Micell Technologies Highlights Data From Published Propensity Analysis of MiStent SES® and Market Standard Xience V® Coronary Stent

Publication in American Journal of Cardiology Demonstrates Reduced Target Lesion Revascularization Rates at One and Three Years Post-Treatment Compared to Durable Polymer Everolimus-Eluting Stent 

DURHAM, N.C., Micell Technologies, Inc. announced that data have been published from a retrospective cross-study propensity analysis comparing MiStent^® Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES) to XIENCE V Everolimus Eluting Coronary Stent System (Xience). The lead author on this paper is Alexandra J. Lansky, M.D., Director, Yale Cardiovascular Clinical Research Program, Yale School of Medicine, New Haven, Conn. The analysis was conducted independently by Dr. Lansky and Dr. Robert A. Byrne, Interventional Cardiologist, German Heart Centre, Munich, Germany with funding from Micell Technologies, MiStent's developer. The paper, "Comparison of the Absorbable Polymer Sirolimus-Eluting Stent (MiStent) to the Durable Polymer Everolimus-Eluting Stent (Xience) (from the DESSOLVE I/II and ISAR-TEST-4 Studies),” was published by The American Journal of Cardiology. The abstract is available online.

The objective of the propensity analysis was to account for baseline differences in patient risk by comparing clinical outcomes of the MiStent SES to the Xience, a durable polymer coated everolimus-eluting cobalt chromium coronary stent, at 12 months and annually up to three years post-implantation. The pre-specified primary endpoint was target lesion failure (TLF) at 12 months and three years comparing pooled data from the DESSOLVE I and DESSOLVE II studies of MiStent SES to the everolimus-eluting Xience arm of the ISAR-TEST-4 study using pre-specified baseline and lesion characteristics. Clinical and angiographic endpoints were compared between the two treatment groups in the matched cohort. Secondary clinical endpoints included the patient-oriented composite of major adverse cardiac events defined as death, myocardial infarction (MI), and target vessel revascularization. More than 800 patients (MiStent = 153 and Xience = 652) were included, with propensity matching in 204 (MiStent and Xience = 102 each).

The propensity-matched analysis demonstrated reduced TLF and target lesion revascularization (TLR) rates at one and three years for MiStent SES as compared to the Xience stent. There was no significant difference in target vessel myocardial infarction (MiStent 1% versus Xience 2%, p=0.57) nor in definite/probable stent thrombosis (MiStent 0% versus Xience 1%, p=0.31). 

At three years, there were no differences between the groups in cardiac death (MiStent 2.0% versus Xience 2.1%, p>0.99), or in target vessel myocardial infarction (MiStent 2.0% versus Xience 3.1%, p=0.34). There were no additional late or very late stent thromboses in either group.

"Based on data from a well-matched patient population with three-year follow up, MiStent's unique drug-release kinetic may confer benefit within the first year, compared with the benchmark Xience stent,” said Alexandra Lansky, M.D.  "In addition, it appears that this benefit is sustained up to three years.”

These results, hypothesized to be due to MiStent's improved device design, are being confirmed by DESSOLVE III, a 1,400 patient, 20 center, all-comers randomized clinical trial, which completed enrollment in December 2015.  The DESSOLVE III trial also includes an optical coherence tomography (OCT) sub-study evaluation of 60 patients at six and 24 months post-treatment to evaluate and compare for superiority of MiStent SES against Xience in the progression of in-stent percent volume obstruction and frequency of neoatheroma formation over time.

Dennis Donohoe, M.D., Micell's Chief Medical Advisor said, "Given the scarcity of randomized trial data, we felt comparing MiStent to a market leader would provide valuable information to the physician community. We are grateful to Dr. Lansky and her colleagues for conducting a rigorous assessment of data spanning three years and including hundreds of patients. We are encouraged that their findings provide preliminary evidence of the favorable safety and effectiveness of MiStent versus Xience.”

MiStent SES has CE Mark in the European Union and is being distributed exclusively by STENTYS around the world with the exception of the United States, Canada, China, South Korea and Japan. STENTYS is currently conducting a controlled launch in select countries in Western Europe, the Middle East and Asia.

Source: Micell Technologies