Studies of Drug-Eluting Stents
To Each His Own?
This article requires a subscription to view the full text. If you have a subscription you may use the login form below to view the article. Access to this article can also be purchased.
All technology has limitations, some of which are not recognized at the time of introduction. Once adopted, technology may be challenged as to whether the initial promise of patient benefit demonstrated in clinical trials has been achieved in the setting of routine practice. This challenge is the objective of observational studies. Among interventional cardiologists, the jury on drug-eluting stents is still out.
Article p 2071
Progress has not been linear for coronary stenting technology. The introduction of 2 new stents that largely prevented the problem of restenosis1,2 was met by an explosive adoption of these techniques by physicians and requests by patients. Within the first 8 months of introduction in Massachusetts, the rate of drug-eluting stents (DES) as a proportion of total stent procedures reached 90%.3 However, reports of late adverse events and stent thrombosis, a rare but morbid event, raised alarm in patients and prompted caution from regulators and physicians. The net outcome has been a return to increased use of bare-metal stents, with DES use decreasing to 64% in the United States (Millenium Research Group, Waltham, Mass, written communication, 2007).
The benefits of restenosis prevention observed in randomized trials comparing DES to bare-metal stents were far greater in magnitude than many other incremental changes in medicine. Relative reductions in the need for repeat procedures to treat restenosis reached 75% to 80%,1,2 a larger jump forward than that achieved with the introduction of bare-metal stents to replace balloon angioplasty.4,5 Although the composite end points in the pivotal trials of drug-eluting stents included myocardial infarction and death and patients were followed for 5 years after stenting, the trials were not powered to detect harm in these important end points.6,7
What Randomized Trials Tell Us
Some have voiced concern that the trials leading to DES approval did not anticipate the broad …