Stentys has announced that patient enrolment in its DESSOLVE III study has been completed. The 1,400-patient randomised clinical trial is comparing the MiStent sirolimus-eluting biodegradable polymer stent with the Xience everolimus-eluting, permanent polymer stent (Abbott Vascular).
A press release reports that the MiStent SES is a balloon-expandable stent that is designed to improve long-term clinical outcomes of patients treated with conventional “workhorse” stents (eg. Xience). It adds that MiStent’s unique crystalline sirolimus technology—in which thousands of microscopic drug crystals slowly dissolve in the surrounding tissue after absorption of the polymer carrier—allows for a gradual, linear and much longer elution of sirolimus than with other competitive stents, hence reducing vessel over-scarring. With 2% re-intervention rate (target lesion revascularisation) at three year follow-up in previous clinical trials, MiStent SES was shown to be superior to Xience in a retrospective propensity analysis (presented by Alexandra Lansky; Heart and Vascular Clinical Research Program, Yale University School of Medicine, New Haven, USA), during the 2015 EuroPCR conference.
Gonzague Issenmann, chief executive officer and co-founder of Stentys, says: “We are very pleased by the speed of enrolment of this landmark study comparing MiStent to the market leader, and by the feedback we received regarding MiStent’s acute performance. If DESSOLVE III results confirm previous trials’ findings, it could truly be game changing since drug-eluting stents all too often require a repeat intervention after several years.”