The everolimus eluting stent (EES) was shown to be non-inferior to the sirolimus stent (SES) with respect to target-lesion revascularisation and angiographic in-segment late loss at eight to 12 months, according to the RESET trial reported in yesterday’s Hot Line session.
Although SES is no longer widely used, said study presenter Professor Takeshi Kimura (pictured right) from Kyoto University Hospital in Japan, it represents the most extensively studied first generation drug eluting stent (DES), and should therefore be regarded as a benchmark for all current and future generation DES.
The Randomised Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial (RESET) trial, randomised 3197 patients between February and July 2010 to either EES (n=1567) or SES (n=1600). An angiographic sub-study evaluating in-segment late lumen loss and angiographic restenosis was performed at eight months in 571 patients.
Subjects were enrolled from 100 Japanese centres, and this all-comers study constitutes the largest trial comparing EES with SES to date.
Results for target lesion revascularisation procedures at one year were 65 (4.3%) in the EES group and 76 (5.0) in the SES group (P non-inferiority <0.0001). Furthermore, the cumulative distribution curves for in-segment late loss were 0.03 mm for the SES stent versus 0.07 for the EES stent (P non-inferiority <0.0001) and in-stent late loss was 0.14 for the SES and 0.16 for the EES (P=0.53).
In a prespecified subgroup analysis no statistical difference was found for target lesion revascularisation between the two groups in diabetic patients, those over 75, and those having hemodialysis. The subgroup analysis, however, did show that in diabetic patients treated with insulin use of the EES was associated with significantly lower target lesion revascularisation (P=0.03); and a trend favouring the SES was found in patients with multivessel disease having PCI (P=0.07).
“One year clinical outcome after both EES and SES use was excellent, with low rates of target-lesion revascularisation and very low rates of stent thromobosis,” said Kimura.
Longer-term follow-up, he added, was important to address whether EES could positively affect the late adverse events beyond one year reported after SES implantation, such as late restenosis and very late stent thrombosis. He said that, despite the all-comers trial design, the population enrolled in the study represented a relatively low-risk group of patients, resulting in lower event rates than anticipated. Future stent trials, he added, should now focus on more complex patients in whom CABG could be considered a reasonable alternative.
The Randomised Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial (RESET) trial, randomised 3197 patients between February and July 2010 to either EES (n=1567) or SES (n=1600). An angiographic sub-study evaluating in-segment late lumen loss and angiographic restenosis was performed at eight months in 571 patients.
Subjects were enrolled from 100 Japanese centres, and this all-comers study constitutes the largest trial comparing EES with SES to date.
Results for target lesion revascularisation procedures at one year were 65 (4.3%) in the EES group and 76 (5.0) in the SES group (P non-inferiority <0.0001). Furthermore, the cumulative distribution curves for in-segment late loss were 0.03 mm for the SES stent versus 0.07 for the EES stent (P non-inferiority <0.0001) and in-stent late loss was 0.14 for the SES and 0.16 for the EES (P=0.53).
In a prespecified subgroup analysis no statistical difference was found for target lesion revascularisation between the two groups in diabetic patients, those over 75, and those having hemodialysis. The subgroup analysis, however, did show that in diabetic patients treated with insulin use of the EES was associated with significantly lower target lesion revascularisation (P=0.03); and a trend favouring the SES was found in patients with multivessel disease having PCI (P=0.07).
“One year clinical outcome after both EES and SES use was excellent, with low rates of target-lesion revascularisation and very low rates of stent thromobosis,” said Kimura.
Longer-term follow-up, he added, was important to address whether EES could positively affect the late adverse events beyond one year reported after SES implantation, such as late restenosis and very late stent thrombosis. He said that, despite the all-comers trial design, the population enrolled in the study represented a relatively low-risk group of patients, resulting in lower event rates than anticipated. Future stent trials, he added, should now focus on more complex patients in whom CABG could be considered a reasonable alternative.