BIOSTEMI: Biodegradable SES remains superior to durable EES at 2 years
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A biodegradable polymer sirolimus-eluting stent remained superior to a durable polymer everolimus-eluting stent at 2 years, researchers reported.
As Healio previously reported, in the 1-year results of BIOSTEMI, the ultrathin-strut biodegradable polymer SES (Orsiro, Biotronik) was superior for prevention of target lesion failure to the durable polymer EES (Xience Xpedition/Alpine, Abbott Vascular) at 1 year in patients with acute STEMI undergoing primary PCI. Thomas Pilgrim, MD, MSc, associate professor of medicine at Inselspital, Bern University Hospital, University of Bern, Switzerland, presented the 2-year results, which were simultaneously published in JACC: Cardiovascular Interventions, at the virtual Cardiovascular Research Technologies meeting.
“Recent refinements of drug-eluting stents involve the reduction of strut thickness of the metallic stent platform and the use of biodegradable polymers as a carrier for the antiproliferative substance,” Pilgrim said during a presentation. “Improvements in stent design may mitigate arterial injury, facilitate endothelialization and reduce neointimal hyperplasia.”
Among the 1,221 patients who completed 2-year follow-up (SES group: mean age, 62 years; 79% men; EES group: mean age, 63 years; 73% men), TLF was lower in the SES group compared with the EES group (5.1% vs. 8.1%; RR = 0.58; 95% Bayesian credible interval, 0.4-0.84; posterior probability of superiority = 0.998), Pilgrim said during the presentation.
The difference was driven by rates of clinically indicated target lesion revascularization, which were 2.5% in the SES group and 5.1% in the EES group (RR = 0.52; 95% Bayesian credible interval, 0.3-0.87; posterior probability of superiority = 0.993), he said.
The primary analyses included historical data from the BIOSCIENCE trial, but the differences in TLF and clinically driven TLR remained after the historical data were excluded, Pilgrim said.
Landmark analyses showed the results did not vary by time, he said.
The groups did not differ at 2 years in death, cardiac death, MI, target vessel MI, repeat revascularization, a composite patient-oriented clinical outcomes endpoint or stent thrombosis, Pilgrim said.
“Of note, while there was a difference in composite device-oriented endpoints, there were no differences in patient-oriented clinical outcomes between the two treatment arms,” Pilgrim said.
In a related editorial published in JACC: Cardiovascular Interventions, Robert A. Byrne, MB BCh, PhD, director of cardiology at Mater Private Hospital, Dublin, chair of cardiovascular research at the RCSI University of Medicine and Health Sciences and head of the Cardiovascular Research Institute Dublin, and J.J. Coughlan, MB BCh, interventional research fellow at Deutsches Herzzentrum München, Technische Universität München, Munich, wrote: “These data are encouraging but should be interpreted in the context of previous large-scale trials comparing the biodegradable-polymer sirolimus-eluting stent with other frequently used contemporary DES. Expressed in Bayesian terms, it remains to be seen whether the present data are sufficient to update our a priori beliefs.”
References:
- Byrne RA, et al. JACC Cardiovasc Interv. 2021;doi:10.1016/j.jcin.2021.01.031.
- Pilgrim T, et al. JACC Cardiovasc Interv. 2021;doi:10.1016/j.jcin.2020.12.011.
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