DESSOLVE II Results Published for Micell's MiStent

May 7, 2014—Results of the DESSOLVE II study were published by Principal Investigator William Wijns, MD, et al online ahead of print in EuroIntervention. DESSOLVE II is a randomized study of the safety and efficacy of the bioabsorbable polymer-coated, sirolimus-eluting MiStent device (Micell Technologies, Inc.) compared to a zotarolimus-eluting stent (ZES).

As summarized in EuroIntervention, the 2:1 randomized trial enrolled 184 patients implanted with a MiStent (n = 123) or a ZES (n = 61). After stent implantation, all patients underwent quantitative coronary angiography at baseline and at 9-month follow-up, and a select subgroup also underwent optical coherence tomography (OCT). 

The primary efficacy hypothesis was superiority of in-stent late lumen loss (LLL) with the MiStent compared to the ZES. At 9 months, the primary endpoint was met, with a mean in-stent LLL of 0.27 ± 0.46 mm in 103 MiStent patients versus 0.58 ± 0.41 mm in 52 ZES patients (P < .001). 

The proportion of uncovered stent struts as demonstrated on OCT at 9 months was very low in both groups. The mean neointimal thickness of covered struts (P = .002) and percent net volume obstruction (P ≤ .003) were significantly lower in the MiStent group than in the ZES group. Major adverse cardiac events and stent thrombosis rates were low and comparable between the groups.

The investigators concluded that the DESSOLVE II trial showed superiority of the MiStent for the primary efficacy endpoint of 9-month mean LLL compared to ZES. Strut coverage evaluated by OCT was high with both stents, and the clinical safety endpoints, including stent thrombosis, were equally low in both groups, reported the investigators in EuroIntervention.