Major adverse cardiac events (MACE) were significantly lower in patients who had everolimus-eluting stents (EES) compared with patients who had sirolimus-eluting stents (SES), according to the 5-year follow-up data of a Scandinavian clinical trial.
The results, recently published in the Journal of American College of Cardiology, indicated that definite stent thrombosis was lower in the group with EES vs SES (0.4% vs 2.0%; hazard ratio [HR]: 0.18; 95% confidence interval [CI]: 0.07-0.46). Within the first year, MACE did not significantly differ between the 2 groups, but between 1 year and 5 years, EES had the lower rate (HR: 0.71; 95% CI: 0.55-0.90; P=.006; P interaction=.12).
A total of 2771 patients were followed up at 5 years. The primary end point was a composite of MACE, including cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), and definite stent thrombosis. All patients had chronic stable coronary artery disease or acute coronary syndromes, and had at least 1 coronary lesion with stenosis of more than 50% diameter that required treatment with a drug-eluting stent (DES).
All death, all MI, or any revascularization occurred in 353 patients (25.4%) who were treated with EES compared with 389 patients (28.1%) treated with SES (HR: 0.89; 95% CI: 0.77-1.03). Stent-related outcomes of cardiac death, target vessel MI, or ischemia-driven TLR occurred in 127 patients (9.2%) with EES vs 158 patients (11.6%) with SES. Both sets of end points did not different within the first year. However, as time went on, the stent-related outcome rate dropped with EES treatment compared with SES treatment (HR: 0.67; 95% CI: 0.50-0.91; P interaction=.09).
“The long-term safety and efficacy of coronary stents in everyday clinical practice need continuous assessment,” researchers wrote. They noted that the evolution of stents—from first to second generation—was born in part out of necessity to decrease the risk of late and very late stent thrombosis.
Meta-analyses of clinical trials such as RESOLUTE have demonstrated that the thin-strut EES may be linked to lower rates of definite stent thrombosis compared with other DES, and surprisingly, even lower than bare metal stents. “The notion of a DES being safer than a bare metal stent represents a paradigm shift in the evolution of PCI,” researchers stated. “Combined, the results obtained with long-term follow-up and the SORT OUT IV confirm the fact that the second-generation EES has a better long-term safety profile than the first-generation SES.”
“Future research should address the pathophysiology of late stent thrombosis in patients with drug-eluting coronary stents,” they concluded, “and determine whether these stents different from thrombotic events occurring within the first year after deployment.”
Jensen LO, Thayssen P, Christiansen EH, et al; for the SORT OUT IV Investigators. Safety and efficacy of everolimus- vs sirolimus-eluting stents: 5-year results from SORT OUT IV. J Am Coll Cardiol. 2016;67(7):751-762. doi: 10.1016/j.jacc.2015.11.051.