Hippocrates revisited: the evidence for drug-eluting stents.

Evidence-based medicine provides proof of efficacy (“to help”) and defines the risk-benefit relationship (“do no harm”) for specific therapeutic intervention. Guidelines provide an algorithm by which evidence-based medicine is incorporated into clinical practice. The cornerstone of evidence-based medicine is the randomized controlled clinical trial. On the basis of carefully constructed and well-executed randomized trials, the US Food and Drug Administration (FDA) has recently approved and released the Cypher sirolimus-eluting Bx VELOCITY coronary stent (Cordis, a Johnson and Johnson Company). Other drugeluting coronary stent prostheses are currently under investigation. Because of its cost, the clinical benefit demonstrated for Cypher (versus uncoated Bx VELOCITY stents) has been scrutinized. The present cost of Cypher ($3195) is at least 3 times that for a new-generation non–drug-eluting stent (DES) and is not borne by a proportional increment in reimbursement. The average incremental reimbursement provided by the Center for Medicare and Medicaid Services for diagnosisrelated group 527 (percutaneous cardiovascular procedure with DES, without acute myocardial infarction) is $1800 (geographically weighted). In societies in which patients are responsible for the large portion of cost increment related to a new technology, utilization of the Cypher stent has been limited. For example, 1 year after the release of Cypher in Europe (April 15, 2002), utilization remains 12% of all coronary stent devices. In the United States, we now find ourselves with an expensive new technology and a limited evidence base from which to determine its optimal use. In the present issue of Circulation, Drs O’Neill and Leon1 and Drs Lemos, Serruys, and Sousa,2 who have pioneered the clinical development of DES, offer their expert opinions on both the merits and the limitations of DES and provide tentative recommendations for their use.