BIOSTEMI: 5-year data show superiority for biodegradable SES vs. durable EES
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Key takeaways:
- After STEMI, a biodegradable polymer sirolimus-eluting stent improved early- and long-term outcomes vs. an everolimus-eluting stent.
- The difference was driven by less target lesion revascularization with SES.
SAN FRANCISCO — A biodegradable polymer sirolimus-eluting stent remained superior to a durable polymer everolimus-eluting stent for treating STEMI at 5 years, a difference driven by lower rates of ischemia-driven repeat revascularizations.
Data from the BIOSTEMI Extended Survival study — the first head-to-head randomized controlled trial comparing two newer-generation drug-eluting stents with a superiority design — also demonstrated the absence of a “late catch-up phenomenon” with newer-generation biodegradable polymer DES in adults with STEMI, Juan F. Iglesias, MD, FESC, consultant cardiologist at Geneva University Hospitals, said during a presentation at TCT 2023.
“BIOSTEMI stands out in a field of noninferiority trials as the first head-to-head randomized trial with long-term follow-up that demonstrates significant differences in clinical outcomes between two contemporary DES in the treatment of patients with STEMI and the absence of a late catchup phenomenon with newer generation biodegradable polymer DES after complete degradation of the polymer coating,” Iglesias said during a press conference.
The 5-year BIOSTEMI data were simultaneously published in The Lancet.
As Healio previously reported, 1-year BIOSTEMI data demonstrated that the ultrathin-strut biodegradable polymer SES (Orsiro, Biotronik) was superior for prevention of TLF to the durable polymer EES (Xience Xpedition/Alpine, Abbott Vascular) in patients with acute STEMI undergoing primary PCI. Two-year data similarly showed the SES remained superior to the EES.
“By design, the biodegradable polymer of the sirolimus-eluting stent degrades within 2 years; therefore, these results do not reflect clinical outcomes that might occur after the complete degradation of the polymer coating and that could potentially offset the early clinical benefits,” Iglesias and colleagues wrote in The Lancet.
Among the 1,298 patients who completed 5-year follow-up (SES group: mean age, 62 years; 79% men; EES group: mean age, 63 years; 73% men), the primary composite endpoint of TLF occurred in 7.7% of the SES group and 11.1% of the EES group, for an RR of 0.7 (95% Bayesian credible interval [BCI], 0.51-0.95; Bayesian posterior probability for superiority, 0.988).
Rates of clinically indicated target lesion revascularization at 5 years were 3.1% for the SES group and 5.4% for the EES group, for an RR of 0.68 (95% BCI, 0.4-1.06; Bayesian posterior probability, 0.956). Rates of stent thrombosis at 5 years were low and did not differ between the two treatment groups throughout 5 years of follow-up, at 1.7% for the SES group and 2.6% for the EES group (HR = 0.65; 95% CI, 0.3-1.38; P = .26).
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, Iglesias said.
“Something we were expecting but actually was not demonstrated before was the safety of this device after polymer degradation,” Iglesias said during a Q&A session after the press conference.
Iglesias said particular features of the biodegradable polymer SES — he noted the combination of a good stent platform with thin struts, good geometry and polymer coating — could represent underlying causes of the differential clinical outcomes compared with durable polymer EES.
“However, in the current era of newer-generation DES, potent antithrombotic therapies and effective secondary preventive treatments, the differences in long-term, stent-related outcomes between newer-generation DES designs do not translate into significant differences in patient-oriented clinical outcomes at 5 years of follow-up ... despite a lower risk for revascularization,” Iglesias said.
Reference:
Perspective
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The 5-year BIOSTEMI results suggest that there are differences in the stent design that markedly impact outcomes. We need to see whether these findings expand to different patient populations, whether it’s a stent design that only benefits patients with STEMI or whether it can translate to patients with ACS and stable ischemic heart disease.
It was unexpected that the stent would perform that well and actually show a superiority signal. That is not the goal of most of these stent trials. If this can be demonstrated to be a better stent design in all-comers, this has the potential to change practice.
There may be a challenge for more data. Many people push back and call for larger-scale, randomized trials against other devices, for example, other DES and contemporary stents on the market. Particularly in the United States, this would need to undergo a larger-scale trial to confirm that the finding is really present.
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Iglesias JF, et al. Late-breaking clinical science session in structural heart disease: Session IV, in collaboration with the Journal of the American College of Cardiology. Presented at: TCT Scientific Symposium; Oct. 23-26, 2023; San Francisco (hybrid meeting).
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