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1. Wise Counsel on Drug-Eluting Stents

   • Bonnie H. Weiner, MD, MSEC, MBA

   President, The Society for Cardiovascular Angiography and Interventions

   To the Editor: Given the intense scrutiny researchers and the media have given to the comparative safety and effectiveness of drug-eluting stents (DES), The Society for Cardiovascular Angiography and Interventions (SCAI) welcomed the balanced, broad overview provided by “Balancing Efficacy and Safety of Drug-Eluting Stents in Patients Undergoing Percutaneous Coronary Intervention,” published in the Feb. 5 edition of Annals of Internal Medicine.

   After examining the research, the authors, Allen Jeremias, M.D., and Ajay Kirtane, M.D., conclude the clinical benefits of DES outweigh the risks posed by an apparent increase in stent thrombosis. The authors base this conclusion on the fact that the rate of serious adverse events has not been shown to be different in DES from bare metal stents, and on the well-documented effectiveness of DES in reducing the need for revascularization.

   The authors concluded that research is still needed on the safety and efficacy of the “off-label” implantation of DES. Fortunately, such research is ongoing, as evidenced in a study published Jan. 24 in the New England Journal of Medicine, which showed DES are as safe as and more effective than bare metal stents in treating patients who were not included in the studies that led to Food and Drug Administration approval (off label). These patients tended to have a higher prevalence of diabetes, hypertension, renal disease, a previous cardiovascular intervention such as a stent or bypass surgery, and multi-vessel coronary disease, and are higher risk for subsequent events but perhaps receiving the most benefit from these newer devices.(1)

   Another important point made by Drs. Jeremias and Kirtane is there is strong evidence that the single most important predictor of stent thrombosis is the premature discontinuation of anti-platelet therapy. It is for this reason that SCAI stresses the importance of evaluating patients to make sure they can stay on their anti-platelet medication for at least a year after DES are implanted.(2) This is further confirmed by the recent description of rebound after cessation in all patients with ACS.(3)

   We commend Drs. Jeremias and Kirtane for a comprehensive and instructive overview of the safety and efficacy of DES. We also appreciate the wise counsel they provide to doctors about carefully evaluating patients and to patients about staying on their anti-platelet medication for at least a year.

   Bonnie Weiner, M.D., MSEC, MBA, FSCAI President, The Society for Cardiovascular Angiography and Interventions

   REFERENCES

   1. Marroquin, Oscar C. et al. “A Comparison of Bare-Metal and Drug- Eluting Stents for Off-Label Indications.” New England Journal of Medicine 2008;358(4):342-352.

   2. Hodgson JM, Stone GW, Lincoff AM, et al. Clinical Alert: Late Stent Thrombosis: Considerations and Practical Advice for the Use of Drug- Eluting Stents: A Report From the Society for Cardiovascular Angiography and Interventions Drug-eluting Stent Task Force. Catheter Cardiovasc Interv 69:327-33. Available at: http://www.scai.org/pdf/DES%20clinical%20alert%20in%20CCI%20Feb07.pdf

   3. Ho, Michael P. et al. “Incidence of Death and Acute Myocardial Infarction Associated With Stopping Clopidogrel After Acute Coronary Syndrome.” JAMA 2008;299(5):532-539.

   Conflict of Interest:

   None declared

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   Published February 19, 2008
2. Antiplatelet therapy

   • Kusum L Kumar, MD

   None

   In order to avoid fatal thrombotic events in patients with drug eluting stents antithrombotic therapy is recommneded. Duration of therapy is still controversial or unclear. What do the authors recommend for their patients who have no contraindications and are tolerating both aspitin and Plavix?

   Conflict of Interest:

   None declared

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   Published December 20, 2007
3. Is there potential for vasculitis?

   • Stanley R Frankel, M.D.

   University of Maryland

   I have observed a case of a 79 year-old white male who 4 months after PCI and paclitaxel-eluting stent placement developed Wegener's granulomatosis with acute renal failure after stent. Although other medications may have also been implicated in this adverse event, I am curious whether others have observed any vasculitis post drug-eluting stent placement?

   Conflict of Interest:

   Employee, F. Hoffmann-La Roche, Inc

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   Published December 18, 2007
4. Source

   • Mark McConnell, MD

   VAMC

   Is it possible to find authors to write this type of review that do not have ties to the industry producing the product they are reviewing? The BMJ does seem to be able to do this more often. Disclosing potential conflict of interest is not quite the same as obtaining a view from someone who does not have a conflict of interest. Respectfully,

   Conflict of Interest:

   None declared

   Submit response
   Published December 18, 2007