DES vs. BMS

In further stent news, according to a new study in the Journal of American Medicine the use of DES rather than bare-metal stents (BMS) has been found to be more effective. Heart attack patients given DES implants are far less likely to suffer from MACE, the study by Marco Valgimgli, M.D., Ph.D., from the Cardiovascular Institute in the University of Ferrara, Italy concluded.


Dr. Valgimgli and associates studied patients who received anticoagulants Abciximab and Tirofiban within 90 minutes of angioplasty procedure. In the 745-patient study taking place between 2004 and 2007, researchers evaluated the effect of high-dose Tirofiban and Sirolimus-releasing stents compared with Abciximab infusion and BMS implantation. The researchers discovered the patients with the DES had fewer incidents of MACE. At 8-month follow-up, occurrence of MACE was approximately halved by DES, compared with BMS. Patients who received DES were found to also be less likely to require revascularization.

In a similar study, the Cardiovascular Research Foundation presented meta-analysis results of comparisons between BMS and DES at the Drug-Eluting Stent Revolution VII, meeting recently held in Chicago. Ajay J. Kirtane, M.D., of New York-Presbyterian Hospital/Columbia University Medical Center, and Gregg W. Stone, M.D., of Columbia University Medical Center provided conclusive analysis of over fifty studies involving nearly 200,000 patients. The study concerned mortality rates for DES usage compared with BMS. The studies demonstrated that DES in either on-label or off-label use were not harmful to patients, a finding that Dr. Kirtane said should be reassuring to both patients and physicians, and favorable for future DES usage. The DES in the studies showed reductions in death, MIs, and tricuspid valve replacement.

Finally, the U.S. Food and Drug Administration has announced issuance of draft guidelines to aid the development, testing and manufacture of DES devices. The concerns over long-term clot formation following implantation of DES led to the production of the FDA guidance document. The guide contains advice for approval applications and recommendations for clinical evaluation in the pre-market stage and also for studies of post-market follow-up. The use of DES combines device and drug technology, therefore the guide received input from both the Center for Devices and Radiological Health and the Center for Drug Evaluation and Research. The FDA document also provides guidance on incorporating studies of the toxicology of drug substances into evaluations. The guide and its companion document are to provide assistance in minimizing risks of DES devices while maintaining patient benefits, according to Daniel G. Schultz, M.D., director of FDA's Center for Devices and Radiological Health.

Back to HCB News

More Industry Headlines