Transforming medical devices for improved patient outcomes

DESSOLVE II Clinical Trial

DESSOLVE II is a randomized, multi-center study of 184 patients with documented stable or unstable angina pectoris or ischemia, de novo lesions in coronary arteries ranging in diameter from 2.5-3.5mm that were amenable to treatment with a maximum 30mm length stent. Patients were enrolled at 26 clinical sites in Europe and New Zealand.

The primary endpoint for the study was superiority of MiStent SES in minimizing in-stent late lumen loss at nine months, compared to Medtronic’s Endeavor® DES, as measured by an independent angiography core laboratory. Secondary endpoints, such as MACE, TLF, target vessel failure (TVF), and revascularization rates were assessed. The extent of stent coverage, via OCT and endothelial function (vasomotor response), were also evaluated in subgroups of patients at nine months.

Nine-month data confirmed that DESSOLVE II met all study objectives, demonstrated a competitive in-stent late lumen loss, and achieved a good signal for safety. Previously reported imaging studies have revealed high rates of initial healing after implantation of the MiStent SES with early stent strut coverage, with a minimal progression of neointimal hyperplasia through 18 months. Long-term follow-up on patients enrolled in this study continue and future data will be reported as available.

Four-year follow-up data continued to show encouraging results: MACE for MiStent SES of 13.3% vs. 20.3% in the Endeavor® DES (p=0.274), still no definite or probable ST in the MiStent SES arm vs. a 1.7% rate in Endeavor® DES (p=0.330), and TVF of 9.2% vs. 15.3% in Endeavor® DES (p=0.312).

The combined four-year DESSOLVE I and II CD-TLR rate is a low 2.7% with no probable or definite ST.  MiStent continues to show no late catch-up which is a probable contributor to MiStent’s low progression of TLR over long-term follow-up.

Principal Investigator:
William Wijns, M.D., Ph.D., Cardiovascular Center, Aalst, Belgium

More information on the DESSOLVE II trial can be found here.

Read the publications related to this study:

Bioabsorbable Polymer-Coated Sirolimus-Eluting Stent Implantation Preserves Coronary Vasomotion: A DESSOLVE II Trial Sub-study

Randomised Study of a Bioabsorbable Polymer-Coated Sirolimus-Eluting Stent: Results of the DESSOLVE II Trial

Evaluation of a crystalline sirolimus-eluting coronary stent with a bioabsorbable polymer designed for rapid dissolution: two-year outcomes from the DESSOLVE I and II trials

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