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SES with bioabsorbable coating confers no stent thrombosis at 5 years
A novel sirolimus-eluting stent was linked with no occurrences of stent thrombosis at 5 years in patients with symptomatic ischemic heart disease, according to findings published in EuroIntervention.
The device was also associated with low rates of target lesion revascularization and met other safety and effectiveness endpoints at 5 years.
The MiStent SES (Micell Technologies), which includes a bioabsorbable coating for rapid polymer dissolution while allowing continuous drug delivery during and after dissolution to maintain therapeutic drug levels for up to 9 months, was evaluated in the DESSOLVE I1 and II2 trials.
“Permanent polymers on drug-eluting stents have been linked to late stent thrombosis and DES failure due to inciting an inflammatory response,” William Wijns, MD, PhD, from the Cardiovascular Research Center in Aalst, Belgium, and colleagues wrote. “Bioabsorbable poly-based DES were developed to address this limitation with results supporting their use as safe and efficacious alternatives to permanent polymer DES.”
Wijns and colleagues reported 5-year results of the first-in-human, single-arm DESSOLVE I trial and the 2:1 randomized DESSOLVE II trial. Outcomes of interest included MACE, target lesion failure, target vessel failure and stent thrombosis.
In the DESSOLVE I study, 10.3% of patients given the SES had a MACE event within 5 years without TLF.
In DESSOLVE II, 15.1% of those in the SES group had a 5-year MACE event vs. 22% of patients assigned a metallic DES (Endeavor Sprint, Medtronic; P = .295).
TLF at 5 years was 9.2% in the SES group vs. 8.5% in the metallic DES group (P = 1) and 5-year TVF was 10.1% in the SES group vs. 15.3% in the metallic DES group (P = .331).
At 5 years, the SES conferred low rates of TLR in both studies (DESSOLVE I, 0%; DESSOLVE II, 3.4%), and there were no instances of stent thrombosis reported in anyone given the SES in either study. The 5-year stent thrombosis rate for the metallic DES group in DESSOLVE II was 1.7%.
According to Wijns and colleagues, there are limitations to this study and further research is needed.
“Similar to other DES trials, investigators could not be blinded to study device and neither study was powered for clinical outcomes,” they wrote. “Larger trials including more complex patients/lesions along with real-world experience will provide additional information on the MiStent SES.” – by Dave Quaile
Disclosures: The studies were sponsored by Micell Technologies. Wijns reports receiving institutional grants from several device companies, including Medtronic and Micell Technologies, speaker fees from Abbott Vascular, Biotronik and Micro-Port and is the co-founder of Argonauts Partners. Please see the study for the other authors’ relevant financial disclosures.