DES bests BMS in diabetic patients
NEW ORLEANS—Drug-eluting stents (DES) are associated with decreased rates of death, MI and revascularization, compared to bare-metal stents (BMS) in a diabetic population, according to results from the MASS-DAC Registry presented Monday during the late breaking clinical trials at the American Heart Association (AHA) Scientific Sessions, and simultaneously published in Circulation.
Laura Mauri, MD, principal investigator of the study, from Brigham and Women’s Hospital and Harvard Medical School in Boston, presented the data from the Drug-eluting and Bare Metal Stenting in Patients with Diabetes Mellitus: Results from the Mass-DAC Registry.
Researchers used data from a mandatory state registry, identifying 5,051 diabetics who underwent PCI at acute-care, non-federal hospitals between April 2003 and September 2004. Diabetic patients at those hospitals were about twice as likely to get DES compared to BMS (66.1 percent vs. 33.9 percent), according to Mauri.
At three years of follow-up, the unadjusted cumulative endpoint of death was 14.4 percent for DES patients compared to 22.2 percent for BMS patients, Mauri said. She stressed that the study was initially powered to assess the safety implications of DES compared to BMS.
The researchers matched a subset of 1,476 DES and 1,476 BMS patients to control for 63 potential confounders such as concurrent conditions and medications. In that comparison, they found the risk-adjusted mortality at three years was 17.5 percent for DES patients compared to 20.7 percent—a small, but significant 3.2 percent absolute reduction in mortality in DES patients with no excess adverse events, according to Mauri.
Although three-year data were not yet available for rates of heart attack and target vessel revascularization, she said those rates were lower in the DES group compared to the BMS group at two years of follow-up.
Mauri noted that previous studies have indicated that DES reduce the rate of restenosis, but there has been controversy about their safety because of conflicting evidence from smaller studies. She noted that some of those studies found higher mortality associated with DES while others found no safety differences between the two types of stents, however this study showed lower mortality and adverse events.
David O. Williams, MD, from Rhode Island Hospital in Providence, R.I., who commented on the study, said that the hesitation about using PCI in this patient population has been its association with repeat revascularization, which is why he said this is an important patient subset with very aggressive coronary disease.
He also noted that there were no significant differences between sirolimus-eluting stents (Cordis’ Cypher) and paclitaxel-eluting stents (Boston Scientific’s Taxus)—which were the two only stents available during the study period.
“It’s appropriate to conclude that DES are superior to BMS in patients with diabetes in regard to reducing the need for repeat revascularization. It also appears to be safe to conclude that there is no excess death or MI among patients receiving DES. In fact, these provocative findings show that there is a benefit to using DES,” Williams concluded.
Laura Mauri, MD, principal investigator of the study, from Brigham and Women’s Hospital and Harvard Medical School in Boston, presented the data from the Drug-eluting and Bare Metal Stenting in Patients with Diabetes Mellitus: Results from the Mass-DAC Registry.
Researchers used data from a mandatory state registry, identifying 5,051 diabetics who underwent PCI at acute-care, non-federal hospitals between April 2003 and September 2004. Diabetic patients at those hospitals were about twice as likely to get DES compared to BMS (66.1 percent vs. 33.9 percent), according to Mauri.
At three years of follow-up, the unadjusted cumulative endpoint of death was 14.4 percent for DES patients compared to 22.2 percent for BMS patients, Mauri said. She stressed that the study was initially powered to assess the safety implications of DES compared to BMS.
The researchers matched a subset of 1,476 DES and 1,476 BMS patients to control for 63 potential confounders such as concurrent conditions and medications. In that comparison, they found the risk-adjusted mortality at three years was 17.5 percent for DES patients compared to 20.7 percent—a small, but significant 3.2 percent absolute reduction in mortality in DES patients with no excess adverse events, according to Mauri.
Although three-year data were not yet available for rates of heart attack and target vessel revascularization, she said those rates were lower in the DES group compared to the BMS group at two years of follow-up.
Mauri noted that previous studies have indicated that DES reduce the rate of restenosis, but there has been controversy about their safety because of conflicting evidence from smaller studies. She noted that some of those studies found higher mortality associated with DES while others found no safety differences between the two types of stents, however this study showed lower mortality and adverse events.
David O. Williams, MD, from Rhode Island Hospital in Providence, R.I., who commented on the study, said that the hesitation about using PCI in this patient population has been its association with repeat revascularization, which is why he said this is an important patient subset with very aggressive coronary disease.
He also noted that there were no significant differences between sirolimus-eluting stents (Cordis’ Cypher) and paclitaxel-eluting stents (Boston Scientific’s Taxus)—which were the two only stents available during the study period.
“It’s appropriate to conclude that DES are superior to BMS in patients with diabetes in regard to reducing the need for repeat revascularization. It also appears to be safe to conclude that there is no excess death or MI among patients receiving DES. In fact, these provocative findings show that there is a benefit to using DES,” Williams concluded.