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

Thrombosis and Drug-Eluting Stents

An Objective Appraisal

David R. Holmes, Jr, MD^_*,_*, Dean J. Kereiakes, MD, Warren K. Laskey, MD, Antonio Colombo, MD, Stephen G. Ellis, MD^¶, Timothy D. Henry, MD^||, Jeffrey J. Popma, MD^#, Patrick W.J.C. Serruys, MD^_**, Takeshi Kimura, MD, David O. Williams, MD, Stephan Windecker, MD and Mitchell W. Krucoff, MD^¶¶

^_* Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota
The Heart Center of Greater Cincinnati and The Lindner Center at the Christ Hospital, Cincinnati, Ohio
Division of Cardiology, University of New Mexico School of Medicine, Albuquerque, New Mexico
Columbus and San Rafaele Hospitals, Milan, Italy
^¶ Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio
^|| Department of Research, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota
^# Brigham and Women's Hospital, Boston, Massachusetts
^_** Thoraxcenter, Erasmus University, Rotterdam, the Netherlands
Department of Cardiovascular Medicine, Kyoto University School of Medicine, Kyoto, Japan
Division of Cardiology, Rhode Island Hospital, Providence, Rhode Island
Department of Cardiology, University Hospital Bern, Bern, Switzerland
^¶¶ Department of Cardiology, Duke Clinical Research Institute, Durham, North Carolina.

Manuscript received December 22, 2006; revised manuscript received March 20, 2007, accepted April 3, 2007.

^_* Reprint requests and correspondence: Dr. David R. Holmes, Jr., Mayo Clinic, 200 First Street SW, Rochester, Minnesota 55955 (Email: holmes.david{at}mayo.edu).

Stent thrombosis (ST) after percutaneous coronary intervention has been the focus of intense interest because of its attendant morbidity and mortality. There is controversy about several facets of the problem. These include the frequency of ST with drug-eluting stents (DES) versus bare-metal stents (BMS), the timing of the event, clinical consequences, risk factors, adjunctive therapy, and new preventive approaches. Information has accrued rapidly from several sources, including randomized controlled clinical trials of DES versus BMS in carefully selected subsets of patients and registry experiences in larger patient groups, which provide a more universal real-world picture. The results from these different data sets are not completely concordant. However, several general conclusions can be made: 1) ST is an infrequent but very severe complication of both BMS and DES; 2) at the present time, during 4 years of follow-up from randomized controlled trials that compared DES and BMS, there is no apparent difference in overall ST frequency, although the time course for occurrence appears to differ, with a relative numeric excess of ST late after DES implant; 3) despite this relative imbalance, no differences in the end points of death or death and infarction between DES and BMS are observed; 4) longer-term follow-up of these patients as well as larger angiographic and clinical subsets of patients who receive this technology outside of randomized trials are required to fully study this issue; and 5) advances in stent platforms for drug elution as well as adjunctive pharmacologic therapy are being evaluated to enhance long-term safety.

Abbreviations and Acronyms   ARC = Academic Research Consortium   BMS = bare-metal stent(s)   DES = drug-eluting stent(s)   PES = paclitaxel-eluting stent(s)   SES = sirolimus-eluting stent(s)   ST = stent thrombosis

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