Ultrathin, Biodegradable Stents Safe, Effective
(HealthDay News) — Ultrathin strut, biodegradable polymer sirolimus-eluting stents are associated with a similar risk of target lesion failure to thin strut durable polymer everolimus-eluting stents, according to a study published online September 1 in The Lancet. These finding were published to coincide with the annual European Society of Cardiology Congress, held from August 30 to September 3 in Barcelona, Spain.
Thomas Pilgrim, MD, from the University Hospital in Bern, Switzerland, and colleagues randomly assigned (1:1) patients (aged ≥18 years) with chronic stable coronary artery disease or acute coronary syndromes undergoing percutaneous coronary intervention to treatment with either biodegradable polymer sirolimus-eluting stents (1,063 patients; 1,594 lesions) or durable polymer everolimus-eluting stents (1,056 patients, 1,545 lesions). Target lesion failure – a composite of cardiac death, target vessel myocardial infarction, and clinically-indicated target lesion revascularization at 12 months – was the primary end point.
The researchers found that target lesion failure with biodegradable polymer sirolimus-eluting stents (69 cases) was non-inferior to durable polymer everolimus-eluting stents (70 cases) at 12 months (P for non-inferiority < 0.0004). There were no significant differences in rates of definite stent thrombosis (rate ratio, 2.26; 95% confidence interval, 0.70–7.33; P=0.16). In patients with ST-segment elevation myocardial infarction, the biodegradable polymer sirolimus-eluting stents were associated with improved outcome versus the durable polymer everolimus-eluting stents (rate ratio, 0.38; 95% confidence interval, 0.16–0.91; P=0.024).
"In a patient population with minimum exclusion criteria and high adherence to dual antiplatelet therapy, biodegradable polymer sirolimus-eluting stents were non-inferior to durable polymer everolimus-eluting stents for the combined safety and efficacy outcome target lesion failure at 12 months," the authors write. "The noted benefit in the subgroup of patients with ST-segment elevation myocardial infarction needs further study."
Several authors disclosed financial ties to the pharmaceutical industry.