ATLANTA—More research is needed on the relative costs and benefits of using drug-eluting stents (DES) versus bare-metal stents (BMS) in patients who have experienced a STEMI, according to the results of the DEDICATION trial presented Tuesday at the ACC.10 conference.
A team of Danish researchers, led by Peter Clemmensen, MD, of Copenhagen University Hospital in Denmark and president of the Danish Heart Foundation, recently completed a three-year trial examining the effectiveness and risks of DES versus BMS. They randomized 626 patients who received PCI within 12 hours of a STEMI to receive either a DES (313) or a BMS (313). Clemmensen acknowledged that their patient population was “quite small” and therefore not powered to answer questions of mortality.
After three years, patients who had received a BMS were more likely to have experienced a variety of negative outcomes including target lesion revascularization, target vessel revascularization and other major adverse cardiac events (MACE). Patients who received BMS were about 83 percent free from MACE, and patients who received DES were about 90 percent free from MACE (p=0.028). All-cause mortality rates, the rates of a heart attack, re-infarction and stroke, were similar in both groups.
However, patients in the DES group were more likely to die from cardiac-related problems. Both DES and BMS had a more than 90 percent rate free from cardiac mortality—with BMS just under 100 percent and approximately 95 percent (p=0.008). Clemmensen said that their less definitive conclusion is based on this “extremely low mortality rate in the BMS arm that would disfavor the DES arm.”
Also, the cumulative incidence of stent thrombosis provided conflicting data. Any stent thrombosis incidence was slightly more than 4 percent with DES, and about 3 percent with BMS (p=0.511). Yet, the definite stent thrombosis incidence rate was about 3 percent with BMS, and slightly under 2 percent with DES.
“The key message here,” said Clemmensen, “is that we have shown that, despite a finding of lower major adverse cardiac events, cardiac mortality was significantly higher in the drug-eluting stent group.”
In his comments on the trial, David R. Holmes, MD, from the Mayo Clinic in Rochester, Minn., noted the difficulty of integrating these results into clinical practice, particularly with STEMI patients. “Is the middle of the night, when your patient is scared, the appropriate time for a discussion with that individual on the benefits and risks of DES compared with BMS?” he questioned. “Being able to provide informed consent in that setting is a very difficult thing.”
Because of this mixed set of results, the researchers recommended further study to determine the long-term effects of DES versus BMS.
“We encourage other trialists to conduct long-term follow-up in their STEMI trials involving drug-eluting stents,” Clemmensen said.
The DEDICATION study received unrestricted grants from Johnson & Johnson, Medtronic, Abbott and Boston Scientific.