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Off label (or alternative) use of drug-eluting stents in relatively high-risk patients accounts for the majority of stenting procedures performed in the United States. The major trials leading to the approval of drug-eluting stents were conducted in low-risk settings and involved enrollment of largely clinically and angiographically low-risk patients. However, when these stents became available to the medical community, the uptake in clinical practice was rapid, quickly surpassing the evidence on which their approval was based. Usage increased from 50% within 6 months of approval to 82% within 1 year. Subsequently, reports of late-stent thrombosis followed. In fact, at an FDA advisory panel meeting held in December 2006, it was estimated that alternative use in high-risk patients accounted for between 50% and 70% of usage.

Recipients of alternative drug-eluting stents frequently include patients with multivessel coronary artery disease or acute coronary syndromes, as well as those with complex angiographic disease (eg, chronic total occlusions, vein graft disease, and bifurcation lesions). Recent studies have concluded that alternative use of drug-coated stents may significantly increase the short-term risk of death, heart attacks, blood clots, or reclogging of arteries relative to on-label use. In an editorial review published in the May 9, 2007 issue of JAMA, my colleague and I reviewed recent studies that reported on the indications and outcomes associated with alternative use of drug-eluting stents. The discrepancies in event rates and final conclusions we observed highlight the need for a reliable system that allows systematic follow-up and subsequent public reporting for all implanted devices.

Wanted: Standardization for Post-Approval Studies

Alternative use of new technologies clearly furthers the evolution of medicine and should not necessarily be discouraged. However, it's critical to develop an extensive follow-up method to better understand new technologies in areas where they were not initially studied. In addition, a system should be developed that allows standard and reliable information to be attained following approval of devices and drugs. Currently, there is no system in place in the United States that would allow physicians to more systematically analyze new technologies as they are disseminated throughout the medical community.

Adopt Alternative Use Cautiously

Providers use devices, medications, and technologies outside the realm in which they are studied due to necessity and practice. However, the adoption of alternative use should be done with extreme caution, comparing the evidence that already exists to the context in which the technology is being used. In the event that subspecialists make alternative recommendations to referring physicians, those physicians should ask the following questions:

• What is the recommendation based on?

• Why is this indicated?

• What evidence exists to support usage?

• Will the technology improve the outcomes of the patient?

Subspecialists have an obligation to provide this information to referring physicians, but—unfortunately—this dialogue doesn't always take place. It's important for physicians to demand further studies from manufacturers of new technologies so that they can obtain the information they need to draw inferences based on the characteristics of their patients. Manufacturers will provide those studies if the medical community demands more data.

Dr. Harrington has indicated to Physician's Weekly that he has or has had the following financial interest: Cordis, Boston Scientific, Conor, Abbott, Eli Lilly, Daichii-Sankyo, AstraZeneca, TMC, Schering Plough, BMS,Sanofi-Aventis, and Bayer. He has been a consultant for SP Pharmaceuticals, Bristol-Myers Squibb, and sanofi-aventis. He reported that all personal honoraria generated from industry activities (consulting, advisory boards, speaking, etc.) are donated to educational charities.