Less Definite Thrombosis with Everolimus Eluting Stents

Original title: Three-Year Outcomes After Revascularization With Everolimus-and Sirulimus -Eluting Stents From the SORT OUT IV Trial. Reference: Lisette Okkels Jensen et al. J Am CollCardiolIntv, 2014;7: 840-8.

Drug eluting stents (DES) have been shown to safely and effectively reduce restenosis compared to bare-metal stents. While the risk of thrombosis remains a matter of concern when it comes to first generation DES, several studies have shown reduced thrombosis risk with second generation stents. This study compared the safety and efficacy of sirolimus (SES) vs. everolimus (EES) eluting stents as to late thrombosis at 3 year follow up of a SORT OUT IV group of patients. 

2,774 patients were randomized, 1,390 to EES and 1,384 to SES, all of them with stable angina or acute coronary syndrome and, at least, one >50% lesion. Primary end point was MACE and definite thrombosis. Double antiagregation therapy was administered from stenting procedure to one year. The clinical characteristics of both groups were similar.

At 3 years, MACE occurred in 9.8% of EES patients and 11.1% of SES patients. We also observed a definite thrombosis rate of 0.2% in EES patients vs. 1.4% in SES patients, attributable to very late thrombosis (> 12 months) in 0.1% EES vs. 0.8% SES.

Conclusion

The 3 year follow up did no show superiority as regards MACE; however, it did find a significant reduction of in-stent thrombosis presentation, both global and very late in the EES group, especially the latter. 

Editorial Comment

The SORT OUT IV, as well as the following studies that used their data to assess the efficacy of both stents in different subgroups, obtained similar MACE rates. This is the first time both stents are compared to assess their performance with respect to very late thrombosis. The study showed a significant reduction of in-stent thrombosis in the EES group that maximized in the late stages of treatment, when patients were on-aspirin only. The number of thrombosis events in both groups was not enough to modify MACE rates, but with a larger population, this figures would also have seen a reduction.

Courtesy of Dr. Alfonso Francisco Balaguer Quiroga.
Interventional Cardiologist. International Clinic. Lima, Perú.

Alfonso Francisco Balaguer Quiroga

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