Drug-eluting stents: cost versus clinical benefit.

Abstract

The publication in January 2001 of the first-in-man results showing zero restenosis after sirolimus-eluting stent implantation produced enormous excitement in the cardiological community.1 The long-awaited tool—a safe, restenosis-proof, easy-to-use stent—had been found. It was not too long thereafter that paclitaxel-eluting stents also demonstrated their capability to decrease restenosis. Today, both sirolimus- and paclitaxel-eluting stents have been shown in randomized trials to reduce restenosis as compared with conventional metallic stents (Figure 1).2–6 Most of these studies have been recently released in the form of abstracts during medical meetings and are still unpublished.3,5,6 In addition to sirolimus and paclitaxel, other agents have shown promising early results in recent studies, enlarging the body of evidence demonstrating the potential benefits of what are known as drug-eluting stents.7 Regulatory agencies have been very active in evaluating some of these devices in the United States, Europe, South America, and Asia. The sirolimus-eluting stent has been available for routine use in Europe, South America, and Asia since the first half of 2002 and received approval from the US Food and Drug Administration to be marketed in April 2003. Paclitaxel-eluting stents have also received CE (Conformite Europeenne) marking for commercialization in Europe and are now beginning to be commercialized. Figure 1. Randomized trials showing reduction of binary restenosis with drug-eluting stents.2–6 The case seemed to be closed. Restenosis, the Achilles’ heel of percutaneous revascularization, appeared defeated. However, since the sirolimus-eluting stents became available, very little has changed in the everyday life of almost all interventional laboratories in Europe. Why? Has the new treatment presented any undesirable effect? Was the desire to defeat restenosis not as great as supposed? The answer is none of the above. The limitation currently impeding more widespread use of the new technology is nontechnical, nonmedical, and nonbiological. The …