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Everolimus-eluting stent on par with sirolimus-eluting stent in CAD patients

Reuters Health • The Doctor's Channel Daily Newscast

NEW YORK (Reuters Health) – The everolimus-eluting stent and the sirolimus-eluting stent are equally safe and efficacious in patients with coronary artery disease, the SORT OUT IV Trial investigators reported online February 3 in Circulation.

“Among drug-eluting stents released to date, the sirolimus-eluting stent has demonstrated the least amount of late lumen loss, but its efficacy and safety have not been compared head-to-head with the next-generation everolimus-eluting stent,” writes Dr. Lisette Okkels Jensen, from Odense University Hospital, Denmark, and colleagues.

Their study they say is the first head-to-head comparison of the everolimus-eluting stent and the sirolimus-eluting stent in patients with coronary artery disease. The study was a “randomized multicenter, single-blind, all-comer, two-arm, non-inferiority trial.”

A total of 1,390 patients were assigned to receive the everolimus-eluting stent and 1,384 to receive the sirolimus-eluting stent. Intention-to-treat analyses were done at 9-month and 18-month follow-up.

At 9-months, rates of death, cardiac death, myocardial infarction, and clinically driven target vessel and target lesion revascularization did not differ significantly between the two stent groups. This composite primary end point was met by 68 patients (4.9%) in the everolimus group and 72 (5.2%) in the sirolimus group.

“Non-inferiority of the everolimus stent was established, with a 9-month absolute risk difference of -0.3% and the upper limit of one-sided 95% confidence interval at 1.1% (one-sided p value for non-inferiority=0.02),” team reports.

There were also no between-group differences in the composite primary end point at 18 months; 99 patients (7.2%) treated with the everolimus stent vs 105 (7.6%) treated with the sirolimus stent (HR 0.94).

The investigators note that the rate of definite stent thrombosis was lower in the everolimus-eluting stent group at 9 months (2 patients [0.1%] vs 9 patients [0.7%] in the sirolimus group; p=0.053) and at 18 months (3 patients [0.2%] vs 12 patients [0.9%]; p=0.03). They emphasize, however, that this was a secondary end point, it needs to be replicated to be sure it was not a spurious result and until then, the result “should be interpreted with caution.”

The sirolimus-eluting stent is considered the most validated and efficient of first-generation drug-eluting stents, the authors note. This study, they say, documents the “non-inferiority of the everolimus-eluting stent overall and across a variety of patient and lesion subgroups the two treatments yielded similar composite endpoint results, including the presence of diabetes, acute coronary syndrome, complex lesions and multivessel disease.”

The study was supported by unrestricted grants from Abbott Vascular, Boston Scientific and Cordis, Johnson & Johnson. The companies did not have a role in the study design, or data collection, analysis, or interpretation of results. Several authors have disclosed financial relationships with drug companies. A complete list can be found with the original article.

SOURCE:

Randomized Comparison of Everolimus-Eluting and Sirolimus-Eluting Stents in Patients Treated with Percutaneous Coronary Intervention (The SORT OUT IV Trial)

Circulation 2012