Original Title: Safety and efficacy of everolimus-versus sirolimus-eluting stents: 5-Year results from SORT OUT IV. Reference: Jensen LO et al. J Am Coll Cardiol. 2016;67:751-762.
Reassuring long term outcomes from SORT OUT IV confirm the safety and efficacy of second generation everolimus eluting stents (EES) over first generation DES.
The difference at 5-year follow up detected in this trial, and the particularly significant difference in stent thrombosis in favor of the new generation DES had not been evident in the short term.
The SORT OUT IV 2-year follow up outcomes were published in 2012. Back then, EES resulted non inferior to sirolimus eluting stents (the original gold standard). Even though at present the Cypher sirolimus eluting stent may be obsolete, it was important to compare them in the long term.
The SORT OUT IV trial randomized 2774 patients with heart disease to the everolimus eluting stent Xience V/Promus (n = 1,390; Abbott Vascular, Boston Scientific) vs the sirolimus eluting Cypher Select+ (n = 1,384; Cordis) between August 2007 and June 2009.
The combined primary end point global rate at 5 years was 14% for everolimus eluting stent vs. (p=0.02); however, this difference was not evident in the first year follow up.
Vessel revascularization and lesion revascularization rates showed similar behavior (8.3% vs 10.9%; p=0.02 and 4.8% vs 7%; p=0.01, respectively).
The new generation EES showed a lower definite thrombosis rate(0.4% vs 2.0%; p=0.0004) which had not been obvious at first. However, after 12 months, definite thrombosis resulted clearly lower for EES (0.2% vs 1.4%; p=0.003). All patients presenting very late definite thrombosis were in treatment with aspirin as monotherapy.
Conclusion
At 5 year follow up, EES patients rate was significantly lower than sirolimus eluting patients. This difference was based on a lower very late thrombosis.
Editorial Comment
Patient associated events such as all cause death, any MI, and any revascularization, did were no different when comparing both devices at any time during follow up. Long term outcomes showed differences as regards device associated events such as cardiac death, target vessel infarction or ischemia driven revascularization, and only as from the first year.
