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FOCUS ISSUE: DRUG-ELUTING STENTS: STATE-OF-THE-ART PAPER

As Time Goes By

Current Status and Future Directions in the Controversy Over Stenting

Division of Cardiology, Cedars-Sinai Medical Center, and the David Geffen School of Medicine, University of California, Los Angeles, California.

Manuscript received February 12, 2007; revised manuscript received April 16, 2007, accepted April 16, 2007.

^_* Reprint requests and correspondence: Dr. Sanjay Kaul, Division of Cardiology, Cedars-Sinai Medical Center, 8700 Beverly Boulevard, Los Angeles, California 90048. (Email: kaul{at}cshs.org).

Drug-eluting stents (DES) have dramatically transformed the landscape of interventional cardiology largely on the basis of empirical evidence showing profound reduction in angiographic and clinical restenosis without any significant increase in adverse events. Recent data, however, raise questions regarding the increased risk of late stent thrombosis associated with DES in more complex lesions and higher-risk patients than those evaluated in the initial clinical trials or Food and Drug Administration-approved indications, the challenge of continuing long-term antiplatelet therapy, and the danger of early discontinuation of antiplatelet therapy. We herein review the current status of this controversy, describe the additional evidence needed for its resolution, and offer recommendations for regulatory reform and 3 specific recommendations to encourage evidence-based patient management: 1) an emphasis on medical therapies with proven long-term benefit; 2) the use of kinetic modeling to estimate long-term outcomes of therapies based on the available near-term data; and 3) the restructuring of reimbursement incentives to encourage the use of evidence-based clinical management strategies.

Abbreviations and Acronyms   ARC = Academic Research Consortium   BMS = bare-metal stent(s)   CAD = coronary artery disease   CI = confidence interval   CMS = Center for Medicare and Medicaid Services   DES = drug-eluting stent(s)   MI = myocardial infarction   PCI = percutaneous coronary intervention   PES = paclitaxel-eluting stent(s)   SES = sirolimus-eluting stent(s)

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