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Randomized Comparison of Everolimus-Eluting and Sirolimus-Eluting Stents in Patients Treated with Percutaneous Coronary Intervention (The SORT OUT IV Trial)
- Source :
- Jensen, L O, Thayssen, P, Hansen, H S, Christiansen, E H, Tilsted, H-H, Krusell, L R, Villadsen, A B, Junker, A, Hansen, K N, Kaltoft, A, Maeng, M, Pedersen, K E, Kristensen, S D, Bøtker, H E, Ravkilde, J, Sanchez, R, Aarøe, J, Madsen, M, Sørensen, H T, Thuesen, L & Lassen, J F 2012, ' Randomized Comparison of Everolimus-Eluting and Sirolimus-Eluting Stents in Patients Treated with Percutaneous Coronary Intervention (The SORT OUT IV Trial) ', Circulation, pp. 1246-55 . https://doi.org/10.1161/CIRCULATIONAHA.111.063644
- Publication Year :
- 2012
-
Abstract
- BACKGROUND: 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. METHODS AND RESULTS: The Scandinavian Organization for Randomized Trials with Clinical Outcome IV trial was a randomized multicenter, single-blind, all-comer, two-arm, non-inferiority trial comparing the everolimus-eluting stent with the sirolimus-eluting stent in patients with coronary artery disease. The primary end point was a composite of safety (cardiac death, myocardial infarction, definite stent thrombosis) and efficacy (target vessel revascularization) parameters. The non-inferiority criterion was a risk difference of 0.015. Intention-to-treat analyses were done at 9-month and 18-month follow-up. 1,390 patients were assigned to receive the everolimus-eluting stent, and 1,384 patients were assigned to receive the sirolimus-eluting stent. At 9-month follow-up, 68 [4.9%] patients treated with the everolimus-eluting stent versus 72 [5.2%] patients treated with the sirolimus-eluting stent experienced the primary end point (hazard ratio (HR) =0.94; 95% confidence interval (CI): 0.67-1.31) (p for non-inferiority=0.01). At 18-month follow-up, this differential remained: 99 [7.2%] patients treated with the everolimus-eluting stent versus 105 [7.6%] (HR=0.94, 95% CI: 0.71-1.23). At 9-month follow-up, rate of definite stent thrombosis was higher in the sirolimus-eluting group (2 [0.1%] patients versus 9 [0.7%] patients, (HR=0.22, 95% CI:0.05-1.02)).At 18-monthfollow-up, this difference was sustained (3 [0.2%] patients versus 12 [0.9%] patients; (HR=0.25, 95% CI:0.07-0.88). CONCLUSIONS: The everolimus-eluting stent was found to be non-inferior to the sirolimus-eluting stent. CLINICAL TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov; NCT00552877.
- Subjects :
- surgical procedures, operative
cardiovascular diseases
equipment and supplies
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Journal :
- Jensen, L O, Thayssen, P, Hansen, H S, Christiansen, E H, Tilsted, H-H, Krusell, L R, Villadsen, A B, Junker, A, Hansen, K N, Kaltoft, A, Maeng, M, Pedersen, K E, Kristensen, S D, Bøtker, H E, Ravkilde, J, Sanchez, R, Aarøe, J, Madsen, M, Sørensen, H T, Thuesen, L & Lassen, J F 2012, ' Randomized Comparison of Everolimus-Eluting and Sirolimus-Eluting Stents in Patients Treated with Percutaneous Coronary Intervention (The SORT OUT IV Trial) ', Circulation, pp. 1246-55 . https://doi.org/10.1161/CIRCULATIONAHA.111.063644
- Accession number :
- edsair.pure.au.......59a1428e1b840de682152854c70610b1