Coronary Artery Surgery Study (CASS): comparability of 10 year survival in randomized and randomizable patients.

The Coronary Artery Surgery Study (CASS) includes 780 patients with mild or moderate stable angina pectoris or asymptomatic survivors of a myocardial infarction who were randomized to either medical or surgical therapy and 1,319 patients who were eligible for randomization but were not randomized (randomizable patients). There were no substantial aggregate differences observed in any of the survival comparisons after 10 years of follow-up study between the randomized and randomizable patients assigned to the medical (79% versus 80%) or surgical (82% versus 81%) groups or in patient subgroups stratified according to coronary artery disease extent and left ventricular ejection fraction. Cox regression analyses were done with independent variables known to be predictors of survival, including surgical versus medical therapy and randomized versus randomizable group, to test the null hypothesis of a mortality difference between medical versus surgical assignment according to group assignment (randomized versus randomizable). In no case did the initial group category enter as a significant predictor of survival. The results in the randomizable group reinforce those in the randomized group with respect to the medical versus surgical comparison. Two subgroups are identified with a significant surgical advantage: 1) patients with proximal left anterior descending coronary artery stenosis greater than or equal to 70% and an ejection fraction less than 0.50, and 2) patients with three vessel coronary artery disease and an ejection fraction less than 0.50. In both groups, coronary bypass surgery had a statistically significant beneficial effect on survival (p less than 0.05). After a decade of follow-up, the CASS randomizable patients confirm conclusions reached on the basis of the CASS randomized trial.

Ethics in cardiovascular medicine. Task Force IV: Scientific responsibility and integrity in medical research.

Ethical standards are a set of affirmative responsibilities to which the investigator must subscribe; behavior that is incompatible with these responsibilities should be presumed unethical, whether or not it is explicitly proscribed. This Task Force sought to present these standards as principles or guidelines. In undertaking research an investigator must accept that publicly funded or supported research is intended to yield public benefit; personal gain should be only incidental to and not at the expense of the public benefit. The responsibilities of the investigator are summarized as follows: Design of Research To develop a research design that effectively and efficiently addresses the scientific question while minimizing the likelihood of incorrect or misleading results. To protect the rights and welfare of human subjects, assure the humane use of laboratory animals and protect the safety of laboratory workers and the environment. Conduct of Research To ensure that accepted laboratory and research practices are followed and that all data are accurately collected and properly recorded; the investigator must participate in the review of original data. To carry out research in accordance with that approved by the institutional review board and ensure that fully informed consent is obtained, that the welfare of human subjects is protected and that animal welfare and laboratory safety procedures are carried out. To provide effective ongoing supervision of research trainees and technicians. In multidisciplinary collaborative research, to have at least an overview familiarity with the work outside his or her areas of expertise. In fixed protocol, multicenter collaborative research the investigator must be satisfied with the adequacy of the collaborative activities.(ABSTRACT TRUNCATED AT 250 WORDS)

[Operation for replacing coronary vessels: scientific and clinical aspects]. / Operatsiia po zamene koronarnykh sosudov: nauchnye i klinicheskie aspekty.

The paper discusses the modern status of the problem of aorto-coronary bypass in ischaemic heart disease. The good and the weak sides of both surgical and medicinal treatment are considered. The diagnostic value of invasive and noninvasive methods is discussed from the point of view of indications for aorto-coronary bypass. Data on the survival of patients after surgery are given, late prognosis and outcomes of surgical treatment are presented.

Duration of hospitalization in "uncomplicated completed acute myocardial infarction". An Ad Hoc Committee review.

The clinical and laboratory findings diagnostic of acute myocardial infarction include at least two of the following: (1) a history of pain consistent with myocardial ischemia, (2) electorcardiographic findings consistent with infarction, and (3) a rise in the serum level of specific cardiac enzymes. By the 4th or 5th day of illness, specific criteria can be applied to assign certain patients to a subset with "uncomplicated completed acute myocardial infarction." These criteria include the absence of evidence of (1) continuing cardiac ischemia, (2) left ventricular failure, (3) shock, (4) important cardiac arrhythmias, (5) conduction disturbances, and (6) other serious illnesses in patients with an established acute myocardial infarction. In terms of prognosis and management, patients in this subset should be regarded as substantively different from patients in other subsets. They should respond favorably to short periods of immobilization and hospitalization than those generally used. They may remain at bed rest (modified in regard to sitting and the use of a commode) for 4 days. Subsequently, mobilization with a program of progressive activity over the ensuing 5 to 10 days should reduce the duration of hospitalization to less than the current average of 17.5 to 20.8 days for patients with acute myocardial infarction. Nine to 14 days should suffice in most instances. Current and future trials may indicate that still earlier mobilization and shorter hospitalization periods can be applied to certain patient groups, but the evidence on this point is incomplete. For the individual patient, many factors will determine the optimal duration of bed rest and hospital stay. The patient's physician must consider the therapeutic benefits that may attend earlier mobilization and shorter hospitalization while weighing potential disadvantages. When the responsible physician does not regularly care for the patient, consultation with an experienced cardiologist is desirable. Patients whose condition is classified as "uncomplicated" may manifest deterioration during their illness and require assignment to a subset with a different prognosis and requiring different forms of treatment. For patients with uncomplicated acute myocardial infarction, as well as those in other subsets, absolute rules for therapy are unwise and application of broader principles by the alert physician is more likely to be beneficial.