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c doi:10.1016/j.jtcvs.2006.03.035 recent article by Hannan and coworkers including almost 60,000 patients from New York’s cardiac registries forces us to reflect on the reliability of inferences made from randomized controlled trials (RCTs). The same pplies to the treatment decisions exclusively derived from findings of RCTs for atients with coronary heart disease under everyday conditions. Since the mid-1980s, surgical revascularization has become a standardized rocedure. Since then, the coronary artery bypass grafting (CABG) technique has ontinuously improved. The superiority of surgical revascularization over medical herapy was documented at an early stage. Since the introduction of percutaneous transluminal coronary angioplasty and tents, percutaneous coronary intervention (PCI) has become a therapeutic alternaive to medical and surgical therapy in many patients with coronary artery disease. here has been growing demand for, and use of, PCI because it is less invasive, so hat today it is carried out 3 times more frequently than coronary surgery. Over the last 10 years, numerous prospective RCTs have been conducted to nswer the question of whether and in what situations CABG or PCI results in a etter mediumand long-term course. Until very recently, the focus of research has een exclusively on RCTs and meta-analyses, whereas large population-based tudies or cardiac registry analyses have received less attention. The value of stringently conducted RCTs is undisputed because they have great nternal validity. However, the crucial question is whether their results have releance to everyday decision making. In RCTs patients are randomly assigned to tandard and investigational arms and are followed up over a defined period. The nal results of the randomized groups are often compared, irrespective of whether he positive result of one treatment arm was induced in part by using the alternative reatment principle (the intent-to-treat principle) as a result of crossover. Although he intent-to-treat analysis represents a central tenet of RCTs, it might bias the esults versus no difference in the context of a comparison of PCI versus CABG. oreover, it is not an uncommon phenomenon that RCTs are underpowered. Clearly, even the most thoroughly planned and well-executed investigation might ail to answer the research question if the sample size is too small. If an underpowred study does not find statistically significant differences, it is unclear whether here is truly no difference between the treatment options or whether the sample size as prohibitively small to provide sufficient evidence for a statistically significant ifference. Finally, patients are usually recruited on the basis of stringent inclusion and xclusion criteria that are often worryingly dissimilar to the overall patient popuation with coronary artery disease. Meta-analyses do not resolve this problem ecause they are based on those studies just described. This high degree of patient selection represents the crucial limiting factor in any randomized clinical trials; the patients included in such studies seldom reflect he population encountered in routine practice. According to the analysis carried out y Brett and colleagues, many RCTs included markedly less than 10% of all creened patients. Indeed, patients with common-sense indications for CABG and ontraindications for PCI (eg, left main stenosis or diffuse, severe 3-vessel diseases)

Randomized controlled trials do not reflect reality: Real-world analyses are critical for treatment guidelines!