Advertisement
Three of these analyses sought to assess the long-term impact of theCYPHER(R) Stent when the patient with multivessel disease was also diabetic,the length of the blockage was more than 100 mm or the arterial blockage waslocated in a junction between a main artery and a side-branch artery, a typeof blockage also known as bifurcation. A fourth analysis reported the overallincidence of stent thrombosis in the data set using the Academic ResearchConsortium (ARC) definitions.
Advertisement
These analyses based their results on data from the ArterialRevascularization Therapy Study I and II (ARTS I and II Studies). The ARTS IStudy was conducted in 1997 and compared the results of a bare metal stent tothose obtained with bypass surgery. The ARTS II Study included 607 patientsfrom 45 European centers treated with the CYPHER(R) Stent. Investigatorscompared the findings for these patients to those from the ARTS I Study, whichincluded 605 patients treated with bypass surgery and 600 treated with a baremetal stent.
"These analyses contribute significantly to medical understanding ofclinical outcomes for the CYPHER(R) Stent in patients with multivesseldisease, who remain one of the most complex patient populations with coronaryartery disease to treat," said Principal Investigator Patrick W. Serruys,M.D., Ph.D., from Thoraxcenter, Erasmus Medical Center in The Netherlands, whopresented one of the analyses at the congress.
In the subgroup analysis of diabetic patients (367 patients or 20 percentof the total ARTS I and II patient populations), clinical investigators foundsimilar rates of freedom from major adverse cardiac and cerebrovascular events(MACCE) for the CYPHER(R) Stent and bypass surgery out to three years offollow-up. This finding is significant as MACCE -- comprised of death, stroke,myocardial infarction (heart attack) and the need for revascularization (re-treatment) of the blocked artery -- at one-year follow-up was the primaryendpoint of the ARTS II Study. Specifically, 72.1 percent of the diabeticpatients who received the CYPHER(R) Stent remained free of MACCE three yearsafter the procedure, compared to 82.2 percent of the patients in the bypasssurgery arm (p=0.09). Additionally, the CYPHER(R) Stent performedsignificantly better than the bare metal stent arm during the same endpoint,as 52.7 percent of the patients who received a bare metal stent did notexperience a MACCE event after three years. The difference between theCYPHER(R) Stent arm and the bare metal stent arm reached statisticalsignificance (p=0.0003).
Clinical investigators also reported no significant impact on MACCE whenCYPHER(R) Stents were implanted in patients with blockages that measured morethan 100 mm in length (20 percent of the ARTS II patient population).According to this subgroup analysis, 75.8 percent of these patients remainedfree of MACCE out to three years of follow-up, compared to 82.5 percent of thepatients who received CYPHER(R) Stents measuring 100 mm or less in length (p=0.15).
A third analysis showed that implantation of the CYPHER(R) Stent inbifurcations did not affect clinical outcomes. The rate of freedom-from-MACCEfor patients who received a CYPHER(R) Stent to treat a bifurcation (53.4percent of the overall patient population) was 79.8 percent, compared to 81.5percent when the implantation did not take place in a bifurcation (p=0.61).The clinical investigators also found that neither the type of bifurcation(true/substantial or partial) nor the stent implantation strategy (on
