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Efficacy of biodegradable polymer SES sustained out to 5 years
Results from a prospective postmarket surveillance study have offered evidence that a sirolimus-eluting stent with biodegradable polymer is safe and efficacious out to 5 years.
The multicenter CREATE study included prospectively enrolled patients (n=2,077) from four countries who were treated with biodegradable polymer-coated sirolimus-eluting stents (SES; Excel, JW Medical Systems). Five-year clinical follow-up was completed in 1,982 patients (95.4%).
Researchers reported the following adverse event rates at 5 years: cardiac death, 3%; non-fatal MI, 1.5%; target lesion revascularization, 3.7%; and overall MACE, 7.4%. The rate of definite or probable stent thrombosis at 5 years was 1.1%, whereas definite stent thrombosis from 1 to 5 years was 0.3%.
Independent predictors of stent thrombosis included HF (HR=3.324; 95% CI, 1.729-6.391) and prior MI (HR=2.664; 95% CI, 1.358-5.227). Patients had similar clinical outcomes with or without clopidogrel treatment after 6 months.
According to the researchers, drug-eluting stents with durable polymers are associated with significantly increased risks for TLR (7.5%-9.4%) and overall major adverse events (15.4%-24%) compared with early results; however, in this study, rates of TLR (3.7%) and of overall major adverse events of death, MI and TLR (10.4%) were maintained at 5-year follow-up.
“The above numeric differences in long-term clinical events between the present study and other DES studies imply there are potential benefits of biodegradable polymer-based DES in reducing late catch-up, which need further confirmation by randomized comparisons,” they wrote.
Disclosure: The researchers report no relevant financial disclosures.