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DESSOLVE 1 and 2: New sirolimus-eluting stent safe, effective at 2 years
A novel sirolimus-eluting stent demonstrated safety and effectiveness at 2 years in patients with symptomatic ischemic heart disease, according to recent findings published in EuroIntervention.
The MiStent SES (Micell Technologies) includes a bioabsorbable coating for rapid polymer dissolution while still allowing continuous drug delivery. MiStent SES was evaluated in the DESSOLVE 1 and 2 trials.
“DESSOLVE 1 and 2 have revealed a good safety profile for the MiStent SES, with limited MACE events and no [stent thrombosis] reported up to 2 years,” the researchers wrote.
William Wijns, MD, PhD, of the Cardiovascular Research Center Aalst in Belgium, and colleagues gathered results from a first-in-human, single-arm trial (DESSOLVE 1) and a 2:1 randomized trial (DESSOLVE 2) comparing MiStent to a zotarolimus-eluting stent (Endeavor Sprint DES, Medtronic). The researchers enrolled 29 patients in the DESSOLVE 1 trial. In DESSOLVE 2, there were 120 patients in the MiStent group and 60 in the Endeavor Sprint group.
MiStent SES demonstrated a 2-year MACE rate of 3.4% in DESSOLVE 1, and no patients experienced target vessel failure or target lesion failure. In DESSOLVE 2, the 2-year MACE rate was 6.7% in the MiStent group vs. 13.3% in the Endeavor Sprint group (P = .167). TLF was 5% in both the MiStent and Endeavor Sprint groups (P = 1). TVF was 5% in the MiStent group vs. 11.7% in the Endeavor Spring group (P = .129).
Median duration of dual antiplatelet therapy was 364 days in DESSOLVE 1 and 366 days in DESSOLVE 2. No probable or definite stent thrombosis was reported with MiStent for up to 2 years, according to study results. There were no deaths reported over 2 years.
“Clinical follow-up at 2 years … shows good medium-term safety and effectiveness with low event rates, supporting clinical implementation,” the researchers wrote. “On the basis of these results, further evaluation in complex patient and lesion subsets is ongoing in the all-comers DESSOLVE III randomized trial.” – by Julia Ernst, MS
Disclosure: Wijns reports institutional grants from several device companies, including Medtronic and Micell Technologies. He is also co-founder, shareholder and non-executive board member of Argonauts Partners, Cardio3 BioSciences and Genae. Please see the full study for a list of all other authors’ relevant financial disclosures.