News:Drug eluting stents: GRACE Analysis Shows Five Times Higher Mortality Rate Between Six Months and Two Years Among Patients Receivng DES

September 5, 2007 By Scott P. Williams [mailto:swilliams@perfuse.org]

The GRACE registry gathered data comparing survival outcomes for patients receiving DES vs BMS. Currently the study has collected post-PCI data from 6600 patients from 94 hospitals in 14 countries.

For their analysis, Steg and his research pulled data from the GRACE registry on all STEMI patients treated with DES or BMS between 2004 and 2006. The data set included 569 patients treated with DES and 1729 patients treated with BMS.

In the first six months following a PCI, the research group observed no significant difference in patient survival rates between the two types of stents (hazard ratio = 0.988, p=0.9708). Between six months and two years though, the analysis demonstrated a statistically significant difference in mortality rates for the two sets of patients. During this time period 8.6% of patients receiving DES died, compared to only 1.6% of patients receiving BMS (p=0.001). It is unclear at this time if all deaths were cardiovascular. Furthermore, when the GRACE risk score, number of dilated vessels, diabetes, and type of PCI were adjusted for a hazard ratio of 6.691 was observed (p=0.002).

Confirmatory findings in STEMI patients were not observed in a large Swedish Registry of 35,000 patients. Finally, randomized studies such as the TYPHOON study which compared the safety of DES and BMS in STEMI did not identify an increased risk of mortality.

Steg et al. suggest that the higher rate of mortality among patients treated with DES could be due to the greater potential for the formation of gaps between the stent and the vessel wall sometimes observed with DES (late malaposition). This delay in reendothelialization can predispose patients receiving DES to late stent thrombosis.

Steg and associates highlighted that the results of their analysis do not apply to non-STEMI patients. Among the non-STEMI patients recorded in the GRACE registry the mortality rate was 3.9% for patients receiving DES and 2.9% for patients receiving BMS during the six month to two year time period (p=0.5).

The study was limited by the lack of information regarding the type of DES or BMS used in the procedures. Additionally, the GRACE registry does not record the complexity characteristics of stented lesions.

The study’s results suggest that BMS may be a safer treatment option for STEMI patients than are DES due to better long term outcomes. Further long-term research is required to better understand the proper and best use of DES.

The analysis was funded by Sanofi-Aventis.