ABSTRACT

Soon after the introduction of percutaneous transluminal coronary angioplasty (PTCA) in 1979, Andreas Gruentzig stated that randomized trials are ‘clearly needed if we are to evaluate the efficacy of this new technique as compared with current medical and surgical treatments’.1 Despite repeated calls for such studies throughout the 1980s, it was not until 1992 that the first randomized study comparing PTCA to more traditional treatment was published.2 Over the last 30 years an explosive proliferation in the number of PTCA procedures has occurred. In 1997, 459 000 percutaneous coronary interventions (PCIs) were performed in the US alone.3 In this same year over 12 million Americans were medically treated for coronary artery disease and 607 000 underwent CABG.3 As technological advances have occurred, and operator experience has increased, the application of PCI has expanded from balloon dilatation of simple, concentric, single-vessel stenotic lesions to multi-device, stent-facilitated intervention of multiple complex lesions. This growth in PCI has had an enormous impact on the management of patients with coronary artery disease, as well as on the utilization of health care resources and cost. However, despite its rapid proliferation, randomized studies providing data defining and substantiating the role of PCI have only been published in the past 5 years. This chapter will review the published and ongoing studies comparing medical and surgical therapies. The limitations of the studies, their interpretation and application to clinical practice will also be discussed.