Twelve-Month Results Published From DESSOLVE III Trial of Micell's MiStent

 

December 6, 2017—Micell Technologies, Inc. announced that 12-month results from the DESSOLVE III clinical trial of the company's MiStent, a sirolimus-eluting bioabsorbable polymer-coated stent, were published by Prof. Robbert J. de Winter, MD, et al online ahead of print in The Lancet.

Working with the European Cardiovascular Research Institute, Prof. de Winter, along with Prof. Patrick Serruys, MD, and Prof. William Wijns, MD, composed the steering committee that oversaw the DESSOLVE III study design and conduct.

The phase 3 trial met its primary endpoint, showing noninferior safety and efficacy outcomes in a complex patient population for the MiStent device versus the Xience everolimus-eluting coronary stent system (Abbott Vascular).

According to Micell, DESSOLVE III is a prospective, balanced, randomized, controlled, single-blind, multicenter, all-comers study composed of approximately 1,400 patients. The primary endpoint of the trial was a noninferiority comparison of target lesion failure at 12 months after the procedure for the MiStent group versus the Xience group.

Patients in DESSOLVE III had symptomatic coronary artery disease, including chronic stable angina, silent ischemia, or acute coronary syndrome (both non–ST-elevation myocardial infarction and ST-elevation myocardial infarction), and qualified for percutaneous coronary interventions.

MiStent met the endpoint with numerically lower target lesion failure (P = .0001 for noninferiority) and target lesion revascularization rates. Target lesion revascularization rates for MiStent were numerically lower at all time points following the procedure, and at 1 year, the difference increased to 1.2%. In addition, MiStent maintained numerically lower rates of definite or probable stent thrombosis at 12 months.

The investigators also reported positive 6-month outcomes in a DESSOLVE III substudy focused on optical coherence tomographic images showing that neointimal hyperplasia volume obstruction was statistically lower for MiStent versus Xience (15 + 4.1% vs 18.9 + 6.2%; P = .0081). Additionally, abluminal neointimal hyperplasia volume and area were both significantly lower with MiStent versus Xience by 13 mm3 (P = .015) and 0.33 mm2 (P = .0022), respectively. Images for both MiStent-treated lesions and Xience-treated lesions showed equal and nearly complete strut coverage.

In the company's press release, Prof. Serruys commented, "These important results show positive clinical benefits in MiStent's performance versus a market-leading drug-eluting coronary stent. MiStent's unique combination of a crystalline drug formulation and a fast-dissolving polymer stent coating has provided a beneficial point of clinical differentiation."

In May 2017, Prof. de Winter presented the 12-month DESSOLVE III data during a late-breaking trials session at EuroPCR in Paris, France. Enrollment in DESSOLVE III was completed in December 2015.

The MiStent device received European CE Mark approval in 2013 and was launched in Europe in February 2015. It is not approved for sale in the United States, the company advised.

 

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Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing comprehensive coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. Cardiac Interventions Today premiered in March 2007 and each edition contains a variety of topics in a flexible format, including articles covering various perspectives on current clinical topics, in-depth interviews with expert physicians, overviews of available technologies, industry news, and insights into the issues affecting today's interventional cardiology practices.