DURHAM, N.C., Feb. 25, 2016 /PRNewswire/ -- 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).
| MiStent SES (n=102) |
Xience (n=102) |
P-Value |
|
| TLF – 1 Year |
3.0% |
8.0% |
0.08 |
| TLF – 3 Year |
5.0% |
12.5% |
0.07 |
| TLR – 1 Year |
1.0% |
6.0% |
0.05 |
| TLR – 3 Year |
2.0% |
8.4% |
0.04 |
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.
About MiStent SES
MiStent SES® is designed to optimize healing in patients with coronary artery disease. The rapidly absorbable coating of the MiStent SES, which contains crystalline drug (sirolimus) and an absorbable polymer, is intended to precisely and consistently provide for local drug delivery and limit the duration of polymer exposure. These characteristics potentially reduce the safety risks associated with currently commercially available drug-eluting stents.
Using an approved drug (sirolimus) and polymer (PLGA), Micell's patented supercritical fluid technology allows a rigorously controlled drug/polymer coating to be applied to a bare-metal stent. The MiStent SES leverages the benefits of a cobalt chromium coronary stent system, a state-of-the-art, thin-strut, bare-metal stent, which has demonstrated excellent deliverability, conformability and flexibility.
EU approval of MiStent SES was supported by clinical data from two studies, DESSOLVE I and II, which demonstrated superior in-stent late lumen loss rates and an excellent safety profile. Four-year data were presented in October 2015 at the 27th Annual Transcatheter Cardiovascular Therapeutics (TCT) Conference by Alexandra Lansky, M.D., Director, Yale Cardiovascular Clinical Research Program, Yale School of Medicine, New Haven, Conn. Highlights of the data include no target lesion events in the DESSOLVE I study and sustained clinical outcomes in both DESSOLVE I and II through four years' follow-up. There have been no probable or definite stent thromboses in either study. Importantly, MiStent SES continues to show a low combined target lesion revascularization (TLR) rate for DESSOLVE I and II of 2.7% at four years' follow-up, which is consistent with the previously demonstrated lack of late loss progression in the DESSOLVE I study.
About STENTYS
STENTYS is developing and commercializing innovative solutions for the treatment of patients with complex coronary artery disease. STENTYS' Self-Apposing® Stents are designed to adapt to vessels with ambiguous or fluctuating diameters in order to prevent the malapposition problems associated with conventional stents. The company's product portfolio includes MiStent SES®, a coronary DES with a new drug delivery mechanism that is designed to match vessel response. MiStent SES is marketed through STENTYS' commercial network in Europe, the Middle East, Asia and Latin America. More information is available at http://www.stentys.com.
Caution Regarding Forward-Looking Statements
This press release contains forward-looking statements that can be identified by the fact that they do not relate strictly to historical or current facts. Forward-looking statements include words such as "anticipates," "estimates," "expects," "projects," "intends," "plans," "believes" and words and terms of similar substance in connection with the results of a post-marketing clinical program and the commercialization and sale of the MiStent SES® in Europe and other markets. We caution readers that the forward-looking statements contained in this press release are predictions based on our current analysis of, and expectations about, future events and speak only as of the date of this press release. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, including, but not limited to, the following: the results of any further clinical trials and studies; our ability to obtain regulatory approval of the MiStent SES in other jurisdictions; the successful development and commercialization of the MiStent SES in Europe and other markets; the ability of the MiStent SES to effectively and successfully compete with current commercially available drug-eluting stent technologies in Europe and other markets; and our ability to maintain and protect our proprietary stent coating technology. Actual results, performance or achievements could differ materially and adversely from those expressed or implied by any forward-looking statement contained in this press release.
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