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Evidence-based medicine (EBM) has a long history, but was revived in the early 1990s by a campaign mounted by a movement that took its name. The EBM movement focused attention on the need for greater objectivity in medical decision-making and led to the Cochrane Collaboration, which provides reviews of evidence on the basis of comparative research. Important limitations of EBM's effect on medicine have also emerged. Failure to acknowledge the limitations of clinical trials and systematic reviews has limited their applicability to individual patients' circumstances. An almost exclusive focus on drugs and devices has left vast areas of health care in an evidence vacuum. An overdependence on commissions for its research may have limited its independence in selecting what it investigates. EBM needs to widen its scope beyond drugs and devices to address many areas that often lack evidence at present, notably, health policy, management, and reforms.

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Little is known about the benefits and risks of the long-term use of cardiovascular drugs. Evidence from randomized clinical trials (RCTs) rarely goes beyond a few years of follow-up, but patients are often given continuous treatment with multiple drugs well into old age. We focus on 4 commonly used cardiovascular drug classes: aspirin, statins, beta-blockers, and angiotensin-converting enzyme inhibitors given to patients after myocardial infarction. However, the issues raised apply more broadly to all long-term medications across cardiovascular diseases and the whole of medicine. The evidence and limitations of RCTs are addressed, as well as current practice in pre-licensing trials, the increasing problems of polypharmacy (especially in the elderly), the lack of trial evidence for withdrawal of drugs, the role of regulatory authorities and other stakeholders in this challenging situation, and the potential educational solutions for the medical profession. We conclude with a set of recommendations on how to improve the situation of long-term drug use.

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OBJECTIVES: This study was designed to compare the long-term consequences of percutaneous transluminal coronary angioplasty (PTCA) and continued medical treatment. BACKGROUND: The long-term effects of percutaneous coronary intervention need evaluating, especially in comparison with an alternative policy of continued medical treatment. METHODS: The Second Randomized Intervention Treatment of Angina (RITA-2) is a randomized trial of PTCA versus conservative (medical) care in 1,018 patients considered suitable for either treatment option. Information on clinical events, interventions, and symptoms is available for a median seven years follow-up. RESULTS: Death or myocardial infarction (MI) occurred in 73 (14.5%) PTCA patients and 63 (12.3%) medical patients (difference +2.2%, 95% confidence interval -2.0% to +6.4%, p = 0.21). There were 43 deaths in both groups, of which 41% were cardiac-related. Among patients assigned PTCA 12.7% subsequently had coronary artery bypass grafts, and 14.5% required additional non-randomized PTCA. Most of these re-interventions occurred within a year of randomization, and after two years the re-intervention rate was 2.3% per annum. In the medical group, 35.4% required myocardial revascularization: 15.0% in the first year and an annual rate of 3.6% after two years. An initial policy of PTCA was associated with improved anginal symptoms and exercise times. These treatment differences narrowed over time, mainly because of coronary interventions in medical patients with severe symptoms. CONCLUSIONS: In RITA-2 an initial strategy of PTCA did not influence the risk of death or MI, but it improved angina and exercise tolerance. Patients considered suitable for PTCA or medical therapy can be safely managed with continued medical therapy, but percutaneous intervention is appropriate if symptoms are not controlled.

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Practice should, as much as possible, be based on good science. Randomized clinical trials can provide the best evidence, but they have serious limitations. First, many clinical situations, such as cardiac arrest and pain relief, do not lend themselves to randomization. Second, trials seldom can study the effects seen in different subgroups, nor can the results always be extrapolated from the restricted groups of patients recruited into trials. Finally, there is publication bias: the failure to report "negative" trials and the biased presentation of results by investigators and sponsors.

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Clinical trialists and statisticians are very wary of subgroup analysis, for good reasons. Clinicians have to deal with situations in which subgroups of patients differ widely from one another in their prognosis and response to treatment. Few trials are large enough to demonstrate convincingly these differences in outcome, but often provide suggestive evidence. Should we ignore this and treat all patients as the same, or should we allow dubious statistical evidence to buttress biological plausibility in making clinical decisions?

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This manual is intended to help in the training of physicians and nurses concerned with modern methods of managing acute myocardial infarction and is designed to be of use to those who have only a limited knowledge of the anatomy, physiology, pathology, and chlinical presentation of this condition

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