Micell's MiStent Achieves Primary Endpoint in All-Comers DESSOLVE III Trial
May 16, 2017—Micell Technologies, Inc. announced that positive 12-month data from its DESSOLVE III clinical trial were presented by Prof. Robbert J. de Winter, MD, during a late-breaking trials session at EuroPCR in Paris, France. The study met its primary endpoint, showing noninferior safety and effectiveness outcomes in a complex patient population for the company's MiStent sirolimus-eluting absorbable polymer coronary stent system versus the Xience everolimus-eluting coronary stent system (Abbott Vascular).
The MiStent device received European CE Mark approval in 2013 and was launched in February 2015. It is not approved for sale in the United States. Micell's supercritical fluid technology platform allows a drug in microcrystalline form to be combined with a fast-dissolving polymer and applied as a coating on an ultrathin-strut cobalt-chromium stent.
According to the company, DESSOLVE III is a prospective, balanced, randomized, controlled, single-blind, multicenter, all-comers study comprising 1,400 patients. Enrollment was completed in December 2015. The presentation at EuroPCR 2017 highlighted 12-month primary endpoint outcomes.
The company explained that the trial is composed of patients who have symptomatic coronary artery disease, including those with chronic stable angina, silent ischemia, or acute coronary syndrome (including non–ST-segment elevation myocardial infarction and ST-segment elevation myocardial infarction) and who qualified for percutaneous coronary intervention. The primary endpoint was a noninferiority comparison of target lesion failure (TLF) for the MiStent group versus the Xience group at 12 months postprocedure.
In Micell's announcement, Prof. de Winter commented, "MiStent met the primary noninferiority endpoint of TLF at 12 months, with numerically lower TLF and target lesion revascularization (TLR) rates. TLR rates for MiStent were numerically lower at all time points following the procedure, and by 1 year, that difference grew to 1.2%."
Prof de Winter continued, "These results speak to the potential value of slower, controlled drug release allowing for sustained drug presence. These trial results, in conjunction with the 5-year results from the DESSOLVE I and II studies, provide further evidence of the potential value of this technology relative to current DES performance expectations from the perspectives of both safety and efficacy."
DESSOLVE III is being conducted independently by the European Cardiovascular Research Institute in Rotterdam, the Netherlands. The trial is supported by Micell Technologies. The study design and conduct were overseen by a steering committee including Professors Patrick Serruys, MD; Robbert de Winter, MD; and William Wijns, MD.
Findings on the MiStent technology were also featured in a EuroPCR session on novel drug-eluting stent technologies. Professor Krzysztof Milewski, MD, highlighted positive outcomes from assessments of optical coherence tomography (OCT) images from MiStent and Xience patients at 6 months in the DESSOLVE III OCT substudy. Prof. Milewski is Lead Investigator of the study.
Neointimal hyperplasia volume obstruction was statistically lower for MiStent compared to Xience (15% ± 4.1% vs 18.9% ± 6.2%; P < .01). Similarly, both abluminal neointimal hyperplasia volume and area were significantly better with MiStent by 13.3 mm3 (P = .02) and 0.33 mm2 (P < .01), respectively. Both groups demonstrated equal and almost complete strut coverage.
Prof. Milewski commented in Micell's announcement, "We observed a statistically significant difference in favor of MiStent. These OCT data further demonstrate that the unique pharmacokinetics of MiStent, with its microcrystalline sirolimus, reduce the factors that lead to late lumen loss requiring vessel revascularization."