Sirolimus- vs. Everolimus-Eluting Stent After PCI

Feb 13, 2018
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Authors:
de Winter RJ, Katagiri Y, Asano T, et al.
Citation:
A Sirolimus-Eluting Bioabsorbable Polymer-Coated Stent (MiStent) Versus an Everolimus-Eluting Durable Polymer Stent (Xience) After Percutaneous Coronary Intervention (DESSOLVE III): A Randomised, Single-Blind, Multicentre, Non-Inferiority, Phase 3 Trial. Lancet 2018;391:431-40.
Summary By:
Hitinder S. Gurm, MBBS, FACC

Study Questions:

What is the safety and efficacy of the MiStent compared with the everolimus-eluting durable polymer stent?

Methods:

The authors performed a randomised, single-blind, multicentre study (DESSOLVE III) at 20 hospitals in Europe comparing a sirolimus-eluting bioresorbable polymer stent (MiStent) to an everolimus-eluting durable polymer stent (Xience). The primary endpoint was a noninferiority comparison of a device-oriented composite endpoint—cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization at 1 year.

Results:

The study enrolled a total of 1,398 patients with 2,030 lesions, of whom 703 patients with 1,037 lesions were assigned to MiStent, and 695 patients with 993 lesions were assigned to the Xience stent. The primary endpoint at 1 year occurred in 40 patients (5.8%) in the sirolimus-eluting stent group and in 45 patients (6.5%) in the everolimus-eluting stent group (absolute difference, -0.8%; 95% confidence interval, -3.3 to 1.8; pnoninferiority = 0.0001). The rate of definitive or probable stent thrombosis (0.7% vs. 0.9%) was low and did not differ between the two groups.

Conclusions:

The sirolimus-eluting bioabsorbable polymer stent was noninferior to the everolimus-eluting durable polymer stent.

Perspective:

MiStent is a novel drug-eluting stent with an absorbable polymer coating and microcrystalline form of sirolimus. The bioabsorbable coating disappears in 3 months, but sirolimus persists in the vessel walls for up to 9 months. There are theoretical advantages to this approach and this study appears to confirm these assumptions. This study demonstrated excellent outcome with the MiStent and a performance comparable to an excellent second-generation drug-eluting stent. Further studies with longer follow-up are needed to establish the clinical utility of this stent in clinical practice.

Keywords: Absorbable Implants, Drug-Eluting Stents, Myocardial Infarction, Myocardial Revascularization, Percutaneous Coronary Intervention, Polymers, Sirolimus, Stents, Thrombosis


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