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J Thorac Cardiovasc Surg 2006;132:5-7
© 2006 The American Association for Thoracic Surgery

Editorial

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

^a Division of Cardio-Thoracic Surgery, University Hospital, Basel, Switzerland
^b Division of General Surgery and Surgical Research, University Hospital, Basel, Switzerland
^c Department of Cardiovasular Surgery, University Hospital, Freiburg, Germany

Received for publication January 6, 2006; revisions received March 6, 2006; accepted for publication March 15, 2006.

^_* Address for reprints: Martin Grapow, MD, Division of Cardio-Thoracic Surgery, University of Basel, Spitalstrasse 21, CH-4031 Basel, Switzerland. (Email: mgrapow@uhbs.ch).

The first 20% of the full text of this article appears below.

A recent article by Hannan and coworkers ¹ 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 applies to the treatment decisions exclusively derived from findings of RCTs for patients with coronary heart disease under everyday conditions.

Since the mid-1980s, surgical revascularization has become a standardized procedure. Since then, the coronary artery bypass grafting (CABG) technique has continuously improved. ² The superiority of surgical revascularization over medical therapy was documented at an early stage. ³

Since the introduction of percutaneous transluminal coronary angioplasty and stents, percutaneous coronary intervention (PCI) has become a therapeutic alternative to medical and surgical therapy in many patients with coronary artery disease. There has been growing demand for, and use of, PCI because it is less invasive, so that today it is carried out 3 times more frequently than coronary surgery. ⁴

Over the last 10 years, numerous prospective RCTs have been conducted to answer the question of whether and in what situations CABG or PCI results in a better medium- and long-term course. Until very recently, the focus of research has been exclusively on RCTs and meta-analyses, whereas large population-based studies or cardiac registry analyses have received less attention.

The value of stringently conducted RCTs is undisputed because they have great internal validity. However, the crucial question is whether their results have relevance to everyday decision making. In RCTs patients are randomly assigned to standard and investigational arms and are followed up over a defined period. The final results of the randomized groups are often compared, irrespective of whether the positive result of one treatment arm was induced in part by using the alternative treatment principle (the intent-to-treat principle) as . . . [Full Text of this Article]

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