decreased; and the number of patients needing ventilatory support declined, from 89% to 61%. The cardiac index increased significantly and systemic vascular resistance was markedly reduced. Serum creatinine or blood urea nitrogen at 24 hours did not increase significantly after nesiritide infusion.

Carvedilol Helps Patients with Heart Failure

Speaker: William J. Remme, MD, Professor and Director of Research, STICARES-Cardiovascular Institute, Rhoon, The Netherlands

Subgroup analyses of patients in the Carvedilol or Meto-prolol European Trial (COMET) suggest that carvedilol (GlaxoSmithKline) is the preferred beta blocker for treating congestive heart failure (CHF), compared with meto-prolol tartrate (Lopressor®, Novartis), irrespective of patients’ baseline characteristics.

Initial results indicated that at six months’ follow-up, resulted in a better overall survival than metoprolol in 3,029 patients with New York Heart Association (NYHA) class II-IV CHF and an ejection fraction of less than 35%. Of the 1,112 deaths during the trial, 72 were attributed to cardiovascular causes, 480 to sudden death, 365 to circulatory failures CHF), and 51 to stroke.

In the subgroup analysis, for each mode of death, the researchers assessed a number of baseline variables: (1) sex, age, NYHA class, ischemic etiology, heart rate, systolic blood pressure, ejection fraction, dilated cardiomyopathy, body mass index, diabetes, atrial fibrillation, previous myocardial infarction, or hypertension; (2) hemoglobin, creatinine, and sodium levels; (3) therapy with ACE-inhibitors, spironolactone, digitalis, aspirin or an anticoagulant, or statins; and (4) allocation of patients into treatment groups.

In the univariate analyses, carvedilol reduced total and cardiovascular mortality, sudden death, and stroke more than metoprolol for all subgroups. For deaths from CHF, this significant difference was found only in patients with low serum sodium levels or in those taking digitalis.

In the multivariate Cox regression analyses, canadian carvedilol remained superior to metoprolol for the total number of deaths (p = .0007), cardiovascular mortality (p = .0009), sudden death (p = .0073) and death from stroke (p =. 0027). It also showed a nonspecific trend for death from CHF (p = .1).