Biomedical Engineering Reference
In-Depth Information
There were no significant differences in the cumulative rates of death or myocardial
infarction at 4 years.
Another study investigated the effect of SES implantation in a high-risk popula-
tion, i.e., patients who had diabetes and small coronary vessel disease by analyzing
outcomes of the subset of patients who had diabetes and were enrolled in the SES-
SMART, a randomized trial that compared the results of implantation of SESs and
BMSs in small coronary arteries (Ortolani et al.
2005
). The use of SESs was associ-
ated with approximately 60% decreases in the relative incidence of in-segment
angiographic restenosis and in-segment late loss. Angiographic patterns of resteno-
sis were more favorable in the SES group. SES implantation was associated with a
15% absolute decrease in adverse clinical events. In patients who had insulin-
dependent diabetes mellitus, SESs showed a high in-segment restenosis rate (40%)
that was principally due to persistent restenosis. The study concluded that in diabet-
ics with small coronary arteries, SES implantation significantly reduces the inci-
dence of the 8-month angiographic restenosis rate compared with BMS. A pooled
analysis was performed of 1,748 patients in four randomized trials evaluating the
safety of SES as compared with BMS (Spaulding et al. 2007). Results show that the
survival rate at 4 years was 93.3% in the sirolimus-stent group, as compared with
94.6% in the BMS group. In the 428 patients with diabetes, a significant difference
in the survival rate was observed in favor of the BMS group over the SES group.
The lower survival rate among patients with diabetes who were treated with SES
was due to increased numbers of deaths from both cardiovascular and noncardio-
vascular causes. No difference in survival rate was detected among the patients
without diabetes. Rates of myocardial infarction and stent thrombosis were similar
in the two groups. In conclusion, no significant differences were found between the
two treatments in rates of death, myocardial infarction, or stent thrombosis.
In one study, DES implantation for de novo coronary lesions in patients with
significant chronic kidney disease resulted in a lower 1-year incidence of clinical
and angiographic restenosis compared to those with BMS implantation (Jeong et al.
2008
). Review of a large series of patients revealed that the use of DES in the
Swedish “real world” is effective in reducing the clinically driven restenosis rate,
when compared with patients with BMS treatment (Jensen et al.
2006
). In the angio-
graphic follow-up, the average late loss was as low as observed in recent randomized
multicenter trials. A study evaluated 6,033 patients treated with DES and 13,738
patients treated with BMS in 2003 and 2004, using data from the Swedish Coronary
Angiography and Angioplasty Registry (Lagerqvist et al.
2007
). The outcome analy-
sis covering a period of up to 3 years was based on 1,424 deaths and 2,463 myocar-
dial infarctions and was adjusted for differences in baseline characteristics. Results
showed that the two study groups did not differ significantly in the composite of
death and myocardial infarction during 3 years of follow-up. At 6 months, there was
a trend toward a lower unadjusted event rate in patients with DES than in those with
BMS, with 13.4 fewer such events per 1,000 patients. However, after 6 months,
patients with DES had a significantly higher event rate, with 12.7 more events per
1,000 patients per year. At 3 years, mortality was significantly higher in patients with
DES, and from 6 months to 3 years, the adjusted relative risk for death in this group
Search WWH ::
Custom Search